Infectious Diseases

To the Editor:

Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterized by the development of painful abscesses, fistulous tracts, and scars. It most commonly affects the apocrine gland–bearing areas of the body such as the axillary, inguinal, and anogenital regions. With a prevalence of approximately 1%, HS can lead to notable morbidity.¹ The pathogenesis is thought to be due to occlusion of terminal hair follicles that subsequently stimulates release of proinflammatory cytokines from nearby keratinocytes. The mechanism of initial occlusion is not well understood but may be due to friction or trauma. An inflammatory mechanism of disease also has been hypothesized; however, the exact cytokine profile is not known. Treatment of HS consists of several different modalities, including oral retinoids, antibiotics, antiandrogenic therapy, and surgery.^1,2 Adalimumab is a well-known biologic that has been approved by the US Food and Drug Administration for the treatment of HS.

Adalimumab is a human monoclonal antibody against tumor necrosis factor (TNF) α and is thought to improve HS by several mechanisms. Inhibition of TNF-α and other proinflammatory cytokines found in inflammatory lesions and apocrine glands directly decreases the severity of lesion size and the frequency of recurrence.³ Adalimumab also is thought to downregulate expression of keratin 6 and prevent the hyperkeratinization seen in HS.⁴ Additionally, TNF-α inhibition decreases production of IL-1, which has been shown to cause hypercornification of follicles and perpetuate HS pathogenesis.⁵

Adalimumab is considered a safe medication with a low toxicity profile and rarely is associated with serious adverse effects. The most common adverse effects are injection-site reaction, headache, and rash. However, as with any immunosuppressant, there is an elevated incidence of opportunistic infections. Anti-TNF medications have been associated with an increased incidence of viral, bacterial, and fungal infections. We present a patient who developed Candida esophagitis 6 weeks after starting treatment with adalimumab for the treatment of HS. This case highlights the development of esophageal candidiasis as a notable adverse event.

A 41-year-old woman with a history of endometriosis, adenomyosis, polycystic ovary syndrome, interstitial cystitis, asthma, fibromyalgia, depression, and Hashimoto thyroiditis presented to our dermatology clinic with active draining lesions and sinus tracts in the perivaginal area that were consistent with HS, which initially was treated with doxycycline 100 mg twice daily. She experienced minimal improvement of the HS lesions at 2-month follow-up.

Due to disease severity, adalimumab was started. The patient received a loading dose of 4 injections totaling 160 mg and 80 mg on day 15, followed by a maintenance dose of 40 mg/0.4 mL weekly. The patient reported substantial improvement of pain, and complete resolution of active lesions was noted on physical examination after 4 weeks of treatment with adalimumab.

Six weeks after adalimumab was started, the patient developed severe dysphagia. She was evaluated by a gastroenterologist and underwent endoscopy (Figure), which led to a diagnosis of esophageal candidiasis. Adalimumab was discontinued immediately thereafter. The patient started treatment with nystatin oral rinse 4 times daily and oral fluconazole 200 mg daily. The candidiasis resolved within 2 weeks; however, she experienced recurrence of HS with draining lesions in the perivaginal area approximately 8 weeks after discontinuation of adalimumab. The patient requested to restart adalimumab treatment despite the recent history of esophagitis. Adalimumab 40 mg/0.4 mL weekly was restarted along with oral fluconazole 200 mg twice weekly and nystatin oral rinse 4 times daily. This regimen resulted in complete resolution of HS symptoms within 6 weeks with no recurrence of esophageal candidiasis during 6 months of follow-up.

Patients receiving adalimumab for dermatologic or other conditions should be closely monitored for opportunistic infections. Although immunomodulatory medications offer promising therapeutic benefits in patients with HS, larger studies regarding treatment with anti-TNF agents in HS are warranted to prevent complications from treatment and promote long-term efficacy and safety.

To the Editor:

Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterized by the development of painful abscesses, fistulous tracts, and scars. It most commonly affects the apocrine gland–bearing areas of the body such as the axillary, inguinal, and anogenital regions. With a prevalence of approximately 1%, HS can lead to notable morbidity.¹ The pathogenesis is thought to be due to occlusion of terminal hair follicles that subsequently stimulates release of proinflammatory cytokines from nearby keratinocytes. The mechanism of initial occlusion is not well understood but may be due to friction or trauma. An inflammatory mechanism of disease also has been hypothesized; however, the exact cytokine profile is not known. Treatment of HS consists of several different modalities, including oral retinoids, antibiotics, antiandrogenic therapy, and surgery.^1,2 Adalimumab is a well-known biologic that has been approved by the US Food and Drug Administration for the treatment of HS.

Adalimumab is a human monoclonal antibody against tumor necrosis factor (TNF) α and is thought to improve HS by several mechanisms. Inhibition of TNF-α and other proinflammatory cytokines found in inflammatory lesions and apocrine glands directly decreases the severity of lesion size and the frequency of recurrence.³ Adalimumab also is thought to downregulate expression of keratin 6 and prevent the hyperkeratinization seen in HS.⁴ Additionally, TNF-α inhibition decreases production of IL-1, which has been shown to cause hypercornification of follicles and perpetuate HS pathogenesis.⁵

Adalimumab is considered a safe medication with a low toxicity profile and rarely is associated with serious adverse effects. The most common adverse effects are injection-site reaction, headache, and rash. However, as with any immunosuppressant, there is an elevated incidence of opportunistic infections. Anti-TNF medications have been associated with an increased incidence of viral, bacterial, and fungal infections. We present a patient who developed Candida esophagitis 6 weeks after starting treatment with adalimumab for the treatment of HS. This case highlights the development of esophageal candidiasis as a notable adverse event.

A 41-year-old woman with a history of endometriosis, adenomyosis, polycystic ovary syndrome, interstitial cystitis, asthma, fibromyalgia, depression, and Hashimoto thyroiditis presented to our dermatology clinic with active draining lesions and sinus tracts in the perivaginal area that were consistent with HS, which initially was treated with doxycycline 100 mg twice daily. She experienced minimal improvement of the HS lesions at 2-month follow-up.

Due to disease severity, adalimumab was started. The patient received a loading dose of 4 injections totaling 160 mg and 80 mg on day 15, followed by a maintenance dose of 40 mg/0.4 mL weekly. The patient reported substantial improvement of pain, and complete resolution of active lesions was noted on physical examination after 4 weeks of treatment with adalimumab.

Six weeks after adalimumab was started, the patient developed severe dysphagia. She was evaluated by a gastroenterologist and underwent endoscopy (Figure), which led to a diagnosis of esophageal candidiasis. Adalimumab was discontinued immediately thereafter. The patient started treatment with nystatin oral rinse 4 times daily and oral fluconazole 200 mg daily. The candidiasis resolved within 2 weeks; however, she experienced recurrence of HS with draining lesions in the perivaginal area approximately 8 weeks after discontinuation of adalimumab. The patient requested to restart adalimumab treatment despite the recent history of esophagitis. Adalimumab 40 mg/0.4 mL weekly was restarted along with oral fluconazole 200 mg twice weekly and nystatin oral rinse 4 times daily. This regimen resulted in complete resolution of HS symptoms within 6 weeks with no recurrence of esophageal candidiasis during 6 months of follow-up.

Patients receiving adalimumab for dermatologic or other conditions should be closely monitored for opportunistic infections. Although immunomodulatory medications offer promising therapeutic benefits in patients with HS, larger studies regarding treatment with anti-TNF agents in HS are warranted to prevent complications from treatment and promote long-term efficacy and safety.

To the Editor:

Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterized by the development of painful abscesses, fistulous tracts, and scars. It most commonly affects the apocrine gland–bearing areas of the body such as the axillary, inguinal, and anogenital regions. With a prevalence of approximately 1%, HS can lead to notable morbidity.¹ The pathogenesis is thought to be due to occlusion of terminal hair follicles that subsequently stimulates release of proinflammatory cytokines from nearby keratinocytes. The mechanism of initial occlusion is not well understood but may be due to friction or trauma. An inflammatory mechanism of disease also has been hypothesized; however, the exact cytokine profile is not known. Treatment of HS consists of several different modalities, including oral retinoids, antibiotics, antiandrogenic therapy, and surgery.^1,2 Adalimumab is a well-known biologic that has been approved by the US Food and Drug Administration for the treatment of HS.

