Heather Boerner

The COVID-19 pandemic has overshadowed innovations in HIV care and prevention, says Tonia Poteat, PhD, MPH, PA-C, a primary HIV care and HIV pre-exposure prophylaxis (PrEP) clinician and associate professor of social medicine at the University of North Carolina at Chapel Hill. Therefore, even though the U.S. Food and Drug Administration approved monthly injections of cabotegravir/rilpivirine (Cabenuva) in January, none of her patients are taking it.

“We moved our clinic three times during the pandemic,” Dr. Poteat said. “I’m really interested in how on earth we’re going to integrate injectable products into our workflow. We don’t have systems set up yet, so we’re in the process of figuring out what the structure is going to be like. We have people who are interested on a wait list.”

Indeed, in an HIV world still reeling from the dual impact of HIV and COVID-19, the International AIDS Society Conference on HIV Science (IAS 2021) will bring a more coherent narrative on the future of HIV treatment and prevention. That narrative involves long-acting treatment and setting up the systems to make it available to everyone. And IAS offers data showing exactly how much people living with HIV risk poor COVID-19 outcomes.

The conference will be online for the second year in a row and, unlike in 2020, the focus will be much more on HIV treatment and prevention than on that other big infectious disease making news these days.

There will be new data on long-acting forms of prevention, such as the intravaginal ring and monthly PrEP pills. There will be new data on PrEP on demand (2-1-1 PrEP) and the results of a large trial looking at breakthrough HIV infections among those taking daily oral PrEP.

On the treatment side, trial results will be announced on cabotegravir/rilpivirine and islatravir long-acting treatment, as well as additional data on the effectiveness of two-drug antiretrovial therapy dolutegravir/lamivudine (Dovato) and bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy), specifically in Black participants.

On the cure front, intriguing animal studies and ex vivo studies look into the use of cancer immunotherapies for an HIV functional cure, as well as the use of CAR-T to stop HIV replication in the absence of daily medication.

Dr. Poteat is not alone in being interested specifically in the PrEP and long-acting studies. Jonathan Baker, a PA in private practice in New York City, also wants to see the data on the ring and other expanded PrEP options.

But “a prevention method can only work when people are able to use it,” he said. “So [the session] ‘Reducing Barriers to PrEP’ is really relevant as we see inequitable intake failing the populations who need PrEP most.”

This is a concern Dr. Poteat has too. That’s why she’s glad to see there will be sessions on systemic inequities, particularly around what it will take to address those inequities in the U.S. by 2030 in line with “Ending the HIV Epidemic: A Plan for America.” She’s looking forward to sessions on novel service-delivery models with low thresholds of entry for people experiencing homelessness or people who inject drugs; on access to affordable medications; on trans-led care for transgender women in the global South; and on the comorbidities of aging that are keeping her patients sick these days. 

To that end, there are sessions on common comorbidities with HIV, such as reinfection with hepatitis C, sexually transmitted infections, heart disease, and weight gain as a result of newer drug options, as well as drug-drug interactions between HIV medications and those used in gender-affirming care for transgender adults.

“I can count on one hand the number of people for whom the issue is finding the right antiretroviral,” she said. “That’s rarely the issue. The issue is often how do we manage their other comorbid conditions, and what about drug-drug interactions with those conditions? HIV is not the only condition many of them have.”

Mr. Baker reports that his clinic receives funding from Merck, Innovio, and Antiva. Dr. Poteat is a consultant for ViiV Healthcare and serves on a study advisory board for Merck.

A version of this article first appeared on Medscape.com.

The COVID-19 pandemic has overshadowed innovations in HIV care and prevention, says Tonia Poteat, PhD, MPH, PA-C, a primary HIV care and HIV pre-exposure prophylaxis (PrEP) clinician and associate professor of social medicine at the University of North Carolina at Chapel Hill. Therefore, even though the U.S. Food and Drug Administration approved monthly injections of cabotegravir/rilpivirine (Cabenuva) in January, none of her patients are taking it.

“We moved our clinic three times during the pandemic,” Dr. Poteat said. “I’m really interested in how on earth we’re going to integrate injectable products into our workflow. We don’t have systems set up yet, so we’re in the process of figuring out what the structure is going to be like. We have people who are interested on a wait list.”

Indeed, in an HIV world still reeling from the dual impact of HIV and COVID-19, the International AIDS Society Conference on HIV Science (IAS 2021) will bring a more coherent narrative on the future of HIV treatment and prevention. That narrative involves long-acting treatment and setting up the systems to make it available to everyone. And IAS offers data showing exactly how much people living with HIV risk poor COVID-19 outcomes.

The conference will be online for the second year in a row and, unlike in 2020, the focus will be much more on HIV treatment and prevention than on that other big infectious disease making news these days.

There will be new data on long-acting forms of prevention, such as the intravaginal ring and monthly PrEP pills. There will be new data on PrEP on demand (2-1-1 PrEP) and the results of a large trial looking at breakthrough HIV infections among those taking daily oral PrEP.

On the treatment side, trial results will be announced on cabotegravir/rilpivirine and islatravir long-acting treatment, as well as additional data on the effectiveness of two-drug antiretrovial therapy dolutegravir/lamivudine (Dovato) and bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy), specifically in Black participants.

On the cure front, intriguing animal studies and ex vivo studies look into the use of cancer immunotherapies for an HIV functional cure, as well as the use of CAR-T to stop HIV replication in the absence of daily medication.

Dr. Poteat is not alone in being interested specifically in the PrEP and long-acting studies. Jonathan Baker, a PA in private practice in New York City, also wants to see the data on the ring and other expanded PrEP options.

But “a prevention method can only work when people are able to use it,” he said. “So [the session] ‘Reducing Barriers to PrEP’ is really relevant as we see inequitable intake failing the populations who need PrEP most.”

This is a concern Dr. Poteat has too. That’s why she’s glad to see there will be sessions on systemic inequities, particularly around what it will take to address those inequities in the U.S. by 2030 in line with “Ending the HIV Epidemic: A Plan for America.” She’s looking forward to sessions on novel service-delivery models with low thresholds of entry for people experiencing homelessness or people who inject drugs; on access to affordable medications; on trans-led care for transgender women in the global South; and on the comorbidities of aging that are keeping her patients sick these days. 

To that end, there are sessions on common comorbidities with HIV, such as reinfection with hepatitis C, sexually transmitted infections, heart disease, and weight gain as a result of newer drug options, as well as drug-drug interactions between HIV medications and those used in gender-affirming care for transgender adults.

“I can count on one hand the number of people for whom the issue is finding the right antiretroviral,” she said. “That’s rarely the issue. The issue is often how do we manage their other comorbid conditions, and what about drug-drug interactions with those conditions? HIV is not the only condition many of them have.”

Mr. Baker reports that his clinic receives funding from Merck, Innovio, and Antiva. Dr. Poteat is a consultant for ViiV Healthcare and serves on a study advisory board for Merck.

A version of this article first appeared on Medscape.com.

The COVID-19 pandemic has overshadowed innovations in HIV care and prevention, says Tonia Poteat, PhD, MPH, PA-C, a primary HIV care and HIV pre-exposure prophylaxis (PrEP) clinician and associate professor of social medicine at the University of North Carolina at Chapel Hill. Therefore, even though the U.S. Food and Drug Administration approved monthly injections of cabotegravir/rilpivirine (Cabenuva) in January, none of her patients are taking it.

“We moved our clinic three times during the pandemic,” Dr. Poteat said. “I’m really interested in how on earth we’re going to integrate injectable products into our workflow. We don’t have systems set up yet, so we’re in the process of figuring out what the structure is going to be like. We have people who are interested on a wait list.”

Indeed, in an HIV world still reeling from the dual impact of HIV and COVID-19, the International AIDS Society Conference on HIV Science (IAS 2021) will bring a more coherent narrative on the future of HIV treatment and prevention. That narrative involves long-acting treatment and setting up the systems to make it available to everyone. And IAS offers data showing exactly how much people living with HIV risk poor COVID-19 outcomes.

The conference will be online for the second year in a row and, unlike in 2020, the focus will be much more on HIV treatment and prevention than on that other big infectious disease making news these days.

There will be new data on long-acting forms of prevention, such as the intravaginal ring and monthly PrEP pills. There will be new data on PrEP on demand (2-1-1 PrEP) and the results of a large trial looking at breakthrough HIV infections among those taking daily oral PrEP.

On the treatment side, trial results will be announced on cabotegravir/rilpivirine and islatravir long-acting treatment, as well as additional data on the effectiveness of two-drug antiretrovial therapy dolutegravir/lamivudine (Dovato) and bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy), specifically in Black participants.

On the cure front, intriguing animal studies and ex vivo studies look into the use of cancer immunotherapies for an HIV functional cure, as well as the use of CAR-T to stop HIV replication in the absence of daily medication.

Dr. Poteat is not alone in being interested specifically in the PrEP and long-acting studies. Jonathan Baker, a PA in private practice in New York City, also wants to see the data on the ring and other expanded PrEP options.

But “a prevention method can only work when people are able to use it,” he said. “So [the session] ‘Reducing Barriers to PrEP’ is really relevant as we see inequitable intake failing the populations who need PrEP most.”

This is a concern Dr. Poteat has too. That’s why she’s glad to see there will be sessions on systemic inequities, particularly around what it will take to address those inequities in the U.S. by 2030 in line with “Ending the HIV Epidemic: A Plan for America.” She’s looking forward to sessions on novel service-delivery models with low thresholds of entry for people experiencing homelessness or people who inject drugs; on access to affordable medications; on trans-led care for transgender women in the global South; and on the comorbidities of aging that are keeping her patients sick these days. 

To that end, there are sessions on common comorbidities with HIV, such as reinfection with hepatitis C, sexually transmitted infections, heart disease, and weight gain as a result of newer drug options, as well as drug-drug interactions between HIV medications and those used in gender-affirming care for transgender adults.

“I can count on one hand the number of people for whom the issue is finding the right antiretroviral,” she said. “That’s rarely the issue. The issue is often how do we manage their other comorbid conditions, and what about drug-drug interactions with those conditions? HIV is not the only condition many of them have.”

Mr. Baker reports that his clinic receives funding from Merck, Innovio, and Antiva. Dr. Poteat is a consultant for ViiV Healthcare and serves on a study advisory board for Merck.

A version of this article first appeared on Medscape.com.

A single pill of the investigational drug molnupiravir taken twice a day for 5 days eliminated SARS-CoV-2 from the nasopharynx of 49 participants.

That led Carlos del Rio, MD, distinguished professor of medicine at Emory University, Atlanta, to suggest a future in which a drug like molnupiravir could be taken in the first few days of symptoms to prevent severe disease, similar to Tamiflu for influenza.

“I think it’s critically important,” he said of the data. Emory University was involved in the trial of molnupiravir but Dr. del Rio was not part of that team. “This drug offers the first antiviral oral drug that then could be used in an outpatient setting.”

Still, Dr. del Rio said it’s too soon to call this particular drug the breakthrough clinicians need to keep people out of the ICU. “It has the potential to be practice changing; it’s not practice changing at the moment.”

Wendy Painter, MD, of Ridgeback Biotherapeutics, who presented the data at the Conference on Retroviruses and Opportunistic Infections, agreed. While the data are promising, “We will need to see if people get better from actual illness” to assess the real value of the drug in clinical care.

“That’s a phase 3 objective we’ll need to prove,” she said in an interview.

Phase 2/3 efficacy and safety studies of the drug are now underway in hospitalized and nonhospitalized patients.

In a brief prerecorded presentation of the data, Dr. Painter laid out what researchers know so far: Preclinical studies suggest that molnupiravir is effective against a number of viruses, including coronaviruses and specifically SARS-CoV-2. It prevents a virus from replicating by inducing viral error catastrophe (Proc Natl Acad Sci U S A. 2002 Oct 15;99[21]:13374-6) – essentially overloading the virus with replication and mutation until the virus burns itself out and can’t produce replicable copies.

In this phase 2a, randomized, double-blind, controlled trial, researchers recruited 202 adults who were treated at an outpatient clinic with fever or other symptoms of a respiratory virus and confirmed SARS-CoV-2 infection by day 4. Participants were randomly assigned to three different groups: 200 mg of molnupiravir, 400 mg, or 800 mg. The 200-mg arm was matched 1:1 with a placebo-controlled group, and the other two groups had three participants in the active group for every one control.

Participants took the pills twice daily for 5 days, and then were followed for a total of 28 days to monitor for complications or adverse events. At days 3, 5, 7, 14, and 28, researchers also took nasopharyngeal swabs for polymerase chain reaction tests, to sequence the virus, and to grow cultures of SARS-CoV-2 to see if the virus that’s present is actually capable of infecting others.

Notably, the pills do not have to be refrigerated at any point in the process, alleviating the cold-chain challenges that have plagued vaccines.

“There’s an urgent need for an easily produced, transported, stored, and administered antiviral drug against SARS-CoV-2,” Dr. Painter said.

Of the 202 people recruited, 182 had swabs that could be evaluated, of which 78 showed infection at baseline. The results are based on labs of those 78 participants.

By day 3, 28% of patients in the placebo arm had SARS-CoV-2 in their nasopharynx, compared with 20.4% of patients receiving any dose of molnupiravir. But by day 5, none of the participants receiving the active drug had evidence of SARS-CoV-2 in their nasopharynx. In comparison, 24% of people in the placebo arm still had detectable virus.

Halfway through the treatment course, differences in the presence of infectious virus were already evident. By day 3 of the 5-day course, 36.4% of participants in the 200-mg group had detectable virus in the nasopharynx, compared with 21% in the 400-mg group and just 12.5% in the 800-mg group. And although the reduction in SARS-CoV-2 was noticeable in the 200-mg and the 400-mg arms, it was only statistically significant in the 800-mg arm.

In contrast, by the end of the 5 days in the placebo groups, infectious virus varied from 18.2% in the 200-mg placebo group to 30% in the 800-mg group. This points out the variability of the disease course of SARS-CoV-2.

“You just don’t know” which infections will lead to serious disease, Dr. Painter said in an interview. “And don’t you wish we did?”

Seven participants discontinued treatment, though only four experienced adverse events. Three of those discontinued the trial because of adverse events. The study is still blinded, so it’s unclear what those events were, but Dr. Painter said that they were not thought to be related to the study drug.

The bottom line, said Dr. Painter, was that people treated with molnupiravir had starkly different outcomes in lab measures during the study.

“An average of 10 days after symptom onset, 24% of placebo patients remained culture positive” for SARS-CoV-2 – meaning there wasn’t just virus in the nasopharynx, but it was capable of replicating, Dr. Painter said. “In contrast, no infectious virus could be recovered at study day 5 in any molnupiravir-treated patients.”

A version of this article first appeared on Medscape.com.

A single pill of the investigational drug molnupiravir taken twice a day for 5 days eliminated SARS-CoV-2 from the nasopharynx of 49 participants.

That led Carlos del Rio, MD, distinguished professor of medicine at Emory University, Atlanta, to suggest a future in which a drug like molnupiravir could be taken in the first few days of symptoms to prevent severe disease, similar to Tamiflu for influenza.

“I think it’s critically important,” he said of the data. Emory University was involved in the trial of molnupiravir but Dr. del Rio was not part of that team. “This drug offers the first antiviral oral drug that then could be used in an outpatient setting.”

Still, Dr. del Rio said it’s too soon to call this particular drug the breakthrough clinicians need to keep people out of the ICU. “It has the potential to be practice changing; it’s not practice changing at the moment.”

