In human papillomavirus (HPV)-positive, locally advanced oropharyngeal squamous cell carcinoma, an immune checkpoint blockade regimen combined with radiotherapy led to good survival with a reduction in radiation exposure.

First-line therapy for HPV-positive oropharynx cancer is generally high-dose cisplatin combined with high-dose radiotherapy, but this regimen is associated with significant acute and long-term toxicity.

In previous studies among patients with recurrent or metastatic squamous cell carcinoma, nivolumab (Opdiva, Bristol Myers Squibb) improved survival when combined with platinum-based chemotherapy, and pembrolizumab (Keytruda, Merck) improved survival in recurrent disease compared with chemotherapy plus cetuximab.

Those precedents predicted success for HPV-positive oropharynx cancer, according to Maura Gillison, MD, PhD, who presented the results at a press briefing held in November in advance of the Society for Immunotherapy of Cancer’s 37th Annual Meeting. “Given that HPV-positive oropharynx cancers are characterized by an inflamed tumor microenvironment and HPV oncoproteins are omnipresent, required for cancer survival, and are ideal tumor-specific antigens – we hypothesized that induction and concurrent CTLA-4 and PD-1 immune checkpoint blockade, followed by volume- and dose-adapted IMRT (intensity-modulated radiotherapy), would be an effective alternative to the current standard of care,” said Dr. Gillison, who is a professor of medicine at the University of Texas MD Anderson Cancer Center, Houston.

Anti–PD-L1 therapy is approved for head and neck cancer, but the frontier is moving it into the locally advanced setting in combination with CTLA-4 inhibitors, according to Robert Ferris, MD, PhD, who moderated the press briefing and was lead author of the nivolumab in metastatic squamous cell carcinoma study. He added that recent trial data suggest this approach should be more effective and create more durable responses.

The new data support the approach. “The trial provides compelling data to support a new approach for treating newly diagnosed HPV-positive head and neck cancers. Our goal is to treat this cancer with immunotherapy alone. The results of this trial make me optimistic that this will be achievable,” Dr. Gillison said.
 

The study details

The researchers conducted a phase 2 clinical trial, enrolling 35 patients with newly diagnosed HPV-positive oropharynx cancer who were positive for PD-L1 expression.

Patients received 1 mg/kg ipilimumab (Yervoy, Bristol Myers Squibb) and 3 mg/kg nivolumab over a 6-week cycle, followed by a second cycle that was accompanied by 40-44 Gy radiotherapy for patients with a complete response in their primary tumor, and a boost to 50-66 based on postinduction treatment volume. The protocol reduced dose to the neck from 52 to 36 Gy. The radiation was delivered to only one nodal echelon beyond the involved node. Standard care delivers radiotherapy to essentially the entire neck, Dr. Gillison said.

Grade 3 or higher adverse events occurred in 66% of patients, the majority of which were attributable to radiotherapy. The complete response rate was 94% at 6 months as assessed by PET scan, and 2-year progression-free survival was 86%. After a median follow-up of 14.9 months, all patients were alive and cancer-free.

Overall response rate was 14% following induction, but 96% showed a histologic treatment effect. Tumor viability was less than 5% in 48% of patients, and a molecular complete response was observed in 30% as measured by plasma cell-free HPV. Patients received 36% less radiation than typical of standard of care, and the dose to critical areas was reduced by 50%.

At the press conference, Dr. Ferris asked Dr. Gillison whether the researchers observed a spike in cell-free HPV DNA before the decline occurred, suggesting evidence of tumor death and DNA release.

“We did see in a remarkable number of patients within 2 weeks of the first dose, a very strong peak in the cell-free HPV DNA, followed by a rapid decline. In those patients who still have viable tumor at the end of induction immunotherapy, we saw a second robust peak in cell-free HPV DNA at the start of radiation, with rapid clearance. So that gave us confidence that (among) those patients who had cell-free HPV clearance by the end of induction, followed by no further detection through radiation, that it’s an excellent surrogate for tumor control,” Dr. Gillison said.

Dr. Gillison has financial relationships with Eisai, Exilixis, Caladrius, iTeos, Istari, Seagen, Sensei, Bicara, Mirati, Coherus, Debiopharm, Kura, Shattuck, Nektar, Ipsen, EMD Serono, Gilead, LXS, BioNTech, Merck, Bristol Myers Squibb, Bayer, Roche, Genocea, NewLink Genetics, Aspyrian, TRM Oncology, Amgen, AstraZeneca, Celgene, and Agenus. Dr. Ferris has financial relationships with Bristol Myers Squibb, AstraZeneca/MedImmune, Merck, and Celgene.

In human papillomavirus (HPV)-positive, locally advanced oropharyngeal squamous cell carcinoma, an immune checkpoint blockade regimen combined with radiotherapy led to good survival with a reduction in radiation exposure.

First-line therapy for HPV-positive oropharynx cancer is generally high-dose cisplatin combined with high-dose radiotherapy, but this regimen is associated with significant acute and long-term toxicity.

In previous studies among patients with recurrent or metastatic squamous cell carcinoma, nivolumab (Opdiva, Bristol Myers Squibb) improved survival when combined with platinum-based chemotherapy, and pembrolizumab (Keytruda, Merck) improved survival in recurrent disease compared with chemotherapy plus cetuximab.

Those precedents predicted success for HPV-positive oropharynx cancer, according to Maura Gillison, MD, PhD, who presented the results at a press briefing held in November in advance of the Society for Immunotherapy of Cancer’s 37th Annual Meeting. “Given that HPV-positive oropharynx cancers are characterized by an inflamed tumor microenvironment and HPV oncoproteins are omnipresent, required for cancer survival, and are ideal tumor-specific antigens – we hypothesized that induction and concurrent CTLA-4 and PD-1 immune checkpoint blockade, followed by volume- and dose-adapted IMRT (intensity-modulated radiotherapy), would be an effective alternative to the current standard of care,” said Dr. Gillison, who is a professor of medicine at the University of Texas MD Anderson Cancer Center, Houston.

Anti–PD-L1 therapy is approved for head and neck cancer, but the frontier is moving it into the locally advanced setting in combination with CTLA-4 inhibitors, according to Robert Ferris, MD, PhD, who moderated the press briefing and was lead author of the nivolumab in metastatic squamous cell carcinoma study. He added that recent trial data suggest this approach should be more effective and create more durable responses.

The new data support the approach. “The trial provides compelling data to support a new approach for treating newly diagnosed HPV-positive head and neck cancers. Our goal is to treat this cancer with immunotherapy alone. The results of this trial make me optimistic that this will be achievable,” Dr. Gillison said.
 

The study details

The researchers conducted a phase 2 clinical trial, enrolling 35 patients with newly diagnosed HPV-positive oropharynx cancer who were positive for PD-L1 expression.

Patients received 1 mg/kg ipilimumab (Yervoy, Bristol Myers Squibb) and 3 mg/kg nivolumab over a 6-week cycle, followed by a second cycle that was accompanied by 40-44 Gy radiotherapy for patients with a complete response in their primary tumor, and a boost to 50-66 based on postinduction treatment volume. The protocol reduced dose to the neck from 52 to 36 Gy. The radiation was delivered to only one nodal echelon beyond the involved node. Standard care delivers radiotherapy to essentially the entire neck, Dr. Gillison said.

Grade 3 or higher adverse events occurred in 66% of patients, the majority of which were attributable to radiotherapy. The complete response rate was 94% at 6 months as assessed by PET scan, and 2-year progression-free survival was 86%. After a median follow-up of 14.9 months, all patients were alive and cancer-free.

Overall response rate was 14% following induction, but 96% showed a histologic treatment effect. Tumor viability was less than 5% in 48% of patients, and a molecular complete response was observed in 30% as measured by plasma cell-free HPV. Patients received 36% less radiation than typical of standard of care, and the dose to critical areas was reduced by 50%.

At the press conference, Dr. Ferris asked Dr. Gillison whether the researchers observed a spike in cell-free HPV DNA before the decline occurred, suggesting evidence of tumor death and DNA release.

“We did see in a remarkable number of patients within 2 weeks of the first dose, a very strong peak in the cell-free HPV DNA, followed by a rapid decline. In those patients who still have viable tumor at the end of induction immunotherapy, we saw a second robust peak in cell-free HPV DNA at the start of radiation, with rapid clearance. So that gave us confidence that (among) those patients who had cell-free HPV clearance by the end of induction, followed by no further detection through radiation, that it’s an excellent surrogate for tumor control,” Dr. Gillison said.

Dr. Gillison has financial relationships with Eisai, Exilixis, Caladrius, iTeos, Istari, Seagen, Sensei, Bicara, Mirati, Coherus, Debiopharm, Kura, Shattuck, Nektar, Ipsen, EMD Serono, Gilead, LXS, BioNTech, Merck, Bristol Myers Squibb, Bayer, Roche, Genocea, NewLink Genetics, Aspyrian, TRM Oncology, Amgen, AstraZeneca, Celgene, and Agenus. Dr. Ferris has financial relationships with Bristol Myers Squibb, AstraZeneca/MedImmune, Merck, and Celgene.

In human papillomavirus (HPV)-positive, locally advanced oropharyngeal squamous cell carcinoma, an immune checkpoint blockade regimen combined with radiotherapy led to good survival with a reduction in radiation exposure.

First-line therapy for HPV-positive oropharynx cancer is generally high-dose cisplatin combined with high-dose radiotherapy, but this regimen is associated with significant acute and long-term toxicity.

In previous studies among patients with recurrent or metastatic squamous cell carcinoma, nivolumab (Opdiva, Bristol Myers Squibb) improved survival when combined with platinum-based chemotherapy, and pembrolizumab (Keytruda, Merck) improved survival in recurrent disease compared with chemotherapy plus cetuximab.

Those precedents predicted success for HPV-positive oropharynx cancer, according to Maura Gillison, MD, PhD, who presented the results at a press briefing held in November in advance of the Society for Immunotherapy of Cancer’s 37th Annual Meeting. “Given that HPV-positive oropharynx cancers are characterized by an inflamed tumor microenvironment and HPV oncoproteins are omnipresent, required for cancer survival, and are ideal tumor-specific antigens – we hypothesized that induction and concurrent CTLA-4 and PD-1 immune checkpoint blockade, followed by volume- and dose-adapted IMRT (intensity-modulated radiotherapy), would be an effective alternative to the current standard of care,” said Dr. Gillison, who is a professor of medicine at the University of Texas MD Anderson Cancer Center, Houston.

Anti–PD-L1 therapy is approved for head and neck cancer, but the frontier is moving it into the locally advanced setting in combination with CTLA-4 inhibitors, according to Robert Ferris, MD, PhD, who moderated the press briefing and was lead author of the nivolumab in metastatic squamous cell carcinoma study. He added that recent trial data suggest this approach should be more effective and create more durable responses.

The new data support the approach. “The trial provides compelling data to support a new approach for treating newly diagnosed HPV-positive head and neck cancers. Our goal is to treat this cancer with immunotherapy alone. The results of this trial make me optimistic that this will be achievable,” Dr. Gillison said.
 

The study details

The researchers conducted a phase 2 clinical trial, enrolling 35 patients with newly diagnosed HPV-positive oropharynx cancer who were positive for PD-L1 expression.

Patients received 1 mg/kg ipilimumab (Yervoy, Bristol Myers Squibb) and 3 mg/kg nivolumab over a 6-week cycle, followed by a second cycle that was accompanied by 40-44 Gy radiotherapy for patients with a complete response in their primary tumor, and a boost to 50-66 based on postinduction treatment volume. The protocol reduced dose to the neck from 52 to 36 Gy. The radiation was delivered to only one nodal echelon beyond the involved node. Standard care delivers radiotherapy to essentially the entire neck, Dr. Gillison said.

Grade 3 or higher adverse events occurred in 66% of patients, the majority of which were attributable to radiotherapy. The complete response rate was 94% at 6 months as assessed by PET scan, and 2-year progression-free survival was 86%. After a median follow-up of 14.9 months, all patients were alive and cancer-free.

Overall response rate was 14% following induction, but 96% showed a histologic treatment effect. Tumor viability was less than 5% in 48% of patients, and a molecular complete response was observed in 30% as measured by plasma cell-free HPV. Patients received 36% less radiation than typical of standard of care, and the dose to critical areas was reduced by 50%.

