Infectious Disease Practitioner

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

One year into treatment with an every-6-month dose of the investigational drug lenacapavir (LEN, Gilead Sciences) in a dual-treatment combination, 88% of treatment-naive people living with HIV had undetectable viral loads.

The findings, presented at the Conference on Retroviruses and Opportunistic Infections, also showed the drug was well tolerated, with 2 of 182 people developing drug-resistant mutations to lenacapavir and one person developing a nodule at the injection site.

Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust, who was not involved in the trial, called the findings “hugely exciting,” especially given its unique mode of administration. Right now it’s formulated as a subcutaneous injection, not an intramuscular injection like cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare).

“Clearly it’s incredibly exciting to have the option for a subcutaneous drug that could be given at home every 6 months,” Dr. Waters said in an interview. With phase 3 trials and long-term follow-up still to come, she said she’s looking forward to how the treatment evolves.

CALIBRATE is a phase 2, four-arm, open-label, active-control study. Of the 182 participants, 25 were randomized to the active control arm, in which participants took daily oral bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy, Gilead Sciences) as standard of care. The rest of the 182 participants were divided evenly between three arms. In one of those, treatment group three, participants took a daily oral version of 50-mg LEN with emtricitabine and tenofovir alafenamide (F/TAF, Descovy, Gilead Sciences).

The other two arms, treatment groups one and two, were the arms in which Samir K. Gupta, MD, of Indiana University, Indianapolis, and colleagues tried the twice-yearly subcutaneous shots of LEN (LEN SC). Participants in those arms underwent a 2-week lead-in period in which they took 600 mg of LEN orally on days 1 and 2 and then a 300-mg pill on day 8 before starting the shots on day 15. As currently formulated, LEN SC shots can be given into the stomach and are designed to be simple enough to administer at home.

“It’s like doing an insulin shot,” Dr. Gupta said in an interview.

In addition to LEN SC, participants in treatment group one took a daily Descovy lead-in and then engaged in dual therapy of LEN plus TAF. In group two, they took a daily Descovy lead-in and then switched to LEN SC plus bictegravir (BIC) daily at 28 weeks.

Study results presented at the meeting were the results at 54 weeks. Researchers had previously presented 28-week results for CALIBRATE at the International AIDS Society Conference on HIV Science 2021.

Of the participants, 7% were cisgender women, 52% were Black, and 45% were Latinx. A total of 15% of participants had baseline viral loads of more than 100,000 copies, and median CD4 counts were 437. None of the participants in either the active-control arm or the LEN SC plus Descovy group had a history of AIDS, defined as fewer than 200 cells/mcL. In the LEN SC plus Biktarvy group, two did, and there were six people with a history of AIDS in the oral LEN plus Descovy group.

At 54 weeks, 88% of participants in groups one and two – the LEN SC arms – had undetectable viral loads (viral loads below 50 copies/mL). Specifically, 90% of those in the LEN SC plus TAF arm had viral loads below 50 copies. Those taking LEN SC plus BIC had an 85% viral suppression rate. The best performing of all was the control arm, in which 92% had undetectable viral loads. The protocol didn’t allow for analysis of statistical significance between the arms, so it’s unclear if any of the treatments really surpassed the others, Dr. Gupta said.

When they looked only at people whose viral loads became undetectable early, by week 28, the results were slightly better, with 93% of people between the two subcutaneous arms having undetectable viral loads at week 54. Again, the results were slightly higher in the LEN SC plus TAF arm (94%) than the LEN SC plus BIC (92%). People taking daily oral LEN plus Descovy had the lowest rate of viral suppression, but it was still at 90% if they were virally suppressed early. Again, it’s unclear whether those differences were statistically significant.
 

Well tolerated, with a chance of a nodule

Regarding safety, LEN was well tolerated across treatment arms, though the oral LEN group had as many people develop resistance mutations as the other three groups combined. Still, that was only three people, with one each in the two subcutaneous arms and one in the control arm.