Wendy Painter, MD, of Ridgeback Biotherapeutics, who presented the data at the Conference on Retroviruses and Opportunistic Infections, agreed. While the data are promising, “We will need to see if people get better from actual illness” to assess the real value of the drug in clinical care.

“That’s a phase 3 objective we’ll need to prove,” she said in an interview.

Phase 2/3 efficacy and safety studies of the drug are now underway in hospitalized and nonhospitalized patients.

In a brief prerecorded presentation of the data, Dr. Painter laid out what researchers know so far: Preclinical studies suggest that molnupiravir is effective against a number of viruses, including coronaviruses and specifically SARS-CoV-2. It prevents a virus from replicating by inducing viral error catastrophe (Proc Natl Acad Sci U S A. 2002 Oct 15;99[21]:13374-6) – essentially overloading the virus with replication and mutation until the virus burns itself out and can’t produce replicable copies.

In this phase 2a, randomized, double-blind, controlled trial, researchers recruited 202 adults who were treated at an outpatient clinic with fever or other symptoms of a respiratory virus and confirmed SARS-CoV-2 infection by day 4. Participants were randomly assigned to three different groups: 200 mg of molnupiravir, 400 mg, or 800 mg. The 200-mg arm was matched 1:1 with a placebo-controlled group, and the other two groups had three participants in the active group for every one control.

Participants took the pills twice daily for 5 days, and then were followed for a total of 28 days to monitor for complications or adverse events. At days 3, 5, 7, 14, and 28, researchers also took nasopharyngeal swabs for polymerase chain reaction tests, to sequence the virus, and to grow cultures of SARS-CoV-2 to see if the virus that’s present is actually capable of infecting others.

Notably, the pills do not have to be refrigerated at any point in the process, alleviating the cold-chain challenges that have plagued vaccines.

“There’s an urgent need for an easily produced, transported, stored, and administered antiviral drug against SARS-CoV-2,” Dr. Painter said.

Of the 202 people recruited, 182 had swabs that could be evaluated, of which 78 showed infection at baseline. The results are based on labs of those 78 participants.

By day 3, 28% of patients in the placebo arm had SARS-CoV-2 in their nasopharynx, compared with 20.4% of patients receiving any dose of molnupiravir. But by day 5, none of the participants receiving the active drug had evidence of SARS-CoV-2 in their nasopharynx. In comparison, 24% of people in the placebo arm still had detectable virus.

Halfway through the treatment course, differences in the presence of infectious virus were already evident. By day 3 of the 5-day course, 36.4% of participants in the 200-mg group had detectable virus in the nasopharynx, compared with 21% in the 400-mg group and just 12.5% in the 800-mg group. And although the reduction in SARS-CoV-2 was noticeable in the 200-mg and the 400-mg arms, it was only statistically significant in the 800-mg arm.

In contrast, by the end of the 5 days in the placebo groups, infectious virus varied from 18.2% in the 200-mg placebo group to 30% in the 800-mg group. This points out the variability of the disease course of SARS-CoV-2.

“You just don’t know” which infections will lead to serious disease, Dr. Painter said in an interview. “And don’t you wish we did?”

Seven participants discontinued treatment, though only four experienced adverse events. Three of those discontinued the trial because of adverse events. The study is still blinded, so it’s unclear what those events were, but Dr. Painter said that they were not thought to be related to the study drug.

The bottom line, said Dr. Painter, was that people treated with molnupiravir had starkly different outcomes in lab measures during the study.

“An average of 10 days after symptom onset, 24% of placebo patients remained culture positive” for SARS-CoV-2 – meaning there wasn’t just virus in the nasopharynx, but it was capable of replicating, Dr. Painter said. “In contrast, no infectious virus could be recovered at study day 5 in any molnupiravir-treated patients.”

A version of this article first appeared on Medscape.com.

A single pill of the investigational drug molnupiravir taken twice a day for 5 days eliminated SARS-CoV-2 from the nasopharynx of 49 participants.

That led Carlos del Rio, MD, distinguished professor of medicine at Emory University, Atlanta, to suggest a future in which a drug like molnupiravir could be taken in the first few days of symptoms to prevent severe disease, similar to Tamiflu for influenza.

“I think it’s critically important,” he said of the data. Emory University was involved in the trial of molnupiravir but Dr. del Rio was not part of that team. “This drug offers the first antiviral oral drug that then could be used in an outpatient setting.”

Still, Dr. del Rio said it’s too soon to call this particular drug the breakthrough clinicians need to keep people out of the ICU. “It has the potential to be practice changing; it’s not practice changing at the moment.”

Wendy Painter, MD, of Ridgeback Biotherapeutics, who presented the data at the Conference on Retroviruses and Opportunistic Infections, agreed. While the data are promising, “We will need to see if people get better from actual illness” to assess the real value of the drug in clinical care.

“That’s a phase 3 objective we’ll need to prove,” she said in an interview.

Phase 2/3 efficacy and safety studies of the drug are now underway in hospitalized and nonhospitalized patients.

In a brief prerecorded presentation of the data, Dr. Painter laid out what researchers know so far: Preclinical studies suggest that molnupiravir is effective against a number of viruses, including coronaviruses and specifically SARS-CoV-2. It prevents a virus from replicating by inducing viral error catastrophe (Proc Natl Acad Sci U S A. 2002 Oct 15;99[21]:13374-6) – essentially overloading the virus with replication and mutation until the virus burns itself out and can’t produce replicable copies.

In this phase 2a, randomized, double-blind, controlled trial, researchers recruited 202 adults who were treated at an outpatient clinic with fever or other symptoms of a respiratory virus and confirmed SARS-CoV-2 infection by day 4. Participants were randomly assigned to three different groups: 200 mg of molnupiravir, 400 mg, or 800 mg. The 200-mg arm was matched 1:1 with a placebo-controlled group, and the other two groups had three participants in the active group for every one control.

Participants took the pills twice daily for 5 days, and then were followed for a total of 28 days to monitor for complications or adverse events. At days 3, 5, 7, 14, and 28, researchers also took nasopharyngeal swabs for polymerase chain reaction tests, to sequence the virus, and to grow cultures of SARS-CoV-2 to see if the virus that’s present is actually capable of infecting others.

Notably, the pills do not have to be refrigerated at any point in the process, alleviating the cold-chain challenges that have plagued vaccines.

“There’s an urgent need for an easily produced, transported, stored, and administered antiviral drug against SARS-CoV-2,” Dr. Painter said.

Of the 202 people recruited, 182 had swabs that could be evaluated, of which 78 showed infection at baseline. The results are based on labs of those 78 participants.

By day 3, 28% of patients in the placebo arm had SARS-CoV-2 in their nasopharynx, compared with 20.4% of patients receiving any dose of molnupiravir. But by day 5, none of the participants receiving the active drug had evidence of SARS-CoV-2 in their nasopharynx. In comparison, 24% of people in the placebo arm still had detectable virus.

Halfway through the treatment course, differences in the presence of infectious virus were already evident. By day 3 of the 5-day course, 36.4% of participants in the 200-mg group had detectable virus in the nasopharynx, compared with 21% in the 400-mg group and just 12.5% in the 800-mg group. And although the reduction in SARS-CoV-2 was noticeable in the 200-mg and the 400-mg arms, it was only statistically significant in the 800-mg arm.

In contrast, by the end of the 5 days in the placebo groups, infectious virus varied from 18.2% in the 200-mg placebo group to 30% in the 800-mg group. This points out the variability of the disease course of SARS-CoV-2.

“You just don’t know” which infections will lead to serious disease, Dr. Painter said in an interview. “And don’t you wish we did?”

Seven participants discontinued treatment, though only four experienced adverse events. Three of those discontinued the trial because of adverse events. The study is still blinded, so it’s unclear what those events were, but Dr. Painter said that they were not thought to be related to the study drug.

The bottom line, said Dr. Painter, was that people treated with molnupiravir had starkly different outcomes in lab measures during the study.

“An average of 10 days after symptom onset, 24% of placebo patients remained culture positive” for SARS-CoV-2 – meaning there wasn’t just virus in the nasopharynx, but it was capable of replicating, Dr. Painter said. “In contrast, no infectious virus could be recovered at study day 5 in any molnupiravir-treated patients.”

A version of this article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

"The writing is on the wall” that virtual care is not meeting the needs of people with HIV who struggled with viral suppression even before the COVID-19 pandemic, said Jason Farley, PhD, ANP-BC, AACRN, associate professor of nursing at Johns Hopkins University, Baltimore. So it’s time for HIV care teams, especially clinics in the Ryan White HIV/AIDS Program, to get creative in bringing wraparound services to patients.

That may mean reallocating the workforce so that one person serves as a community health worker. Or it could mean increasing texts and video calls; helping patients find online support groups to address problems with alcohol or drug use; and conducting an overall assessment of patients’ needs as the pandemic continues.

“The virtual patient-centered medical home may be the new normal after COVID-19, and we have to be thinking about how we use this model with patients for whom it works, but supplement this model in patients that it does not,” Farley said at the virtual Association of Nurses in AIDS Care (ANAC) 2020 Annual Meeting. That work “is essential to our being able to facilitate the best patient outcomes possible.”
 

Early data, tiered interventions

Farley referred to an article published in September in the Journal AIDS that confirmed unpublished data mentioned at the International AIDS Conference 2020. The article reported that viral suppression rates among people with HIV who attended San Francisco’s Ward 86 HIV clinic dropped by 31% from pre-COVID levels.

Of the 1766 people who attended the clinic, about 1 in 5 had detectable HIV viral loads at any point in 2019. But that rate was 31% higher after shelter-in-place orders were issued. And although patients participated in telemedicine visits at more or less the same rate before and after the pandemic (31% vs. 30% no-shows), viral suppression rates dropped. The impact was especially acute for homeless individuals.

“This destabilization occurred despite our population attending telemedicine visits at a higher rate than expected, given the 60% drop in ambulatory care visit volume nationwide,” the authors stated in their article. “Telehealth visits, while offering greater patient convenience, may lead to less access to clinic-based social support services essential to achieving viral suppression among vulnerable groups.”

That’s the challenge HIV clinics now face, Farley said at the ANAC meeting.

He suggested a differentiated care approach in which there are four tiers of care, starting with the standard level of outreach, which may include email, electronic health record blasts, and robo-calls to remind people of their appointments and to refill their medications. Those with sustained viral suppression may only need 90-day automatic refills of their medications. Those who are vulnerable to nonadherence may need to be contacted weekly or more often by the clinic. Such contact could be made by a social worker, a community health worker, or through some form of virtual support.

Patients at tier 4, who have labile viral suppression, need far more than that. These are the 15% of patients with HIV who struggled with viral suppression before the pandemic. They are the patients that Farley’s team focuses on at Baltimore’s John G. Bartlett Specialty Clinic for Infectious Disease.

“We’ve completely deconstructed the patient-centered medical home,” he said of the early move to virtual care. He suggested that clinicians assess their services and ask themselves some questions:

• Has someone on the team reached out to every patient and checked in to see what their biggest needs are, medical or not, during the pandemic? Have they assessed the patient’s ability to receive video calls or text messages?
• How have group-support programs that address stigma or the social determinants of health fared in the transition to virtual medicine?
• Are patients who are in recovery being supported in order that they may engage with recovery programs online?
• How well have counseling services done in engaging people in virtual care? Currently, given the overall increase in mental health challenges during the pandemic, one would expect that the use of mental health counseling is increasing. “If they’re stagnant or going down, someone needs to be reflecting on that issue internally in the clinic,” he said.
• Are patients being contacted regarding the effects that isolation is having on their lives? “The things that would normally allow us to self-mitigate and self-manage these conditions, like going to the gym, meeting with friends, religious services – all of those are being cut,” he said.
• Is there an early alert from an in-person pharmacy to trigger outreach via a community health worker for patients who haven’t picked up their medications in a week or more?

Farley pointed to a 2015 model for an enhanced e-health approach to chronic care management that called for e-support from the community and that was enhanced through virtual communities.

These are some of the approaches Farley has taken at his clinic. He leads a team that focuses specifically on patients who struggled with engagement before the pandemic. Through a grant from the US Department of Health & Human Services’ Health Resources and Services Administration – even before the pandemic – that team has been funding community health workers who have multiple contacts with patients online and virtually and are able to offer what he calls “unapologetically enabling” support for patients so that they are able to focus on their health.

He gave the following example. Before the pandemic, a community health worker on the team had been working with a patient who showed up at every scheduled visit and swore that she was taking her medications, although clearly she was not. A community health worker, who was made available through the grant, was able to recognize that the patient’s biggest challenge in her life was providing childcare for her special-needs child. The community health worker worked with the patient for months to find stable childcare for the child, paid 2 months of rent for the patient so that she would not become homeless, and helped her find transitional housing. When the pandemic hit, the community health worker was already texting and conducting video calls with the patient regularly.

For the past 9 months, that patient has had an undetectable viral load, Farley said.

“Nine months during a pandemic,” Farley reiterated, “and the community health worker keeps working with her, keeps meeting with her.”
 

Stigma on stigma

The need for this level of support from the clinic may be even more important for people with HIV who acquire COVID-19, said Orlando Harris, PhD, assistant professor of community health systems at the University of California, San Francisco, (UCSF) School of Nursing. HIV-related stigma is a well-known deterrent to care for people living with the virus. During the presentation, Harris asked Farley about the impact of COVID-19 stigma on people with both HIV and COVID-19.

Farley said that patients at his clinic have told him that they have “ostracized” friends who have tested positive for COVID-19. Harris remembered a person with HIV who participated in one of his trials telling the researchers that despite all his precautions – wearing a mask, staying socially distant – he still acquired COVID-19. There was nothing he could have done, Harris said, other than just not go to the grocery store.

The fear of contracting another disease that is associated with stigma, as well as the need to disclose it, can inflame memories of the trauma of being diagnosed with HIV, Harris said. And with patient-centered medical homes struggling to reconstitute their wraparound services via telehealth, he said he wonders whether clinicians should be doing more.

“I worry about people who have survived being diagnosed with HIV in the ‘80s and the ‘90s before antiretroviral therapy showed up on the scene,” he told Medscape Medical News. “I worry that the folks that survived one pandemic [may] be feeling fearful or living in that fear that this new pandemic might take them out. That’s why I’m stressing the need for us to really consider, as clinicians and also as researchers the support systems, the coping mechanisms, the counseling, or what have you to support those living with HIV and vulnerable to COVID-19.”

During telehealth visits, that can be achieved simply by asking people how they are really doing and what their coping mechanisms are.

For their part, the clinicians at San Francisco’s Ward 86 are not trying to provide that support through telehealth on the same level as they were at the beginning of the pandemic, said Matthew Spinelli, MD, assistant professor of medicine, and Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases and Global Medicine, who are both at UCSF and are coauthors of the study.

They still offer telemedicine appointments to patients who request them, said Spinelli. He said about one-third of his patients still prefer to receive their care virtually. The rest have gone back to face-to-face support.

“The analysis led us to promptly open up care as much as possible to our patients, with the idea that telehealth is not cutting it for vulnerable patients with HIV,” Gandhi told Medscape Medical News via email. “We don’t think it’s right for a population who relies on social support from the clinic.”
 

This article first appeared on Medscape.com.

"The writing is on the wall” that virtual care is not meeting the needs of people with HIV who struggled with viral suppression even before the COVID-19 pandemic, said Jason Farley, PhD, ANP-BC, AACRN, associate professor of nursing at Johns Hopkins University, Baltimore. So it’s time for HIV care teams, especially clinics in the Ryan White HIV/AIDS Program, to get creative in bringing wraparound services to patients.