At the press conference, Dr. Ferris asked Dr. Gillison whether the researchers observed a spike in cell-free HPV DNA before the decline occurred, suggesting evidence of tumor death and DNA release.

“We did see in a remarkable number of patients within 2 weeks of the first dose, a very strong peak in the cell-free HPV DNA, followed by a rapid decline. In those patients who still have viable tumor at the end of induction immunotherapy, we saw a second robust peak in cell-free HPV DNA at the start of radiation, with rapid clearance. So that gave us confidence that (among) those patients who had cell-free HPV clearance by the end of induction, followed by no further detection through radiation, that it’s an excellent surrogate for tumor control,” Dr. Gillison said.

Dr. Gillison has financial relationships with Eisai, Exilixis, Caladrius, iTeos, Istari, Seagen, Sensei, Bicara, Mirati, Coherus, Debiopharm, Kura, Shattuck, Nektar, Ipsen, EMD Serono, Gilead, LXS, BioNTech, Merck, Bristol Myers Squibb, Bayer, Roche, Genocea, NewLink Genetics, Aspyrian, TRM Oncology, Amgen, AstraZeneca, Celgene, and Agenus. Dr. Ferris has financial relationships with Bristol Myers Squibb, AstraZeneca/MedImmune, Merck, and Celgene.

Latinx individuals have a lower overall risk of melanoma than non-Latinx Whites (NLW), but they are more likely to be diagnosed with advanced disease, and experience greater mortality. A new qualitative study of Latinx and low-income NLW individuals in California has revealed some of the socioeconomic and community factors that may play a role in preventing early access to care.

Thicker melanomas, which are more likely to be lethal, are on the rise in the United States among people with lower socioeconomic status (SES), as well as African Americans and Hispanics, and both Black and Latinx people are more likely than NLW people to present with stage 3 or stage 4 disease. “That has really prompted us to look at community engagement and outreach and then really understand the qualitative aspects that are driving individuals into higher risk for melanoma, apart from just limited insurance and access to health care,” said Susan Swetter, MD, who presented the results of the study at the annual meeting of the American Society of Clinical Oncology.

Other studies, such as a Boston-area survey published in 2020, suggest that Hispanics are less likely than Whites to know the meaning of the term melanoma (odds ratio, 0.27; P =.0037), suggesting the need for educational efforts. The authors of that study noted that knowledge of melanoma in 2017, when the survey was conducted, remained essentially unchanged since a previous study was published in 1996.

“Our results support a need for better public educational programs, particularly those geared toward minority populations. Educational programs that are culturally relevant and include specific sections for skin of color have been shown to better promote early melanoma detection in individuals of ethnic minorities and may help decrease the ethnic disparities in melanoma-related mortality. At the patient-physician level, dermatologists may educate their patients, including Hispanic patients, should they choose to perform (skin self-examinations) to specifically inspect the extremities and acral areas, given the higher incidence rates of melanoma on those areas in this population,” the authors wrote.

The goal of the new study is to get a better understanding of the factors that affect attitudes toward health care, and the researchers found a complex mixture that including ethnicity, cultural, gender identity, geography, skin color, gender norms, and socioeconomic status (SES). “Qualitative research can inform our preventive and early detection strategies. For instance, in the Latinx group, there’s a lot of mistrust of health systems, medical providers, and who is providing that knowledge. We have to figure out ways to provide a trusted source of information. Doctors and physicians and health providers tend to be trusted, but there are many barriers to getting lower SES patients into care. We’re now investigating the use of community health workers and even individuals in various settings and community centers, religious settings or religious leaders, where we’ve determined through this focus group research that there is increased trust,” Dr. Swetter said.

The researchers assembled 19 focus groups with 176 total adult participants, interviewing them about perceptions of melanoma risk, prevention and screening strategies and their acceptability, and barriers to melanoma prevention and care. The sample include people from urban and semirural areas; 55%-62% of participants self-identified as Latinx or Hispanic and 26%-27% as NLW.

Latinx and semirural participants reported having minimal conversations with family about melanoma prevention, and those who reported having darker skin perceived their risk from skin cancer as lower. Participants who lived in rural areas, were Latinx, or of low SES status indicated that health care access challenges included out-of-pocket costs, past experiences of physicians showing less concern about them, and little confidence that rural physicians had the needed expertise or would make an appropriate referral.

The study is just the first step in a series of efforts to improve melanoma outcomes in high-risk populations, which is being pursued through Stanford University’s Wipe Out Melanoma–California statewide initiative and research consortium. “What we aim to do is use this knowledge to now design programs to reach the populations who are more likely to present with worse disease, and to prevent that disease from happening. These qualitative analyses are few and far between in the world of melanoma, and we’re really happy to really push this envelope and change the way we deliver preventive and early detection efforts,” said Dr. Swetter, who is a professor of dermatology and director of the pigmented lesion/melanoma and cutaneous oncology programs at Stanford (Calif.) University Medical Center. Dr. Swetter also chairs the National Comprehensive Cancer Network guidelines for cutaneous melanoma.

The study could also improve care of advanced melanoma. “There’s clear evidence that many of these patient and SES factors, economic and knowledge barriers are the same when it comes to getting patients with advanced melanoma into appropriate care and on clinical trials, and that’s true across all races and ethnicities,” said Dr. Swetter.

The ultimate goal of these approaches is to give individuals greater “self-efficacy, such that a person feels more competent to manage his or her own health outcomes. One aspect of this approach is the use of novel technology such as smartphone apps that can track moles or help visualize lesions during teledermatology. “I think that the future of melanoma prevention and early detection is bright, especially if we incorporate novel technologies and engage patients and their communities in the effort. It’s a different strategy, as opposed to the top-down approach of physicians imparting knowledge and providing the exam. Increasing community engagement is critical to reaching the populations at highest risk for advanced disease and getting them into care and detection early,” Dr. Swetter said.

Dr. Swetter has no relevant financial disclosures.

Latinx individuals have a lower overall risk of melanoma than non-Latinx Whites (NLW), but they are more likely to be diagnosed with advanced disease, and experience greater mortality. A new qualitative study of Latinx and low-income NLW individuals in California has revealed some of the socioeconomic and community factors that may play a role in preventing early access to care.

Thicker melanomas, which are more likely to be lethal, are on the rise in the United States among people with lower socioeconomic status (SES), as well as African Americans and Hispanics, and both Black and Latinx people are more likely than NLW people to present with stage 3 or stage 4 disease. “That has really prompted us to look at community engagement and outreach and then really understand the qualitative aspects that are driving individuals into higher risk for melanoma, apart from just limited insurance and access to health care,” said Susan Swetter, MD, who presented the results of the study at the annual meeting of the American Society of Clinical Oncology.

Other studies, such as a Boston-area survey published in 2020, suggest that Hispanics are less likely than Whites to know the meaning of the term melanoma (odds ratio, 0.27; P =.0037), suggesting the need for educational efforts. The authors of that study noted that knowledge of melanoma in 2017, when the survey was conducted, remained essentially unchanged since a previous study was published in 1996.

“Our results support a need for better public educational programs, particularly those geared toward minority populations. Educational programs that are culturally relevant and include specific sections for skin of color have been shown to better promote early melanoma detection in individuals of ethnic minorities and may help decrease the ethnic disparities in melanoma-related mortality. At the patient-physician level, dermatologists may educate their patients, including Hispanic patients, should they choose to perform (skin self-examinations) to specifically inspect the extremities and acral areas, given the higher incidence rates of melanoma on those areas in this population,” the authors wrote.

The goal of the new study is to get a better understanding of the factors that affect attitudes toward health care, and the researchers found a complex mixture that including ethnicity, cultural, gender identity, geography, skin color, gender norms, and socioeconomic status (SES). “Qualitative research can inform our preventive and early detection strategies. For instance, in the Latinx group, there’s a lot of mistrust of health systems, medical providers, and who is providing that knowledge. We have to figure out ways to provide a trusted source of information. Doctors and physicians and health providers tend to be trusted, but there are many barriers to getting lower SES patients into care. We’re now investigating the use of community health workers and even individuals in various settings and community centers, religious settings or religious leaders, where we’ve determined through this focus group research that there is increased trust,” Dr. Swetter said.

The researchers assembled 19 focus groups with 176 total adult participants, interviewing them about perceptions of melanoma risk, prevention and screening strategies and their acceptability, and barriers to melanoma prevention and care. The sample include people from urban and semirural areas; 55%-62% of participants self-identified as Latinx or Hispanic and 26%-27% as NLW.

Latinx and semirural participants reported having minimal conversations with family about melanoma prevention, and those who reported having darker skin perceived their risk from skin cancer as lower. Participants who lived in rural areas, were Latinx, or of low SES status indicated that health care access challenges included out-of-pocket costs, past experiences of physicians showing less concern about them, and little confidence that rural physicians had the needed expertise or would make an appropriate referral.

The study is just the first step in a series of efforts to improve melanoma outcomes in high-risk populations, which is being pursued through Stanford University’s Wipe Out Melanoma–California statewide initiative and research consortium. “What we aim to do is use this knowledge to now design programs to reach the populations who are more likely to present with worse disease, and to prevent that disease from happening. These qualitative analyses are few and far between in the world of melanoma, and we’re really happy to really push this envelope and change the way we deliver preventive and early detection efforts,” said Dr. Swetter, who is a professor of dermatology and director of the pigmented lesion/melanoma and cutaneous oncology programs at Stanford (Calif.) University Medical Center. Dr. Swetter also chairs the National Comprehensive Cancer Network guidelines for cutaneous melanoma.

The study could also improve care of advanced melanoma. “There’s clear evidence that many of these patient and SES factors, economic and knowledge barriers are the same when it comes to getting patients with advanced melanoma into appropriate care and on clinical trials, and that’s true across all races and ethnicities,” said Dr. Swetter.

The ultimate goal of these approaches is to give individuals greater “self-efficacy, such that a person feels more competent to manage his or her own health outcomes. One aspect of this approach is the use of novel technology such as smartphone apps that can track moles or help visualize lesions during teledermatology. “I think that the future of melanoma prevention and early detection is bright, especially if we incorporate novel technologies and engage patients and their communities in the effort. It’s a different strategy, as opposed to the top-down approach of physicians imparting knowledge and providing the exam. Increasing community engagement is critical to reaching the populations at highest risk for advanced disease and getting them into care and detection early,” Dr. Swetter said.

Dr. Swetter has no relevant financial disclosures.

Latinx individuals have a lower overall risk of melanoma than non-Latinx Whites (NLW), but they are more likely to be diagnosed with advanced disease, and experience greater mortality. A new qualitative study of Latinx and low-income NLW individuals in California has revealed some of the socioeconomic and community factors that may play a role in preventing early access to care.

Thicker melanomas, which are more likely to be lethal, are on the rise in the United States among people with lower socioeconomic status (SES), as well as African Americans and Hispanics, and both Black and Latinx people are more likely than NLW people to present with stage 3 or stage 4 disease. “That has really prompted us to look at community engagement and outreach and then really understand the qualitative aspects that are driving individuals into higher risk for melanoma, apart from just limited insurance and access to health care,” said Susan Swetter, MD, who presented the results of the study at the annual meeting of the American Society of Clinical Oncology.

Other studies, such as a Boston-area survey published in 2020, suggest that Hispanics are less likely than Whites to know the meaning of the term melanoma (odds ratio, 0.27; P =.0037), suggesting the need for educational efforts. The authors of that study noted that knowledge of melanoma in 2017, when the survey was conducted, remained essentially unchanged since a previous study was published in 1996.

“Our results support a need for better public educational programs, particularly those geared toward minority populations. Educational programs that are culturally relevant and include specific sections for skin of color have been shown to better promote early melanoma detection in individuals of ethnic minorities and may help decrease the ethnic disparities in melanoma-related mortality. At the patient-physician level, dermatologists may educate their patients, including Hispanic patients, should they choose to perform (skin self-examinations) to specifically inspect the extremities and acral areas, given the higher incidence rates of melanoma on those areas in this population,” the authors wrote.

The goal of the new study is to get a better understanding of the factors that affect attitudes toward health care, and the researchers found a complex mixture that including ethnicity, cultural, gender identity, geography, skin color, gender norms, and socioeconomic status (SES). “Qualitative research can inform our preventive and early detection strategies. For instance, in the Latinx group, there’s a lot of mistrust of health systems, medical providers, and who is providing that knowledge. We have to figure out ways to provide a trusted source of information. Doctors and physicians and health providers tend to be trusted, but there are many barriers to getting lower SES patients into care. We’re now investigating the use of community health workers and even individuals in various settings and community centers, religious settings or religious leaders, where we’ve determined through this focus group research that there is increased trust,” Dr. Swetter said.