Two people developed resistance to LEN – one in the LEN SC plus BIC arm and one in the oral LEN plus Descovy arm. In the LEN SC plus BIC arm, the mutations Q67H and K70R emerged at week 10, following a mutation that’s common when people don’t take integrase inhibitors as they’re supposed to (M184M/I). This led Dr. Gupta to conclude that lack of adherence to the oral part of the regimen may have contributed to the development of resistance, rather than an issue with LEN SC itself.

In the oral LEN plus Descovy arm, mutation Q67H didn’t emerge until week 54, when pill counts and drug levels revealed that that participant hadn’t been taking his Descovy as prescribed. In both cases, viral loads in those participants returned to undetectable after switching to an integrase inhibitor–based three-drug regimen.

Most safety concerns were mild and included nausea, diarrhea, and vomiting. But that was for non–injection-site reactions. There were more side effects of that sort, with most of them being pain, hardening of the site, and swelling. But 11% of participants developed more serious side effects, including nodules. Only one nodule was considered a grade 3 reaction; that person didn’t leave the trial because of it.

“These phase 2 data from the ongoing CALIBRATE trial support the further evaluation of lenacapavir for treatment and prevention of HIV-1,” he said.
 

Finding the right partner

In short, the findings are promising, Dr. Gupta told this news organization . But the question now, as Gilead prepares to begin a phase 3 efficacy trial, is what would be a good combination with LEN SC?

“Lenacapavir in a two-drug regimen should work,” he said. “The question now, though, is you have to find a suitable, potent, second agent to pair it with.”

Indeed, the long-acting HIV treatment pipeline sustained a blow in December 2021 when the U.S. Food and Drug Administration halted all trials for Merck’s investigational, long-acting drug islatravir. This led Dr. Waters to tweet: “Is it just me or are the islatravir abstracts at #CROI2022 quite sad to read?” She ended the tweet with, “I just hope it recovers!”

Indeed, Merck and Gilead have entered into an agreement to codevelop lenacapavir and islatravir as a weekly oral tablet. Islatravir seemed like the obvious choice as a partner to lenacapavir if phase 3 trials are successful, said Dr. Gupta. But now, it’s anyone’s guess as to what will happen. And while it’s too soon to say that lenacapavir is a success, it does leave the field wondering about how to use LEN SC without another, equally long-acting agent.

“When I talk about LEN, I show a picture of a man standing solo at a party, leaning against the wall looking a bit lonely, with ‘lenacapavir’ written over his head,” she said in an interview. “Right now, lenacapavir is the only drug at the 6-monthly party. It’s going to need some other guests if that party is going to rock.”

The study was funded by Gilead Sciences. Dr. Gupta has received research funding from ViiV Healthcare and advisory board fees from Gilead Sciences and ViiV Healthcare. Dr. Waters has received speaker or advisory fees from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

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

One year into treatment with an every-6-month dose of the investigational drug lenacapavir (LEN, Gilead Sciences) in a dual-treatment combination, 88% of treatment-naive people living with HIV had undetectable viral loads.

The findings, presented at the Conference on Retroviruses and Opportunistic Infections, also showed the drug was well tolerated, with 2 of 182 people developing drug-resistant mutations to lenacapavir and one person developing a nodule at the injection site.

Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust, who was not involved in the trial, called the findings “hugely exciting,” especially given its unique mode of administration. Right now it’s formulated as a subcutaneous injection, not an intramuscular injection like cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare).

“Clearly it’s incredibly exciting to have the option for a subcutaneous drug that could be given at home every 6 months,” Dr. Waters said in an interview. With phase 3 trials and long-term follow-up still to come, she said she’s looking forward to how the treatment evolves.

CALIBRATE is a phase 2, four-arm, open-label, active-control study. Of the 182 participants, 25 were randomized to the active control arm, in which participants took daily oral bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy, Gilead Sciences) as standard of care. The rest of the 182 participants were divided evenly between three arms. In one of those, treatment group three, participants took a daily oral version of 50-mg LEN with emtricitabine and tenofovir alafenamide (F/TAF, Descovy, Gilead Sciences).