That may mean reallocating the workforce so that one person serves as a community health worker. Or it could mean increasing texts and video calls; helping patients find online support groups to address problems with alcohol or drug use; and conducting an overall assessment of patients’ needs as the pandemic continues.

“The virtual patient-centered medical home may be the new normal after COVID-19, and we have to be thinking about how we use this model with patients for whom it works, but supplement this model in patients that it does not,” Farley said at the virtual Association of Nurses in AIDS Care (ANAC) 2020 Annual Meeting. That work “is essential to our being able to facilitate the best patient outcomes possible.”
 

Early data, tiered interventions

Farley referred to an article published in September in the Journal AIDS that confirmed unpublished data mentioned at the International AIDS Conference 2020. The article reported that viral suppression rates among people with HIV who attended San Francisco’s Ward 86 HIV clinic dropped by 31% from pre-COVID levels.

Of the 1766 people who attended the clinic, about 1 in 5 had detectable HIV viral loads at any point in 2019. But that rate was 31% higher after shelter-in-place orders were issued. And although patients participated in telemedicine visits at more or less the same rate before and after the pandemic (31% vs. 30% no-shows), viral suppression rates dropped. The impact was especially acute for homeless individuals.

“This destabilization occurred despite our population attending telemedicine visits at a higher rate than expected, given the 60% drop in ambulatory care visit volume nationwide,” the authors stated in their article. “Telehealth visits, while offering greater patient convenience, may lead to less access to clinic-based social support services essential to achieving viral suppression among vulnerable groups.”

That’s the challenge HIV clinics now face, Farley said at the ANAC meeting.

He suggested a differentiated care approach in which there are four tiers of care, starting with the standard level of outreach, which may include email, electronic health record blasts, and robo-calls to remind people of their appointments and to refill their medications. Those with sustained viral suppression may only need 90-day automatic refills of their medications. Those who are vulnerable to nonadherence may need to be contacted weekly or more often by the clinic. Such contact could be made by a social worker, a community health worker, or through some form of virtual support.

Patients at tier 4, who have labile viral suppression, need far more than that. These are the 15% of patients with HIV who struggled with viral suppression before the pandemic. They are the patients that Farley’s team focuses on at Baltimore’s John G. Bartlett Specialty Clinic for Infectious Disease.

“We’ve completely deconstructed the patient-centered medical home,” he said of the early move to virtual care. He suggested that clinicians assess their services and ask themselves some questions:

• Has someone on the team reached out to every patient and checked in to see what their biggest needs are, medical or not, during the pandemic? Have they assessed the patient’s ability to receive video calls or text messages?
• How have group-support programs that address stigma or the social determinants of health fared in the transition to virtual medicine?
• Are patients who are in recovery being supported in order that they may engage with recovery programs online?
• How well have counseling services done in engaging people in virtual care? Currently, given the overall increase in mental health challenges during the pandemic, one would expect that the use of mental health counseling is increasing. “If they’re stagnant or going down, someone needs to be reflecting on that issue internally in the clinic,” he said.
• Are patients being contacted regarding the effects that isolation is having on their lives? “The things that would normally allow us to self-mitigate and self-manage these conditions, like going to the gym, meeting with friends, religious services – all of those are being cut,” he said.
• Is there an early alert from an in-person pharmacy to trigger outreach via a community health worker for patients who haven’t picked up their medications in a week or more?

Farley pointed to a 2015 model for an enhanced e-health approach to chronic care management that called for e-support from the community and that was enhanced through virtual communities.

These are some of the approaches Farley has taken at his clinic. He leads a team that focuses specifically on patients who struggled with engagement before the pandemic. Through a grant from the US Department of Health & Human Services’ Health Resources and Services Administration – even before the pandemic – that team has been funding community health workers who have multiple contacts with patients online and virtually and are able to offer what he calls “unapologetically enabling” support for patients so that they are able to focus on their health.

He gave the following example. Before the pandemic, a community health worker on the team had been working with a patient who showed up at every scheduled visit and swore that she was taking her medications, although clearly she was not. A community health worker, who was made available through the grant, was able to recognize that the patient’s biggest challenge in her life was providing childcare for her special-needs child. The community health worker worked with the patient for months to find stable childcare for the child, paid 2 months of rent for the patient so that she would not become homeless, and helped her find transitional housing. When the pandemic hit, the community health worker was already texting and conducting video calls with the patient regularly.

For the past 9 months, that patient has had an undetectable viral load, Farley said.

“Nine months during a pandemic,” Farley reiterated, “and the community health worker keeps working with her, keeps meeting with her.”
 

Stigma on stigma

The need for this level of support from the clinic may be even more important for people with HIV who acquire COVID-19, said Orlando Harris, PhD, assistant professor of community health systems at the University of California, San Francisco, (UCSF) School of Nursing. HIV-related stigma is a well-known deterrent to care for people living with the virus. During the presentation, Harris asked Farley about the impact of COVID-19 stigma on people with both HIV and COVID-19.

Farley said that patients at his clinic have told him that they have “ostracized” friends who have tested positive for COVID-19. Harris remembered a person with HIV who participated in one of his trials telling the researchers that despite all his precautions – wearing a mask, staying socially distant – he still acquired COVID-19. There was nothing he could have done, Harris said, other than just not go to the grocery store.

The fear of contracting another disease that is associated with stigma, as well as the need to disclose it, can inflame memories of the trauma of being diagnosed with HIV, Harris said. And with patient-centered medical homes struggling to reconstitute their wraparound services via telehealth, he said he wonders whether clinicians should be doing more.

“I worry about people who have survived being diagnosed with HIV in the ‘80s and the ‘90s before antiretroviral therapy showed up on the scene,” he told Medscape Medical News. “I worry that the folks that survived one pandemic [may] be feeling fearful or living in that fear that this new pandemic might take them out. That’s why I’m stressing the need for us to really consider, as clinicians and also as researchers the support systems, the coping mechanisms, the counseling, or what have you to support those living with HIV and vulnerable to COVID-19.”

During telehealth visits, that can be achieved simply by asking people how they are really doing and what their coping mechanisms are.

For their part, the clinicians at San Francisco’s Ward 86 are not trying to provide that support through telehealth on the same level as they were at the beginning of the pandemic, said Matthew Spinelli, MD, assistant professor of medicine, and Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases and Global Medicine, who are both at UCSF and are coauthors of the study.

They still offer telemedicine appointments to patients who request them, said Spinelli. He said about one-third of his patients still prefer to receive their care virtually. The rest have gone back to face-to-face support.

“The analysis led us to promptly open up care as much as possible to our patients, with the idea that telehealth is not cutting it for vulnerable patients with HIV,” Gandhi told Medscape Medical News via email. “We don’t think it’s right for a population who relies on social support from the clinic.”
 

This article first appeared on Medscape.com.

"The writing is on the wall” that virtual care is not meeting the needs of people with HIV who struggled with viral suppression even before the COVID-19 pandemic, said Jason Farley, PhD, ANP-BC, AACRN, associate professor of nursing at Johns Hopkins University, Baltimore. So it’s time for HIV care teams, especially clinics in the Ryan White HIV/AIDS Program, to get creative in bringing wraparound services to patients.

That may mean reallocating the workforce so that one person serves as a community health worker. Or it could mean increasing texts and video calls; helping patients find online support groups to address problems with alcohol or drug use; and conducting an overall assessment of patients’ needs as the pandemic continues.

“The virtual patient-centered medical home may be the new normal after COVID-19, and we have to be thinking about how we use this model with patients for whom it works, but supplement this model in patients that it does not,” Farley said at the virtual Association of Nurses in AIDS Care (ANAC) 2020 Annual Meeting. That work “is essential to our being able to facilitate the best patient outcomes possible.”
 

Early data, tiered interventions

Farley referred to an article published in September in the Journal AIDS that confirmed unpublished data mentioned at the International AIDS Conference 2020. The article reported that viral suppression rates among people with HIV who attended San Francisco’s Ward 86 HIV clinic dropped by 31% from pre-COVID levels.

Of the 1766 people who attended the clinic, about 1 in 5 had detectable HIV viral loads at any point in 2019. But that rate was 31% higher after shelter-in-place orders were issued. And although patients participated in telemedicine visits at more or less the same rate before and after the pandemic (31% vs. 30% no-shows), viral suppression rates dropped. The impact was especially acute for homeless individuals.

“This destabilization occurred despite our population attending telemedicine visits at a higher rate than expected, given the 60% drop in ambulatory care visit volume nationwide,” the authors stated in their article. “Telehealth visits, while offering greater patient convenience, may lead to less access to clinic-based social support services essential to achieving viral suppression among vulnerable groups.”

That’s the challenge HIV clinics now face, Farley said at the ANAC meeting.

He suggested a differentiated care approach in which there are four tiers of care, starting with the standard level of outreach, which may include email, electronic health record blasts, and robo-calls to remind people of their appointments and to refill their medications. Those with sustained viral suppression may only need 90-day automatic refills of their medications. Those who are vulnerable to nonadherence may need to be contacted weekly or more often by the clinic. Such contact could be made by a social worker, a community health worker, or through some form of virtual support.

Patients at tier 4, who have labile viral suppression, need far more than that. These are the 15% of patients with HIV who struggled with viral suppression before the pandemic. They are the patients that Farley’s team focuses on at Baltimore’s John G. Bartlett Specialty Clinic for Infectious Disease.

“We’ve completely deconstructed the patient-centered medical home,” he said of the early move to virtual care. He suggested that clinicians assess their services and ask themselves some questions:

• Has someone on the team reached out to every patient and checked in to see what their biggest needs are, medical or not, during the pandemic? Have they assessed the patient’s ability to receive video calls or text messages?
• How have group-support programs that address stigma or the social determinants of health fared in the transition to virtual medicine?
• Are patients who are in recovery being supported in order that they may engage with recovery programs online?
• How well have counseling services done in engaging people in virtual care? Currently, given the overall increase in mental health challenges during the pandemic, one would expect that the use of mental health counseling is increasing. “If they’re stagnant or going down, someone needs to be reflecting on that issue internally in the clinic,” he said.
• Are patients being contacted regarding the effects that isolation is having on their lives? “The things that would normally allow us to self-mitigate and self-manage these conditions, like going to the gym, meeting with friends, religious services – all of those are being cut,” he said.
• Is there an early alert from an in-person pharmacy to trigger outreach via a community health worker for patients who haven’t picked up their medications in a week or more?

Farley pointed to a 2015 model for an enhanced e-health approach to chronic care management that called for e-support from the community and that was enhanced through virtual communities.

These are some of the approaches Farley has taken at his clinic. He leads a team that focuses specifically on patients who struggled with engagement before the pandemic. Through a grant from the US Department of Health & Human Services’ Health Resources and Services Administration – even before the pandemic – that team has been funding community health workers who have multiple contacts with patients online and virtually and are able to offer what he calls “unapologetically enabling” support for patients so that they are able to focus on their health.

He gave the following example. Before the pandemic, a community health worker on the team had been working with a patient who showed up at every scheduled visit and swore that she was taking her medications, although clearly she was not. A community health worker, who was made available through the grant, was able to recognize that the patient’s biggest challenge in her life was providing childcare for her special-needs child. The community health worker worked with the patient for months to find stable childcare for the child, paid 2 months of rent for the patient so that she would not become homeless, and helped her find transitional housing. When the pandemic hit, the community health worker was already texting and conducting video calls with the patient regularly.

For the past 9 months, that patient has had an undetectable viral load, Farley said.

“Nine months during a pandemic,” Farley reiterated, “and the community health worker keeps working with her, keeps meeting with her.”
 

Stigma on stigma

The need for this level of support from the clinic may be even more important for people with HIV who acquire COVID-19, said Orlando Harris, PhD, assistant professor of community health systems at the University of California, San Francisco, (UCSF) School of Nursing. HIV-related stigma is a well-known deterrent to care for people living with the virus. During the presentation, Harris asked Farley about the impact of COVID-19 stigma on people with both HIV and COVID-19.

Farley said that patients at his clinic have told him that they have “ostracized” friends who have tested positive for COVID-19. Harris remembered a person with HIV who participated in one of his trials telling the researchers that despite all his precautions – wearing a mask, staying socially distant – he still acquired COVID-19. There was nothing he could have done, Harris said, other than just not go to the grocery store.

The fear of contracting another disease that is associated with stigma, as well as the need to disclose it, can inflame memories of the trauma of being diagnosed with HIV, Harris said. And with patient-centered medical homes struggling to reconstitute their wraparound services via telehealth, he said he wonders whether clinicians should be doing more.

“I worry about people who have survived being diagnosed with HIV in the ‘80s and the ‘90s before antiretroviral therapy showed up on the scene,” he told Medscape Medical News. “I worry that the folks that survived one pandemic [may] be feeling fearful or living in that fear that this new pandemic might take them out. That’s why I’m stressing the need for us to really consider, as clinicians and also as researchers the support systems, the coping mechanisms, the counseling, or what have you to support those living with HIV and vulnerable to COVID-19.”

During telehealth visits, that can be achieved simply by asking people how they are really doing and what their coping mechanisms are.

For their part, the clinicians at San Francisco’s Ward 86 are not trying to provide that support through telehealth on the same level as they were at the beginning of the pandemic, said Matthew Spinelli, MD, assistant professor of medicine, and Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases and Global Medicine, who are both at UCSF and are coauthors of the study.

They still offer telemedicine appointments to patients who request them, said Spinelli. He said about one-third of his patients still prefer to receive their care virtually. The rest have gone back to face-to-face support.

“The analysis led us to promptly open up care as much as possible to our patients, with the idea that telehealth is not cutting it for vulnerable patients with HIV,” Gandhi told Medscape Medical News via email. “We don’t think it’s right for a population who relies on social support from the clinic.”
 

This article first appeared on Medscape.com.

When people were offered preexposure prophylaxis (PrEP) outside of traditional clinics, regardless of specific risk factors, as part of the Sustainable East Africa Research in Community Health (SEARCH) study, new HIV acquisitions dropped by 74%.

It’s a valuable lesson to providers around the world, said Catherine Koss, MD, assistant professor of medicine in HIV, infectious disease, and global medicine at the University of California, San Francisco.

“We haven’t really seen PrEP being scaled up and offered at such a broad level in communities,” Koss said during the International AIDS Conference 2020. “Offering PrEP in a way that’s more universal and with a low barrier to both men and women can result in reductions in incidence.”

The first part of SEARCH, which looked at the impact of universal testing and access to HIV treatment immediately after diagnosis, showed that the strategy resulted in a population-wide 30% reduction in new HIV acquisitions. In other words, treatment alone wasn’t enough to end the HIV epidemic.

But the researchers always knew “there were likely going to be new HIV infections,” even with universal HIV testing and treatment, Koss said.

So the second part of the study was designed to see whether PrEP — with the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) — could further reduce rates of HIV acquisition.
 

PrEP out in the community

During the PrEP part of the SEARCH study, researchers discussed HIV risk with adults in 16 communities in rural Kenya and Uganda during population-level testing that took place at health fairs, beaches, trading centers, other community sites, and even in participants’ homes. PrEP was offered to anyone in a relationship with someone living with HIV, to anyone determined to be at elevated risk for infection by a previously validated algorithm, and to anyone who did not fit those criteria but who wanted a prescription.

Of the 15,632 adults eligible for PrEP, 5,447 (35%) chose to start the HIV prevention pill.