The researchers assembled 19 focus groups with 176 total adult participants, interviewing them about perceptions of melanoma risk, prevention and screening strategies and their acceptability, and barriers to melanoma prevention and care. The sample include people from urban and semirural areas; 55%-62% of participants self-identified as Latinx or Hispanic and 26%-27% as NLW.

Latinx and semirural participants reported having minimal conversations with family about melanoma prevention, and those who reported having darker skin perceived their risk from skin cancer as lower. Participants who lived in rural areas, were Latinx, or of low SES status indicated that health care access challenges included out-of-pocket costs, past experiences of physicians showing less concern about them, and little confidence that rural physicians had the needed expertise or would make an appropriate referral.

The study is just the first step in a series of efforts to improve melanoma outcomes in high-risk populations, which is being pursued through Stanford University’s Wipe Out Melanoma–California statewide initiative and research consortium. “What we aim to do is use this knowledge to now design programs to reach the populations who are more likely to present with worse disease, and to prevent that disease from happening. These qualitative analyses are few and far between in the world of melanoma, and we’re really happy to really push this envelope and change the way we deliver preventive and early detection efforts,” said Dr. Swetter, who is a professor of dermatology and director of the pigmented lesion/melanoma and cutaneous oncology programs at Stanford (Calif.) University Medical Center. Dr. Swetter also chairs the National Comprehensive Cancer Network guidelines for cutaneous melanoma.

The study could also improve care of advanced melanoma. “There’s clear evidence that many of these patient and SES factors, economic and knowledge barriers are the same when it comes to getting patients with advanced melanoma into appropriate care and on clinical trials, and that’s true across all races and ethnicities,” said Dr. Swetter.

The ultimate goal of these approaches is to give individuals greater “self-efficacy, such that a person feels more competent to manage his or her own health outcomes. One aspect of this approach is the use of novel technology such as smartphone apps that can track moles or help visualize lesions during teledermatology. “I think that the future of melanoma prevention and early detection is bright, especially if we incorporate novel technologies and engage patients and their communities in the effort. It’s a different strategy, as opposed to the top-down approach of physicians imparting knowledge and providing the exam. Increasing community engagement is critical to reaching the populations at highest risk for advanced disease and getting them into care and detection early,” Dr. Swetter said.

Dr. Swetter has no relevant financial disclosures.

Two short-course bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis showed “robust evidence” for superior efficacy and less ototoxicity compared to a 9-month injectable control regimen, researchers report.

The findings validate the World Health Organization’s current recommendation of a 9-month, bedaquiline-based oral regimen, “which was based only on observational data,” noted lead author Ruth Goodall, PhD, from the Medical Research Council Clinical Trials Unit at University College London, and colleagues.

The study was published in The Lancet.

The Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB (STREAM) stage 2 study was a randomized, phase 3, noninferiority trial conducted at 13 hospital clinics in seven countries that had prespecified tests for superiority if noninferiority was shown. The study enrolled individuals aged 15 years or older who had rifampicin-resistant TB without fluoroquinolone or aminoglycoside resistance.

The study’s first stage, STREAM stage 1, showed that a 9-month injectable regimen was noninferior to the WHO’s 2011 recommendation of a 20-month injectable regimen. The 9-month regimen was recommended by the WHO in 2016. That recommendation was superceded in 2020 when concerns of hearing loss associated with aminoglycosides prompted the WHO to endorse a 9-month bedaquiline-containing, injectable-free alternative, the authors write.
 

Seeking shorter treatment for better outcomes

STREAM stage 2 used a 9-month injectable regimen as its control. The investigators measured it against a fully oral 9-month bedaquiline-based treatment (primary comparison), as well as a 6-month oral bedaquiline regimen that included 8 weeks of a second-line injectable (secondary comparison).

The 9-month fully oral treatment included levofloxacin, clofazimine, ethambutol, and pyrazinamide for 40 weeks; bedaquiline, high-dose isoniazid, and prothionamide were given for the 16-week intensive phase.

The 6-month regimen included bedaquiline, clofazimine, pyrazinamide, and levofloxacin for 28 weeks, supplemented by high-dose isoniazid with kanamycin for an 8-week intensive phase.

For both comparisons, the primary outcome was favorable status at 76 weeks, defined as cultures that were negative for Mycobacterium tuberculosis without a preceding unfavorable outcome (defined as any death, bacteriologic failure or recurrence, or major treatment change).

Among 517 participants in the modified intention-to-treat population across the study groups, 62% were men, and 38% were women (median age, 32.5 years).

For the primary comparison, 71% of the control group and 83% of the oral regimen group had a favorable outcome.

In the secondary comparison, 69% had a favorable outcome in the control group, compared with 91% of those receiving the 6-month regimen.

Although the rate of grade 3 or 4 adverse events was similar in all three groups, there was significantly less ototoxicity among patients who received the oral regimen, compared with control patients (2% vs. 9%); 4% of those taking the 6-month regimen had hearing loss, compared with 8% of control patients.

Exploratory analyses comparing both bedaquiline-containing regimens revealed a significantly higher proportion of favorable outcomes among participants receiving the 6-month regimen (91%), compared with patients taking the fully oral 9-month regimen (79%). There were no significant differences in the rate of grade 3 or 4 adverse events.

The trial’s main limitation was its open-label design, which might have influenced decisions about treatment change, note the investigators.

“STREAM stage 2 has shown that two short-course, bedaquiline-containing regimens are not only non-inferior but superior to a 9-month injectable-containing regimen,” they conclude.

“The STREAM stage 2 fully oral regimen avoided the toxicity of aminoglycosides, and the 6-month regimen was highly effective, with reduced levels of ototoxicity. These two regimens offer promising treatment options for patients with MDR or rifampicin-resistant tuberculosis,” the authors write.

Dr. Goodall added, “Although both STREAM regimens were very effective, participants experienced relatively high levels of adverse events during the trial (though many of these were likely due to the close laboratory monitoring of the trial).

“While hearing loss was reduced on the 6-month regimen, it was not entirely eliminated,” she said. “Other new regimens in the field containing the medicine linezolid report side effects such as anemia and peripheral neuropathy. So more work needs to be done to ensure the treatment regimens are as safe and tolerable for patients as possible. In addition, even 6 months’ treatment is long for patients to tolerate, and further regimen shortening would be a welcome development for patients and health systems.”
 

‘A revolution in MDR tuberculosis’

“The authors must be commended on completing this challenging high-quality, phase 3, non-inferiority, randomized controlled trial involving 13 health care facilities across Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, and Uganda ... despite the COVID-19 pandemic,” noted Keertan Dheda, MD, PhD, and Christoph Lange, MD, PhD, in an accompanying comment titled, “A Revolution in the Management of Multidrug-Resistant Tuberculosis”.

Although the WHO recently approved an all-oral 6-month bedaquiline, pretomanid, and linezolid plus moxifloxacin (BPaLM) regimen, results from the alternate 6-month regimen examined in STREAM stage 2 “do provide confidence in using 2 months of an injectable as part of a salvage regimen in patients for whom MDR tuberculosis treatment is not successful” or in those with extensively drug-resistant (XDR) or pre-XDR TB, “for whom therapeutic options are few,” noted Dr. Dheda, from the University of Cape Town (South Africa) and the London School of Hygiene and Tropical Medicine, and Dr. Lange, from the University of Lübeck (Germany), Baylor College of Medicine, and Texas Children’s Hospital, both in Houston.

The study authors and the commentators stress that safer and simpler treatments are still needed for MDR TB. “The search is now on for regimens that could further reduce duration, toxicity, and pill burden,” note Dr. Dheda and Dr. Lange.

However, they also note that “substantial resistance” to bedaquiline is already emerging. “Therefore, if we are to protect key drugs from becoming functionally redundant, drug-susceptibility testing capacity will need to be rapidly improved to minimize resistance amplification and onward disease transmission.”

The study was funded by USAID and Janssen Research and Development. Dr. Goodall has disclosed no relevant financial relationships. Dr. Dheda has received funding from the EU and the South African Medical Research Council for studies related to the diagnosis or management of drug-resistant tuberculosis. Dr. Lange is supported by the German Center for Infection Research and has received funding from the European Commission for studies on the development of novel antituberculosis medicines and for studies related to novel diagnostics of tuberculosis; consulting fees from INSMED; speaker’s fees from INSMED, GILEAD, and Janssen; and is a member of the data safety board of trials from Medicines sans Frontiers, all of which are unrelated to the current study.

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

Two short-course bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis showed “robust evidence” for superior efficacy and less ototoxicity compared to a 9-month injectable control regimen, researchers report.

The findings validate the World Health Organization’s current recommendation of a 9-month, bedaquiline-based oral regimen, “which was based only on observational data,” noted lead author Ruth Goodall, PhD, from the Medical Research Council Clinical Trials Unit at University College London, and colleagues.

The study was published in The Lancet.

The Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB (STREAM) stage 2 study was a randomized, phase 3, noninferiority trial conducted at 13 hospital clinics in seven countries that had prespecified tests for superiority if noninferiority was shown. The study enrolled individuals aged 15 years or older who had rifampicin-resistant TB without fluoroquinolone or aminoglycoside resistance.

The study’s first stage, STREAM stage 1, showed that a 9-month injectable regimen was noninferior to the WHO’s 2011 recommendation of a 20-month injectable regimen. The 9-month regimen was recommended by the WHO in 2016. That recommendation was superceded in 2020 when concerns of hearing loss associated with aminoglycosides prompted the WHO to endorse a 9-month bedaquiline-containing, injectable-free alternative, the authors write.
 

Seeking shorter treatment for better outcomes

STREAM stage 2 used a 9-month injectable regimen as its control. The investigators measured it against a fully oral 9-month bedaquiline-based treatment (primary comparison), as well as a 6-month oral bedaquiline regimen that included 8 weeks of a second-line injectable (secondary comparison).

The 9-month fully oral treatment included levofloxacin, clofazimine, ethambutol, and pyrazinamide for 40 weeks; bedaquiline, high-dose isoniazid, and prothionamide were given for the 16-week intensive phase.

The 6-month regimen included bedaquiline, clofazimine, pyrazinamide, and levofloxacin for 28 weeks, supplemented by high-dose isoniazid with kanamycin for an 8-week intensive phase.

For both comparisons, the primary outcome was favorable status at 76 weeks, defined as cultures that were negative for Mycobacterium tuberculosis without a preceding unfavorable outcome (defined as any death, bacteriologic failure or recurrence, or major treatment change).

Among 517 participants in the modified intention-to-treat population across the study groups, 62% were men, and 38% were women (median age, 32.5 years).

For the primary comparison, 71% of the control group and 83% of the oral regimen group had a favorable outcome.

In the secondary comparison, 69% had a favorable outcome in the control group, compared with 91% of those receiving the 6-month regimen.

Although the rate of grade 3 or 4 adverse events was similar in all three groups, there was significantly less ototoxicity among patients who received the oral regimen, compared with control patients (2% vs. 9%); 4% of those taking the 6-month regimen had hearing loss, compared with 8% of control patients.

Exploratory analyses comparing both bedaquiline-containing regimens revealed a significantly higher proportion of favorable outcomes among participants receiving the 6-month regimen (91%), compared with patients taking the fully oral 9-month regimen (79%). There were no significant differences in the rate of grade 3 or 4 adverse events.

The trial’s main limitation was its open-label design, which might have influenced decisions about treatment change, note the investigators.

“STREAM stage 2 has shown that two short-course, bedaquiline-containing regimens are not only non-inferior but superior to a 9-month injectable-containing regimen,” they conclude.

“The STREAM stage 2 fully oral regimen avoided the toxicity of aminoglycosides, and the 6-month regimen was highly effective, with reduced levels of ototoxicity. These two regimens offer promising treatment options for patients with MDR or rifampicin-resistant tuberculosis,” the authors write.

Dr. Goodall added, “Although both STREAM regimens were very effective, participants experienced relatively high levels of adverse events during the trial (though many of these were likely due to the close laboratory monitoring of the trial).