Adalimumab is a human monoclonal antibody against tumor necrosis factor (TNF) α and is thought to improve HS by several mechanisms. Inhibition of TNF-α and other proinflammatory cytokines found in inflammatory lesions and apocrine glands directly decreases the severity of lesion size and the frequency of recurrence.³ Adalimumab also is thought to downregulate expression of keratin 6 and prevent the hyperkeratinization seen in HS.⁴ Additionally, TNF-α inhibition decreases production of IL-1, which has been shown to cause hypercornification of follicles and perpetuate HS pathogenesis.⁵

Adalimumab is considered a safe medication with a low toxicity profile and rarely is associated with serious adverse effects. The most common adverse effects are injection-site reaction, headache, and rash. However, as with any immunosuppressant, there is an elevated incidence of opportunistic infections. Anti-TNF medications have been associated with an increased incidence of viral, bacterial, and fungal infections. We present a patient who developed Candida esophagitis 6 weeks after starting treatment with adalimumab for the treatment of HS. This case highlights the development of esophageal candidiasis as a notable adverse event.

A 41-year-old woman with a history of endometriosis, adenomyosis, polycystic ovary syndrome, interstitial cystitis, asthma, fibromyalgia, depression, and Hashimoto thyroiditis presented to our dermatology clinic with active draining lesions and sinus tracts in the perivaginal area that were consistent with HS, which initially was treated with doxycycline 100 mg twice daily. She experienced minimal improvement of the HS lesions at 2-month follow-up.

Due to disease severity, adalimumab was started. The patient received a loading dose of 4 injections totaling 160 mg and 80 mg on day 15, followed by a maintenance dose of 40 mg/0.4 mL weekly. The patient reported substantial improvement of pain, and complete resolution of active lesions was noted on physical examination after 4 weeks of treatment with adalimumab.

Six weeks after adalimumab was started, the patient developed severe dysphagia. She was evaluated by a gastroenterologist and underwent endoscopy (Figure), which led to a diagnosis of esophageal candidiasis. Adalimumab was discontinued immediately thereafter. The patient started treatment with nystatin oral rinse 4 times daily and oral fluconazole 200 mg daily. The candidiasis resolved within 2 weeks; however, she experienced recurrence of HS with draining lesions in the perivaginal area approximately 8 weeks after discontinuation of adalimumab. The patient requested to restart adalimumab treatment despite the recent history of esophagitis. Adalimumab 40 mg/0.4 mL weekly was restarted along with oral fluconazole 200 mg twice weekly and nystatin oral rinse 4 times daily. This regimen resulted in complete resolution of HS symptoms within 6 weeks with no recurrence of esophageal candidiasis during 6 months of follow-up.

Patients receiving adalimumab for dermatologic or other conditions should be closely monitored for opportunistic infections. Although immunomodulatory medications offer promising therapeutic benefits in patients with HS, larger studies regarding treatment with anti-TNF agents in HS are warranted to prevent complications from treatment and promote long-term efficacy and safety.

Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.

More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.

“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.

Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.

The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).

“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”

The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”

By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”

Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.

Analyzing surveillance data

To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).

The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.

At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.

Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.

Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.

The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.

Rates of outcomes “of interest” were no higher among these women than in the general population. 

In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”  

Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.

Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.

“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.

The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”

Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.

Vaccination could benefit infants

In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.

“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”

Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.

Dr. Shimabukuro has reported no relevant financial relationships.

Lindsay Kalter contributed to the reporting for this story.

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

Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.

More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.

“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.

Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.

The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).

“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”

The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”

By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”

Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.

Analyzing surveillance data

To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).

The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.

At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.

Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.

Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.

The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.

Rates of outcomes “of interest” were no higher among these women than in the general population. 

In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”  

Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.

Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.

“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.

The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”

Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.

Vaccination could benefit infants

In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.

“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”

Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.

Dr. Shimabukuro has reported no relevant financial relationships.

Lindsay Kalter contributed to the reporting for this story.

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

Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.

More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.

“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.

Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.

The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).

“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”

The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”

By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”

Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.

Analyzing surveillance data

To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).

The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.

At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.

Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.

Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.

The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.

Rates of outcomes “of interest” were no higher among these women than in the general population. 

In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”  

Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.

Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.

“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.

The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”

Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.

Vaccination could benefit infants

In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.

“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”

Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.

Dr. Shimabukuro has reported no relevant financial relationships.

Lindsay Kalter contributed to the reporting for this story.

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

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.

Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus. Many medications have been touted as cures, even when doctors and scientists say they don’t work.

Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.

The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
 

NIH updates treatment guidelines

A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.

Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.

In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.

In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
 

Hydroxychloroquine and casirivimab + imdevimab

One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.

Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.

Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.

Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus. Many medications have been touted as cures, even when doctors and scientists say they don’t work.

Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.

The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
 

NIH updates treatment guidelines

A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.

Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.

In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.

In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
 

Hydroxychloroquine and casirivimab + imdevimab

One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.

Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.

Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.

Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus. Many medications have been touted as cures, even when doctors and scientists say they don’t work.

Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.

The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
 

NIH updates treatment guidelines

A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.

Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.

In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.

In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
 

Hydroxychloroquine and casirivimab + imdevimab

One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.

Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.

Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

The number of new COVID-19 cases in children dropped by 17.1% in the latest reporting week, after 2 consecutive weeks of relatively small declines, according to data gathered by the American Academy of Pediatrics and the Children’s Hospital Association.

From Feb. 19 to March 4, the drop in new cases averaged just 5% each week, compared with 13.3% per week over the 5-week period from Jan. 15 to Feb. 18. For the week of March 5-11, a total of 52,695 COVID-19 cases were reported in children, down from 63,562 the previous week and the lowest number since late October, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

In those jurisdictions, 3.28 million children have been infected with SARS-CoV-2, representing 13.2% of all cases since the beginning of the pandemic. The cumulative rate of COVID-19 has now risen to 4,364 cases per 100,000 children nationally, with state rates ranging from 1,062 per 100,000 in Hawaii to 8,692 per 100,000 in North Dakota, the AAP and CHA said in their weekly COVID-19 report.

Hospitalization data are more limited – 24 states and New York City – but continue to show that serious illness is much less common in younger individuals: Children represent just 1.9% of all hospitalizations, and only 0.8% of the children who have been infected were hospitalized. Neither rate has changed since early February, the AAP and CHA said.

The number of deaths in children, however, rose from 253 to 266, the largest 1-week increase since early February in the 43 states (along with New York City, Puerto Rico, and Guam) that are tracking mortality data by age, the AAP and CHA reported.

Among those 46 jurisdictions, there are 10 (9 states and the District of Columbia) that have not yet reported a COVID-19–related child death, while Texas has almost twice as many deaths, 47, as the next state, Arizona, which has 24. Meanwhile, California’s total of 452,000 cases is almost 2½ times higher than the 183,000 recorded by Illinois, according to the report.

[email protected]

The number of new COVID-19 cases in children dropped by 17.1% in the latest reporting week, after 2 consecutive weeks of relatively small declines, according to data gathered by the American Academy of Pediatrics and the Children’s Hospital Association.

From Feb. 19 to March 4, the drop in new cases averaged just 5% each week, compared with 13.3% per week over the 5-week period from Jan. 15 to Feb. 18. For the week of March 5-11, a total of 52,695 COVID-19 cases were reported in children, down from 63,562 the previous week and the lowest number since late October, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

In those jurisdictions, 3.28 million children have been infected with SARS-CoV-2, representing 13.2% of all cases since the beginning of the pandemic. The cumulative rate of COVID-19 has now risen to 4,364 cases per 100,000 children nationally, with state rates ranging from 1,062 per 100,000 in Hawaii to 8,692 per 100,000 in North Dakota, the AAP and CHA said in their weekly COVID-19 report.

Hospitalization data are more limited – 24 states and New York City – but continue to show that serious illness is much less common in younger individuals: Children represent just 1.9% of all hospitalizations, and only 0.8% of the children who have been infected were hospitalized. Neither rate has changed since early February, the AAP and CHA said.

The number of deaths in children, however, rose from 253 to 266, the largest 1-week increase since early February in the 43 states (along with New York City, Puerto Rico, and Guam) that are tracking mortality data by age, the AAP and CHA reported.

Among those 46 jurisdictions, there are 10 (9 states and the District of Columbia) that have not yet reported a COVID-19–related child death, while Texas has almost twice as many deaths, 47, as the next state, Arizona, which has 24. Meanwhile, California’s total of 452,000 cases is almost 2½ times higher than the 183,000 recorded by Illinois, according to the report.