A rapid-enrollment protocol meant that people received their prescription at the time of screening or soon after that. Participants underwent testing for HIV antibodies — also out in the community — at weeks 4 and 12, and every 12 weeks thereafter; this will continue out to week 144.

HIV-negative adults who were part of the larger SEARCH cohort in the year before PrEP was made available — and from the same communities — served as the control group.

Interim 60-week data show that the rate of acquisition was 74% lower in the PrEP group than in the control group (incidence rate ratio, 0.26; P = .01). In women, the acquisition rate was 76% lower (incidence rate ratio, 0.24; P = .04), and in men, it was 40% lower (incidence rate ratio, 0.60; P = .54).

The reduction was not significant for men, probably because so few men acquired HIV, Koss reported. The powerful drop in new HIV cases overall was related to PrEP use by women; cases in women fell from 1.52 to 0.40 per 100 person-years.

Blood tests showed that 72% of the people who acquired HIV during the study period had not taken a PrEP pill for at least 30 days before their diagnosis.

“Making PrEP more easily accessible and more community-based could be very powerful in the United States,” said Koss.

“Allowing people to test for HIV and start PrEP outside of health clinics or standard health facilities could help reach more people,” she told Medscape Medical News. “Many of the people who benefit from PrEP may not otherwise need to seek medical care regularly if they’re otherwise healthy and often young.”

When PrEP is made available — easily available —  people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV.

The findings were hailed by others in the field of HIV prevention.

“They’re fantastic,” said Jared Baeten, MD, vice dean of the School of Public Health and professor of global health, medicine, and epidemiology at the University of Washington in Seattle. He was involved in Partners PrEP, a study of PrEP use in mixed-HIV-status couples, the Partners Demonstration Project, and HOPE, a study of the dapivirine ring for HIV prevention.

“These data provide real evidence that when PrEP is made available — easily available — people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV,” he said in an interview.

Even more, they clarify something that has stymied American regulators and clinicians.

Early studies of PrEP use by single women were stopped because participants weren’t taking the pills; adherence was so low that researchers couldn’t show efficacy. Since then, various trials — including Partners PrEP — have shown that PrEP works in women, but doubts have lingered, leading women to “get the short end of the stick in discussions about PrEP,” Baeten explained.

“There really shouldn’t be questions anymore,” he said. “These findings should put to rest any question about women in Africa being able to benefit from PrEP.”

This article first appeared on Medscape.com.

When people were offered preexposure prophylaxis (PrEP) outside of traditional clinics, regardless of specific risk factors, as part of the Sustainable East Africa Research in Community Health (SEARCH) study, new HIV acquisitions dropped by 74%.

It’s a valuable lesson to providers around the world, said Catherine Koss, MD, assistant professor of medicine in HIV, infectious disease, and global medicine at the University of California, San Francisco.

“We haven’t really seen PrEP being scaled up and offered at such a broad level in communities,” Koss said during the International AIDS Conference 2020. “Offering PrEP in a way that’s more universal and with a low barrier to both men and women can result in reductions in incidence.”

The first part of SEARCH, which looked at the impact of universal testing and access to HIV treatment immediately after diagnosis, showed that the strategy resulted in a population-wide 30% reduction in new HIV acquisitions. In other words, treatment alone wasn’t enough to end the HIV epidemic.

But the researchers always knew “there were likely going to be new HIV infections,” even with universal HIV testing and treatment, Koss said.

So the second part of the study was designed to see whether PrEP — with the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) — could further reduce rates of HIV acquisition.
 

PrEP out in the community

During the PrEP part of the SEARCH study, researchers discussed HIV risk with adults in 16 communities in rural Kenya and Uganda during population-level testing that took place at health fairs, beaches, trading centers, other community sites, and even in participants’ homes. PrEP was offered to anyone in a relationship with someone living with HIV, to anyone determined to be at elevated risk for infection by a previously validated algorithm, and to anyone who did not fit those criteria but who wanted a prescription.

Of the 15,632 adults eligible for PrEP, 5,447 (35%) chose to start the HIV prevention pill.

A rapid-enrollment protocol meant that people received their prescription at the time of screening or soon after that. Participants underwent testing for HIV antibodies — also out in the community — at weeks 4 and 12, and every 12 weeks thereafter; this will continue out to week 144.

HIV-negative adults who were part of the larger SEARCH cohort in the year before PrEP was made available — and from the same communities — served as the control group.

Interim 60-week data show that the rate of acquisition was 74% lower in the PrEP group than in the control group (incidence rate ratio, 0.26; P = .01). In women, the acquisition rate was 76% lower (incidence rate ratio, 0.24; P = .04), and in men, it was 40% lower (incidence rate ratio, 0.60; P = .54).

The reduction was not significant for men, probably because so few men acquired HIV, Koss reported. The powerful drop in new HIV cases overall was related to PrEP use by women; cases in women fell from 1.52 to 0.40 per 100 person-years.

Blood tests showed that 72% of the people who acquired HIV during the study period had not taken a PrEP pill for at least 30 days before their diagnosis.

“Making PrEP more easily accessible and more community-based could be very powerful in the United States,” said Koss.

“Allowing people to test for HIV and start PrEP outside of health clinics or standard health facilities could help reach more people,” she told Medscape Medical News. “Many of the people who benefit from PrEP may not otherwise need to seek medical care regularly if they’re otherwise healthy and often young.”

When PrEP is made available — easily available —  people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV.

The findings were hailed by others in the field of HIV prevention.

“They’re fantastic,” said Jared Baeten, MD, vice dean of the School of Public Health and professor of global health, medicine, and epidemiology at the University of Washington in Seattle. He was involved in Partners PrEP, a study of PrEP use in mixed-HIV-status couples, the Partners Demonstration Project, and HOPE, a study of the dapivirine ring for HIV prevention.

“These data provide real evidence that when PrEP is made available — easily available — people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV,” he said in an interview.

Even more, they clarify something that has stymied American regulators and clinicians.

Early studies of PrEP use by single women were stopped because participants weren’t taking the pills; adherence was so low that researchers couldn’t show efficacy. Since then, various trials — including Partners PrEP — have shown that PrEP works in women, but doubts have lingered, leading women to “get the short end of the stick in discussions about PrEP,” Baeten explained.

“There really shouldn’t be questions anymore,” he said. “These findings should put to rest any question about women in Africa being able to benefit from PrEP.”

This article first appeared on Medscape.com.

When people were offered preexposure prophylaxis (PrEP) outside of traditional clinics, regardless of specific risk factors, as part of the Sustainable East Africa Research in Community Health (SEARCH) study, new HIV acquisitions dropped by 74%.

It’s a valuable lesson to providers around the world, said Catherine Koss, MD, assistant professor of medicine in HIV, infectious disease, and global medicine at the University of California, San Francisco.

“We haven’t really seen PrEP being scaled up and offered at such a broad level in communities,” Koss said during the International AIDS Conference 2020. “Offering PrEP in a way that’s more universal and with a low barrier to both men and women can result in reductions in incidence.”

The first part of SEARCH, which looked at the impact of universal testing and access to HIV treatment immediately after diagnosis, showed that the strategy resulted in a population-wide 30% reduction in new HIV acquisitions. In other words, treatment alone wasn’t enough to end the HIV epidemic.

But the researchers always knew “there were likely going to be new HIV infections,” even with universal HIV testing and treatment, Koss said.

So the second part of the study was designed to see whether PrEP — with the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) — could further reduce rates of HIV acquisition.
 

PrEP out in the community

During the PrEP part of the SEARCH study, researchers discussed HIV risk with adults in 16 communities in rural Kenya and Uganda during population-level testing that took place at health fairs, beaches, trading centers, other community sites, and even in participants’ homes. PrEP was offered to anyone in a relationship with someone living with HIV, to anyone determined to be at elevated risk for infection by a previously validated algorithm, and to anyone who did not fit those criteria but who wanted a prescription.

Of the 15,632 adults eligible for PrEP, 5,447 (35%) chose to start the HIV prevention pill.

A rapid-enrollment protocol meant that people received their prescription at the time of screening or soon after that. Participants underwent testing for HIV antibodies — also out in the community — at weeks 4 and 12, and every 12 weeks thereafter; this will continue out to week 144.

HIV-negative adults who were part of the larger SEARCH cohort in the year before PrEP was made available — and from the same communities — served as the control group.

Interim 60-week data show that the rate of acquisition was 74% lower in the PrEP group than in the control group (incidence rate ratio, 0.26; P = .01). In women, the acquisition rate was 76% lower (incidence rate ratio, 0.24; P = .04), and in men, it was 40% lower (incidence rate ratio, 0.60; P = .54).

The reduction was not significant for men, probably because so few men acquired HIV, Koss reported. The powerful drop in new HIV cases overall was related to PrEP use by women; cases in women fell from 1.52 to 0.40 per 100 person-years.

Blood tests showed that 72% of the people who acquired HIV during the study period had not taken a PrEP pill for at least 30 days before their diagnosis.

“Making PrEP more easily accessible and more community-based could be very powerful in the United States,” said Koss.

“Allowing people to test for HIV and start PrEP outside of health clinics or standard health facilities could help reach more people,” she told Medscape Medical News. “Many of the people who benefit from PrEP may not otherwise need to seek medical care regularly if they’re otherwise healthy and often young.”

When PrEP is made available — easily available —  people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV.

The findings were hailed by others in the field of HIV prevention.

“They’re fantastic,” said Jared Baeten, MD, vice dean of the School of Public Health and professor of global health, medicine, and epidemiology at the University of Washington in Seattle. He was involved in Partners PrEP, a study of PrEP use in mixed-HIV-status couples, the Partners Demonstration Project, and HOPE, a study of the dapivirine ring for HIV prevention.

“These data provide real evidence that when PrEP is made available — easily available — people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV,” he said in an interview.

Even more, they clarify something that has stymied American regulators and clinicians.

Early studies of PrEP use by single women were stopped because participants weren’t taking the pills; adherence was so low that researchers couldn’t show efficacy. Since then, various trials — including Partners PrEP — have shown that PrEP works in women, but doubts have lingered, leading women to “get the short end of the stick in discussions about PrEP,” Baeten explained.

“There really shouldn’t be questions anymore,” he said. “These findings should put to rest any question about women in Africa being able to benefit from PrEP.”

This article first appeared on Medscape.com.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

Injections of cabotegravir (ViiV Healthcare) given every other month are more effective in blocking HIV transmission than is the once-a-day combination of tenofovir disoproxil fumarate and emtricitabine (Truvada, Gilead Science), new data from the HPTN 083 trial show.

The findings “could transform the HIV prevention landscape for so many people,” said Megan Coleman, DNP, from Whitman-Walker Health in Washington, DC, who regularly prescribes Truvada as pre-exposure prophylaxis (PrEP).

At Whitman-Walker alone, about 3000 people were taking the pill in early 2020, but “for some people, taking a pill every day just isn’t a viable option,” said Coleman. “To have something that can support a patient’s choice and a patient’s ability to reduce their own risk of HIV is amazing.”

Final results from the trial — which looked at the drug in cisgender men and transgender women who have sex with men — were presented at the International AIDS Conference 2020.
 

Early Study Termination

Half of the 4566 study participants — from 43 sites in Africa, Asia, Latin America, and the United States — were younger than 30 years, 12.4% were transgender women, 29.7% were black, and 46.1% were Hispanic.

By design, ViiV Healthcare, the study sponsor, required that 50% of American participants be black to reflect the population at risk for HIV in the United States, said Raphael Landovitz, MD, from the UCLA David Geffen School of Medicine in Los Angeles, who is protocol chair for HPTN 083. In fact, 49.7% of the American cohort was black and 17.8% was Hispanic.

Patients randomized to the cabotegravir group received daily oral cabotegravir plus daily oral placebo for 5 weeks, to assess safety, followed by a cabotegravir injection at weeks 5 and 9 and every 2 months thereafter out to week 153 plus daily oral placebo. Patients randomized to the Truvada group received daily oral Truvada plus daily oral placebo for 5 weeks, followed by daily oral Truvada plus placebo injection, on the same schedule, out to week 153.

After the final injection, all participants continued on daily oral Truvada for 48 weeks.

The researchers expected to wait until 172 participants acquired HIV; they decided at the outset that this number would be sufficient to power a decision on whether or not cabotegravir injections are better than daily oral Truvada. But by May 2020, when 52 of the study participants had acquired HIV, the results were so lopsided in favor of cabotegravir that the trial was stopped. At that point, all participants were offered cabotegravir injections every 2 months.

Thirty-nine of the 52 (75%) new HIV infections occurred in the Truvada group. In fact, people in the cabotegravir group were less likely to acquire HIV than those in the Truvada group (hazard ratio, 0.34).

“This definitively establishes the superiority of cabotegravir,” said Landovitz.

He and his colleagues had been legitimately concerned that HIV acquisition would be so low in the trial that they wouldn’t be able to show how effective the injectable was. The success of Truvada PrEP has made it difficult to design prevention trials.

“We know that Truvada works extremely well, so the fact that we were able to show that cabotegravir in this population works better” is a powerful observation, said Landovitz. This is especially true because the rates of sexually transmitted infections — which are thought to increase risk for HIV transmission — were so high. Overall, 16.5% of the participants tested positive for syphilis during the trial, 13.3% tested positive for gonorrhea, and 21.1% tested positive for Chlamydia.
 

Five Surprising Seroconversions

Eleven of the 15 HIV infections in the cabotegravir group occurred in people who had received at least one injection. Three of these infections actually occurred during the first 5 weeks of the study when participants were taking oral cabotegravir, two occurred when participants chose to discontinue the injection and return to daily oral Truvada, and one occurred after a participant missed the injection for a prolonged period of time.

But five of the transmissions occurred in participants who appeared to be perfectly adherent.

Landovitz offered a number of possible reasons for this surprising finding.

“Number one could be that there’s something about these five particular individuals such that they grind up and eliminate the cabotegravir faster than other people, so an 8-week interval is too long for them,” he explained. “Another possibility, although pretty rare, is that there is a rare circulating virus that is intrinsically resistant to cabotegravir.”

Breakthrough HIV transmissions have been rare in people taking oral PrEP.

Disruptions caused by the COVID-19 pandemic have meant that the researchers don’t yet have the data on drug-resistant mutations or drug levels for these five participants, but they will.

“I suspect the truth is that there will never be a 100% failsafe HIV prevention mechanism,” said Landovitz.
 

“Impressive” Findings

The findings were greeted with excitement, although questions remain.

They are “impressive,” especially the data on black and Hispanic participants, said Paul Sax, MD, medical director of the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston.

However, he said he is interested in the data showing that although participants in both groups gained weight during the study, there was early weight loss in the Truvada group, meaning that those in the cabotegravir group weighed more at the end of the study than those in the Truvada group.

“I’ve been watching the data on weight with integrase inhibitors,” he explained, including weight data specific to Truvada and to the combination of emtricitabine and tenofovir alafenamide (Descovy, Gilead). It looks like Truvada “has some sort of weight-suppressive effects. That’s going to be a thing we’re going to have to watch.”

Coleman said she is already thinking about patients at Whitman-Walker who might do well on cabotegravir and those who can start PrEP for the first time with this option.

“Not only would people probably switch to this option, but maybe people would be interested in starting a biomedical prevention approach that isn’t a pill every day,” she said. “It’s just exciting to have another option. Hopefully, in a few years, we’ll have implantable devices and rings; I can’t even imagine what all those brilliant minds are coming up with.”

But that’s still a ways off. First, cabotegravir has yet to be approved for HIV prevention, and ideally, eventually, there will be a way to determine if cabotegravir is safe for each patient that doesn’t involve a month of daily pills.