“While hearing loss was reduced on the 6-month regimen, it was not entirely eliminated,” she said. “Other new regimens in the field containing the medicine linezolid report side effects such as anemia and peripheral neuropathy. So more work needs to be done to ensure the treatment regimens are as safe and tolerable for patients as possible. In addition, even 6 months’ treatment is long for patients to tolerate, and further regimen shortening would be a welcome development for patients and health systems.”
 

‘A revolution in MDR tuberculosis’

“The authors must be commended on completing this challenging high-quality, phase 3, non-inferiority, randomized controlled trial involving 13 health care facilities across Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, and Uganda ... despite the COVID-19 pandemic,” noted Keertan Dheda, MD, PhD, and Christoph Lange, MD, PhD, in an accompanying comment titled, “A Revolution in the Management of Multidrug-Resistant Tuberculosis”.

Although the WHO recently approved an all-oral 6-month bedaquiline, pretomanid, and linezolid plus moxifloxacin (BPaLM) regimen, results from the alternate 6-month regimen examined in STREAM stage 2 “do provide confidence in using 2 months of an injectable as part of a salvage regimen in patients for whom MDR tuberculosis treatment is not successful” or in those with extensively drug-resistant (XDR) or pre-XDR TB, “for whom therapeutic options are few,” noted Dr. Dheda, from the University of Cape Town (South Africa) and the London School of Hygiene and Tropical Medicine, and Dr. Lange, from the University of Lübeck (Germany), Baylor College of Medicine, and Texas Children’s Hospital, both in Houston.

The study authors and the commentators stress that safer and simpler treatments are still needed for MDR TB. “The search is now on for regimens that could further reduce duration, toxicity, and pill burden,” note Dr. Dheda and Dr. Lange.

However, they also note that “substantial resistance” to bedaquiline is already emerging. “Therefore, if we are to protect key drugs from becoming functionally redundant, drug-susceptibility testing capacity will need to be rapidly improved to minimize resistance amplification and onward disease transmission.”

The study was funded by USAID and Janssen Research and Development. Dr. Goodall has disclosed no relevant financial relationships. Dr. Dheda has received funding from the EU and the South African Medical Research Council for studies related to the diagnosis or management of drug-resistant tuberculosis. Dr. Lange is supported by the German Center for Infection Research and has received funding from the European Commission for studies on the development of novel antituberculosis medicines and for studies related to novel diagnostics of tuberculosis; consulting fees from INSMED; speaker’s fees from INSMED, GILEAD, and Janssen; and is a member of the data safety board of trials from Medicines sans Frontiers, all of which are unrelated to the current study.

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

Two short-course bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis showed “robust evidence” for superior efficacy and less ototoxicity compared to a 9-month injectable control regimen, researchers report.

The findings validate the World Health Organization’s current recommendation of a 9-month, bedaquiline-based oral regimen, “which was based only on observational data,” noted lead author Ruth Goodall, PhD, from the Medical Research Council Clinical Trials Unit at University College London, and colleagues.

The study was published in The Lancet.

The Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB (STREAM) stage 2 study was a randomized, phase 3, noninferiority trial conducted at 13 hospital clinics in seven countries that had prespecified tests for superiority if noninferiority was shown. The study enrolled individuals aged 15 years or older who had rifampicin-resistant TB without fluoroquinolone or aminoglycoside resistance.

The study’s first stage, STREAM stage 1, showed that a 9-month injectable regimen was noninferior to the WHO’s 2011 recommendation of a 20-month injectable regimen. The 9-month regimen was recommended by the WHO in 2016. That recommendation was superceded in 2020 when concerns of hearing loss associated with aminoglycosides prompted the WHO to endorse a 9-month bedaquiline-containing, injectable-free alternative, the authors write.
 

Seeking shorter treatment for better outcomes

STREAM stage 2 used a 9-month injectable regimen as its control. The investigators measured it against a fully oral 9-month bedaquiline-based treatment (primary comparison), as well as a 6-month oral bedaquiline regimen that included 8 weeks of a second-line injectable (secondary comparison).

The 9-month fully oral treatment included levofloxacin, clofazimine, ethambutol, and pyrazinamide for 40 weeks; bedaquiline, high-dose isoniazid, and prothionamide were given for the 16-week intensive phase.

The 6-month regimen included bedaquiline, clofazimine, pyrazinamide, and levofloxacin for 28 weeks, supplemented by high-dose isoniazid with kanamycin for an 8-week intensive phase.

For both comparisons, the primary outcome was favorable status at 76 weeks, defined as cultures that were negative for Mycobacterium tuberculosis without a preceding unfavorable outcome (defined as any death, bacteriologic failure or recurrence, or major treatment change).

Among 517 participants in the modified intention-to-treat population across the study groups, 62% were men, and 38% were women (median age, 32.5 years).

For the primary comparison, 71% of the control group and 83% of the oral regimen group had a favorable outcome.

In the secondary comparison, 69% had a favorable outcome in the control group, compared with 91% of those receiving the 6-month regimen.

Although the rate of grade 3 or 4 adverse events was similar in all three groups, there was significantly less ototoxicity among patients who received the oral regimen, compared with control patients (2% vs. 9%); 4% of those taking the 6-month regimen had hearing loss, compared with 8% of control patients.

Exploratory analyses comparing both bedaquiline-containing regimens revealed a significantly higher proportion of favorable outcomes among participants receiving the 6-month regimen (91%), compared with patients taking the fully oral 9-month regimen (79%). There were no significant differences in the rate of grade 3 or 4 adverse events.

The trial’s main limitation was its open-label design, which might have influenced decisions about treatment change, note the investigators.

“STREAM stage 2 has shown that two short-course, bedaquiline-containing regimens are not only non-inferior but superior to a 9-month injectable-containing regimen,” they conclude.

“The STREAM stage 2 fully oral regimen avoided the toxicity of aminoglycosides, and the 6-month regimen was highly effective, with reduced levels of ototoxicity. These two regimens offer promising treatment options for patients with MDR or rifampicin-resistant tuberculosis,” the authors write.

Dr. Goodall added, “Although both STREAM regimens were very effective, participants experienced relatively high levels of adverse events during the trial (though many of these were likely due to the close laboratory monitoring of the trial).

“While hearing loss was reduced on the 6-month regimen, it was not entirely eliminated,” she said. “Other new regimens in the field containing the medicine linezolid report side effects such as anemia and peripheral neuropathy. So more work needs to be done to ensure the treatment regimens are as safe and tolerable for patients as possible. In addition, even 6 months’ treatment is long for patients to tolerate, and further regimen shortening would be a welcome development for patients and health systems.”
 

‘A revolution in MDR tuberculosis’

“The authors must be commended on completing this challenging high-quality, phase 3, non-inferiority, randomized controlled trial involving 13 health care facilities across Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, and Uganda ... despite the COVID-19 pandemic,” noted Keertan Dheda, MD, PhD, and Christoph Lange, MD, PhD, in an accompanying comment titled, “A Revolution in the Management of Multidrug-Resistant Tuberculosis”.

Although the WHO recently approved an all-oral 6-month bedaquiline, pretomanid, and linezolid plus moxifloxacin (BPaLM) regimen, results from the alternate 6-month regimen examined in STREAM stage 2 “do provide confidence in using 2 months of an injectable as part of a salvage regimen in patients for whom MDR tuberculosis treatment is not successful” or in those with extensively drug-resistant (XDR) or pre-XDR TB, “for whom therapeutic options are few,” noted Dr. Dheda, from the University of Cape Town (South Africa) and the London School of Hygiene and Tropical Medicine, and Dr. Lange, from the University of Lübeck (Germany), Baylor College of Medicine, and Texas Children’s Hospital, both in Houston.

The study authors and the commentators stress that safer and simpler treatments are still needed for MDR TB. “The search is now on for regimens that could further reduce duration, toxicity, and pill burden,” note Dr. Dheda and Dr. Lange.

However, they also note that “substantial resistance” to bedaquiline is already emerging. “Therefore, if we are to protect key drugs from becoming functionally redundant, drug-susceptibility testing capacity will need to be rapidly improved to minimize resistance amplification and onward disease transmission.”

The study was funded by USAID and Janssen Research and Development. Dr. Goodall has disclosed no relevant financial relationships. Dr. Dheda has received funding from the EU and the South African Medical Research Council for studies related to the diagnosis or management of drug-resistant tuberculosis. Dr. Lange is supported by the German Center for Infection Research and has received funding from the European Commission for studies on the development of novel antituberculosis medicines and for studies related to novel diagnostics of tuberculosis; consulting fees from INSMED; speaker’s fees from INSMED, GILEAD, and Janssen; and is a member of the data safety board of trials from Medicines sans Frontiers, all of which are unrelated to the current study.

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

Major cardiovascular societies are more apt to give out awards to men and White individuals than to women and minorities, according to a look at 2 decades’ worth of data.

“Women received significantly fewer awards than men in all societies, countries, and award categories,” author Martha Gulati, MD, director of preventive cardiology at Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a news release. “This bias may be responsible for preventing underrepresented groups from ascending the academic ladder and receiving senior awards like lifetime achievement awards.”

The study was published online in the Journal of the American College of Cardiology.
 

A slow climb

The findings are based on a review of honors given from 2000 to 2021 by the ACC, the American Heart Association, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, the Heart Rhythm Society, the European Society of Cardiology, and the Canadian Cardiovascular Society.

Among the 173 unique awards, 94 were given by the AHA, 27 by the HRS, 17 by the ACC, 16 by the CCS, 8 by the ASE, 7 by the ESC, and 4 by the SCAI. There were 3,044 recipients of these awards, including 2,830 unique awardees.

The vast majority of the awardees were White (75.2%), with Asian, Hispanic/Latino, and Black awardees representing just 18.9%, 4.5%, and 1.4% of the total awardees, respectively.

In a gender analysis, the researchers looked at 169 awards after excluding female-specific awards. These 169 awards were distributed to 2,995 recipients. More than three-quarters of these awardees (76.2%) were men, with women making up less than one-quarter (23.8%).

Encouragingly, there was an increasing trend in recognition of women over time, with 7.7% of female awardees in 2000 and climbing to 31.2% in 2021 (average annual percentage change, 6.6%; P < .05).

The distribution of awards also became more racially/ethnically diverse over time; in 2000, 92.3% of awardees were White versus 62.8% in 2021 (AAPC, –1.4%; P < .001).

There was also a significant increase in Asian (AAPC, 5.7%; P < .001), Hispanic/Latino (AAPC, 4.8%; P = .040), and Black (AAPC, 7.8%; P < .05) honorees.
 

Core influencers

By award type, women received fewer leadership awards than men, “which can be attributed to fewer leadership opportunities for women and a lack of acknowledgment of leadership responsibilities fulfilled by women,” the researchers said.

Award recipients with a PhD degree were nearly gender balanced (48.2% women), whereas men formed an overwhelming majority of awardees with an MD (84.7%).

Awards with male eponyms had fewer women recipients than did noneponymous awards (20.9% vs. 23.2%; P < .01).

“Male-eponymous awards can deter women applicants and give a subtle hint to selection committees to favor men as winners, creating an implicit bias,” the researchers said.

“Given the increased emphasis on redesigning cardiovascular health care delivery by incorporating the tenets of diversity, equity, and inclusion (DEI), cardiovascular societies have a significant role as core influencers,” Dr. Gulati and colleagues wrote.

They said that equitable award distribution can be a “key strategy to celebrate women and diverse members of the cardiovascular workforce and promulgate DEI.”

“Recognition of their contributions is pivotal to enhancing their self-perception. In addition to boosting confidence, receiving an award can also catalyze their career trajectory,” the authors added.

The study had no specific funding. The authors have declared no relevant conflicts of interest.

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

Major cardiovascular societies are more apt to give out awards to men and White individuals than to women and minorities, according to a look at 2 decades’ worth of data.

“Women received significantly fewer awards than men in all societies, countries, and award categories,” author Martha Gulati, MD, director of preventive cardiology at Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a news release. “This bias may be responsible for preventing underrepresented groups from ascending the academic ladder and receiving senior awards like lifetime achievement awards.”

The study was published online in the Journal of the American College of Cardiology.
 

A slow climb

The findings are based on a review of honors given from 2000 to 2021 by the ACC, the American Heart Association, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, the Heart Rhythm Society, the European Society of Cardiology, and the Canadian Cardiovascular Society.

Among the 173 unique awards, 94 were given by the AHA, 27 by the HRS, 17 by the ACC, 16 by the CCS, 8 by the ASE, 7 by the ESC, and 4 by the SCAI. There were 3,044 recipients of these awards, including 2,830 unique awardees.