[email protected]

The number of new COVID-19 cases in children dropped by 17.1% in the latest reporting week, after 2 consecutive weeks of relatively small declines, according to data gathered by the American Academy of Pediatrics and the Children’s Hospital Association.

From Feb. 19 to March 4, the drop in new cases averaged just 5% each week, compared with 13.3% per week over the 5-week period from Jan. 15 to Feb. 18. For the week of March 5-11, a total of 52,695 COVID-19 cases were reported in children, down from 63,562 the previous week and the lowest number since late October, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

In those jurisdictions, 3.28 million children have been infected with SARS-CoV-2, representing 13.2% of all cases since the beginning of the pandemic. The cumulative rate of COVID-19 has now risen to 4,364 cases per 100,000 children nationally, with state rates ranging from 1,062 per 100,000 in Hawaii to 8,692 per 100,000 in North Dakota, the AAP and CHA said in their weekly COVID-19 report.

Hospitalization data are more limited – 24 states and New York City – but continue to show that serious illness is much less common in younger individuals: Children represent just 1.9% of all hospitalizations, and only 0.8% of the children who have been infected were hospitalized. Neither rate has changed since early February, the AAP and CHA said.

The number of deaths in children, however, rose from 253 to 266, the largest 1-week increase since early February in the 43 states (along with New York City, Puerto Rico, and Guam) that are tracking mortality data by age, the AAP and CHA reported.

Among those 46 jurisdictions, there are 10 (9 states and the District of Columbia) that have not yet reported a COVID-19–related child death, while Texas has almost twice as many deaths, 47, as the next state, Arizona, which has 24. Meanwhile, California’s total of 452,000 cases is almost 2½ times higher than the 183,000 recorded by Illinois, according to the report.

[email protected]

REFERENCES

1. CDC. Expedited partner therapy. Accessed March 15, 2021. www.cdc.gov/std/ept/default.htm
2. St. Cyr S, Barbee L, Workowski KA, et al. Update to CDC's treatment guidelines for gonococcal infection, 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1911-1916. Accessed March 15, 2021. https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm
3. CDC. Gonococcal infections. Accessed March 15, 2021. www.cdc.gov/std/tg2015/gonorrhea.htm

REFERENCES

1. CDC. Expedited partner therapy. Accessed March 15, 2021. www.cdc.gov/std/ept/default.htm
2. St. Cyr S, Barbee L, Workowski KA, et al. Update to CDC's treatment guidelines for gonococcal infection, 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1911-1916. Accessed March 15, 2021. https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm
3. CDC. Gonococcal infections. Accessed March 15, 2021. www.cdc.gov/std/tg2015/gonorrhea.htm

REFERENCES

1. CDC. Expedited partner therapy. Accessed March 15, 2021. www.cdc.gov/std/ept/default.htm
2. St. Cyr S, Barbee L, Workowski KA, et al. Update to CDC's treatment guidelines for gonococcal infection, 2020. MMWR Morbid Mortal Wkly Rep. 2020;69:1911-1916. Accessed March 15, 2021. https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm
3. CDC. Gonococcal infections. Accessed March 15, 2021. www.cdc.gov/std/tg2015/gonorrhea.htm

Pregnant patients with COVID-19 infections were more likely to experience severe disease if they had preexisting comorbidities, such as chronic hypertension, asthma, or pregestational diabetes, according to findings from a new study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The study included outcomes for the largest multistate cohort of pregnant patients with COVID-19 outside of what the Centers for Disease Control and Prevention is tracking. Its findings also mirrored those of a multicenter, retrospective study in Washington state, published in the American Journal of Obstetrics & Gynecology. That study also found that pregnant patients hospitalized for COVID-19 were more likely to have comorbidities, and both studies found an increased likelihood of preterm birth among pregnant patients with severe or critical disease.
 

Disease severity linked to risk of perinatal complications

In the abstract presented at the SMFM meeting, more severe disease was associated with older age and a higher median body mass index, as seen in the general population, but the researchers found no differences in disease severity occurred by race or ethnicity, Torri D. Metz, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, told attendees of the conference. The researchers also found that perinatal complications were more prevalent in those with severe or critical COVID-19 disease but not in those with mild or moderate disease. Vertical COVID-19 transmission from mother to child was rare.

The observational study included all patients who had a singleton pregnancy, had a positive SARS-CoV-2 test, and delivered between March 1 and July 31, 2020, at one of the 33 U.S. hospitals in the NICHD Maternal-Fetal Medicine Units Network, spread across 14 states. The researchers used electronic medical records to determine incidence of cesarean delivery, postpartum hemorrhage, hypertensive disorders of pregnancy, preterm birth (less than 37 weeks), maternal death, infant death, and positive infant COVID-19 test. They tracked mothers through 6 weeks post partum and newborns through delivery hospitalization.

Of 1,291 patients in the cohort, 1,219 received their first positive COVID-19 test during pregnancy. The others tested positive while in the hospital for delivery or within a month and a half after discharge. Limiting their analysis to those who developed COVID-19 while pregnant prior to delivery, nearly half (47%) were asymptomatic.

The disease was mild in 27%, moderate in 14%, severe in 8%, and critical in 4%. The researchers used the National Institutes of Health classifications for severity and included deaths in the critical group. The most common symptom was a cough, reported by a third of the patients (34%). Four of six maternal deaths that occurred were caused by COVID-19.

Compared with an average age of 28 in those without symptoms, the mean age was 29 in those with mild/moderate disease and 30 in those with severe/critical disease (P = .006). Similarly, the mean BMI was 28.3 in asymptomatic patients, 29 in those with mild/moderate disease, and 32.3 in those with severe/critical disease (P < .001). Despite a diverse cohort – 53% Hispanic, 23% Black, and 15% White – the researches found no racial/ethnic trends in disease severity.

Patients who had asthma, chronic obstructive pulmonary disorder, pregestational diabetes, chronic hypertension, chronic liver disease, or a seizure disorder were all significantly more likely to have critical/severe disease than mild/moderate disease, and more likely to have mild/moderate disease than asymptomatic (P values ranged from < .001 to .02).

The mothers with critical or severe illness were 1.6 times more likely to have cesarean births and to have hypertensive disorders of pregnancy, and they were twice as likely to have postpartum hemorrhage (P < .001; P = .007). Those with mild or moderate disease, however, had no increased risks for perinatal complications over asymptomatic patients.

Critical or severe illness was also associated with more than triple the risk of preterm birth (adjusted risk ratio, 3.6; P < .001). Newborns of mothers with critical or severe illness also had three times greater risk of neonatal ICU admission (ARR, 3.1; P <. 001) and weighed an average 385 g less than newborns of asymptomatic mothers. COVID-19 rate among infants was only 1% during delivery hospitalization.

Since the study cutoff was July 30 and COVID infections only became prevalent in March, the researchers were unable to evaluate women for outcomes resulting from COVID infections in early pregnancy, such as congenital anomalies or early miscarriage, Dr. Metz said. In addition, since many of the sites are urban centers, the data may not be generalizable to rural areas.

Peter S. Bernstein, MD, MPH, of Montefiore Medical Center, New York, asked whether the increased cesarean deliveries and preterm births in the group of women with severe disease were caused by usual obstetric causes or the treatment of COVID-19 infection. Dr. Metz said the vast majority of preterm deliveries were indicated, but only a small proportion were induced for COVID-19 alone. “A lot had hypertensive disorders of pregnancies or PPROM, so it’s partly driven by the infection itself but also partly driven by some of those perinatal complications,” she said.
 

Similar findings in Washington

In the Washington study, among 240 pregnant patients with confirmed COVID-19 infection between March 1 and July 30, 2020, 1 in 11 developed severe or critical disease, and 1 in 10 were hospitalized. The pregnant patients had more than triple the risk of hospitalization compared with adults of similar ages in the general population (10% vs. 2.8%; rate ratio, 3.5). Similar to the multistate NICHD study, women were more likely to be hospitalized if they had asthma, hypertension, type 2 diabetes, autoimmune disease, or class III obesity.

Three mothers died of COVID-19, resulting in a case fatality rate 13.6 times greater than nonpregnant patients with COVID-19 in the general population. The absolute difference in the rate was 1.2%. As seen in the NICHD study, preterm birth was more common in mothers with severe or critical COVID-19. Nearly half (45.4%) of mothers with severe or critical COVID-19 delivered preterm compared to 5.2% in those with mild COVID-19 (P < .001).