“We need to solve that problem because it’s so complicated to do an oral lead-in for a month or so,” said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. “Otherwise it’s not going to be feasible.”

We need to make sure this gets licensed for men and women and transgender individuals.

Even with these positive data, Dieffenbach and other officials are not keen to have ViiV apply for licensing right away. Last October, Descovy was the second oral PrEP pill approved for HIV prevention, but only for use by gay men and transgender women — it hadn’t been well studied in cisgender women — causing an outcry. Now, officials are suggesting that ViiV not make the same mistake.

They are urging the company to hold off until data from the sister study of the medication in women — HPTN 084 — is completed in 2022.

“We need to make sure this gets licensed for men and women and transgender individuals,” Dieffenbach told Medscape Medical News. “We just need to give this a little more time and then build a plan with contingencies, so that if something happens, we still have collected all the safety data in women so we can say it’s safe.”
 

ViiV seems to be making such a plan.

“Our goal is to seek approval across all genders and we will work with the FDA and other regulatory agencies to map out a plan to achieve this goal,” said Kimberly Smith, MD, head of research and development at ViiV Healthcare.

The World Health Organization (WHO), meanwhile, doesn’t expect to change its guidelines on HIV prevention medications until data from HPTN 084 are reported.

“What’s important when we look at guidelines is that we also look across populations,” said Meg Doherty, coordinator of treatment and care in the Department of HIV/AIDS at WHO. “We’re waiting to know more about how cabotegravir works in women, because we certainly want to have prevention drugs that can be used in men and women at different age ranges and, ideally, during pregnancy.”

International AIDS Conference 2020: Abstracts OAXLB01. Presented July 8, 2020.
 

This article first appeared on Medscape.com.

Injections of cabotegravir (ViiV Healthcare) given every other month are more effective in blocking HIV transmission than is the once-a-day combination of tenofovir disoproxil fumarate and emtricitabine (Truvada, Gilead Science), new data from the HPTN 083 trial show.

The findings “could transform the HIV prevention landscape for so many people,” said Megan Coleman, DNP, from Whitman-Walker Health in Washington, DC, who regularly prescribes Truvada as pre-exposure prophylaxis (PrEP).

At Whitman-Walker alone, about 3000 people were taking the pill in early 2020, but “for some people, taking a pill every day just isn’t a viable option,” said Coleman. “To have something that can support a patient’s choice and a patient’s ability to reduce their own risk of HIV is amazing.”

Final results from the trial — which looked at the drug in cisgender men and transgender women who have sex with men — were presented at the International AIDS Conference 2020.
 

Early Study Termination

Half of the 4566 study participants — from 43 sites in Africa, Asia, Latin America, and the United States — were younger than 30 years, 12.4% were transgender women, 29.7% were black, and 46.1% were Hispanic.

By design, ViiV Healthcare, the study sponsor, required that 50% of American participants be black to reflect the population at risk for HIV in the United States, said Raphael Landovitz, MD, from the UCLA David Geffen School of Medicine in Los Angeles, who is protocol chair for HPTN 083. In fact, 49.7% of the American cohort was black and 17.8% was Hispanic.

Patients randomized to the cabotegravir group received daily oral cabotegravir plus daily oral placebo for 5 weeks, to assess safety, followed by a cabotegravir injection at weeks 5 and 9 and every 2 months thereafter out to week 153 plus daily oral placebo. Patients randomized to the Truvada group received daily oral Truvada plus daily oral placebo for 5 weeks, followed by daily oral Truvada plus placebo injection, on the same schedule, out to week 153.

After the final injection, all participants continued on daily oral Truvada for 48 weeks.

The researchers expected to wait until 172 participants acquired HIV; they decided at the outset that this number would be sufficient to power a decision on whether or not cabotegravir injections are better than daily oral Truvada. But by May 2020, when 52 of the study participants had acquired HIV, the results were so lopsided in favor of cabotegravir that the trial was stopped. At that point, all participants were offered cabotegravir injections every 2 months.

Thirty-nine of the 52 (75%) new HIV infections occurred in the Truvada group. In fact, people in the cabotegravir group were less likely to acquire HIV than those in the Truvada group (hazard ratio, 0.34).

“This definitively establishes the superiority of cabotegravir,” said Landovitz.

He and his colleagues had been legitimately concerned that HIV acquisition would be so low in the trial that they wouldn’t be able to show how effective the injectable was. The success of Truvada PrEP has made it difficult to design prevention trials.

“We know that Truvada works extremely well, so the fact that we were able to show that cabotegravir in this population works better” is a powerful observation, said Landovitz. This is especially true because the rates of sexually transmitted infections — which are thought to increase risk for HIV transmission — were so high. Overall, 16.5% of the participants tested positive for syphilis during the trial, 13.3% tested positive for gonorrhea, and 21.1% tested positive for Chlamydia.
 

Five Surprising Seroconversions

Eleven of the 15 HIV infections in the cabotegravir group occurred in people who had received at least one injection. Three of these infections actually occurred during the first 5 weeks of the study when participants were taking oral cabotegravir, two occurred when participants chose to discontinue the injection and return to daily oral Truvada, and one occurred after a participant missed the injection for a prolonged period of time.

But five of the transmissions occurred in participants who appeared to be perfectly adherent.

Landovitz offered a number of possible reasons for this surprising finding.

“Number one could be that there’s something about these five particular individuals such that they grind up and eliminate the cabotegravir faster than other people, so an 8-week interval is too long for them,” he explained. “Another possibility, although pretty rare, is that there is a rare circulating virus that is intrinsically resistant to cabotegravir.”

Breakthrough HIV transmissions have been rare in people taking oral PrEP.

Disruptions caused by the COVID-19 pandemic have meant that the researchers don’t yet have the data on drug-resistant mutations or drug levels for these five participants, but they will.

“I suspect the truth is that there will never be a 100% failsafe HIV prevention mechanism,” said Landovitz.
 

“Impressive” Findings

The findings were greeted with excitement, although questions remain.

They are “impressive,” especially the data on black and Hispanic participants, said Paul Sax, MD, medical director of the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston.

However, he said he is interested in the data showing that although participants in both groups gained weight during the study, there was early weight loss in the Truvada group, meaning that those in the cabotegravir group weighed more at the end of the study than those in the Truvada group.

“I’ve been watching the data on weight with integrase inhibitors,” he explained, including weight data specific to Truvada and to the combination of emtricitabine and tenofovir alafenamide (Descovy, Gilead). It looks like Truvada “has some sort of weight-suppressive effects. That’s going to be a thing we’re going to have to watch.”

Coleman said she is already thinking about patients at Whitman-Walker who might do well on cabotegravir and those who can start PrEP for the first time with this option.

“Not only would people probably switch to this option, but maybe people would be interested in starting a biomedical prevention approach that isn’t a pill every day,” she said. “It’s just exciting to have another option. Hopefully, in a few years, we’ll have implantable devices and rings; I can’t even imagine what all those brilliant minds are coming up with.”

But that’s still a ways off. First, cabotegravir has yet to be approved for HIV prevention, and ideally, eventually, there will be a way to determine if cabotegravir is safe for each patient that doesn’t involve a month of daily pills.

“We need to solve that problem because it’s so complicated to do an oral lead-in for a month or so,” said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. “Otherwise it’s not going to be feasible.”

We need to make sure this gets licensed for men and women and transgender individuals.

Even with these positive data, Dieffenbach and other officials are not keen to have ViiV apply for licensing right away. Last October, Descovy was the second oral PrEP pill approved for HIV prevention, but only for use by gay men and transgender women — it hadn’t been well studied in cisgender women — causing an outcry. Now, officials are suggesting that ViiV not make the same mistake.

They are urging the company to hold off until data from the sister study of the medication in women — HPTN 084 — is completed in 2022.

“We need to make sure this gets licensed for men and women and transgender individuals,” Dieffenbach told Medscape Medical News. “We just need to give this a little more time and then build a plan with contingencies, so that if something happens, we still have collected all the safety data in women so we can say it’s safe.”
 

ViiV seems to be making such a plan.

“Our goal is to seek approval across all genders and we will work with the FDA and other regulatory agencies to map out a plan to achieve this goal,” said Kimberly Smith, MD, head of research and development at ViiV Healthcare.

The World Health Organization (WHO), meanwhile, doesn’t expect to change its guidelines on HIV prevention medications until data from HPTN 084 are reported.

“What’s important when we look at guidelines is that we also look across populations,” said Meg Doherty, coordinator of treatment and care in the Department of HIV/AIDS at WHO. “We’re waiting to know more about how cabotegravir works in women, because we certainly want to have prevention drugs that can be used in men and women at different age ranges and, ideally, during pregnancy.”

International AIDS Conference 2020: Abstracts OAXLB01. Presented July 8, 2020.
 

This article first appeared on Medscape.com.

Injections of cabotegravir (ViiV Healthcare) given every other month are more effective in blocking HIV transmission than is the once-a-day combination of tenofovir disoproxil fumarate and emtricitabine (Truvada, Gilead Science), new data from the HPTN 083 trial show.

The findings “could transform the HIV prevention landscape for so many people,” said Megan Coleman, DNP, from Whitman-Walker Health in Washington, DC, who regularly prescribes Truvada as pre-exposure prophylaxis (PrEP).

At Whitman-Walker alone, about 3000 people were taking the pill in early 2020, but “for some people, taking a pill every day just isn’t a viable option,” said Coleman. “To have something that can support a patient’s choice and a patient’s ability to reduce their own risk of HIV is amazing.”

Final results from the trial — which looked at the drug in cisgender men and transgender women who have sex with men — were presented at the International AIDS Conference 2020.
 

Early Study Termination

Half of the 4566 study participants — from 43 sites in Africa, Asia, Latin America, and the United States — were younger than 30 years, 12.4% were transgender women, 29.7% were black, and 46.1% were Hispanic.

By design, ViiV Healthcare, the study sponsor, required that 50% of American participants be black to reflect the population at risk for HIV in the United States, said Raphael Landovitz, MD, from the UCLA David Geffen School of Medicine in Los Angeles, who is protocol chair for HPTN 083. In fact, 49.7% of the American cohort was black and 17.8% was Hispanic.

Patients randomized to the cabotegravir group received daily oral cabotegravir plus daily oral placebo for 5 weeks, to assess safety, followed by a cabotegravir injection at weeks 5 and 9 and every 2 months thereafter out to week 153 plus daily oral placebo. Patients randomized to the Truvada group received daily oral Truvada plus daily oral placebo for 5 weeks, followed by daily oral Truvada plus placebo injection, on the same schedule, out to week 153.

After the final injection, all participants continued on daily oral Truvada for 48 weeks.

The researchers expected to wait until 172 participants acquired HIV; they decided at the outset that this number would be sufficient to power a decision on whether or not cabotegravir injections are better than daily oral Truvada. But by May 2020, when 52 of the study participants had acquired HIV, the results were so lopsided in favor of cabotegravir that the trial was stopped. At that point, all participants were offered cabotegravir injections every 2 months.

Thirty-nine of the 52 (75%) new HIV infections occurred in the Truvada group. In fact, people in the cabotegravir group were less likely to acquire HIV than those in the Truvada group (hazard ratio, 0.34).

“This definitively establishes the superiority of cabotegravir,” said Landovitz.

He and his colleagues had been legitimately concerned that HIV acquisition would be so low in the trial that they wouldn’t be able to show how effective the injectable was. The success of Truvada PrEP has made it difficult to design prevention trials.

“We know that Truvada works extremely well, so the fact that we were able to show that cabotegravir in this population works better” is a powerful observation, said Landovitz. This is especially true because the rates of sexually transmitted infections — which are thought to increase risk for HIV transmission — were so high. Overall, 16.5% of the participants tested positive for syphilis during the trial, 13.3% tested positive for gonorrhea, and 21.1% tested positive for Chlamydia.
 

Five Surprising Seroconversions

Eleven of the 15 HIV infections in the cabotegravir group occurred in people who had received at least one injection. Three of these infections actually occurred during the first 5 weeks of the study when participants were taking oral cabotegravir, two occurred when participants chose to discontinue the injection and return to daily oral Truvada, and one occurred after a participant missed the injection for a prolonged period of time.

But five of the transmissions occurred in participants who appeared to be perfectly adherent.

Landovitz offered a number of possible reasons for this surprising finding.

“Number one could be that there’s something about these five particular individuals such that they grind up and eliminate the cabotegravir faster than other people, so an 8-week interval is too long for them,” he explained. “Another possibility, although pretty rare, is that there is a rare circulating virus that is intrinsically resistant to cabotegravir.”

Breakthrough HIV transmissions have been rare in people taking oral PrEP.

Disruptions caused by the COVID-19 pandemic have meant that the researchers don’t yet have the data on drug-resistant mutations or drug levels for these five participants, but they will.

“I suspect the truth is that there will never be a 100% failsafe HIV prevention mechanism,” said Landovitz.
 

“Impressive” Findings

The findings were greeted with excitement, although questions remain.

They are “impressive,” especially the data on black and Hispanic participants, said Paul Sax, MD, medical director of the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston.

However, he said he is interested in the data showing that although participants in both groups gained weight during the study, there was early weight loss in the Truvada group, meaning that those in the cabotegravir group weighed more at the end of the study than those in the Truvada group.

“I’ve been watching the data on weight with integrase inhibitors,” he explained, including weight data specific to Truvada and to the combination of emtricitabine and tenofovir alafenamide (Descovy, Gilead). It looks like Truvada “has some sort of weight-suppressive effects. That’s going to be a thing we’re going to have to watch.”

Coleman said she is already thinking about patients at Whitman-Walker who might do well on cabotegravir and those who can start PrEP for the first time with this option.

“Not only would people probably switch to this option, but maybe people would be interested in starting a biomedical prevention approach that isn’t a pill every day,” she said. “It’s just exciting to have another option. Hopefully, in a few years, we’ll have implantable devices and rings; I can’t even imagine what all those brilliant minds are coming up with.”

But that’s still a ways off. First, cabotegravir has yet to be approved for HIV prevention, and ideally, eventually, there will be a way to determine if cabotegravir is safe for each patient that doesn’t involve a month of daily pills.

“We need to solve that problem because it’s so complicated to do an oral lead-in for a month or so,” said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. “Otherwise it’s not going to be feasible.”

We need to make sure this gets licensed for men and women and transgender individuals.

Even with these positive data, Dieffenbach and other officials are not keen to have ViiV apply for licensing right away. Last October, Descovy was the second oral PrEP pill approved for HIV prevention, but only for use by gay men and transgender women — it hadn’t been well studied in cisgender women — causing an outcry. Now, officials are suggesting that ViiV not make the same mistake.

They are urging the company to hold off until data from the sister study of the medication in women — HPTN 084 — is completed in 2022.

“We need to make sure this gets licensed for men and women and transgender individuals,” Dieffenbach told Medscape Medical News. “We just need to give this a little more time and then build a plan with contingencies, so that if something happens, we still have collected all the safety data in women so we can say it’s safe.”
 

ViiV seems to be making such a plan.

“Our goal is to seek approval across all genders and we will work with the FDA and other regulatory agencies to map out a plan to achieve this goal,” said Kimberly Smith, MD, head of research and development at ViiV Healthcare.

The World Health Organization (WHO), meanwhile, doesn’t expect to change its guidelines on HIV prevention medications until data from HPTN 084 are reported.