The vast majority of the awardees were White (75.2%), with Asian, Hispanic/Latino, and Black awardees representing just 18.9%, 4.5%, and 1.4% of the total awardees, respectively.

In a gender analysis, the researchers looked at 169 awards after excluding female-specific awards. These 169 awards were distributed to 2,995 recipients. More than three-quarters of these awardees (76.2%) were men, with women making up less than one-quarter (23.8%).

Encouragingly, there was an increasing trend in recognition of women over time, with 7.7% of female awardees in 2000 and climbing to 31.2% in 2021 (average annual percentage change, 6.6%; P < .05).

The distribution of awards also became more racially/ethnically diverse over time; in 2000, 92.3% of awardees were White versus 62.8% in 2021 (AAPC, –1.4%; P < .001).

There was also a significant increase in Asian (AAPC, 5.7%; P < .001), Hispanic/Latino (AAPC, 4.8%; P = .040), and Black (AAPC, 7.8%; P < .05) honorees.
 

Core influencers

By award type, women received fewer leadership awards than men, “which can be attributed to fewer leadership opportunities for women and a lack of acknowledgment of leadership responsibilities fulfilled by women,” the researchers said.

Award recipients with a PhD degree were nearly gender balanced (48.2% women), whereas men formed an overwhelming majority of awardees with an MD (84.7%).

Awards with male eponyms had fewer women recipients than did noneponymous awards (20.9% vs. 23.2%; P < .01).

“Male-eponymous awards can deter women applicants and give a subtle hint to selection committees to favor men as winners, creating an implicit bias,” the researchers said.

“Given the increased emphasis on redesigning cardiovascular health care delivery by incorporating the tenets of diversity, equity, and inclusion (DEI), cardiovascular societies have a significant role as core influencers,” Dr. Gulati and colleagues wrote.

They said that equitable award distribution can be a “key strategy to celebrate women and diverse members of the cardiovascular workforce and promulgate DEI.”

“Recognition of their contributions is pivotal to enhancing their self-perception. In addition to boosting confidence, receiving an award can also catalyze their career trajectory,” the authors added.

The study had no specific funding. The authors have declared no relevant conflicts of interest.

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

Major cardiovascular societies are more apt to give out awards to men and White individuals than to women and minorities, according to a look at 2 decades’ worth of data.

“Women received significantly fewer awards than men in all societies, countries, and award categories,” author Martha Gulati, MD, director of preventive cardiology at Smidt Heart Institute at Cedars-Sinai, Los Angeles, said in a news release. “This bias may be responsible for preventing underrepresented groups from ascending the academic ladder and receiving senior awards like lifetime achievement awards.”

The study was published online in the Journal of the American College of Cardiology.
 

A slow climb

The findings are based on a review of honors given from 2000 to 2021 by the ACC, the American Heart Association, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, the Heart Rhythm Society, the European Society of Cardiology, and the Canadian Cardiovascular Society.

Among the 173 unique awards, 94 were given by the AHA, 27 by the HRS, 17 by the ACC, 16 by the CCS, 8 by the ASE, 7 by the ESC, and 4 by the SCAI. There were 3,044 recipients of these awards, including 2,830 unique awardees.

The vast majority of the awardees were White (75.2%), with Asian, Hispanic/Latino, and Black awardees representing just 18.9%, 4.5%, and 1.4% of the total awardees, respectively.

In a gender analysis, the researchers looked at 169 awards after excluding female-specific awards. These 169 awards were distributed to 2,995 recipients. More than three-quarters of these awardees (76.2%) were men, with women making up less than one-quarter (23.8%).

Encouragingly, there was an increasing trend in recognition of women over time, with 7.7% of female awardees in 2000 and climbing to 31.2% in 2021 (average annual percentage change, 6.6%; P < .05).

The distribution of awards also became more racially/ethnically diverse over time; in 2000, 92.3% of awardees were White versus 62.8% in 2021 (AAPC, –1.4%; P < .001).

There was also a significant increase in Asian (AAPC, 5.7%; P < .001), Hispanic/Latino (AAPC, 4.8%; P = .040), and Black (AAPC, 7.8%; P < .05) honorees.
 

Core influencers

By award type, women received fewer leadership awards than men, “which can be attributed to fewer leadership opportunities for women and a lack of acknowledgment of leadership responsibilities fulfilled by women,” the researchers said.

Award recipients with a PhD degree were nearly gender balanced (48.2% women), whereas men formed an overwhelming majority of awardees with an MD (84.7%).

Awards with male eponyms had fewer women recipients than did noneponymous awards (20.9% vs. 23.2%; P < .01).

“Male-eponymous awards can deter women applicants and give a subtle hint to selection committees to favor men as winners, creating an implicit bias,” the researchers said.

“Given the increased emphasis on redesigning cardiovascular health care delivery by incorporating the tenets of diversity, equity, and inclusion (DEI), cardiovascular societies have a significant role as core influencers,” Dr. Gulati and colleagues wrote.

They said that equitable award distribution can be a “key strategy to celebrate women and diverse members of the cardiovascular workforce and promulgate DEI.”

“Recognition of their contributions is pivotal to enhancing their self-perception. In addition to boosting confidence, receiving an award can also catalyze their career trajectory,” the authors added.

The study had no specific funding. The authors have declared no relevant conflicts of interest.

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

A newly discovered genetic variant that is associated with type 2 diabetes (T2D) is responsible for almost 7% of all diabetes cases in Greenland, according to a whole-genome sequencing analysis of 448 Greenlandic Inuit individuals.

The variant, identified as c.1108G>T, “has the largest population impact of any previously reported variant” within the HNF1A gene – a gene that can cause maturity-onset diabetes of the young (MODY), reported senior author Torben Hansen, MD, PhD, of the University of Copenhagen, and colleagues in The Lancet Regional Health–Europe. The c.1108G>T variant does not cause MODY, but other variants within the HNF1A gene do. However, carriers of this variant, which is present in 1.9% of the Greenlandic Inuit population and has not been found elsewhere, have normal insulin sensitivity, but decreased beta-cell function and a more than fourfold risk of developing type 2 diabetes. “This adds to a previous discovery that about 11% of all diabetes in Greenlandic Inuit is explained by a mutation in the TBC1D4 variant,” Dr. Hansen told this publication. “Thus 1 in 5 patients diagnosed with type 2 diabetes in Greenland have a specific mutation explaining their diabetes. In European populations only about 1%-2% of patients diagnosed with type 2 diabetes have a known genetic etiology.”

The finding “provides new avenues to subgroup patients, detect diabetes in family members, and pursue precision treatment trials,” noted the authors, although they acknowledged that treatment choices for individuals with this variant still need to be explored. “We know from HNF1A-mutation carriers with European ancestry that they benefit from sulfonylurea treatment,” said Dr. Hansen. “However, we have not yet done treatment studies in Inuit.” The investigators noted that “it is not always the case that variants in HNF1A result in an increased insulin secretory response to sulfonylurea. ... Whether carriers of the c.1108G>T variant could benefit from treatment with sulfonylurea should be pursued within the context of a randomized clinical trial establishing both short- and long-term efficacy of sulfonylurea in these patients.”

A total of 4,497 study participants were randomly sampled from two cross-sectional cohorts in an adult Greenlandic population health survey. Among 448 participants who had whole genome sequencing, 14 known MODY genes were screened for both previously identified as well as novel variants. This identified the c.1108G>T variant, which was then genotyped in the full cohort in order to estimate an allele frequency of 1.3% in the general Greenlandic population, and 1.9% in the Inuit component. The variant was not found in genome sequences of other populations.

The researchers then tested the association of the variant with T2D and showed strong association with T2D (odds ratio, 4.35) and higher hemoglobin A1c levels.

“This is very well-conducted and exciting research that highlights the importance of studying the genetics of diverse populations,” said Miriam Udler, MD, PhD, director of the Massachusetts General Diabetes Genetics Clinic, and assistant professor at Harvard University, both in Boston. “This manuscript builds on prior work from the researchers identifying another genetic variant specific to the Greenlandic Inuit population in the gene TBC1D4,” she added. “About 3.8% of people in this population carry two copies of the TBC1D4 variant and have about a 10-fold increased risk of diabetes. Together the two variants affect 18% of Greenlanders with diabetes.”

With its fourfold increased risk of diabetes, the new variant falls into “an ever-growing category” of “intermediate risk” genetic variants, explained Dr. Udler – “meaning that they have a large impact on diabetes risk, but cannot fully predict whether someone will get diabetes. The contribution of additional risk factors is particularly important for ‘intermediate risk’ genetic variants,” she added. “Thus, clinically, we can tell patients who have variants such as HNF1A c.1108>T that they are at substantial increased risk of diabetes, but that many will not develop diabetes. And for those who do develop diabetes, we are not yet able to advise on particular therapeutic strategies.”

Still, she emphasized, the importance of studying diverse populations with specific genetic risk factors is the end-goal of precision medicine. “An active area of research is determining whether and how to return such information about ‘intermediate risk’ variants to patients who get clinical genetic testing for diabetes, since typically only variants that are very high risk ... are returned in clinical testing reports.” Dr. Udler added that “many more such “intermediate risk’ variants likely exist in all populations, but have yet to be characterized because they are less common than HNF1A c.1108>T; however, ongoing worldwide efforts to increase the sample sizes of human genetic studies will facilitate such discovery.”

The study was funded by Novo Nordisk Foundation, Independent Research Fund Denmark, and Karen Elise Jensen’s Foundation. Dr. Hansen and Dr. Udler had no disclosures.
 

A newly discovered genetic variant that is associated with type 2 diabetes (T2D) is responsible for almost 7% of all diabetes cases in Greenland, according to a whole-genome sequencing analysis of 448 Greenlandic Inuit individuals.

The variant, identified as c.1108G>T, “has the largest population impact of any previously reported variant” within the HNF1A gene – a gene that can cause maturity-onset diabetes of the young (MODY), reported senior author Torben Hansen, MD, PhD, of the University of Copenhagen, and colleagues in The Lancet Regional Health–Europe. The c.1108G>T variant does not cause MODY, but other variants within the HNF1A gene do. However, carriers of this variant, which is present in 1.9% of the Greenlandic Inuit population and has not been found elsewhere, have normal insulin sensitivity, but decreased beta-cell function and a more than fourfold risk of developing type 2 diabetes. “This adds to a previous discovery that about 11% of all diabetes in Greenlandic Inuit is explained by a mutation in the TBC1D4 variant,” Dr. Hansen told this publication. “Thus 1 in 5 patients diagnosed with type 2 diabetes in Greenland have a specific mutation explaining their diabetes. In European populations only about 1%-2% of patients diagnosed with type 2 diabetes have a known genetic etiology.”

The finding “provides new avenues to subgroup patients, detect diabetes in family members, and pursue precision treatment trials,” noted the authors, although they acknowledged that treatment choices for individuals with this variant still need to be explored. “We know from HNF1A-mutation carriers with European ancestry that they benefit from sulfonylurea treatment,” said Dr. Hansen. “However, we have not yet done treatment studies in Inuit.” The investigators noted that “it is not always the case that variants in HNF1A result in an increased insulin secretory response to sulfonylurea. ... Whether carriers of the c.1108G>T variant could benefit from treatment with sulfonylurea should be pursued within the context of a randomized clinical trial establishing both short- and long-term efficacy of sulfonylurea in these patients.”

A total of 4,497 study participants were randomly sampled from two cross-sectional cohorts in an adult Greenlandic population health survey. Among 448 participants who had whole genome sequencing, 14 known MODY genes were screened for both previously identified as well as novel variants. This identified the c.1108G>T variant, which was then genotyped in the full cohort in order to estimate an allele frequency of 1.3% in the general Greenlandic population, and 1.9% in the Inuit component. The variant was not found in genome sequences of other populations.

The researchers then tested the association of the variant with T2D and showed strong association with T2D (odds ratio, 4.35) and higher hemoglobin A1c levels.

“This is very well-conducted and exciting research that highlights the importance of studying the genetics of diverse populations,” said Miriam Udler, MD, PhD, director of the Massachusetts General Diabetes Genetics Clinic, and assistant professor at Harvard University, both in Boston. “This manuscript builds on prior work from the researchers identifying another genetic variant specific to the Greenlandic Inuit population in the gene TBC1D4,” she added. “About 3.8% of people in this population carry two copies of the TBC1D4 variant and have about a 10-fold increased risk of diabetes. Together the two variants affect 18% of Greenlanders with diabetes.”