The other two arms, treatment groups one and two, were the arms in which Samir K. Gupta, MD, of Indiana University, Indianapolis, and colleagues tried the twice-yearly subcutaneous shots of LEN (LEN SC). Participants in those arms underwent a 2-week lead-in period in which they took 600 mg of LEN orally on days 1 and 2 and then a 300-mg pill on day 8 before starting the shots on day 15. As currently formulated, LEN SC shots can be given into the stomach and are designed to be simple enough to administer at home.

“It’s like doing an insulin shot,” Dr. Gupta said in an interview.

In addition to LEN SC, participants in treatment group one took a daily Descovy lead-in and then engaged in dual therapy of LEN plus TAF. In group two, they took a daily Descovy lead-in and then switched to LEN SC plus bictegravir (BIC) daily at 28 weeks.

Study results presented at the meeting were the results at 54 weeks. Researchers had previously presented 28-week results for CALIBRATE at the International AIDS Society Conference on HIV Science 2021.

Of the participants, 7% were cisgender women, 52% were Black, and 45% were Latinx. A total of 15% of participants had baseline viral loads of more than 100,000 copies, and median CD4 counts were 437. None of the participants in either the active-control arm or the LEN SC plus Descovy group had a history of AIDS, defined as fewer than 200 cells/mcL. In the LEN SC plus Biktarvy group, two did, and there were six people with a history of AIDS in the oral LEN plus Descovy group.

At 54 weeks, 88% of participants in groups one and two – the LEN SC arms – had undetectable viral loads (viral loads below 50 copies/mL). Specifically, 90% of those in the LEN SC plus TAF arm had viral loads below 50 copies. Those taking LEN SC plus BIC had an 85% viral suppression rate. The best performing of all was the control arm, in which 92% had undetectable viral loads. The protocol didn’t allow for analysis of statistical significance between the arms, so it’s unclear if any of the treatments really surpassed the others, Dr. Gupta said.

When they looked only at people whose viral loads became undetectable early, by week 28, the results were slightly better, with 93% of people between the two subcutaneous arms having undetectable viral loads at week 54. Again, the results were slightly higher in the LEN SC plus TAF arm (94%) than the LEN SC plus BIC (92%). People taking daily oral LEN plus Descovy had the lowest rate of viral suppression, but it was still at 90% if they were virally suppressed early. Again, it’s unclear whether those differences were statistically significant.
 

Well tolerated, with a chance of a nodule

Regarding safety, LEN was well tolerated across treatment arms, though the oral LEN group had as many people develop resistance mutations as the other three groups combined. Still, that was only three people, with one each in the two subcutaneous arms and one in the control arm.

Two people developed resistance to LEN – one in the LEN SC plus BIC arm and one in the oral LEN plus Descovy arm. In the LEN SC plus BIC arm, the mutations Q67H and K70R emerged at week 10, following a mutation that’s common when people don’t take integrase inhibitors as they’re supposed to (M184M/I). This led Dr. Gupta to conclude that lack of adherence to the oral part of the regimen may have contributed to the development of resistance, rather than an issue with LEN SC itself.

In the oral LEN plus Descovy arm, mutation Q67H didn’t emerge until week 54, when pill counts and drug levels revealed that that participant hadn’t been taking his Descovy as prescribed. In both cases, viral loads in those participants returned to undetectable after switching to an integrase inhibitor–based three-drug regimen.

Most safety concerns were mild and included nausea, diarrhea, and vomiting. But that was for non–injection-site reactions. There were more side effects of that sort, with most of them being pain, hardening of the site, and swelling. But 11% of participants developed more serious side effects, including nodules. Only one nodule was considered a grade 3 reaction; that person didn’t leave the trial because of it.

“These phase 2 data from the ongoing CALIBRATE trial support the further evaluation of lenacapavir for treatment and prevention of HIV-1,” he said.
 

Finding the right partner

In short, the findings are promising, Dr. Gupta told this news organization . But the question now, as Gilead prepares to begin a phase 3 efficacy trial, is what would be a good combination with LEN SC?

“Lenacapavir in a two-drug regimen should work,” he said. “The question now, though, is you have to find a suitable, potent, second agent to pair it with.”