“Our finding that deaths in pregnant patients contributed disproportionately to deaths from COVID-19 among 20- to 39-year-olds in Washington state is similar to what was observed during the influenza A virus H1N1 2009 pandemic,” Erica M. Lokken, PhD, MS, of the departments of global health and ob.gyn. at the University of Washington, Seattle, and colleagues wrote in the Washington study. But they noted that it took 8 months into the pandemic before pregnant patients were identified as a high-risk group for COVID-19.

“Given the similarity in clinical course between COVID-19 and IAV H1N1 2009 with an increased risk for mortality during pregnancy and the postpartum period, we strongly recommend that pregnant patients should be considered a high-risk population to novel highly pathogenic respiratory viruses until proven otherwise by population-based studies with good ascertainment of pregnancy status,” they wrote.

Judette Louis, MD, MPH, associate professor of ob.gyn. and department chair at the University of South Florida, Tampa, said in an interview that the findings in these studies were fairly expected, but it’s important to have data from such a large cohort as the one presented at SMFM.

“It confirmed that those who had severe disease were more likely to have chronic medical conditions, mirroring what we saw in the general population who isn’t pregnant,” Dr. Louis said. “I thought this was very crucial because as pregnant women are trying to decide whether they should get the COVID vaccine, this provides support to say that if you’re pregnant, you’re more likely to have severe disease [if you have] other chronic medical conditions.”

The findings also confirm the importance of pregnant people taking precautions to avoid infection.

“Even though these individuals are, as a group, in an age cohort that mostly has asymptomatic disease, for some of them, it results in severe disease and even maternal death,” she said. “They should still take it seriously if they’re pregnant.”

The SMFM abstract study was funded by the NICHD. The Washington study was funded by the University of Washington Population Health Initiative, the National Institutes of Health, and philanthropic gift funds. One coauthor of the Washington study is on a Pfizer and GlaxoSmithKline advisory board for immunizations. No other authors or individuals interviewed reported any disclosures.

Pregnant patients with COVID-19 infections were more likely to experience severe disease if they had preexisting comorbidities, such as chronic hypertension, asthma, or pregestational diabetes, according to findings from a new study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The study included outcomes for the largest multistate cohort of pregnant patients with COVID-19 outside of what the Centers for Disease Control and Prevention is tracking. Its findings also mirrored those of a multicenter, retrospective study in Washington state, published in the American Journal of Obstetrics & Gynecology. That study also found that pregnant patients hospitalized for COVID-19 were more likely to have comorbidities, and both studies found an increased likelihood of preterm birth among pregnant patients with severe or critical disease.
 

Disease severity linked to risk of perinatal complications

In the abstract presented at the SMFM meeting, more severe disease was associated with older age and a higher median body mass index, as seen in the general population, but the researchers found no differences in disease severity occurred by race or ethnicity, Torri D. Metz, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, told attendees of the conference. The researchers also found that perinatal complications were more prevalent in those with severe or critical COVID-19 disease but not in those with mild or moderate disease. Vertical COVID-19 transmission from mother to child was rare.

The observational study included all patients who had a singleton pregnancy, had a positive SARS-CoV-2 test, and delivered between March 1 and July 31, 2020, at one of the 33 U.S. hospitals in the NICHD Maternal-Fetal Medicine Units Network, spread across 14 states. The researchers used electronic medical records to determine incidence of cesarean delivery, postpartum hemorrhage, hypertensive disorders of pregnancy, preterm birth (less than 37 weeks), maternal death, infant death, and positive infant COVID-19 test. They tracked mothers through 6 weeks post partum and newborns through delivery hospitalization.

Of 1,291 patients in the cohort, 1,219 received their first positive COVID-19 test during pregnancy. The others tested positive while in the hospital for delivery or within a month and a half after discharge. Limiting their analysis to those who developed COVID-19 while pregnant prior to delivery, nearly half (47%) were asymptomatic.

The disease was mild in 27%, moderate in 14%, severe in 8%, and critical in 4%. The researchers used the National Institutes of Health classifications for severity and included deaths in the critical group. The most common symptom was a cough, reported by a third of the patients (34%). Four of six maternal deaths that occurred were caused by COVID-19.

Compared with an average age of 28 in those without symptoms, the mean age was 29 in those with mild/moderate disease and 30 in those with severe/critical disease (P = .006). Similarly, the mean BMI was 28.3 in asymptomatic patients, 29 in those with mild/moderate disease, and 32.3 in those with severe/critical disease (P < .001). Despite a diverse cohort – 53% Hispanic, 23% Black, and 15% White – the researches found no racial/ethnic trends in disease severity.

Patients who had asthma, chronic obstructive pulmonary disorder, pregestational diabetes, chronic hypertension, chronic liver disease, or a seizure disorder were all significantly more likely to have critical/severe disease than mild/moderate disease, and more likely to have mild/moderate disease than asymptomatic (P values ranged from < .001 to .02).

The mothers with critical or severe illness were 1.6 times more likely to have cesarean births and to have hypertensive disorders of pregnancy, and they were twice as likely to have postpartum hemorrhage (P < .001; P = .007). Those with mild or moderate disease, however, had no increased risks for perinatal complications over asymptomatic patients.

Critical or severe illness was also associated with more than triple the risk of preterm birth (adjusted risk ratio, 3.6; P < .001). Newborns of mothers with critical or severe illness also had three times greater risk of neonatal ICU admission (ARR, 3.1; P <. 001) and weighed an average 385 g less than newborns of asymptomatic mothers. COVID-19 rate among infants was only 1% during delivery hospitalization.

Since the study cutoff was July 30 and COVID infections only became prevalent in March, the researchers were unable to evaluate women for outcomes resulting from COVID infections in early pregnancy, such as congenital anomalies or early miscarriage, Dr. Metz said. In addition, since many of the sites are urban centers, the data may not be generalizable to rural areas.

Peter S. Bernstein, MD, MPH, of Montefiore Medical Center, New York, asked whether the increased cesarean deliveries and preterm births in the group of women with severe disease were caused by usual obstetric causes or the treatment of COVID-19 infection. Dr. Metz said the vast majority of preterm deliveries were indicated, but only a small proportion were induced for COVID-19 alone. “A lot had hypertensive disorders of pregnancies or PPROM, so it’s partly driven by the infection itself but also partly driven by some of those perinatal complications,” she said.
 

Similar findings in Washington

In the Washington study, among 240 pregnant patients with confirmed COVID-19 infection between March 1 and July 30, 2020, 1 in 11 developed severe or critical disease, and 1 in 10 were hospitalized. The pregnant patients had more than triple the risk of hospitalization compared with adults of similar ages in the general population (10% vs. 2.8%; rate ratio, 3.5). Similar to the multistate NICHD study, women were more likely to be hospitalized if they had asthma, hypertension, type 2 diabetes, autoimmune disease, or class III obesity.

Three mothers died of COVID-19, resulting in a case fatality rate 13.6 times greater than nonpregnant patients with COVID-19 in the general population. The absolute difference in the rate was 1.2%. As seen in the NICHD study, preterm birth was more common in mothers with severe or critical COVID-19. Nearly half (45.4%) of mothers with severe or critical COVID-19 delivered preterm compared to 5.2% in those with mild COVID-19 (P < .001).

“Our finding that deaths in pregnant patients contributed disproportionately to deaths from COVID-19 among 20- to 39-year-olds in Washington state is similar to what was observed during the influenza A virus H1N1 2009 pandemic,” Erica M. Lokken, PhD, MS, of the departments of global health and ob.gyn. at the University of Washington, Seattle, and colleagues wrote in the Washington study. But they noted that it took 8 months into the pandemic before pregnant patients were identified as a high-risk group for COVID-19.

“Given the similarity in clinical course between COVID-19 and IAV H1N1 2009 with an increased risk for mortality during pregnancy and the postpartum period, we strongly recommend that pregnant patients should be considered a high-risk population to novel highly pathogenic respiratory viruses until proven otherwise by population-based studies with good ascertainment of pregnancy status,” they wrote.

Judette Louis, MD, MPH, associate professor of ob.gyn. and department chair at the University of South Florida, Tampa, said in an interview that the findings in these studies were fairly expected, but it’s important to have data from such a large cohort as the one presented at SMFM.