With its fourfold increased risk of diabetes, the new variant falls into “an ever-growing category” of “intermediate risk” genetic variants, explained Dr. Udler – “meaning that they have a large impact on diabetes risk, but cannot fully predict whether someone will get diabetes. The contribution of additional risk factors is particularly important for ‘intermediate risk’ genetic variants,” she added. “Thus, clinically, we can tell patients who have variants such as HNF1A c.1108>T that they are at substantial increased risk of diabetes, but that many will not develop diabetes. And for those who do develop diabetes, we are not yet able to advise on particular therapeutic strategies.”

Still, she emphasized, the importance of studying diverse populations with specific genetic risk factors is the end-goal of precision medicine. “An active area of research is determining whether and how to return such information about ‘intermediate risk’ variants to patients who get clinical genetic testing for diabetes, since typically only variants that are very high risk ... are returned in clinical testing reports.” Dr. Udler added that “many more such “intermediate risk’ variants likely exist in all populations, but have yet to be characterized because they are less common than HNF1A c.1108>T; however, ongoing worldwide efforts to increase the sample sizes of human genetic studies will facilitate such discovery.”

The study was funded by Novo Nordisk Foundation, Independent Research Fund Denmark, and Karen Elise Jensen’s Foundation. Dr. Hansen and Dr. Udler had no disclosures.
 

A newly discovered genetic variant that is associated with type 2 diabetes (T2D) is responsible for almost 7% of all diabetes cases in Greenland, according to a whole-genome sequencing analysis of 448 Greenlandic Inuit individuals.

The variant, identified as c.1108G>T, “has the largest population impact of any previously reported variant” within the HNF1A gene – a gene that can cause maturity-onset diabetes of the young (MODY), reported senior author Torben Hansen, MD, PhD, of the University of Copenhagen, and colleagues in The Lancet Regional Health–Europe. The c.1108G>T variant does not cause MODY, but other variants within the HNF1A gene do. However, carriers of this variant, which is present in 1.9% of the Greenlandic Inuit population and has not been found elsewhere, have normal insulin sensitivity, but decreased beta-cell function and a more than fourfold risk of developing type 2 diabetes. “This adds to a previous discovery that about 11% of all diabetes in Greenlandic Inuit is explained by a mutation in the TBC1D4 variant,” Dr. Hansen told this publication. “Thus 1 in 5 patients diagnosed with type 2 diabetes in Greenland have a specific mutation explaining their diabetes. In European populations only about 1%-2% of patients diagnosed with type 2 diabetes have a known genetic etiology.”

The finding “provides new avenues to subgroup patients, detect diabetes in family members, and pursue precision treatment trials,” noted the authors, although they acknowledged that treatment choices for individuals with this variant still need to be explored. “We know from HNF1A-mutation carriers with European ancestry that they benefit from sulfonylurea treatment,” said Dr. Hansen. “However, we have not yet done treatment studies in Inuit.” The investigators noted that “it is not always the case that variants in HNF1A result in an increased insulin secretory response to sulfonylurea. ... Whether carriers of the c.1108G>T variant could benefit from treatment with sulfonylurea should be pursued within the context of a randomized clinical trial establishing both short- and long-term efficacy of sulfonylurea in these patients.”

A total of 4,497 study participants were randomly sampled from two cross-sectional cohorts in an adult Greenlandic population health survey. Among 448 participants who had whole genome sequencing, 14 known MODY genes were screened for both previously identified as well as novel variants. This identified the c.1108G>T variant, which was then genotyped in the full cohort in order to estimate an allele frequency of 1.3% in the general Greenlandic population, and 1.9% in the Inuit component. The variant was not found in genome sequences of other populations.

The researchers then tested the association of the variant with T2D and showed strong association with T2D (odds ratio, 4.35) and higher hemoglobin A1c levels.

“This is very well-conducted and exciting research that highlights the importance of studying the genetics of diverse populations,” said Miriam Udler, MD, PhD, director of the Massachusetts General Diabetes Genetics Clinic, and assistant professor at Harvard University, both in Boston. “This manuscript builds on prior work from the researchers identifying another genetic variant specific to the Greenlandic Inuit population in the gene TBC1D4,” she added. “About 3.8% of people in this population carry two copies of the TBC1D4 variant and have about a 10-fold increased risk of diabetes. Together the two variants affect 18% of Greenlanders with diabetes.”

With its fourfold increased risk of diabetes, the new variant falls into “an ever-growing category” of “intermediate risk” genetic variants, explained Dr. Udler – “meaning that they have a large impact on diabetes risk, but cannot fully predict whether someone will get diabetes. The contribution of additional risk factors is particularly important for ‘intermediate risk’ genetic variants,” she added. “Thus, clinically, we can tell patients who have variants such as HNF1A c.1108>T that they are at substantial increased risk of diabetes, but that many will not develop diabetes. And for those who do develop diabetes, we are not yet able to advise on particular therapeutic strategies.”

Still, she emphasized, the importance of studying diverse populations with specific genetic risk factors is the end-goal of precision medicine. “An active area of research is determining whether and how to return such information about ‘intermediate risk’ variants to patients who get clinical genetic testing for diabetes, since typically only variants that are very high risk ... are returned in clinical testing reports.” Dr. Udler added that “many more such “intermediate risk’ variants likely exist in all populations, but have yet to be characterized because they are less common than HNF1A c.1108>T; however, ongoing worldwide efforts to increase the sample sizes of human genetic studies will facilitate such discovery.”

The study was funded by Novo Nordisk Foundation, Independent Research Fund Denmark, and Karen Elise Jensen’s Foundation. Dr. Hansen and Dr. Udler had no disclosures.
 

TAMPA – Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

• F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
• F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
• CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

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

TAMPA – Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

• F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
• F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
• CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

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

TAMPA – Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

• F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
• F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
• CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

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

TAMPA – People living with HIV (PLWH) were more likely than other populations to get vaccinated for flu and COVID-19, to seek reputable sources of information, and to be connected through essential community organizations that share essential health and wellness information, according to the results of a large survey.

PLWH, therefore, would have been an ideal model population for creating and disseminating effective messaging around COVID-19 immunizations earlier in the pandemic, said Kathleen Gallagher, MPH, an epidemiologist, researcher, and health services administrator at the Patient Advocate Foundation.

The PLWH community can still offer valuable insights into effective ways to reach out to people, to disseminate correct information, and to link people with resources, Ms. Gallagher said during a poster presentation at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

In addition, the PLWH response to the pandemic illustrates the importance of community. Local, community-based organizations “are the people that these individuals trust, they are people entrenched in their community, and they have existing relationships with them in terms of getting vaccinated and listening to their concerns,” Ms. Gallagher said.

“It’s a missed opportunity.”
 

A highly compliant group

The July 2021 survey of 271 PLWH was part of a larger, longitudinal survey of 1,400 people with any chronic illness asked about attitudes and barriers to vaccination. The PLWH population was important to focus on, the researchers note, because they could be potentially high risk for more serious COVID-19 outcomes.

The PLWH group was 81% White and 90% male, and 83% were age 56 or older. In addition, 86% had an annual household income below $48,000.

Ninety-three percent of the PLWH group had had flu vaccination in the prior 3 years and received at least one COVID-19 vaccination.
 

Unable vs. unwilling to vaccinate

Ms. Gallagher and colleagues found 12 people (4%) in the PLWH group did not get vaccinated against COVID-19. It’s a small number, “so you have to take this with a grain of salt,” she said. “But we asked them why they were hesitant. They either were unable or unwilling – and the unable part is not surprising.”

Those who were unable to get vaccinated were either homebound or had concerns about being in a clinic where they could be exposed to COVID while waiting to get the vaccine.

“And then there were some who were just not willing” to get vaccinated, Ms. Gallagher said. She added most cited vaccine safety concerns and “a lot of the misinformation or confusing information around efficacy.”
 

Trusted information sources

Although people reported getting COVID-19 vaccine information from multiple sources, including online and from television, 64% or nearly two-thirds sought information from their doctors or health care teams.

In fact, doctors emerged as the most trusted source, as indicated by 72% of PLWH.

“I was a little surprised that doctors scored so highly because, sometimes in other cohorts that we looked at, it wasn’t the case,” Ms. Gallagher said. However, she added, a lot of PLWH “have a very strong trust bond with their provider because this is a very personal, very sensitive diagnosis.”

How did social media score? “A whopping 1%,” she said. “So at least this was a savvy group, and they realized that that was not the place to go for vaccination information.”
 

Overcoming barriers

A lack of vaccine availability at the time of their appointment was the number one barrier to immunization. Also, a small number of people said knowing someone who had an adverse reaction to COVID-19 vaccination was a barrier for them. Ms. Gallagher explained that, by definition in the survey, an adverse reaction to vaccination had to be serious enough to drive people to seek medical care.

When asked to comment on the poster, Andrew Komensky, RN, told this news organization that he found the results “interesting, because I’m an infection preventionist, in addition to being an HIV nurse.” He is director of infection prevention and control at CharterCARE Health Partners, Providence, R.I.

Mr. Komensky said he was surprised that a high proportion of PLWH cited their doctor – and not their nurse – as the most trusted source of information. “In my experience in COVID care ... it was a nursing staff who had most of the contact with patients, who did most of the education, and provided most of the information surrounding vaccination and potential side effects.”

It made sense to Mr. Komensky that the PLWH population would be compliant with vaccinations. “People who are living with HIV do everything they possibly can just to stay healthy.”

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

TAMPA – People living with HIV (PLWH) were more likely than other populations to get vaccinated for flu and COVID-19, to seek reputable sources of information, and to be connected through essential community organizations that share essential health and wellness information, according to the results of a large survey.

PLWH, therefore, would have been an ideal model population for creating and disseminating effective messaging around COVID-19 immunizations earlier in the pandemic, said Kathleen Gallagher, MPH, an epidemiologist, researcher, and health services administrator at the Patient Advocate Foundation.

The PLWH community can still offer valuable insights into effective ways to reach out to people, to disseminate correct information, and to link people with resources, Ms. Gallagher said during a poster presentation at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

In addition, the PLWH response to the pandemic illustrates the importance of community. Local, community-based organizations “are the people that these individuals trust, they are people entrenched in their community, and they have existing relationships with them in terms of getting vaccinated and listening to their concerns,” Ms. Gallagher said.

“It’s a missed opportunity.”
 

A highly compliant group

The July 2021 survey of 271 PLWH was part of a larger, longitudinal survey of 1,400 people with any chronic illness asked about attitudes and barriers to vaccination. The PLWH population was important to focus on, the researchers note, because they could be potentially high risk for more serious COVID-19 outcomes.

The PLWH group was 81% White and 90% male, and 83% were age 56 or older. In addition, 86% had an annual household income below $48,000.

Ninety-three percent of the PLWH group had had flu vaccination in the prior 3 years and received at least one COVID-19 vaccination.
 

Unable vs. unwilling to vaccinate

Ms. Gallagher and colleagues found 12 people (4%) in the PLWH group did not get vaccinated against COVID-19. It’s a small number, “so you have to take this with a grain of salt,” she said. “But we asked them why they were hesitant. They either were unable or unwilling – and the unable part is not surprising.”

Those who were unable to get vaccinated were either homebound or had concerns about being in a clinic where they could be exposed to COVID while waiting to get the vaccine.

“And then there were some who were just not willing” to get vaccinated, Ms. Gallagher said. She added most cited vaccine safety concerns and “a lot of the misinformation or confusing information around efficacy.”
 

Trusted information sources

Although people reported getting COVID-19 vaccine information from multiple sources, including online and from television, 64% or nearly two-thirds sought information from their doctors or health care teams.

In fact, doctors emerged as the most trusted source, as indicated by 72% of PLWH.

“I was a little surprised that doctors scored so highly because, sometimes in other cohorts that we looked at, it wasn’t the case,” Ms. Gallagher said. However, she added, a lot of PLWH “have a very strong trust bond with their provider because this is a very personal, very sensitive diagnosis.”

How did social media score? “A whopping 1%,” she said. “So at least this was a savvy group, and they realized that that was not the place to go for vaccination information.”
 