Indeed, the long-acting HIV treatment pipeline sustained a blow in December 2021 when the U.S. Food and Drug Administration halted all trials for Merck’s investigational, long-acting drug islatravir. This led Dr. Waters to tweet: “Is it just me or are the islatravir abstracts at #CROI2022 quite sad to read?” She ended the tweet with, “I just hope it recovers!”

Indeed, Merck and Gilead have entered into an agreement to codevelop lenacapavir and islatravir as a weekly oral tablet. Islatravir seemed like the obvious choice as a partner to lenacapavir if phase 3 trials are successful, said Dr. Gupta. But now, it’s anyone’s guess as to what will happen. And while it’s too soon to say that lenacapavir is a success, it does leave the field wondering about how to use LEN SC without another, equally long-acting agent.

“When I talk about LEN, I show a picture of a man standing solo at a party, leaning against the wall looking a bit lonely, with ‘lenacapavir’ written over his head,” she said in an interview. “Right now, lenacapavir is the only drug at the 6-monthly party. It’s going to need some other guests if that party is going to rock.”

The study was funded by Gilead Sciences. Dr. Gupta has received research funding from ViiV Healthcare and advisory board fees from Gilead Sciences and ViiV Healthcare. Dr. Waters has received speaker or advisory fees from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

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

One year into treatment with an every-6-month dose of the investigational drug lenacapavir (LEN, Gilead Sciences) in a dual-treatment combination, 88% of treatment-naive people living with HIV had undetectable viral loads.

The findings, presented at the Conference on Retroviruses and Opportunistic Infections, also showed the drug was well tolerated, with 2 of 182 people developing drug-resistant mutations to lenacapavir and one person developing a nodule at the injection site.

Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust, who was not involved in the trial, called the findings “hugely exciting,” especially given its unique mode of administration. Right now it’s formulated as a subcutaneous injection, not an intramuscular injection like cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare).

“Clearly it’s incredibly exciting to have the option for a subcutaneous drug that could be given at home every 6 months,” Dr. Waters said in an interview. With phase 3 trials and long-term follow-up still to come, she said she’s looking forward to how the treatment evolves.

CALIBRATE is a phase 2, four-arm, open-label, active-control study. Of the 182 participants, 25 were randomized to the active control arm, in which participants took daily oral bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy, Gilead Sciences) as standard of care. The rest of the 182 participants were divided evenly between three arms. In one of those, treatment group three, participants took a daily oral version of 50-mg LEN with emtricitabine and tenofovir alafenamide (F/TAF, Descovy, Gilead Sciences).

The other two arms, treatment groups one and two, were the arms in which Samir K. Gupta, MD, of Indiana University, Indianapolis, and colleagues tried the twice-yearly subcutaneous shots of LEN (LEN SC). Participants in those arms underwent a 2-week lead-in period in which they took 600 mg of LEN orally on days 1 and 2 and then a 300-mg pill on day 8 before starting the shots on day 15. As currently formulated, LEN SC shots can be given into the stomach and are designed to be simple enough to administer at home.

“It’s like doing an insulin shot,” Dr. Gupta said in an interview.

In addition to LEN SC, participants in treatment group one took a daily Descovy lead-in and then engaged in dual therapy of LEN plus TAF. In group two, they took a daily Descovy lead-in and then switched to LEN SC plus bictegravir (BIC) daily at 28 weeks.

Study results presented at the meeting were the results at 54 weeks. Researchers had previously presented 28-week results for CALIBRATE at the International AIDS Society Conference on HIV Science 2021.

Of the participants, 7% were cisgender women, 52% were Black, and 45% were Latinx. A total of 15% of participants had baseline viral loads of more than 100,000 copies, and median CD4 counts were 437. None of the participants in either the active-control arm or the LEN SC plus Descovy group had a history of AIDS, defined as fewer than 200 cells/mcL. In the LEN SC plus Biktarvy group, two did, and there were six people with a history of AIDS in the oral LEN plus Descovy group.