“It confirmed that those who had severe disease were more likely to have chronic medical conditions, mirroring what we saw in the general population who isn’t pregnant,” Dr. Louis said. “I thought this was very crucial because as pregnant women are trying to decide whether they should get the COVID vaccine, this provides support to say that if you’re pregnant, you’re more likely to have severe disease [if you have] other chronic medical conditions.”

The findings also confirm the importance of pregnant people taking precautions to avoid infection.

“Even though these individuals are, as a group, in an age cohort that mostly has asymptomatic disease, for some of them, it results in severe disease and even maternal death,” she said. “They should still take it seriously if they’re pregnant.”

The SMFM abstract study was funded by the NICHD. The Washington study was funded by the University of Washington Population Health Initiative, the National Institutes of Health, and philanthropic gift funds. One coauthor of the Washington study is on a Pfizer and GlaxoSmithKline advisory board for immunizations. No other authors or individuals interviewed reported any disclosures.

Pregnant patients with COVID-19 infections were more likely to experience severe disease if they had preexisting comorbidities, such as chronic hypertension, asthma, or pregestational diabetes, according to findings from a new study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The study included outcomes for the largest multistate cohort of pregnant patients with COVID-19 outside of what the Centers for Disease Control and Prevention is tracking. Its findings also mirrored those of a multicenter, retrospective study in Washington state, published in the American Journal of Obstetrics & Gynecology. That study also found that pregnant patients hospitalized for COVID-19 were more likely to have comorbidities, and both studies found an increased likelihood of preterm birth among pregnant patients with severe or critical disease.
 

Disease severity linked to risk of perinatal complications

In the abstract presented at the SMFM meeting, more severe disease was associated with older age and a higher median body mass index, as seen in the general population, but the researchers found no differences in disease severity occurred by race or ethnicity, Torri D. Metz, MD, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, told attendees of the conference. The researchers also found that perinatal complications were more prevalent in those with severe or critical COVID-19 disease but not in those with mild or moderate disease. Vertical COVID-19 transmission from mother to child was rare.

The observational study included all patients who had a singleton pregnancy, had a positive SARS-CoV-2 test, and delivered between March 1 and July 31, 2020, at one of the 33 U.S. hospitals in the NICHD Maternal-Fetal Medicine Units Network, spread across 14 states. The researchers used electronic medical records to determine incidence of cesarean delivery, postpartum hemorrhage, hypertensive disorders of pregnancy, preterm birth (less than 37 weeks), maternal death, infant death, and positive infant COVID-19 test. They tracked mothers through 6 weeks post partum and newborns through delivery hospitalization.

Of 1,291 patients in the cohort, 1,219 received their first positive COVID-19 test during pregnancy. The others tested positive while in the hospital for delivery or within a month and a half after discharge. Limiting their analysis to those who developed COVID-19 while pregnant prior to delivery, nearly half (47%) were asymptomatic.

The disease was mild in 27%, moderate in 14%, severe in 8%, and critical in 4%. The researchers used the National Institutes of Health classifications for severity and included deaths in the critical group. The most common symptom was a cough, reported by a third of the patients (34%). Four of six maternal deaths that occurred were caused by COVID-19.

Compared with an average age of 28 in those without symptoms, the mean age was 29 in those with mild/moderate disease and 30 in those with severe/critical disease (P = .006). Similarly, the mean BMI was 28.3 in asymptomatic patients, 29 in those with mild/moderate disease, and 32.3 in those with severe/critical disease (P < .001). Despite a diverse cohort – 53% Hispanic, 23% Black, and 15% White – the researches found no racial/ethnic trends in disease severity.

Patients who had asthma, chronic obstructive pulmonary disorder, pregestational diabetes, chronic hypertension, chronic liver disease, or a seizure disorder were all significantly more likely to have critical/severe disease than mild/moderate disease, and more likely to have mild/moderate disease than asymptomatic (P values ranged from < .001 to .02).

The mothers with critical or severe illness were 1.6 times more likely to have cesarean births and to have hypertensive disorders of pregnancy, and they were twice as likely to have postpartum hemorrhage (P < .001; P = .007). Those with mild or moderate disease, however, had no increased risks for perinatal complications over asymptomatic patients.

Critical or severe illness was also associated with more than triple the risk of preterm birth (adjusted risk ratio, 3.6; P < .001). Newborns of mothers with critical or severe illness also had three times greater risk of neonatal ICU admission (ARR, 3.1; P <. 001) and weighed an average 385 g less than newborns of asymptomatic mothers. COVID-19 rate among infants was only 1% during delivery hospitalization.

Since the study cutoff was July 30 and COVID infections only became prevalent in March, the researchers were unable to evaluate women for outcomes resulting from COVID infections in early pregnancy, such as congenital anomalies or early miscarriage, Dr. Metz said. In addition, since many of the sites are urban centers, the data may not be generalizable to rural areas.

Peter S. Bernstein, MD, MPH, of Montefiore Medical Center, New York, asked whether the increased cesarean deliveries and preterm births in the group of women with severe disease were caused by usual obstetric causes or the treatment of COVID-19 infection. Dr. Metz said the vast majority of preterm deliveries were indicated, but only a small proportion were induced for COVID-19 alone. “A lot had hypertensive disorders of pregnancies or PPROM, so it’s partly driven by the infection itself but also partly driven by some of those perinatal complications,” she said.
 

Similar findings in Washington

In the Washington study, among 240 pregnant patients with confirmed COVID-19 infection between March 1 and July 30, 2020, 1 in 11 developed severe or critical disease, and 1 in 10 were hospitalized. The pregnant patients had more than triple the risk of hospitalization compared with adults of similar ages in the general population (10% vs. 2.8%; rate ratio, 3.5). Similar to the multistate NICHD study, women were more likely to be hospitalized if they had asthma, hypertension, type 2 diabetes, autoimmune disease, or class III obesity.

Three mothers died of COVID-19, resulting in a case fatality rate 13.6 times greater than nonpregnant patients with COVID-19 in the general population. The absolute difference in the rate was 1.2%. As seen in the NICHD study, preterm birth was more common in mothers with severe or critical COVID-19. Nearly half (45.4%) of mothers with severe or critical COVID-19 delivered preterm compared to 5.2% in those with mild COVID-19 (P < .001).

“Our finding that deaths in pregnant patients contributed disproportionately to deaths from COVID-19 among 20- to 39-year-olds in Washington state is similar to what was observed during the influenza A virus H1N1 2009 pandemic,” Erica M. Lokken, PhD, MS, of the departments of global health and ob.gyn. at the University of Washington, Seattle, and colleagues wrote in the Washington study. But they noted that it took 8 months into the pandemic before pregnant patients were identified as a high-risk group for COVID-19.

“Given the similarity in clinical course between COVID-19 and IAV H1N1 2009 with an increased risk for mortality during pregnancy and the postpartum period, we strongly recommend that pregnant patients should be considered a high-risk population to novel highly pathogenic respiratory viruses until proven otherwise by population-based studies with good ascertainment of pregnancy status,” they wrote.

Judette Louis, MD, MPH, associate professor of ob.gyn. and department chair at the University of South Florida, Tampa, said in an interview that the findings in these studies were fairly expected, but it’s important to have data from such a large cohort as the one presented at SMFM.

“It confirmed that those who had severe disease were more likely to have chronic medical conditions, mirroring what we saw in the general population who isn’t pregnant,” Dr. Louis said. “I thought this was very crucial because as pregnant women are trying to decide whether they should get the COVID vaccine, this provides support to say that if you’re pregnant, you’re more likely to have severe disease [if you have] other chronic medical conditions.”

The findings also confirm the importance of pregnant people taking precautions to avoid infection.

“Even though these individuals are, as a group, in an age cohort that mostly has asymptomatic disease, for some of them, it results in severe disease and even maternal death,” she said. “They should still take it seriously if they’re pregnant.”

The SMFM abstract study was funded by the NICHD. The Washington study was funded by the University of Washington Population Health Initiative, the National Institutes of Health, and philanthropic gift funds. One coauthor of the Washington study is on a Pfizer and GlaxoSmithKline advisory board for immunizations. No other authors or individuals interviewed reported any disclosures.

In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.

Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.

Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.

Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers and depoliticizing prevention strategies.

The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.

As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.

Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY

In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.

Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.

Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.

Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers and depoliticizing prevention strategies.

The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.

As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.

Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY

In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.

Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.

Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.

Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers and depoliticizing prevention strategies.

The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.

As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.

Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY

Liposomal doxorubicin (Dox) plus pomalidomide (Pom) was safe and active in heavily pretreated patients with Kaposi sarcoma, according to results from a phase 1/2 trial.