Overcoming barriers

A lack of vaccine availability at the time of their appointment was the number one barrier to immunization. Also, a small number of people said knowing someone who had an adverse reaction to COVID-19 vaccination was a barrier for them. Ms. Gallagher explained that, by definition in the survey, an adverse reaction to vaccination had to be serious enough to drive people to seek medical care.

When asked to comment on the poster, Andrew Komensky, RN, told this news organization that he found the results “interesting, because I’m an infection preventionist, in addition to being an HIV nurse.” He is director of infection prevention and control at CharterCARE Health Partners, Providence, R.I.

Mr. Komensky said he was surprised that a high proportion of PLWH cited their doctor – and not their nurse – as the most trusted source of information. “In my experience in COVID care ... it was a nursing staff who had most of the contact with patients, who did most of the education, and provided most of the information surrounding vaccination and potential side effects.”

It made sense to Mr. Komensky that the PLWH population would be compliant with vaccinations. “People who are living with HIV do everything they possibly can just to stay healthy.”

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

TAMPA – People living with HIV (PLWH) were more likely than other populations to get vaccinated for flu and COVID-19, to seek reputable sources of information, and to be connected through essential community organizations that share essential health and wellness information, according to the results of a large survey.

PLWH, therefore, would have been an ideal model population for creating and disseminating effective messaging around COVID-19 immunizations earlier in the pandemic, said Kathleen Gallagher, MPH, an epidemiologist, researcher, and health services administrator at the Patient Advocate Foundation.

The PLWH community can still offer valuable insights into effective ways to reach out to people, to disseminate correct information, and to link people with resources, Ms. Gallagher said during a poster presentation at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

In addition, the PLWH response to the pandemic illustrates the importance of community. Local, community-based organizations “are the people that these individuals trust, they are people entrenched in their community, and they have existing relationships with them in terms of getting vaccinated and listening to their concerns,” Ms. Gallagher said.

“It’s a missed opportunity.”
 

A highly compliant group

The July 2021 survey of 271 PLWH was part of a larger, longitudinal survey of 1,400 people with any chronic illness asked about attitudes and barriers to vaccination. The PLWH population was important to focus on, the researchers note, because they could be potentially high risk for more serious COVID-19 outcomes.

The PLWH group was 81% White and 90% male, and 83% were age 56 or older. In addition, 86% had an annual household income below $48,000.

Ninety-three percent of the PLWH group had had flu vaccination in the prior 3 years and received at least one COVID-19 vaccination.
 

Unable vs. unwilling to vaccinate

Ms. Gallagher and colleagues found 12 people (4%) in the PLWH group did not get vaccinated against COVID-19. It’s a small number, “so you have to take this with a grain of salt,” she said. “But we asked them why they were hesitant. They either were unable or unwilling – and the unable part is not surprising.”

Those who were unable to get vaccinated were either homebound or had concerns about being in a clinic where they could be exposed to COVID while waiting to get the vaccine.

“And then there were some who were just not willing” to get vaccinated, Ms. Gallagher said. She added most cited vaccine safety concerns and “a lot of the misinformation or confusing information around efficacy.”
 

Trusted information sources

Although people reported getting COVID-19 vaccine information from multiple sources, including online and from television, 64% or nearly two-thirds sought information from their doctors or health care teams.

In fact, doctors emerged as the most trusted source, as indicated by 72% of PLWH.

“I was a little surprised that doctors scored so highly because, sometimes in other cohorts that we looked at, it wasn’t the case,” Ms. Gallagher said. However, she added, a lot of PLWH “have a very strong trust bond with their provider because this is a very personal, very sensitive diagnosis.”

How did social media score? “A whopping 1%,” she said. “So at least this was a savvy group, and they realized that that was not the place to go for vaccination information.”
 

Overcoming barriers

A lack of vaccine availability at the time of their appointment was the number one barrier to immunization. Also, a small number of people said knowing someone who had an adverse reaction to COVID-19 vaccination was a barrier for them. Ms. Gallagher explained that, by definition in the survey, an adverse reaction to vaccination had to be serious enough to drive people to seek medical care.

When asked to comment on the poster, Andrew Komensky, RN, told this news organization that he found the results “interesting, because I’m an infection preventionist, in addition to being an HIV nurse.” He is director of infection prevention and control at CharterCARE Health Partners, Providence, R.I.

Mr. Komensky said he was surprised that a high proportion of PLWH cited their doctor – and not their nurse – as the most trusted source of information. “In my experience in COVID care ... it was a nursing staff who had most of the contact with patients, who did most of the education, and provided most of the information surrounding vaccination and potential side effects.”

It made sense to Mr. Komensky that the PLWH population would be compliant with vaccinations. “People who are living with HIV do everything they possibly can just to stay healthy.”

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

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.^1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.^2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).^2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?¹

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.^1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.^2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).^2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?¹

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

On November 1, the US Preventive Services Task Force (USPSTF) published updated recommendations (and a supporting evidence report) for the use of hormone therapy in postmenopausal women for the prevention of chronic medical conditions, such as heart disease, cancer, and osteoporosis.^1,2 The USPSTF continues to recommend against the use of either estrogen or combined estrogen plus progesterone for this purpose.

A bit of context. These recommendations apply to asymptomatic postmenopausal women and do not apply to those who are unable to manage menopausal symptoms (eg, hot flashes or vaginal dryness) with other interventions, or to those who have premature or surgically caused menopause.

This update is a reconfirmation of USPSTF’s 2017 recommendations on this topic. These recommendations are consistent with those of multiple other organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American College of Physicians, and the American Heart Association.

A look at the evidence. The evidence report included data from 20 randomized clinical trials and 3 cohort studies that examined the use of oral or transdermal hormone therapy. The most commonly used therapy was oral conjugated equine estrogen 0.625 mg/d, with or without medroxyprogesterone acetate 2.5 mg/d. The strongest evidence is from the Women’s Health Initiative, which included postmenopausal women ages 50 to 79 years and had follow-up of 7.2 years for the estrogen-only trial, 5.6 years for the estrogen plus progestin trial, and a long-term follow-up of up to 20.7 years.^2,3

Benefits and harms of hormone therapy. Among postmenopausal women, use of estrogen alone was associated with absolute reduction in risk for fractures (–388 per 10,000 women), diabetes (–134), and breast cancer (–52) and an absolute increase in risk for urinary incontinence (+ 885 per 10,000 women), gallbladder disease (+ 377), stroke (+ 79), and venous thromboembolism (+ 77). Use of estrogen plus progestin was associated with reduced risk for fractures (–230 per 10,000 women), diabetes (–78), and colorectal cancer (–34) and an increased risk for urinary incontinence ( + 562 per 10,000 women), gallbladder disease (+ 260), venous thromboembolism (+ 120), dementia (+ 88), stroke (+ 52), and breast cancer (+ 51).^2,3

Lingering questions. The USPSTF felt that the evidence is too limited to answer the following: (1) Are the potential benefits and harms of hormone therapy affected by participants’ age or by the timing of therapy initiation in relation to menopause onset? and (2) Do different types, doses, or delivery modes of hormone therapy affect benefits and harms?¹

The bottom line. In asymptomatic, healthy, postmenopausal women, do not prescribe hormone therapy to try to prevent chronic conditions.

People living with HIV (PLWH) had a “mistimed circadian phase” and a shorter night’s sleep compared with HIV-negative individuals with a similar lifestyle, according to findings that suggest both a possible mechanism for increased comorbidities in PLWH and potential solutions.

“It is very well known that sleep problems are common in people living with HIV, and many different reasons for this have been proposed,” coauthor Malcolm von Schantz, PhD, professor of chronobiology at Northumbria University in Newcastle upon Tyne, England, said in an interview. “But the novelty of our findings is the observation of delayed circadian rhythms.”

The mistimed circadian phase in PLWH is linked to later sleep onset and earlier waking and has “important potential implications” for the health and well-being of PLWH, wrote senior author Karine Scheuermaier, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and coauthors.

Until now, research on sleep in HIV has focused primarily on its homeostatic components, such as sleep duration and staging, rather than on circadian-related aspects, they noted.

“If the lifestyle‐independent circadian misalignment observed in the current study is confirmed to be a constant feature of chronic HIV infection, then it may be a mediator both of poorer sleep health and of poorer physical health in PLWH, which could potentially be alleviated through light therapy or chronobiotic medication or supplements,” they suggested.
 

HIV endemic in study population

The study analyzed a random sample of 187 participants (36 with HIV and 151 without) in the HAALSI (Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study, which is part of the Agincourt Health and Socio-demographic Surveillance System.

The study population ranged in age from 45 to 93 years, with an average age of 60.6 years in the HIV-positive group and 68.2 years in the HIV-negative group. Demographic data, Pittsburgh Sleep Quality Index score, and valid actigraphy (measured with an accelerometer for 14 consecutive days) were available for 172 participants (18% with HIV). A subgroup of 51 participants (22% with HIV) also had valid dim light melatonin onset (DLMO) data, a sensitive measure of the internal circadian clock. DLMO was measured for a minimum of 5 consecutive days with hourly saliva sampling between 5 p.m. and 11 p.m. while sitting in a dimly lit room.

In 36 participants (16% with HIV) with both valid actigraphy and DLMO data, circadian phase angle of entrainment was calculated by subtracting DLMO time from habitual sleep-onset time obtained from actigraphy.

After adjustment for age and sex, the study found a slightly later sleep onset (adjusted average delay of 10 minutes), earlier awakening (adjusted average advance of 10 minutes), and shorter sleep duration in PLWH compared with HIV-negative participants.

At the same time, melatonin production in PLWH started more than an hour later on average than in HIV-negative participants, “with half of the HIV+ group having an earlier habitual sleep onset than DLMO time” the authors wrote. In a subgroup of 36 participants with both valid actigraphy and DLMO data, the median circadian phase angle of entrainment was smaller in PLWH (–6 minutes vs. +1 hour 25 minutes in the HIV-negative group).

“Collectively, our data suggest that the sleep phase occurred earlier than what would be biologically optimal among the HIV+ participants,” they added.
 

Asynchrony between bedtime and circadian time

“Ideally, with this delayed timing of circadian phase, they should have delayed their sleep phase (sleep timing) by an equal amount to be sleeping at their optimal biological time,” Dr. Scheuermaier explained. “Their sleep onset was delayed by 12 minutes (statistically significant but biologically not that much) while their circadian phase was delayed by more than an hour.”

Possible consequences of a smaller phase angle of entrainment include difficulty in initiating and maintaining sleep, the authors wrote. “The shorter, potentially mistimed sleep relative to the endogenous circadian cycle observed in this study provides objectively measured evidence supporting the abundant previous subjective reports of poor sleep quality and insomnia in PLWH.”

They noted that a strength of their study is that participants were recruited from rural South Africa, where HIV prevalence is not confined to the so-called “high-risk” groups of gay men, other men who have sex with men, people who inject drugs, and sex workers.

“Behavioral factors associated with belonging to one or more of these groups would be strong potential confounders for studies of sleep and circadian phase,” they explained. “By contrast, in rural southern Africa, the epidemic has been less demographically discriminating ... There are no notable differences in lifestyle between the HIV– and HIV+ individuals in this study. The members of this aging population are mostly beyond retirement age, living quiet, rural lives supported by government remittances and subsistence farming.”
 

Direct evidence warrants further study

The study is “unique” in that it provides “the first direct evidence for potential circadian disturbances in PWLH,” agreed Peng Li, PhD, who was not involved in the study.

“The assessment of dim light melatonin onset in PLWH is a strength of the study; together with actigraphy-based sleep onset assessment, it provides a measure for the phase angle of entrainment,” said Dr. Li, who is research director of the medical biodynamics program, division of sleep and circadian disorders, Brigham and Women’s Hospital, Boston.

But actigraphy has limitations that affect the interpretation of the results, he told this news organization.

“Without the help of sleep diaries, low specificity in assessing sleep using actigraphy has been consistently reported,” he said. “The low specificity means a significant overestimation of sleep. This lowers the value of the reported sleep readouts and limits the validity of sleep onset estimation, especially considering that differences in sleep measures between the two groups are relatively small, compromising the clinical meaning.”

Additionally, he explained that it’s not clear whether sleep onset in the study participants was spontaneous or was “forced” to accommodate routines. “This is a limitation in field study as compared with in-lab studies,” he said.

Dr. Li also pointed to the small sample size and younger age of PLWH, suggesting the study might have benefited from a matched design. Finally, he said the study did not examine gender differences.