At 54 weeks, 88% of participants in groups one and two – the LEN SC arms – had undetectable viral loads (viral loads below 50 copies/mL). Specifically, 90% of those in the LEN SC plus TAF arm had viral loads below 50 copies. Those taking LEN SC plus BIC had an 85% viral suppression rate. The best performing of all was the control arm, in which 92% had undetectable viral loads. The protocol didn’t allow for analysis of statistical significance between the arms, so it’s unclear if any of the treatments really surpassed the others, Dr. Gupta said.

When they looked only at people whose viral loads became undetectable early, by week 28, the results were slightly better, with 93% of people between the two subcutaneous arms having undetectable viral loads at week 54. Again, the results were slightly higher in the LEN SC plus TAF arm (94%) than the LEN SC plus BIC (92%). People taking daily oral LEN plus Descovy had the lowest rate of viral suppression, but it was still at 90% if they were virally suppressed early. Again, it’s unclear whether those differences were statistically significant.
 

Well tolerated, with a chance of a nodule

Regarding safety, LEN was well tolerated across treatment arms, though the oral LEN group had as many people develop resistance mutations as the other three groups combined. Still, that was only three people, with one each in the two subcutaneous arms and one in the control arm.

Two people developed resistance to LEN – one in the LEN SC plus BIC arm and one in the oral LEN plus Descovy arm. In the LEN SC plus BIC arm, the mutations Q67H and K70R emerged at week 10, following a mutation that’s common when people don’t take integrase inhibitors as they’re supposed to (M184M/I). This led Dr. Gupta to conclude that lack of adherence to the oral part of the regimen may have contributed to the development of resistance, rather than an issue with LEN SC itself.

In the oral LEN plus Descovy arm, mutation Q67H didn’t emerge until week 54, when pill counts and drug levels revealed that that participant hadn’t been taking his Descovy as prescribed. In both cases, viral loads in those participants returned to undetectable after switching to an integrase inhibitor–based three-drug regimen.

Most safety concerns were mild and included nausea, diarrhea, and vomiting. But that was for non–injection-site reactions. There were more side effects of that sort, with most of them being pain, hardening of the site, and swelling. But 11% of participants developed more serious side effects, including nodules. Only one nodule was considered a grade 3 reaction; that person didn’t leave the trial because of it.

“These phase 2 data from the ongoing CALIBRATE trial support the further evaluation of lenacapavir for treatment and prevention of HIV-1,” he said.
 

Finding the right partner

In short, the findings are promising, Dr. Gupta told this news organization . But the question now, as Gilead prepares to begin a phase 3 efficacy trial, is what would be a good combination with LEN SC?

“Lenacapavir in a two-drug regimen should work,” he said. “The question now, though, is you have to find a suitable, potent, second agent to pair it with.”

Indeed, the long-acting HIV treatment pipeline sustained a blow in December 2021 when the U.S. Food and Drug Administration halted all trials for Merck’s investigational, long-acting drug islatravir. This led Dr. Waters to tweet: “Is it just me or are the islatravir abstracts at #CROI2022 quite sad to read?” She ended the tweet with, “I just hope it recovers!”

Indeed, Merck and Gilead have entered into an agreement to codevelop lenacapavir and islatravir as a weekly oral tablet. Islatravir seemed like the obvious choice as a partner to lenacapavir if phase 3 trials are successful, said Dr. Gupta. But now, it’s anyone’s guess as to what will happen. And while it’s too soon to say that lenacapavir is a success, it does leave the field wondering about how to use LEN SC without another, equally long-acting agent.

“When I talk about LEN, I show a picture of a man standing solo at a party, leaning against the wall looking a bit lonely, with ‘lenacapavir’ written over his head,” she said in an interview. “Right now, lenacapavir is the only drug at the 6-monthly party. It’s going to need some other guests if that party is going to rock.”

The study was funded by Gilead Sciences. Dr. Gupta has received research funding from ViiV Healthcare and advisory board fees from Gilead Sciences and ViiV Healthcare. Dr. Waters has received speaker or advisory fees from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

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

New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.

“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
 

The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.

Marc Bruxelle/Getty Images

The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.