“The results of our phase 1/2 study suggest pomalidomide and liposomal doxorubicin is safe with evidence of activity among patients with Kaposi sarcoma,” said investigator Ramya Ramaswami, MBBS, MPH, of the HIV & AIDS malignancy branch at the National Cancer Institute. The results were presented at the Conference on Retroviruses and Opportunistic Infections.

The researchers evaluated the safety and tolerability of Pom/Dox in two groups of patients with Kaposi sarcoma: group 1 included patients with Kaposi sarcoma alone and group 2 included patients with Kaposi sarcoma–associated herpesvirus and concurrent multicentric Castleman disease (KSHV-MCD) and KSHV inflammatory cytokine syndrome (KICS).

“Kaposi sarcoma can be challenging to treat when it co-occurs with KSHV-MCD or KICS, resulting in high mortality rates,” Dr. Ramaswami explained.

Study participants received IV liposomal Dox at 20 mg/m² on day 1 of a 28-day cycle, in addition to oral Pom once daily on days 1-21 at three escalating dose levels (2 mg, 3 mg, or 4 mg, respectively) using a standard 3 + 3 design until plateau of response, progression, dose-limiting toxicities (DLTs) or patient preference. Some eligibility criteria differed between groups 1 and 2. Participants in group 1 were required to be on antiretroviral therapy for at least 1 month and had a performance status of 2 or less, while those in group 2 had a performance status of 3 or less and could be antiretroviral therapy naive.

All participants received oral aspirin thromboprophylaxis (81 mg daily) and could have received prior Kaposi sarcoma therapy.

With respect to outcomes, Kaposi sarcoma responses were assessed using the modified AIDS Clinical Trial Group criteria and KICS and KSHV-MCD responses were evaluated using an NCI clinical benefit criteria.
 

Results

Overall, 34 cisgender men were enrolled in the study: 21 (62%) in group 1 and 13 (38%) in group 2. All participants had severe (T1) Kaposi sarcoma; 32 (94%) participants were HIV-infected and 22 (65%) had prior chemotherapy for Kaposi sarcoma.

While the HIV viral load was largely controlled in both groups, the CD4 count differed, with median CD4 counts of 286 and 92 cells/mcL in groups 1 and 2, respectively.

With respect to safety, no DLTs were observed in group 1. As a result, 12 participants were treated at the maximum tolerated dose (MTD) of 4 mg of Pom. However, two DLTs (grade 3 rash and pharyngeal edema) were observed in group 2 at the 3 mg dose level.

A median of six cycles were administered for all participants and the most common grade 3/4 toxicity was neutropenia; nine patients with grade 3 neutropenia required dose reduction and three patients had febrile neutropenia requiring hospitalization. Other Pom-related adverse events were rash, constipation, and fatigue.

Among evaluable participants receiving two or more cycles, 17 (81%) patients in group 1 had a response (95% confidence interval, 58-95%; 16 partial response and 1 complete response) and 5 (50%) patients in group 2 had a response (95% CI, 19-81%; 4 PR and 1 CR).

“Our waterfall plots indicated that the vast majority of patients in group 1 had a positive change in nodular lesions at baseline,” Dr. Ramaswami said. “Participants in group 2 showed some decrease in nodular lesions, but this was usually temporary.”

Among seven participants with KICS responses, four participants (57%) experienced a CR or PR in symptoms and lab abnormalities associated with KICS; three of six participants (50%) with KSHV-MCD responses experienced a PR as per response criteria.

“While activity was noted, the combination was less well tolerated in patients with Kaposi sarcoma and concurrent KSHV-MCD or KICS,” Dr. Ramaswami said.

During a live discussion, Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles, asked Dr. Ramaswami about the use of liposomal doxorubicin alone in patients with Kaposi sarcoma and concurrent KSHV-MCD or KICS.

While there is currently no data on the use of doxorubicin alone in this population, Dr. Ramaswami noted that she was more confident administering Pom/Dox combination therapy for these patients.

Dr. Ramaswami disclosed financial relationships with the National Cancer Institute, Celgene/Bristol-Myers Squibb, EMD Serono, Merck, CTI Biopharma, and Janssen. The study was funded by a cooperative research and drug development agreement between the National Cancer Institute and Celgene/BMS, EMD Serono, Merck, CTI Biopharma, and Janssen.

Liposomal doxorubicin (Dox) plus pomalidomide (Pom) was safe and active in heavily pretreated patients with Kaposi sarcoma, according to results from a phase 1/2 trial.

“The results of our phase 1/2 study suggest pomalidomide and liposomal doxorubicin is safe with evidence of activity among patients with Kaposi sarcoma,” said investigator Ramya Ramaswami, MBBS, MPH, of the HIV & AIDS malignancy branch at the National Cancer Institute. The results were presented at the Conference on Retroviruses and Opportunistic Infections.

The researchers evaluated the safety and tolerability of Pom/Dox in two groups of patients with Kaposi sarcoma: group 1 included patients with Kaposi sarcoma alone and group 2 included patients with Kaposi sarcoma–associated herpesvirus and concurrent multicentric Castleman disease (KSHV-MCD) and KSHV inflammatory cytokine syndrome (KICS).

“Kaposi sarcoma can be challenging to treat when it co-occurs with KSHV-MCD or KICS, resulting in high mortality rates,” Dr. Ramaswami explained.

Study participants received IV liposomal Dox at 20 mg/m² on day 1 of a 28-day cycle, in addition to oral Pom once daily on days 1-21 at three escalating dose levels (2 mg, 3 mg, or 4 mg, respectively) using a standard 3 + 3 design until plateau of response, progression, dose-limiting toxicities (DLTs) or patient preference. Some eligibility criteria differed between groups 1 and 2. Participants in group 1 were required to be on antiretroviral therapy for at least 1 month and had a performance status of 2 or less, while those in group 2 had a performance status of 3 or less and could be antiretroviral therapy naive.

All participants received oral aspirin thromboprophylaxis (81 mg daily) and could have received prior Kaposi sarcoma therapy.

With respect to outcomes, Kaposi sarcoma responses were assessed using the modified AIDS Clinical Trial Group criteria and KICS and KSHV-MCD responses were evaluated using an NCI clinical benefit criteria.
 

Results

Overall, 34 cisgender men were enrolled in the study: 21 (62%) in group 1 and 13 (38%) in group 2. All participants had severe (T1) Kaposi sarcoma; 32 (94%) participants were HIV-infected and 22 (65%) had prior chemotherapy for Kaposi sarcoma.

While the HIV viral load was largely controlled in both groups, the CD4 count differed, with median CD4 counts of 286 and 92 cells/mcL in groups 1 and 2, respectively.

With respect to safety, no DLTs were observed in group 1. As a result, 12 participants were treated at the maximum tolerated dose (MTD) of 4 mg of Pom. However, two DLTs (grade 3 rash and pharyngeal edema) were observed in group 2 at the 3 mg dose level.

A median of six cycles were administered for all participants and the most common grade 3/4 toxicity was neutropenia; nine patients with grade 3 neutropenia required dose reduction and three patients had febrile neutropenia requiring hospitalization. Other Pom-related adverse events were rash, constipation, and fatigue.

Among evaluable participants receiving two or more cycles, 17 (81%) patients in group 1 had a response (95% confidence interval, 58-95%; 16 partial response and 1 complete response) and 5 (50%) patients in group 2 had a response (95% CI, 19-81%; 4 PR and 1 CR).

“Our waterfall plots indicated that the vast majority of patients in group 1 had a positive change in nodular lesions at baseline,” Dr. Ramaswami said. “Participants in group 2 showed some decrease in nodular lesions, but this was usually temporary.”

Among seven participants with KICS responses, four participants (57%) experienced a CR or PR in symptoms and lab abnormalities associated with KICS; three of six participants (50%) with KSHV-MCD responses experienced a PR as per response criteria.

“While activity was noted, the combination was less well tolerated in patients with Kaposi sarcoma and concurrent KSHV-MCD or KICS,” Dr. Ramaswami said.

During a live discussion, Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles, asked Dr. Ramaswami about the use of liposomal doxorubicin alone in patients with Kaposi sarcoma and concurrent KSHV-MCD or KICS.

While there is currently no data on the use of doxorubicin alone in this population, Dr. Ramaswami noted that she was more confident administering Pom/Dox combination therapy for these patients.