“What’s important when we look at guidelines is that we also look across populations,” said Meg Doherty, coordinator of treatment and care in the Department of HIV/AIDS at WHO. “We’re waiting to know more about how cabotegravir works in women, because we certainly want to have prevention drugs that can be used in men and women at different age ranges and, ideally, during pregnancy.”

International AIDS Conference 2020: Abstracts OAXLB01. Presented July 8, 2020.
 

This article first appeared on Medscape.com.

A 35-year-old Brazilian man who participated in a trial in which he received an intensified antiretroviral regimen plus supplemental vitamin B₃ for 48 weeks has joined the short list of patients who have experienced a period of remission from HIV in the absence of effective treatment.

Along with the Mississippi baby, a San Francisco man, a 24-year-old Thai man, a 9-year-old South African child, and the London and Berlin patients, the Brazilian man has an undetectable viral load and, more than a year after stopping treatment, his HIV antibody test is negative.

But as with the Berlin and London patients, it seems unlikely that – even if the man remains HIV free into the future – the circumstances of his remission will be broadly applicable to other people with HIV, said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“I don’t think it’s replicable,” Dieffenbach told Medscape Medical News. Researchers should still try to confirm the finding, but they will probably learn more by studying the man’s unique genetic characteristics and immune system “than to go out and treat another 200 people with the same protocol.”
 

‘Shock-and-kill strategy’

The man had been on treatment since his HIV diagnosis in 2012, and was one of 30 people to enroll in a Brazilian study – the Multi Interventional Study Exploring HIV-1 Residual Replication: A Step Toward HIV Eradication and Sterilizing Cure – in 2016. At that point, his regimen consisted of the combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate (Symfi, Mylan Pharmaceuticals) and his viral load was undetectable.

He was one of five people in the study to be randomized to receive the integrase inhibitor dolutegravir (Tivicay, ViiV Healthcare), the CCR5 receptor inhibitor maraviroc (Selzentry, ViiV Healthcare), and twice-daily nicotinamide 500 mg, a form of vitamin B₃, in addition to his regular regimen for 48 weeks.

Nicotinamide has been used for decades because of its anti-infective properties, particularly in tuberculosis. In vitro, it also works to reverse HIV latency, said study investigator Ricardo Diaz, MD, from the Federal University of São Paulo, who presented the data at a press conference for the International AIDS Conference (AIDS) 2020.

“This is a shock-and-kill strategy,” said Leila Giron, PhD, from the Wistar Institute in Philadelphia, who was one of the study investigators. “We did in vitro studies to make sure nicotinamide took HIV out of the cells.”

“The cell machinery changed a lot,” she told Medscape Medical News. “And because it’s a B vitamin, all five participants didn’t have any side effects.”

But the patient was the only person in his treatment group to experience viral load “blips” during treatment – at weeks 16 and 24. And viral DNA was present at low levels in his peripheral blood spots and rectal tissue at baseline and at 48 weeks, and his HIV antibodies dropped from 91.8 RLU at baseline to 58.0 RLU at week 48.

“He had a decline in cell activation, inflammation, and a very deep decline in antibody titers,” Diaz reported.

After 48 weeks of the intensified treatment, the patient returned to his usual regimen for 3 years. Then, in March 2019, he agreed to try an analytical treatment interruption and discontinued all HIV treatment.

“What’s interesting is right before the analytical treatment interruption, the HIV DNA sequences were completely negative,” said Diaz.

Every 3 weeks for the next 64.7 weeks, his viral load came back undetectable, and so did HIV DNA in blood spots. One thing did change, though: in February 2020, the man’s HIV antibody test came back negative.

The team checked that he wasn’t still taking his antiretroviral medication, which might have explained the undetectable viral load, and he wasn’t.
 

Surprise, skepticism, and hope

The results have prompted surprise, skepticism, and questions from clinicians and researchers.

The remission is notable because it occurred without the invasive process of a stem cell transplant that both the London and Berlin patients underwent, said Anton Pozniak, MD, from Chelsea and Westminster Hospital in London, who is cochair of AIDS 2020.

“They need a bigger study to see whether or not [the participant] is one of these guys who stopped treatment and might take a year or two, or four, to rebound,” he said. But if other studies replicate the results, the control of HIV in “one in five people would still be huge.”

The rationale behind treatment intensification for HIV remission is that “the three-drug ART regimen was perhaps insufficient to completely block HIV replication” in the reservoirs, even though that replication could be happening below levels detectable with current tests, said Laura Persaud, MD, from the Johns Hopkins University School of Medicine in Baltimore, who is chair of the International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT) HIV Cure Committee and was not involved in the study.

“The idea was to see if you could accelerate the decay of the reservoir” if you added medications that targeted different parts of the HIV lifecycle. Symfi, for instance, targets just one step in the viral replication process: the point where HIV RNA reverse transcribes itself into DNA so it can integrate into immune cells. But CCR5 inhibitors block entry of HIV into the cell in the first place, and integrase inhibitors, like raltegravir (Isentress, Merck) and dolutegravir, prevent HIV DNA from integrating into the host chromosome after it has reverse transcribed itself.

Still, recent data suggest that treatment intensification might not be as effective as hypothesized, she said. And the nicotinamide study was in vitro. To what extent this is a direct result of this treatment strategy is unclear.

“It’s hard to believe, in this small study, that this agent [nicotinamide] would have such a striking effect on DNA proviral levels,” she said. “We learn from each of these cases. But this is a single case, with multiple mechanisms that may have contributed to the outcome here. To what extent this is a direct result of this treatment strategy is unclear.”

Only time will tell, and Persaud knows this first hand. Back in 2014, she presented data at another HIV conference on the Mississippi baby who, after 21 months of no treatment, still didn›t have an HIV viral load.

At the time, the baby was hailed as “functionally cured,” but just 6 months later, the virus returned.

Dieffenbach agrees. “There are 10,000 genetic variations that need to be considered, and it all adds up to a unique individual,” he said of the Brazilian patient. “This one is one person, and it’s still early days.”
 

Counseling patients on niacin supplementation

Some clinicians are already bracing for the flood of people with HIV now wanting to take, or who are already taking, a niacin supplement because of this case, said Laura Waters, MD, from Mortimer Market Centre in London, who is chair of the British HIV Association.

But nicotinamide is different than nicotinic acid, which is what many people mean when they talk about niacin supplementation, according to data from the Office of Dietary Supplements (ODS) at the National Institutes of Health. Nicotinic acid has been used as a supplement for people with high cholesterol for years. Most Americans get more than the recommended daily intake of both types of niacin – 16 mg for adult men and 14 mg for adult women – in their regular diet, according to the 2015/16 National Health and Nutrition Examination Survey.

The Brazilian patient received a total daily dose of nicotinamide of 1000 mg, which is not associated with any adverse effects. Doses above 3000 mg daily can lead to diarrhea and a decrease in platelet count, according to the ODS.

Although Diaz said he doesn’t think people with HIV should run out and start taking a supplement right away, Waters said she sees it as inevitable.

The good news is that if people really are taking nicotinamide – not nicotinic acid – it seems “fairly well tolerated without many side effects,” she said, but added: “I expect shortages of nicotinamide from tomorrow.”

This story first appeared on Medscape.com.

A 35-year-old Brazilian man who participated in a trial in which he received an intensified antiretroviral regimen plus supplemental vitamin B₃ for 48 weeks has joined the short list of patients who have experienced a period of remission from HIV in the absence of effective treatment.

Along with the Mississippi baby, a San Francisco man, a 24-year-old Thai man, a 9-year-old South African child, and the London and Berlin patients, the Brazilian man has an undetectable viral load and, more than a year after stopping treatment, his HIV antibody test is negative.

But as with the Berlin and London patients, it seems unlikely that – even if the man remains HIV free into the future – the circumstances of his remission will be broadly applicable to other people with HIV, said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“I don’t think it’s replicable,” Dieffenbach told Medscape Medical News. Researchers should still try to confirm the finding, but they will probably learn more by studying the man’s unique genetic characteristics and immune system “than to go out and treat another 200 people with the same protocol.”
 

‘Shock-and-kill strategy’

The man had been on treatment since his HIV diagnosis in 2012, and was one of 30 people to enroll in a Brazilian study – the Multi Interventional Study Exploring HIV-1 Residual Replication: A Step Toward HIV Eradication and Sterilizing Cure – in 2016. At that point, his regimen consisted of the combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate (Symfi, Mylan Pharmaceuticals) and his viral load was undetectable.

He was one of five people in the study to be randomized to receive the integrase inhibitor dolutegravir (Tivicay, ViiV Healthcare), the CCR5 receptor inhibitor maraviroc (Selzentry, ViiV Healthcare), and twice-daily nicotinamide 500 mg, a form of vitamin B₃, in addition to his regular regimen for 48 weeks.

Nicotinamide has been used for decades because of its anti-infective properties, particularly in tuberculosis. In vitro, it also works to reverse HIV latency, said study investigator Ricardo Diaz, MD, from the Federal University of São Paulo, who presented the data at a press conference for the International AIDS Conference (AIDS) 2020.

“This is a shock-and-kill strategy,” said Leila Giron, PhD, from the Wistar Institute in Philadelphia, who was one of the study investigators. “We did in vitro studies to make sure nicotinamide took HIV out of the cells.”

“The cell machinery changed a lot,” she told Medscape Medical News. “And because it’s a B vitamin, all five participants didn’t have any side effects.”

But the patient was the only person in his treatment group to experience viral load “blips” during treatment – at weeks 16 and 24. And viral DNA was present at low levels in his peripheral blood spots and rectal tissue at baseline and at 48 weeks, and his HIV antibodies dropped from 91.8 RLU at baseline to 58.0 RLU at week 48.

“He had a decline in cell activation, inflammation, and a very deep decline in antibody titers,” Diaz reported.

After 48 weeks of the intensified treatment, the patient returned to his usual regimen for 3 years. Then, in March 2019, he agreed to try an analytical treatment interruption and discontinued all HIV treatment.

“What’s interesting is right before the analytical treatment interruption, the HIV DNA sequences were completely negative,” said Diaz.

Every 3 weeks for the next 64.7 weeks, his viral load came back undetectable, and so did HIV DNA in blood spots. One thing did change, though: in February 2020, the man’s HIV antibody test came back negative.

The team checked that he wasn’t still taking his antiretroviral medication, which might have explained the undetectable viral load, and he wasn’t.
 

Surprise, skepticism, and hope

The results have prompted surprise, skepticism, and questions from clinicians and researchers.

The remission is notable because it occurred without the invasive process of a stem cell transplant that both the London and Berlin patients underwent, said Anton Pozniak, MD, from Chelsea and Westminster Hospital in London, who is cochair of AIDS 2020.

“They need a bigger study to see whether or not [the participant] is one of these guys who stopped treatment and might take a year or two, or four, to rebound,” he said. But if other studies replicate the results, the control of HIV in “one in five people would still be huge.”

The rationale behind treatment intensification for HIV remission is that “the three-drug ART regimen was perhaps insufficient to completely block HIV replication” in the reservoirs, even though that replication could be happening below levels detectable with current tests, said Laura Persaud, MD, from the Johns Hopkins University School of Medicine in Baltimore, who is chair of the International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT) HIV Cure Committee and was not involved in the study.

“The idea was to see if you could accelerate the decay of the reservoir” if you added medications that targeted different parts of the HIV lifecycle. Symfi, for instance, targets just one step in the viral replication process: the point where HIV RNA reverse transcribes itself into DNA so it can integrate into immune cells. But CCR5 inhibitors block entry of HIV into the cell in the first place, and integrase inhibitors, like raltegravir (Isentress, Merck) and dolutegravir, prevent HIV DNA from integrating into the host chromosome after it has reverse transcribed itself.

Still, recent data suggest that treatment intensification might not be as effective as hypothesized, she said. And the nicotinamide study was in vitro. To what extent this is a direct result of this treatment strategy is unclear.

“It’s hard to believe, in this small study, that this agent [nicotinamide] would have such a striking effect on DNA proviral levels,” she said. “We learn from each of these cases. But this is a single case, with multiple mechanisms that may have contributed to the outcome here. To what extent this is a direct result of this treatment strategy is unclear.”

Only time will tell, and Persaud knows this first hand. Back in 2014, she presented data at another HIV conference on the Mississippi baby who, after 21 months of no treatment, still didn›t have an HIV viral load.

At the time, the baby was hailed as “functionally cured,” but just 6 months later, the virus returned.

Dieffenbach agrees. “There are 10,000 genetic variations that need to be considered, and it all adds up to a unique individual,” he said of the Brazilian patient. “This one is one person, and it’s still early days.”
 

Counseling patients on niacin supplementation

Some clinicians are already bracing for the flood of people with HIV now wanting to take, or who are already taking, a niacin supplement because of this case, said Laura Waters, MD, from Mortimer Market Centre in London, who is chair of the British HIV Association.

But nicotinamide is different than nicotinic acid, which is what many people mean when they talk about niacin supplementation, according to data from the Office of Dietary Supplements (ODS) at the National Institutes of Health. Nicotinic acid has been used as a supplement for people with high cholesterol for years. Most Americans get more than the recommended daily intake of both types of niacin – 16 mg for adult men and 14 mg for adult women – in their regular diet, according to the 2015/16 National Health and Nutrition Examination Survey.

The Brazilian patient received a total daily dose of nicotinamide of 1000 mg, which is not associated with any adverse effects. Doses above 3000 mg daily can lead to diarrhea and a decrease in platelet count, according to the ODS.

Although Diaz said he doesn’t think people with HIV should run out and start taking a supplement right away, Waters said she sees it as inevitable.

The good news is that if people really are taking nicotinamide – not nicotinic acid – it seems “fairly well tolerated without many side effects,” she said, but added: “I expect shortages of nicotinamide from tomorrow.”

This story first appeared on Medscape.com.

A 35-year-old Brazilian man who participated in a trial in which he received an intensified antiretroviral regimen plus supplemental vitamin B₃ for 48 weeks has joined the short list of patients who have experienced a period of remission from HIV in the absence of effective treatment.

Along with the Mississippi baby, a San Francisco man, a 24-year-old Thai man, a 9-year-old South African child, and the London and Berlin patients, the Brazilian man has an undetectable viral load and, more than a year after stopping treatment, his HIV antibody test is negative.

But as with the Berlin and London patients, it seems unlikely that – even if the man remains HIV free into the future – the circumstances of his remission will be broadly applicable to other people with HIV, said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“I don’t think it’s replicable,” Dieffenbach told Medscape Medical News. Researchers should still try to confirm the finding, but they will probably learn more by studying the man’s unique genetic characteristics and immune system “than to go out and treat another 200 people with the same protocol.”
 

‘Shock-and-kill strategy’

The man had been on treatment since his HIV diagnosis in 2012, and was one of 30 people to enroll in a Brazilian study – the Multi Interventional Study Exploring HIV-1 Residual Replication: A Step Toward HIV Eradication and Sterilizing Cure – in 2016. At that point, his regimen consisted of the combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate (Symfi, Mylan Pharmaceuticals) and his viral load was undetectable.

He was one of five people in the study to be randomized to receive the integrase inhibitor dolutegravir (Tivicay, ViiV Healthcare), the CCR5 receptor inhibitor maraviroc (Selzentry, ViiV Healthcare), and twice-daily nicotinamide 500 mg, a form of vitamin B₃, in addition to his regular regimen for 48 weeks.

Nicotinamide has been used for decades because of its anti-infective properties, particularly in tuberculosis. In vitro, it also works to reverse HIV latency, said study investigator Ricardo Diaz, MD, from the Federal University of São Paulo, who presented the data at a press conference for the International AIDS Conference (AIDS) 2020.