“In the general population, it is known that females usually have advanced circadian phase compared to males. ... More rigorous design and analyses based on sex/gender especially in this often-marginalized population are warranted to better inform HIV-specific or general clinical guidelines.”

The study was supported by the Academy of Medical Sciences. The authors did not mention any competing interests. Dr. Li reported grant support from the BrightFocus Foundation. The study is not directly related to this paper. He also receives grant support from the NIH through a Departmental Award, Harvard University Center for AIDS Research and a Pilot Project, HIV and Aging Research Consortium. The projects are on circadian disturbances and cognitive performance in PLWH.

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

People living with HIV (PLWH) had a “mistimed circadian phase” and a shorter night’s sleep compared with HIV-negative individuals with a similar lifestyle, according to findings that suggest both a possible mechanism for increased comorbidities in PLWH and potential solutions.

“It is very well known that sleep problems are common in people living with HIV, and many different reasons for this have been proposed,” coauthor Malcolm von Schantz, PhD, professor of chronobiology at Northumbria University in Newcastle upon Tyne, England, said in an interview. “But the novelty of our findings is the observation of delayed circadian rhythms.”

The mistimed circadian phase in PLWH is linked to later sleep onset and earlier waking and has “important potential implications” for the health and well-being of PLWH, wrote senior author Karine Scheuermaier, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and coauthors.

Until now, research on sleep in HIV has focused primarily on its homeostatic components, such as sleep duration and staging, rather than on circadian-related aspects, they noted.

“If the lifestyle‐independent circadian misalignment observed in the current study is confirmed to be a constant feature of chronic HIV infection, then it may be a mediator both of poorer sleep health and of poorer physical health in PLWH, which could potentially be alleviated through light therapy or chronobiotic medication or supplements,” they suggested.
 

HIV endemic in study population

The study analyzed a random sample of 187 participants (36 with HIV and 151 without) in the HAALSI (Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study, which is part of the Agincourt Health and Socio-demographic Surveillance System.

The study population ranged in age from 45 to 93 years, with an average age of 60.6 years in the HIV-positive group and 68.2 years in the HIV-negative group. Demographic data, Pittsburgh Sleep Quality Index score, and valid actigraphy (measured with an accelerometer for 14 consecutive days) were available for 172 participants (18% with HIV). A subgroup of 51 participants (22% with HIV) also had valid dim light melatonin onset (DLMO) data, a sensitive measure of the internal circadian clock. DLMO was measured for a minimum of 5 consecutive days with hourly saliva sampling between 5 p.m. and 11 p.m. while sitting in a dimly lit room.

In 36 participants (16% with HIV) with both valid actigraphy and DLMO data, circadian phase angle of entrainment was calculated by subtracting DLMO time from habitual sleep-onset time obtained from actigraphy.

After adjustment for age and sex, the study found a slightly later sleep onset (adjusted average delay of 10 minutes), earlier awakening (adjusted average advance of 10 minutes), and shorter sleep duration in PLWH compared with HIV-negative participants.

At the same time, melatonin production in PLWH started more than an hour later on average than in HIV-negative participants, “with half of the HIV+ group having an earlier habitual sleep onset than DLMO time” the authors wrote. In a subgroup of 36 participants with both valid actigraphy and DLMO data, the median circadian phase angle of entrainment was smaller in PLWH (–6 minutes vs. +1 hour 25 minutes in the HIV-negative group).

“Collectively, our data suggest that the sleep phase occurred earlier than what would be biologically optimal among the HIV+ participants,” they added.
 

Asynchrony between bedtime and circadian time

“Ideally, with this delayed timing of circadian phase, they should have delayed their sleep phase (sleep timing) by an equal amount to be sleeping at their optimal biological time,” Dr. Scheuermaier explained. “Their sleep onset was delayed by 12 minutes (statistically significant but biologically not that much) while their circadian phase was delayed by more than an hour.”

Possible consequences of a smaller phase angle of entrainment include difficulty in initiating and maintaining sleep, the authors wrote. “The shorter, potentially mistimed sleep relative to the endogenous circadian cycle observed in this study provides objectively measured evidence supporting the abundant previous subjective reports of poor sleep quality and insomnia in PLWH.”

They noted that a strength of their study is that participants were recruited from rural South Africa, where HIV prevalence is not confined to the so-called “high-risk” groups of gay men, other men who have sex with men, people who inject drugs, and sex workers.

“Behavioral factors associated with belonging to one or more of these groups would be strong potential confounders for studies of sleep and circadian phase,” they explained. “By contrast, in rural southern Africa, the epidemic has been less demographically discriminating ... There are no notable differences in lifestyle between the HIV– and HIV+ individuals in this study. The members of this aging population are mostly beyond retirement age, living quiet, rural lives supported by government remittances and subsistence farming.”
 

Direct evidence warrants further study

The study is “unique” in that it provides “the first direct evidence for potential circadian disturbances in PWLH,” agreed Peng Li, PhD, who was not involved in the study.

“The assessment of dim light melatonin onset in PLWH is a strength of the study; together with actigraphy-based sleep onset assessment, it provides a measure for the phase angle of entrainment,” said Dr. Li, who is research director of the medical biodynamics program, division of sleep and circadian disorders, Brigham and Women’s Hospital, Boston.

But actigraphy has limitations that affect the interpretation of the results, he told this news organization.

“Without the help of sleep diaries, low specificity in assessing sleep using actigraphy has been consistently reported,” he said. “The low specificity means a significant overestimation of sleep. This lowers the value of the reported sleep readouts and limits the validity of sleep onset estimation, especially considering that differences in sleep measures between the two groups are relatively small, compromising the clinical meaning.”

Additionally, he explained that it’s not clear whether sleep onset in the study participants was spontaneous or was “forced” to accommodate routines. “This is a limitation in field study as compared with in-lab studies,” he said.

Dr. Li also pointed to the small sample size and younger age of PLWH, suggesting the study might have benefited from a matched design. Finally, he said the study did not examine gender differences.

“In the general population, it is known that females usually have advanced circadian phase compared to males. ... More rigorous design and analyses based on sex/gender especially in this often-marginalized population are warranted to better inform HIV-specific or general clinical guidelines.”

The study was supported by the Academy of Medical Sciences. The authors did not mention any competing interests. Dr. Li reported grant support from the BrightFocus Foundation. The study is not directly related to this paper. He also receives grant support from the NIH through a Departmental Award, Harvard University Center for AIDS Research and a Pilot Project, HIV and Aging Research Consortium. The projects are on circadian disturbances and cognitive performance in PLWH.

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

People living with HIV (PLWH) had a “mistimed circadian phase” and a shorter night’s sleep compared with HIV-negative individuals with a similar lifestyle, according to findings that suggest both a possible mechanism for increased comorbidities in PLWH and potential solutions.

“It is very well known that sleep problems are common in people living with HIV, and many different reasons for this have been proposed,” coauthor Malcolm von Schantz, PhD, professor of chronobiology at Northumbria University in Newcastle upon Tyne, England, said in an interview. “But the novelty of our findings is the observation of delayed circadian rhythms.”

The mistimed circadian phase in PLWH is linked to later sleep onset and earlier waking and has “important potential implications” for the health and well-being of PLWH, wrote senior author Karine Scheuermaier, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and coauthors.

Until now, research on sleep in HIV has focused primarily on its homeostatic components, such as sleep duration and staging, rather than on circadian-related aspects, they noted.

“If the lifestyle‐independent circadian misalignment observed in the current study is confirmed to be a constant feature of chronic HIV infection, then it may be a mediator both of poorer sleep health and of poorer physical health in PLWH, which could potentially be alleviated through light therapy or chronobiotic medication or supplements,” they suggested.
 

HIV endemic in study population

The study analyzed a random sample of 187 participants (36 with HIV and 151 without) in the HAALSI (Health and Ageing in Africa: A Longitudinal Study of an INDEPTH Community in South Africa) study, which is part of the Agincourt Health and Socio-demographic Surveillance System.

The study population ranged in age from 45 to 93 years, with an average age of 60.6 years in the HIV-positive group and 68.2 years in the HIV-negative group. Demographic data, Pittsburgh Sleep Quality Index score, and valid actigraphy (measured with an accelerometer for 14 consecutive days) were available for 172 participants (18% with HIV). A subgroup of 51 participants (22% with HIV) also had valid dim light melatonin onset (DLMO) data, a sensitive measure of the internal circadian clock. DLMO was measured for a minimum of 5 consecutive days with hourly saliva sampling between 5 p.m. and 11 p.m. while sitting in a dimly lit room.

In 36 participants (16% with HIV) with both valid actigraphy and DLMO data, circadian phase angle of entrainment was calculated by subtracting DLMO time from habitual sleep-onset time obtained from actigraphy.

After adjustment for age and sex, the study found a slightly later sleep onset (adjusted average delay of 10 minutes), earlier awakening (adjusted average advance of 10 minutes), and shorter sleep duration in PLWH compared with HIV-negative participants.

At the same time, melatonin production in PLWH started more than an hour later on average than in HIV-negative participants, “with half of the HIV+ group having an earlier habitual sleep onset than DLMO time” the authors wrote. In a subgroup of 36 participants with both valid actigraphy and DLMO data, the median circadian phase angle of entrainment was smaller in PLWH (–6 minutes vs. +1 hour 25 minutes in the HIV-negative group).

“Collectively, our data suggest that the sleep phase occurred earlier than what would be biologically optimal among the HIV+ participants,” they added.
 

Asynchrony between bedtime and circadian time

“Ideally, with this delayed timing of circadian phase, they should have delayed their sleep phase (sleep timing) by an equal amount to be sleeping at their optimal biological time,” Dr. Scheuermaier explained. “Their sleep onset was delayed by 12 minutes (statistically significant but biologically not that much) while their circadian phase was delayed by more than an hour.”

Possible consequences of a smaller phase angle of entrainment include difficulty in initiating and maintaining sleep, the authors wrote. “The shorter, potentially mistimed sleep relative to the endogenous circadian cycle observed in this study provides objectively measured evidence supporting the abundant previous subjective reports of poor sleep quality and insomnia in PLWH.”

They noted that a strength of their study is that participants were recruited from rural South Africa, where HIV prevalence is not confined to the so-called “high-risk” groups of gay men, other men who have sex with men, people who inject drugs, and sex workers.

“Behavioral factors associated with belonging to one or more of these groups would be strong potential confounders for studies of sleep and circadian phase,” they explained. “By contrast, in rural southern Africa, the epidemic has been less demographically discriminating ... There are no notable differences in lifestyle between the HIV– and HIV+ individuals in this study. The members of this aging population are mostly beyond retirement age, living quiet, rural lives supported by government remittances and subsistence farming.”
 

Direct evidence warrants further study

The study is “unique” in that it provides “the first direct evidence for potential circadian disturbances in PWLH,” agreed Peng Li, PhD, who was not involved in the study.

“The assessment of dim light melatonin onset in PLWH is a strength of the study; together with actigraphy-based sleep onset assessment, it provides a measure for the phase angle of entrainment,” said Dr. Li, who is research director of the medical biodynamics program, division of sleep and circadian disorders, Brigham and Women’s Hospital, Boston.

But actigraphy has limitations that affect the interpretation of the results, he told this news organization.

“Without the help of sleep diaries, low specificity in assessing sleep using actigraphy has been consistently reported,” he said. “The low specificity means a significant overestimation of sleep. This lowers the value of the reported sleep readouts and limits the validity of sleep onset estimation, especially considering that differences in sleep measures between the two groups are relatively small, compromising the clinical meaning.”

Additionally, he explained that it’s not clear whether sleep onset in the study participants was spontaneous or was “forced” to accommodate routines. “This is a limitation in field study as compared with in-lab studies,” he said.

Dr. Li also pointed to the small sample size and younger age of PLWH, suggesting the study might have benefited from a matched design. Finally, he said the study did not examine gender differences.

“In the general population, it is known that females usually have advanced circadian phase compared to males. ... More rigorous design and analyses based on sex/gender especially in this often-marginalized population are warranted to better inform HIV-specific or general clinical guidelines.”

The study was supported by the Academy of Medical Sciences. The authors did not mention any competing interests. Dr. Li reported grant support from the BrightFocus Foundation. The study is not directly related to this paper. He also receives grant support from the NIH through a Departmental Award, Harvard University Center for AIDS Research and a Pilot Project, HIV and Aging Research Consortium. The projects are on circadian disturbances and cognitive performance in PLWH.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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