Dr. Ramaswami disclosed financial relationships with the National Cancer Institute, Celgene/Bristol-Myers Squibb, EMD Serono, Merck, CTI Biopharma, and Janssen. The study was funded by a cooperative research and drug development agreement between the National Cancer Institute and Celgene/BMS, EMD Serono, Merck, CTI Biopharma, and Janssen.

Liposomal doxorubicin (Dox) plus pomalidomide (Pom) was safe and active in heavily pretreated patients with Kaposi sarcoma, according to results from a phase 1/2 trial.

“The results of our phase 1/2 study suggest pomalidomide and liposomal doxorubicin is safe with evidence of activity among patients with Kaposi sarcoma,” said investigator Ramya Ramaswami, MBBS, MPH, of the HIV & AIDS malignancy branch at the National Cancer Institute. The results were presented at the Conference on Retroviruses and Opportunistic Infections.

The researchers evaluated the safety and tolerability of Pom/Dox in two groups of patients with Kaposi sarcoma: group 1 included patients with Kaposi sarcoma alone and group 2 included patients with Kaposi sarcoma–associated herpesvirus and concurrent multicentric Castleman disease (KSHV-MCD) and KSHV inflammatory cytokine syndrome (KICS).

“Kaposi sarcoma can be challenging to treat when it co-occurs with KSHV-MCD or KICS, resulting in high mortality rates,” Dr. Ramaswami explained.

Study participants received IV liposomal Dox at 20 mg/m² on day 1 of a 28-day cycle, in addition to oral Pom once daily on days 1-21 at three escalating dose levels (2 mg, 3 mg, or 4 mg, respectively) using a standard 3 + 3 design until plateau of response, progression, dose-limiting toxicities (DLTs) or patient preference. Some eligibility criteria differed between groups 1 and 2. Participants in group 1 were required to be on antiretroviral therapy for at least 1 month and had a performance status of 2 or less, while those in group 2 had a performance status of 3 or less and could be antiretroviral therapy naive.

All participants received oral aspirin thromboprophylaxis (81 mg daily) and could have received prior Kaposi sarcoma therapy.

With respect to outcomes, Kaposi sarcoma responses were assessed using the modified AIDS Clinical Trial Group criteria and KICS and KSHV-MCD responses were evaluated using an NCI clinical benefit criteria.
 

Results

Overall, 34 cisgender men were enrolled in the study: 21 (62%) in group 1 and 13 (38%) in group 2. All participants had severe (T1) Kaposi sarcoma; 32 (94%) participants were HIV-infected and 22 (65%) had prior chemotherapy for Kaposi sarcoma.

While the HIV viral load was largely controlled in both groups, the CD4 count differed, with median CD4 counts of 286 and 92 cells/mcL in groups 1 and 2, respectively.

With respect to safety, no DLTs were observed in group 1. As a result, 12 participants were treated at the maximum tolerated dose (MTD) of 4 mg of Pom. However, two DLTs (grade 3 rash and pharyngeal edema) were observed in group 2 at the 3 mg dose level.

A median of six cycles were administered for all participants and the most common grade 3/4 toxicity was neutropenia; nine patients with grade 3 neutropenia required dose reduction and three patients had febrile neutropenia requiring hospitalization. Other Pom-related adverse events were rash, constipation, and fatigue.

Among evaluable participants receiving two or more cycles, 17 (81%) patients in group 1 had a response (95% confidence interval, 58-95%; 16 partial response and 1 complete response) and 5 (50%) patients in group 2 had a response (95% CI, 19-81%; 4 PR and 1 CR).

“Our waterfall plots indicated that the vast majority of patients in group 1 had a positive change in nodular lesions at baseline,” Dr. Ramaswami said. “Participants in group 2 showed some decrease in nodular lesions, but this was usually temporary.”

Among seven participants with KICS responses, four participants (57%) experienced a CR or PR in symptoms and lab abnormalities associated with KICS; three of six participants (50%) with KSHV-MCD responses experienced a PR as per response criteria.

“While activity was noted, the combination was less well tolerated in patients with Kaposi sarcoma and concurrent KSHV-MCD or KICS,” Dr. Ramaswami said.

During a live discussion, Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles, asked Dr. Ramaswami about the use of liposomal doxorubicin alone in patients with Kaposi sarcoma and concurrent KSHV-MCD or KICS.

While there is currently no data on the use of doxorubicin alone in this population, Dr. Ramaswami noted that she was more confident administering Pom/Dox combination therapy for these patients.

Dr. Ramaswami disclosed financial relationships with the National Cancer Institute, Celgene/Bristol-Myers Squibb, EMD Serono, Merck, CTI Biopharma, and Janssen. The study was funded by a cooperative research and drug development agreement between the National Cancer Institute and Celgene/BMS, EMD Serono, Merck, CTI Biopharma, and Janssen.

Elevated vaginal pH at the time of cervical intraepithelial neoplasia 2 diagnosis may be a useful marker of CIN 2 persistence/progression, as well as the rate of persistence/progression in HIV-positive women, new research suggests.

“We analyzed data from the Women’s Interagency HIV Study [WIHS], an observational, longitudinal cohort of women with and without HIV to determine factors that may influence CIN 2 natural history,” said Kate Michel, PhD, MPH, of Georgetown University, Washington. She presented the results at the Conference on Retroviruses and Opportunistic Infections.

As previous data have shown a high incidence of CIN 2 progression among women with HIV, the researchers evaluated the role of human papillomavirus (HPV) type, local immune response, and markers of the cervicovaginal microbiome on the risk of CIN 2 persistence/progression.

Within the cohort, follow-up visits occur every 6 months, and clinical data is collected via questionnaires, physical and gynecologic exams, and biological samples. As no specific treatment is offered in the WIHS, treatment for cervical abnormalities is abstracted from medical records.

In the present study, Dr. Michel and colleagues selected up to four banked cervicovaginal lavage (CVL) samples per woman, with the first sample selected 6-12 months prior to CIN 2 diagnosis, the second at CIN 2 diagnosis, the third between CIN 2 diagnosis and outcome, and the fourth at the outcome visit.

The investigators performed HPV typing and muiltiplex immune mediator testing on each CVL sample. Lab results from WIHS core testing were also extracted, including plasma CD4+ T-cell count and HIV viral load, as well as vaginal pH and Nugent’s score.

Study outcomes included persistence/progression and regression, defined as a subsequent CIN 2 or CIN 3 diagnosis and subsequent CIN 1 or normal diagnosis, respectively. Logistic regression models were used to determine CIN 2 regression versus persistence/progression.
 

Results

A total of 337 samples were obtained and 94 women were included in the analysis. Key demographic and behavioral factor were similar at CIN 2 diagnosis.

The majority of participants were African American (53.2%) and on antiretroviral therapy (66.0%). The most prevalent high-risk types were HPV-58 (18.4%) and HPV-16 (17.5%).

After a median 12.5 years of follow-up, 33 participants (35.1%) with incident CIN 2 had a subsequent CIN 2/CIN 3 diagnosis and those who regressed had a higher CD4 T-cell count at CIN 2 diagnosis (P = .02).

Each subsequent high-risk HPV type identified at the pre–CIN 2 visit was associated with higher odds of CIN2 persistence/progression (odds ratio, 2.27; 95% confidence interval, 1.15-4.50).

Bacterial vaginosis (adjusted OR, 5.08; 95% CI, 1.30-19.94) and vaginal pH (aOR, 2.27; 95% CI, 1.15-4.50) at the CIN 2 diagnosis visit were each associated with increased odds of CIN 2 persistence/progression.

Vaginal pH greater than 4.5 at CIN 2 diagnosis was also associated with unadjusted time to CIN 2 persistence/progression (log rank P = .002) and an increased rate of CIN 2 persistence/progression (adjusted hazard ratio, 3.37; 95% CI, 1.26-8.99).

Furthermore, among participants who did not receive CIN 2 treatment, vaginal pH remained associated with greater odds of CIN 2 persistence/progression (OR, 2.46; 95% CI, 1.19-5.13). Cervicovaginal immune mediator levels were not associated with CIN 2 persistence/progression.

“The most striking finding from this work was that vaginal pH was associated with higher odds of, quicker time to, and increased hazard of CIN 2 persistence/progression,” Dr. Michel said. “We postulate this effect is mediated by the cervical microbiome, but more work is needed to establish the exact mechanism.”