“This is a shock-and-kill strategy,” said Leila Giron, PhD, from the Wistar Institute in Philadelphia, who was one of the study investigators. “We did in vitro studies to make sure nicotinamide took HIV out of the cells.”

“The cell machinery changed a lot,” she told Medscape Medical News. “And because it’s a B vitamin, all five participants didn’t have any side effects.”

But the patient was the only person in his treatment group to experience viral load “blips” during treatment – at weeks 16 and 24. And viral DNA was present at low levels in his peripheral blood spots and rectal tissue at baseline and at 48 weeks, and his HIV antibodies dropped from 91.8 RLU at baseline to 58.0 RLU at week 48.

“He had a decline in cell activation, inflammation, and a very deep decline in antibody titers,” Diaz reported.

After 48 weeks of the intensified treatment, the patient returned to his usual regimen for 3 years. Then, in March 2019, he agreed to try an analytical treatment interruption and discontinued all HIV treatment.

“What’s interesting is right before the analytical treatment interruption, the HIV DNA sequences were completely negative,” said Diaz.

Every 3 weeks for the next 64.7 weeks, his viral load came back undetectable, and so did HIV DNA in blood spots. One thing did change, though: in February 2020, the man’s HIV antibody test came back negative.

The team checked that he wasn’t still taking his antiretroviral medication, which might have explained the undetectable viral load, and he wasn’t.
 

Surprise, skepticism, and hope

The results have prompted surprise, skepticism, and questions from clinicians and researchers.

The remission is notable because it occurred without the invasive process of a stem cell transplant that both the London and Berlin patients underwent, said Anton Pozniak, MD, from Chelsea and Westminster Hospital in London, who is cochair of AIDS 2020.

“They need a bigger study to see whether or not [the participant] is one of these guys who stopped treatment and might take a year or two, or four, to rebound,” he said. But if other studies replicate the results, the control of HIV in “one in five people would still be huge.”

The rationale behind treatment intensification for HIV remission is that “the three-drug ART regimen was perhaps insufficient to completely block HIV replication” in the reservoirs, even though that replication could be happening below levels detectable with current tests, said Laura Persaud, MD, from the Johns Hopkins University School of Medicine in Baltimore, who is chair of the International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT) HIV Cure Committee and was not involved in the study.

“The idea was to see if you could accelerate the decay of the reservoir” if you added medications that targeted different parts of the HIV lifecycle. Symfi, for instance, targets just one step in the viral replication process: the point where HIV RNA reverse transcribes itself into DNA so it can integrate into immune cells. But CCR5 inhibitors block entry of HIV into the cell in the first place, and integrase inhibitors, like raltegravir (Isentress, Merck) and dolutegravir, prevent HIV DNA from integrating into the host chromosome after it has reverse transcribed itself.

Still, recent data suggest that treatment intensification might not be as effective as hypothesized, she said. And the nicotinamide study was in vitro. To what extent this is a direct result of this treatment strategy is unclear.

“It’s hard to believe, in this small study, that this agent [nicotinamide] would have such a striking effect on DNA proviral levels,” she said. “We learn from each of these cases. But this is a single case, with multiple mechanisms that may have contributed to the outcome here. To what extent this is a direct result of this treatment strategy is unclear.”

Only time will tell, and Persaud knows this first hand. Back in 2014, she presented data at another HIV conference on the Mississippi baby who, after 21 months of no treatment, still didn›t have an HIV viral load.

At the time, the baby was hailed as “functionally cured,” but just 6 months later, the virus returned.

Dieffenbach agrees. “There are 10,000 genetic variations that need to be considered, and it all adds up to a unique individual,” he said of the Brazilian patient. “This one is one person, and it’s still early days.”
 

Counseling patients on niacin supplementation

Some clinicians are already bracing for the flood of people with HIV now wanting to take, or who are already taking, a niacin supplement because of this case, said Laura Waters, MD, from Mortimer Market Centre in London, who is chair of the British HIV Association.

But nicotinamide is different than nicotinic acid, which is what many people mean when they talk about niacin supplementation, according to data from the Office of Dietary Supplements (ODS) at the National Institutes of Health. Nicotinic acid has been used as a supplement for people with high cholesterol for years. Most Americans get more than the recommended daily intake of both types of niacin – 16 mg for adult men and 14 mg for adult women – in their regular diet, according to the 2015/16 National Health and Nutrition Examination Survey.

The Brazilian patient received a total daily dose of nicotinamide of 1000 mg, which is not associated with any adverse effects. Doses above 3000 mg daily can lead to diarrhea and a decrease in platelet count, according to the ODS.

Although Diaz said he doesn’t think people with HIV should run out and start taking a supplement right away, Waters said she sees it as inevitable.

The good news is that if people really are taking nicotinamide – not nicotinic acid – it seems “fairly well tolerated without many side effects,” she said, but added: “I expect shortages of nicotinamide from tomorrow.”

This story first appeared on Medscape.com.

When the COVID-19 pandemic led to a blanket shelter-in-place order in California in March, it did more than shut down in-person visits at Ward 86, the HIV clinic for publicly insured patients at San Francisco General Hospital. It also led to a decrease in viral suppression among the clinic›s clients. By the end of June, the percentage of patients with an undetectable viral load had dropped by nearly one-third.

This is exactly what Monica Gandhi, MD, associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, and medical director of the clinic, was afraid of.

“We’re profoundly worried about the impact of COVID-19 on actual treatment outcomes,” said Dr. Gandhi, cochair of the virtual International AIDS Conference (AIDS) 2020.

And it’s not just the clinic’s clients at risk. Of the 106 countries served by the Global Fund to Fight HIV, Tuberculosis, and Malaria, 85% saw disruptions in HIV programs, according to a report released last month.

These service disruptions are considerable and “life threatening,” affecting some of the people at greatest risk for HIV acquisition and poor outcomes – such as people engaged in transactional sex (40%), men who have sex with men (37%), and transgender people (31%) – the 2020 Global AIDS Update, released today by UNAIDS, reports.

“In sub-Saharan Africa alone, if there is a 6-month interruption in HIV treatment services, it will account for an additional 500,000 deaths. That doubles the number of deaths in sub-Saharan Africa alone and brings us back to 2008 mortality levels,” said Shannon Hader, MD, deputy executive director of UNAIDS. “We just can’t allow that to happen.”

In addition, 73 countries are at risk of running out of HIV medications, according to a World Health Organization report, also released today.
 

Quantifying the impact

The impact is not the same for all patients, said Anton Pozniak, MD, consulting physician in HIV medicine at the Chelsea and Westminster Hospital in London, and international cochair of AIDS 2020.

For some, COVID-19 has not changed much. Their viral loads remain undetectable and all they need is multimonth supplies of their antiretroviral therapy (ART) medications, he told Medscape Medical News. Still, he said he worries about the well-documented effects that social isolation is having on the mental health of these patients, and the increase in substance use associated with the pandemic.

Then there is a small group of patients with HIV who had put off starting ART before the pandemic, but now want to start, he reported.

And finally, there are the people for whom the fear of COVID-19 has crippled their ability to get care.

There are people who have decided they don’t want to come to the hospital or come to the clinic because they’re scared of getting COVID-19.

“It’s really very striking,” said Dr. Pozniak. “There are people who have decided they don’t want to come to the hospital or come to the clinic because they’re scared of getting COVID-19. We’ve offered to deliver treatment, but they don’t want the stigma of parcels of drugs arriving.”

In a study presented at the conference, four of 12 care and substance-use treatment facilities in Europe and North America – including Seattle and Philadelphia – reported patients taking longer to fill ART prescriptions. And four of the 12 also reported that clients who injected drugs and were at risk for or living with HIV were having trouble adhering to prescribed therapies. In addition, at 11 of the sites, HIV testing has either nearly or completely shut down.
 

Structural barriers to telemedicine

And then there are structural barriers to care – poverty, lack of transportation, lack of or slow internet access, and lack of insurance – which affect 10% to 20% of the people with HIV that Jodie Dionne-Odom, MD, sees at the 1917 Ryan White HIV clinic at the University of Alabama at Birmingham.

These are the patients she said she worries about most, the ones who, even before COVID-19, were barely managing to pay their rent, car payments, and cell phone bills.

“With COVID-19 and being at home or being laid off, those things could no longer be paid. They’ve lost their phone, they’ve lost their car,” said Dionne-Odom, chief of women’s health services for the clinic. “That’s a really significant impact, because that’s exactly the group you can’t reach by telemedicine.”

In March, when the 1917 Clinic began providing the majority of services online, these people fell off the radar, said Aadia Rana, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, who also works at the clinic.

This is not for lack of trying, she explained. Staff called patients weekly to check in and reschedule appointments, but there were some they just couldn’t reach.

Although the data for the second quarter have not yet been analyzed, “I would expect that our typically close to 90% viral suppression rate is going to decrease,” she said.

This decrease is likely widespread, said Rana, who is principle investigator of the Long-Acting Therapy to Improve Treatment Success in Daily Life (LATITUDE) study.

Many of the 33 sites involved in LATITUDE shut down in the early months of the pandemic, but some are now coming back online. In fact, “we are getting all these pleas from sites around the country saying, ‘Hey, once LATITUDE is open for enrollment, we have so many people who would now be eligible’,” she told Medscape Medical News.

“Why are they now eligible and they weren’t eligible before? I’m assuming it’s because they now have a detectable viral load,” which is one of the requirements for enrollment in LATITUDE, she explained.
 

Impact on the LGBTI community

At the onset of the COVID-19 pandemic, Erik Lamontagne, senior economist at UNAIDS, wondered how the quarantine was affecting LGBTI people.

To find out, he and his colleagues launched a survey asking just that. He is also coprinciple investigator of the LGBT Happiness Survey, a multicountry survey of LGBTI people launched last year.

The 13,562 LGBTI respondents came from 138 countries or territories. Of the 1,140 respondents living with HIV, 26% had seen their HIV care disrupted or restricted in some way during the pandemic, and 55% of those had no more than a month’s worth of HIV medications on hand.

But the pandemic hasn’t just affected people already living with HIV, Mr. Lamontagne reported. Nine of 10 respondents were living under some form of stay-at-home order, 73% were not meeting their basic needs, 37% had missed meals as a result of economic hardship, and half of those who were still working expected to lose their jobs.

Many could not afford to quarantine, Mr. Lamontagne told Medscape Medical News. And financial resources were stretched so thin that about 1% of respondents reported engaging in transactional sex for the first time. Some reported that their economic circumstances were so dire that they couldn’t require clients to wear condoms, increasing their risk for both COVID-19 and HIV.

“What they can eat in the evening is what they can earn during the day,” Mr. Lamontagne explained.

Unfortunately, it is the people already in a situation of economic vulnerability – often those from the LGBTI community – who are most affected by COVID-19, he added.
 

PrEP use changing

The pandemic has also affected the use of pre-exposure prophylaxis (PrEP).

South African women taking PrEP to protect themselves from HIV during pregnancy were 2.36 times more likely to miss a clinic visit to refill their prescription after COVID-19 lockdowns began than before, data presented at the conference showed. The women cited fear of acquiring COVID-19 at the medical facility, fear of police, transportation barriers, and long clinic wait times to explain the missed visits.

A study on the use of PrEP at Fenway Health, a sexual health clinic in Boston, showed a 278% increase in unfilled PrEP prescriptions after stay-at-home orders and a 72.1% drop in new PrEP prescriptions.

It’s unclear what these data, which will be presented at the conference later this week, mean, said Douglas Krakower, MD, assistant professor of medicine and population medicine at Harvard Medical School in Boston.

“We don’t know whether this represents people having trouble accessing PrEP” out of concern about getting COVID “or concerns about financial implications,” he explained.

“They may have had hardships from unemployment or other financial constraints” and have lost insurance or are still having to pay copays, he told Medscape Medical News. Or it could just be that they’re not going out or having sex, so they’ve discontinued the medication.

“Anecdotally we’ve heard that some patients are sheltering in place and not having sex and so have chosen not to use PrEP,” he added.

It’s also possible that people are rationing pills or have moved themselves to the PrEP 2-1-1 protocol, which is used only when someone is having sex, said Dr. Krakower, citing a study showing that sexual behavior is continuing as usual during quarantine for about half the gay men in the United States.
 

Resilience and fragility

It’s not just people living with HIV whose routines have changed during the pandemic. A survey of HIV clinicians around the world conducted by the International Association of Providers of AIDS Care showed that 88% of HIV clinicians have been pulled away from their regular work to manage COVID-19 in their communities.

But the COVID-19 pandemic shows no signs of stopping, and clinicians are now having to re-engage with their HIV patients.

“What COVID-19 has represented for us is a looking glass to see the resilience, but also the fragility, in HIV responses, not just in the global south, but also in the global north,” José Zuniga, PhD, IAPAC president and chief executive officer, said during a preconference session on controlling the HIV epidemic.

For Dr. Dionne-Odom, reopening the 1917 Clinic in Alabama meant tracking down patients who could not participate in telemedicine. Fortunately (or unfortunately, depending on how you look at it), the clinic, which serves a population with a high level of economic insecurity, has worked to get as many phone numbers as possible for each patient. So when the clinic opened back up, staff was able to call family members, friends, and trusted contacts to bring their patients back into the clinic.

“No one wanted to reopen too quickly,” said Dr. Dionne-Odom. “But having people come in allowed us to do all the other things that are the key part of HIV care: getting them connected with a social worker and making sure they have enough food, helping them with their electricity bills and their housing issues, all the wrap-around services that are so crucial for these patients.”

This article first appeared on Medscape.com.

When the COVID-19 pandemic led to a blanket shelter-in-place order in California in March, it did more than shut down in-person visits at Ward 86, the HIV clinic for publicly insured patients at San Francisco General Hospital. It also led to a decrease in viral suppression among the clinic›s clients. By the end of June, the percentage of patients with an undetectable viral load had dropped by nearly one-third.

This is exactly what Monica Gandhi, MD, associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, and medical director of the clinic, was afraid of.

“We’re profoundly worried about the impact of COVID-19 on actual treatment outcomes,” said Dr. Gandhi, cochair of the virtual International AIDS Conference (AIDS) 2020.

And it’s not just the clinic’s clients at risk. Of the 106 countries served by the Global Fund to Fight HIV, Tuberculosis, and Malaria, 85% saw disruptions in HIV programs, according to a report released last month.

These service disruptions are considerable and “life threatening,” affecting some of the people at greatest risk for HIV acquisition and poor outcomes – such as people engaged in transactional sex (40%), men who have sex with men (37%), and transgender people (31%) – the 2020 Global AIDS Update, released today by UNAIDS, reports.

“In sub-Saharan Africa alone, if there is a 6-month interruption in HIV treatment services, it will account for an additional 500,000 deaths. That doubles the number of deaths in sub-Saharan Africa alone and brings us back to 2008 mortality levels,” said Shannon Hader, MD, deputy executive director of UNAIDS. “We just can’t allow that to happen.”

In addition, 73 countries are at risk of running out of HIV medications, according to a World Health Organization report, also released today.
 

Quantifying the impact

The impact is not the same for all patients, said Anton Pozniak, MD, consulting physician in HIV medicine at the Chelsea and Westminster Hospital in London, and international cochair of AIDS 2020.

For some, COVID-19 has not changed much. Their viral loads remain undetectable and all they need is multimonth supplies of their antiretroviral therapy (ART) medications, he told Medscape Medical News. Still, he said he worries about the well-documented effects that social isolation is having on the mental health of these patients, and the increase in substance use associated with the pandemic.