The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.

Mario Olaya/Pixabay

In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.

The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.

“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.

Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.

Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.

“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.

Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.

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

New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.

“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
 

The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.

Marc Bruxelle/Getty Images

The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.

The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.

Mario Olaya/Pixabay

In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.

The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.

“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.

Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.

Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.

“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.

Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.

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

New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.

“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
 

The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.

Marc Bruxelle/Getty Images

The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.

The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.

Mario Olaya/Pixabay

In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.

The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.

“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.

Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.

Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.

“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.

Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.

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

The Food and Drug Administration has approved secnidazole for the treatment of bacterial vaginosis (BV) and trichomoniasis in patients aged 12 years and older.

The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.

Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.

The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.

The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.

Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.

Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.

The Food and Drug Administration has approved secnidazole for the treatment of bacterial vaginosis (BV) and trichomoniasis in patients aged 12 years and older.

The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.

Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.

The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.

The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.

Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.

Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.

The Food and Drug Administration has approved secnidazole for the treatment of bacterial vaginosis (BV) and trichomoniasis in patients aged 12 years and older.

The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.

Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.

The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.

The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.

Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.

Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.

Reports based on a press release in October 2021 suggested it, but now the full data tell the story: Early monitoring and treatment of anal high-grade squamous intraepithelial lesions (HSIL) cut risk for anal cancer by 57% in people living with HIV.

“We now show, for the first time, that treatment of anal HSIL is effective in reducing the incidence of anal cancer,” said Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the Anal Neoplasia Clinic at the University of California, San Francisco. “These data should be included in an overall assessment for inclusion of screening for and treating HSIL as standard of care in people living with HIV.”

Dr. Palefsky presented the full results in a special session at the Conference on Retroviruses and Opportunistic Infections, which drew excitement, gratitude, and relief from both researchers and clinicians, who flocked to the session.

But it’s not just people with HIV who will benefit from this research. Dr. Palefsky suggested that the findings should also be considered as guides for other people at high-risk for anal cancer, such as people who are immunocompromised for other reasons, including those with lupus, ulcerative colitis, Crohn’s disease, or cisgender women who have had vulvar or cervical cancer or precancer.

“If we can show efficacy in the most challenging group of all, which are people living with HIV, we think the results can be as good, if not even better, in the other groups at high risk of anal cancer,” Dr. Palefsky said.

But to serve anyone – whether living with HIV or not – infrastructure, algorithms, and workforce training are going be needed to meet the currently unserved people through use of high-resolution anoscopy (HRA) and other screening technology, he said.

Dr. Palefsy and colleagues screened 10,723 people living with HIV being served at 15 clinics nationwide. More than half, 52.2%, had anal HSIL – 53.3% of the cisgender men living with HIV in the trial, 45.8% of the cis women living with HIV, and a full 62.5% of transgender participants.

Those 4,446 participants were split evenly between the treatment arm and the control arm. Those in the treatment arm received treatment for HSIL on their first study visit via one of five options: hyfrecation, office-based electrocautery ablation, infrared coagulation, topical 5-fluorouracil cream, or topical imiquimod. Then, every 6 months after that, they came in for HRA, blood tests, anal Pap smears, and biopsies to check for any lingering or new HSIL. If clinicians found such cells, they received treatment again. If biopsies still showed HSIL and clinician and participant were worried about cancer, they could come in as frequently as every 3 months and receive treatment each time.

The active-monitoring control group still received an anal Pap smear, blood tests, biopsy, and HRA every 6 months – a level of care that is currently not mandated anywhere for people living with HIV, Dr. Palefsky said in an interview. They were also able to come in for more frequent monitoring (every 3 months) if clinicians were worried about cancer.

“Those in both arms would have been getting more attention than if they had not participated in the study,” he said.

In addition, during screening, researchers found that cancer was already present in 17 other people, who skipped the study to go right to treatment.

Participants reflected the demographics of the HIV epidemic in the United States. They were older (median age, 51 years), mostly gay (78%), and cisgender male (80%). Close to half, 42%, were Black, and 16% were Latinx. In addition, cisgender women made up 16% of the participants and transgender people, and nonbinary individuals accounted for more than 3% of the participants. In addition, one in three smoked.