“It would be interesting to test whether this association might be explained by different vaginal cleaning techniques, such as douching,” said moderator Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles.

“We’re currently working on an analysis of cervicovaginal bacterial species to explore the microbiome in more detail,” Dr. Michel concluded.

Dr. Michel disclosed no conflicts of interest. The study was supported by multiple sources, including the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, and the Georgetown-Howard Universities Center for Clinical and Translational Science.

Elevated vaginal pH at the time of cervical intraepithelial neoplasia 2 diagnosis may be a useful marker of CIN 2 persistence/progression, as well as the rate of persistence/progression in HIV-positive women, new research suggests.

“We analyzed data from the Women’s Interagency HIV Study [WIHS], an observational, longitudinal cohort of women with and without HIV to determine factors that may influence CIN 2 natural history,” said Kate Michel, PhD, MPH, of Georgetown University, Washington. She presented the results at the Conference on Retroviruses and Opportunistic Infections.

As previous data have shown a high incidence of CIN 2 progression among women with HIV, the researchers evaluated the role of human papillomavirus (HPV) type, local immune response, and markers of the cervicovaginal microbiome on the risk of CIN 2 persistence/progression.

Within the cohort, follow-up visits occur every 6 months, and clinical data is collected via questionnaires, physical and gynecologic exams, and biological samples. As no specific treatment is offered in the WIHS, treatment for cervical abnormalities is abstracted from medical records.

In the present study, Dr. Michel and colleagues selected up to four banked cervicovaginal lavage (CVL) samples per woman, with the first sample selected 6-12 months prior to CIN 2 diagnosis, the second at CIN 2 diagnosis, the third between CIN 2 diagnosis and outcome, and the fourth at the outcome visit.

The investigators performed HPV typing and muiltiplex immune mediator testing on each CVL sample. Lab results from WIHS core testing were also extracted, including plasma CD4+ T-cell count and HIV viral load, as well as vaginal pH and Nugent’s score.

Study outcomes included persistence/progression and regression, defined as a subsequent CIN 2 or CIN 3 diagnosis and subsequent CIN 1 or normal diagnosis, respectively. Logistic regression models were used to determine CIN 2 regression versus persistence/progression.
 

Results

A total of 337 samples were obtained and 94 women were included in the analysis. Key demographic and behavioral factor were similar at CIN 2 diagnosis.

The majority of participants were African American (53.2%) and on antiretroviral therapy (66.0%). The most prevalent high-risk types were HPV-58 (18.4%) and HPV-16 (17.5%).

After a median 12.5 years of follow-up, 33 participants (35.1%) with incident CIN 2 had a subsequent CIN 2/CIN 3 diagnosis and those who regressed had a higher CD4 T-cell count at CIN 2 diagnosis (P = .02).

Each subsequent high-risk HPV type identified at the pre–CIN 2 visit was associated with higher odds of CIN2 persistence/progression (odds ratio, 2.27; 95% confidence interval, 1.15-4.50).

Bacterial vaginosis (adjusted OR, 5.08; 95% CI, 1.30-19.94) and vaginal pH (aOR, 2.27; 95% CI, 1.15-4.50) at the CIN 2 diagnosis visit were each associated with increased odds of CIN 2 persistence/progression.

Vaginal pH greater than 4.5 at CIN 2 diagnosis was also associated with unadjusted time to CIN 2 persistence/progression (log rank P = .002) and an increased rate of CIN 2 persistence/progression (adjusted hazard ratio, 3.37; 95% CI, 1.26-8.99).

Furthermore, among participants who did not receive CIN 2 treatment, vaginal pH remained associated with greater odds of CIN 2 persistence/progression (OR, 2.46; 95% CI, 1.19-5.13). Cervicovaginal immune mediator levels were not associated with CIN 2 persistence/progression.

“The most striking finding from this work was that vaginal pH was associated with higher odds of, quicker time to, and increased hazard of CIN 2 persistence/progression,” Dr. Michel said. “We postulate this effect is mediated by the cervical microbiome, but more work is needed to establish the exact mechanism.”

“It would be interesting to test whether this association might be explained by different vaginal cleaning techniques, such as douching,” said moderator Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles.

“We’re currently working on an analysis of cervicovaginal bacterial species to explore the microbiome in more detail,” Dr. Michel concluded.

Dr. Michel disclosed no conflicts of interest. The study was supported by multiple sources, including the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, and the Georgetown-Howard Universities Center for Clinical and Translational Science.

Elevated vaginal pH at the time of cervical intraepithelial neoplasia 2 diagnosis may be a useful marker of CIN 2 persistence/progression, as well as the rate of persistence/progression in HIV-positive women, new research suggests.

“We analyzed data from the Women’s Interagency HIV Study [WIHS], an observational, longitudinal cohort of women with and without HIV to determine factors that may influence CIN 2 natural history,” said Kate Michel, PhD, MPH, of Georgetown University, Washington. She presented the results at the Conference on Retroviruses and Opportunistic Infections.

As previous data have shown a high incidence of CIN 2 progression among women with HIV, the researchers evaluated the role of human papillomavirus (HPV) type, local immune response, and markers of the cervicovaginal microbiome on the risk of CIN 2 persistence/progression.

Within the cohort, follow-up visits occur every 6 months, and clinical data is collected via questionnaires, physical and gynecologic exams, and biological samples. As no specific treatment is offered in the WIHS, treatment for cervical abnormalities is abstracted from medical records.

In the present study, Dr. Michel and colleagues selected up to four banked cervicovaginal lavage (CVL) samples per woman, with the first sample selected 6-12 months prior to CIN 2 diagnosis, the second at CIN 2 diagnosis, the third between CIN 2 diagnosis and outcome, and the fourth at the outcome visit.

The investigators performed HPV typing and muiltiplex immune mediator testing on each CVL sample. Lab results from WIHS core testing were also extracted, including plasma CD4+ T-cell count and HIV viral load, as well as vaginal pH and Nugent’s score.

Study outcomes included persistence/progression and regression, defined as a subsequent CIN 2 or CIN 3 diagnosis and subsequent CIN 1 or normal diagnosis, respectively. Logistic regression models were used to determine CIN 2 regression versus persistence/progression.
 

Results

A total of 337 samples were obtained and 94 women were included in the analysis. Key demographic and behavioral factor were similar at CIN 2 diagnosis.

The majority of participants were African American (53.2%) and on antiretroviral therapy (66.0%). The most prevalent high-risk types were HPV-58 (18.4%) and HPV-16 (17.5%).

After a median 12.5 years of follow-up, 33 participants (35.1%) with incident CIN 2 had a subsequent CIN 2/CIN 3 diagnosis and those who regressed had a higher CD4 T-cell count at CIN 2 diagnosis (P = .02).

Each subsequent high-risk HPV type identified at the pre–CIN 2 visit was associated with higher odds of CIN2 persistence/progression (odds ratio, 2.27; 95% confidence interval, 1.15-4.50).

Bacterial vaginosis (adjusted OR, 5.08; 95% CI, 1.30-19.94) and vaginal pH (aOR, 2.27; 95% CI, 1.15-4.50) at the CIN 2 diagnosis visit were each associated with increased odds of CIN 2 persistence/progression.

Vaginal pH greater than 4.5 at CIN 2 diagnosis was also associated with unadjusted time to CIN 2 persistence/progression (log rank P = .002) and an increased rate of CIN 2 persistence/progression (adjusted hazard ratio, 3.37; 95% CI, 1.26-8.99).

Furthermore, among participants who did not receive CIN 2 treatment, vaginal pH remained associated with greater odds of CIN 2 persistence/progression (OR, 2.46; 95% CI, 1.19-5.13). Cervicovaginal immune mediator levels were not associated with CIN 2 persistence/progression.

“The most striking finding from this work was that vaginal pH was associated with higher odds of, quicker time to, and increased hazard of CIN 2 persistence/progression,” Dr. Michel said. “We postulate this effect is mediated by the cervical microbiome, but more work is needed to establish the exact mechanism.”

“It would be interesting to test whether this association might be explained by different vaginal cleaning techniques, such as douching,” said moderator Ronald T. Mitsuyasu, MD, of the University of California, Los Angeles.

“We’re currently working on an analysis of cervicovaginal bacterial species to explore the microbiome in more detail,” Dr. Michel concluded.

Dr. Michel disclosed no conflicts of interest. The study was supported by multiple sources, including the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, and the Georgetown-Howard Universities Center for Clinical and Translational Science.