Then there is a small group of patients with HIV who had put off starting ART before the pandemic, but now want to start, he reported.

And finally, there are the people for whom the fear of COVID-19 has crippled their ability to get care.

There are people who have decided they don’t want to come to the hospital or come to the clinic because they’re scared of getting COVID-19.

“It’s really very striking,” said Dr. Pozniak. “There are people who have decided they don’t want to come to the hospital or come to the clinic because they’re scared of getting COVID-19. We’ve offered to deliver treatment, but they don’t want the stigma of parcels of drugs arriving.”

In a study presented at the conference, four of 12 care and substance-use treatment facilities in Europe and North America – including Seattle and Philadelphia – reported patients taking longer to fill ART prescriptions. And four of the 12 also reported that clients who injected drugs and were at risk for or living with HIV were having trouble adhering to prescribed therapies. In addition, at 11 of the sites, HIV testing has either nearly or completely shut down.
 

Structural barriers to telemedicine

And then there are structural barriers to care – poverty, lack of transportation, lack of or slow internet access, and lack of insurance – which affect 10% to 20% of the people with HIV that Jodie Dionne-Odom, MD, sees at the 1917 Ryan White HIV clinic at the University of Alabama at Birmingham.

These are the patients she said she worries about most, the ones who, even before COVID-19, were barely managing to pay their rent, car payments, and cell phone bills.

“With COVID-19 and being at home or being laid off, those things could no longer be paid. They’ve lost their phone, they’ve lost their car,” said Dionne-Odom, chief of women’s health services for the clinic. “That’s a really significant impact, because that’s exactly the group you can’t reach by telemedicine.”

In March, when the 1917 Clinic began providing the majority of services online, these people fell off the radar, said Aadia Rana, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, who also works at the clinic.

This is not for lack of trying, she explained. Staff called patients weekly to check in and reschedule appointments, but there were some they just couldn’t reach.

Although the data for the second quarter have not yet been analyzed, “I would expect that our typically close to 90% viral suppression rate is going to decrease,” she said.

This decrease is likely widespread, said Rana, who is principle investigator of the Long-Acting Therapy to Improve Treatment Success in Daily Life (LATITUDE) study.

Many of the 33 sites involved in LATITUDE shut down in the early months of the pandemic, but some are now coming back online. In fact, “we are getting all these pleas from sites around the country saying, ‘Hey, once LATITUDE is open for enrollment, we have so many people who would now be eligible’,” she told Medscape Medical News.

“Why are they now eligible and they weren’t eligible before? I’m assuming it’s because they now have a detectable viral load,” which is one of the requirements for enrollment in LATITUDE, she explained.
 

Impact on the LGBTI community

At the onset of the COVID-19 pandemic, Erik Lamontagne, senior economist at UNAIDS, wondered how the quarantine was affecting LGBTI people.

To find out, he and his colleagues launched a survey asking just that. He is also coprinciple investigator of the LGBT Happiness Survey, a multicountry survey of LGBTI people launched last year.

The 13,562 LGBTI respondents came from 138 countries or territories. Of the 1,140 respondents living with HIV, 26% had seen their HIV care disrupted or restricted in some way during the pandemic, and 55% of those had no more than a month’s worth of HIV medications on hand.

But the pandemic hasn’t just affected people already living with HIV, Mr. Lamontagne reported. Nine of 10 respondents were living under some form of stay-at-home order, 73% were not meeting their basic needs, 37% had missed meals as a result of economic hardship, and half of those who were still working expected to lose their jobs.

Many could not afford to quarantine, Mr. Lamontagne told Medscape Medical News. And financial resources were stretched so thin that about 1% of respondents reported engaging in transactional sex for the first time. Some reported that their economic circumstances were so dire that they couldn’t require clients to wear condoms, increasing their risk for both COVID-19 and HIV.

“What they can eat in the evening is what they can earn during the day,” Mr. Lamontagne explained.

Unfortunately, it is the people already in a situation of economic vulnerability – often those from the LGBTI community – who are most affected by COVID-19, he added.
 

PrEP use changing

The pandemic has also affected the use of pre-exposure prophylaxis (PrEP).

South African women taking PrEP to protect themselves from HIV during pregnancy were 2.36 times more likely to miss a clinic visit to refill their prescription after COVID-19 lockdowns began than before, data presented at the conference showed. The women cited fear of acquiring COVID-19 at the medical facility, fear of police, transportation barriers, and long clinic wait times to explain the missed visits.

A study on the use of PrEP at Fenway Health, a sexual health clinic in Boston, showed a 278% increase in unfilled PrEP prescriptions after stay-at-home orders and a 72.1% drop in new PrEP prescriptions.

It’s unclear what these data, which will be presented at the conference later this week, mean, said Douglas Krakower, MD, assistant professor of medicine and population medicine at Harvard Medical School in Boston.

“We don’t know whether this represents people having trouble accessing PrEP” out of concern about getting COVID “or concerns about financial implications,” he explained.

“They may have had hardships from unemployment or other financial constraints” and have lost insurance or are still having to pay copays, he told Medscape Medical News. Or it could just be that they’re not going out or having sex, so they’ve discontinued the medication.

“Anecdotally we’ve heard that some patients are sheltering in place and not having sex and so have chosen not to use PrEP,” he added.

It’s also possible that people are rationing pills or have moved themselves to the PrEP 2-1-1 protocol, which is used only when someone is having sex, said Dr. Krakower, citing a study showing that sexual behavior is continuing as usual during quarantine for about half the gay men in the United States.
 

Resilience and fragility

It’s not just people living with HIV whose routines have changed during the pandemic. A survey of HIV clinicians around the world conducted by the International Association of Providers of AIDS Care showed that 88% of HIV clinicians have been pulled away from their regular work to manage COVID-19 in their communities.

But the COVID-19 pandemic shows no signs of stopping, and clinicians are now having to re-engage with their HIV patients.

“What COVID-19 has represented for us is a looking glass to see the resilience, but also the fragility, in HIV responses, not just in the global south, but also in the global north,” José Zuniga, PhD, IAPAC president and chief executive officer, said during a preconference session on controlling the HIV epidemic.

For Dr. Dionne-Odom, reopening the 1917 Clinic in Alabama meant tracking down patients who could not participate in telemedicine. Fortunately (or unfortunately, depending on how you look at it), the clinic, which serves a population with a high level of economic insecurity, has worked to get as many phone numbers as possible for each patient. So when the clinic opened back up, staff was able to call family members, friends, and trusted contacts to bring their patients back into the clinic.

“No one wanted to reopen too quickly,” said Dr. Dionne-Odom. “But having people come in allowed us to do all the other things that are the key part of HIV care: getting them connected with a social worker and making sure they have enough food, helping them with their electricity bills and their housing issues, all the wrap-around services that are so crucial for these patients.”

This article first appeared on Medscape.com.

When the COVID-19 pandemic led to a blanket shelter-in-place order in California in March, it did more than shut down in-person visits at Ward 86, the HIV clinic for publicly insured patients at San Francisco General Hospital. It also led to a decrease in viral suppression among the clinic›s clients. By the end of June, the percentage of patients with an undetectable viral load had dropped by nearly one-third.

This is exactly what Monica Gandhi, MD, associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, and medical director of the clinic, was afraid of.

“We’re profoundly worried about the impact of COVID-19 on actual treatment outcomes,” said Dr. Gandhi, cochair of the virtual International AIDS Conference (AIDS) 2020.

And it’s not just the clinic’s clients at risk. Of the 106 countries served by the Global Fund to Fight HIV, Tuberculosis, and Malaria, 85% saw disruptions in HIV programs, according to a report released last month.

These service disruptions are considerable and “life threatening,” affecting some of the people at greatest risk for HIV acquisition and poor outcomes – such as people engaged in transactional sex (40%), men who have sex with men (37%), and transgender people (31%) – the 2020 Global AIDS Update, released today by UNAIDS, reports.

“In sub-Saharan Africa alone, if there is a 6-month interruption in HIV treatment services, it will account for an additional 500,000 deaths. That doubles the number of deaths in sub-Saharan Africa alone and brings us back to 2008 mortality levels,” said Shannon Hader, MD, deputy executive director of UNAIDS. “We just can’t allow that to happen.”

In addition, 73 countries are at risk of running out of HIV medications, according to a World Health Organization report, also released today.
 

Quantifying the impact

The impact is not the same for all patients, said Anton Pozniak, MD, consulting physician in HIV medicine at the Chelsea and Westminster Hospital in London, and international cochair of AIDS 2020.

For some, COVID-19 has not changed much. Their viral loads remain undetectable and all they need is multimonth supplies of their antiretroviral therapy (ART) medications, he told Medscape Medical News. Still, he said he worries about the well-documented effects that social isolation is having on the mental health of these patients, and the increase in substance use associated with the pandemic.

Then there is a small group of patients with HIV who had put off starting ART before the pandemic, but now want to start, he reported.

And finally, there are the people for whom the fear of COVID-19 has crippled their ability to get care.

There are people who have decided they don’t want to come to the hospital or come to the clinic because they’re scared of getting COVID-19.

“It’s really very striking,” said Dr. Pozniak. “There are people who have decided they don’t want to come to the hospital or come to the clinic because they’re scared of getting COVID-19. We’ve offered to deliver treatment, but they don’t want the stigma of parcels of drugs arriving.”

In a study presented at the conference, four of 12 care and substance-use treatment facilities in Europe and North America – including Seattle and Philadelphia – reported patients taking longer to fill ART prescriptions. And four of the 12 also reported that clients who injected drugs and were at risk for or living with HIV were having trouble adhering to prescribed therapies. In addition, at 11 of the sites, HIV testing has either nearly or completely shut down.
 

Structural barriers to telemedicine

And then there are structural barriers to care – poverty, lack of transportation, lack of or slow internet access, and lack of insurance – which affect 10% to 20% of the people with HIV that Jodie Dionne-Odom, MD, sees at the 1917 Ryan White HIV clinic at the University of Alabama at Birmingham.

These are the patients she said she worries about most, the ones who, even before COVID-19, were barely managing to pay their rent, car payments, and cell phone bills.

“With COVID-19 and being at home or being laid off, those things could no longer be paid. They’ve lost their phone, they’ve lost their car,” said Dionne-Odom, chief of women’s health services for the clinic. “That’s a really significant impact, because that’s exactly the group you can’t reach by telemedicine.”

In March, when the 1917 Clinic began providing the majority of services online, these people fell off the radar, said Aadia Rana, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, who also works at the clinic.

This is not for lack of trying, she explained. Staff called patients weekly to check in and reschedule appointments, but there were some they just couldn’t reach.

Although the data for the second quarter have not yet been analyzed, “I would expect that our typically close to 90% viral suppression rate is going to decrease,” she said.

This decrease is likely widespread, said Rana, who is principle investigator of the Long-Acting Therapy to Improve Treatment Success in Daily Life (LATITUDE) study.

Many of the 33 sites involved in LATITUDE shut down in the early months of the pandemic, but some are now coming back online. In fact, “we are getting all these pleas from sites around the country saying, ‘Hey, once LATITUDE is open for enrollment, we have so many people who would now be eligible’,” she told Medscape Medical News.

“Why are they now eligible and they weren’t eligible before? I’m assuming it’s because they now have a detectable viral load,” which is one of the requirements for enrollment in LATITUDE, she explained.
 

Impact on the LGBTI community

At the onset of the COVID-19 pandemic, Erik Lamontagne, senior economist at UNAIDS, wondered how the quarantine was affecting LGBTI people.

To find out, he and his colleagues launched a survey asking just that. He is also coprinciple investigator of the LGBT Happiness Survey, a multicountry survey of LGBTI people launched last year.

The 13,562 LGBTI respondents came from 138 countries or territories. Of the 1,140 respondents living with HIV, 26% had seen their HIV care disrupted or restricted in some way during the pandemic, and 55% of those had no more than a month’s worth of HIV medications on hand.

But the pandemic hasn’t just affected people already living with HIV, Mr. Lamontagne reported. Nine of 10 respondents were living under some form of stay-at-home order, 73% were not meeting their basic needs, 37% had missed meals as a result of economic hardship, and half of those who were still working expected to lose their jobs.

Many could not afford to quarantine, Mr. Lamontagne told Medscape Medical News. And financial resources were stretched so thin that about 1% of respondents reported engaging in transactional sex for the first time. Some reported that their economic circumstances were so dire that they couldn’t require clients to wear condoms, increasing their risk for both COVID-19 and HIV.

“What they can eat in the evening is what they can earn during the day,” Mr. Lamontagne explained.

Unfortunately, it is the people already in a situation of economic vulnerability – often those from the LGBTI community – who are most affected by COVID-19, he added.
 

PrEP use changing

The pandemic has also affected the use of pre-exposure prophylaxis (PrEP).

South African women taking PrEP to protect themselves from HIV during pregnancy were 2.36 times more likely to miss a clinic visit to refill their prescription after COVID-19 lockdowns began than before, data presented at the conference showed. The women cited fear of acquiring COVID-19 at the medical facility, fear of police, transportation barriers, and long clinic wait times to explain the missed visits.

A study on the use of PrEP at Fenway Health, a sexual health clinic in Boston, showed a 278% increase in unfilled PrEP prescriptions after stay-at-home orders and a 72.1% drop in new PrEP prescriptions.

It’s unclear what these data, which will be presented at the conference later this week, mean, said Douglas Krakower, MD, assistant professor of medicine and population medicine at Harvard Medical School in Boston.

“We don’t know whether this represents people having trouble accessing PrEP” out of concern about getting COVID “or concerns about financial implications,” he explained.

“They may have had hardships from unemployment or other financial constraints” and have lost insurance or are still having to pay copays, he told Medscape Medical News. Or it could just be that they’re not going out or having sex, so they’ve discontinued the medication.

“Anecdotally we’ve heard that some patients are sheltering in place and not having sex and so have chosen not to use PrEP,” he added.

It’s also possible that people are rationing pills or have moved themselves to the PrEP 2-1-1 protocol, which is used only when someone is having sex, said Dr. Krakower, citing a study showing that sexual behavior is continuing as usual during quarantine for about half the gay men in the United States.
 

Resilience and fragility

It’s not just people living with HIV whose routines have changed during the pandemic. A survey of HIV clinicians around the world conducted by the International Association of Providers of AIDS Care showed that 88% of HIV clinicians have been pulled away from their regular work to manage COVID-19 in their communities.

But the COVID-19 pandemic shows no signs of stopping, and clinicians are now having to re-engage with their HIV patients.

“What COVID-19 has represented for us is a looking glass to see the resilience, but also the fragility, in HIV responses, not just in the global south, but also in the global north,” José Zuniga, PhD, IAPAC president and chief executive officer, said during a preconference session on controlling the HIV epidemic.

For Dr. Dionne-Odom, reopening the 1917 Clinic in Alabama meant tracking down patients who could not participate in telemedicine. Fortunately (or unfortunately, depending on how you look at it), the clinic, which serves a population with a high level of economic insecurity, has worked to get as many phone numbers as possible for each patient. So when the clinic opened back up, staff was able to call family members, friends, and trusted contacts to bring their patients back into the clinic.

“No one wanted to reopen too quickly,” said Dr. Dionne-Odom. “But having people come in allowed us to do all the other things that are the key part of HIV care: getting them connected with a social worker and making sure they have enough food, helping them with their electricity bills and their housing issues, all the wrap-around services that are so crucial for these patients.”

This article first appeared on Medscape.com.