The vast majority of participants had well-controlled HIV and healthy immune systems, though half in each arm had a history of AIDS, defined as lowest-ever CD4 immune cell counts below 200. Today, more than 80% of participants had undetectable viral loads, defined as a viral load less than 50 copies/mL, and another 7% had HIV viral loads below 200. In total, 9.3% in the treatment arm and 10.9% in the control arm had HIV viral loads higher than that. At time of enrollment, CD4 counts were above 600 in each group, indicating healthy immune systems.

Although all participants were there because they had anal HSIL, more than 1 in 10 – 13% – had abnormal cells so extensive that they covered more than half of the anal canal or the perianal region.

Once everyone was enrolled, researchers began monitoring and treatment, looking specifically for 31 cases of cancer – a number the team had determined that they’d need in order to draw any conclusions. Dr. Palefsky didn’t have to wait long. They were still trying to enroll the last 1,000 participants to have the power necessary to reach that number when the cancer diagnoses came in.

Dr. Palefsky told this news organization that the reason for that is unclear. It could be that some of those cases would have resolved on their own, and so the swiftness with which they reached the required number of cancer cases belies their seriousness. It could also be that the particular people who enrolled in this trial were engaging in behaviors that put them at even higher risk for anal cancer than the population of people living with HIV in the United States.

Or it could be that symptom-based screening is missing a lot of cancers that currently go untreated.

“So perhaps we will be seeing an increase in anal cancer reported in the future compared to the currently reported rates,” he said. “We don’t really know.”

Regardless of the reason for the speed to cases of cancer, the results were definitive: Nine participants were diagnosed with invasive anal cancer in the treatment arm, while 21 were diagnosed with invasive anal cancer in the control arm. That’s a 57% reduction in cancer occurrence between the arms. Or, to put it another way, the rate of anal cancer among people in the treatment arm was 173 per 100,000 people-years. In the active monitoring arm, it was 402 per 100,000 person-years. For context, the overall rate of anal cancer among people living with HIV is 50 per 100,000 person-years. The rate in the general U.S. population is 8 per 100,000 people-years.

The experimental treatment was such a definitive success that the investigators stopped the trial and shifted all participants in the control arm to treatment.
 

‘We have to build’

Before Dr. Palefsky was even done presenting the data, clinicians, people living with HIV, and experts at the session were already brainstorming as to how to get these results into practice.

“These data are what we have long needed to fuel some action on this important problem, including medical cost reimbursement through insurance and increasing the number of persons trained and capable in anal cancer screening,” John Brooks, MD, head of the epidemiology research team at the Centers for Disease Control and Prevention’s division of HIV/AIDS prevention, wrote in the virtual chat.

Jeff Taylor, a member of the ANCHOR advisory board and a person living with HIV who participated in one of the first azidothymidine trials in the late 1980s, responded quickly.

“What kind of advocacy from researchers, HIV clinicians and [people living with HIV] is needed to get this on treatment guidelines, HRA providers trained and certified, and payors to cover this so [people living with HIV] actually have access to lifesaving screening and [treatment]?” Mr. Taylor asked.

It’s a serious challenge. David Malebranche, MD, an Atlanta-based internal medicine physician who specializes in sexual health and HIV, commented in an interview. When he saw the initial press release last year on the ANCHOR findings, his first reaction was: “Thank god. We finally have some data to show what we’ve been trying to get people to do” all along.

But then he wondered, who is going to perform these tests? It’s a fair question. Currently, the wait for an HRA is 6-12 months in many parts of the country. And Dr. Malebranche can’t imagine this being added to his already full plate as a primary care provider.

“If you tell a primary care provider now that they have to do a rectal Pap smear, that’s going to be a problem while you’re also asking them to screen each patient for depression, anxiety, domestic abuse, intimate partner violence, all the healthcare maintenance and all the other screening tests – and then you deal with not only the urgent complaint but then all the complex medical issues on top of that – in a 15-minute or 10-minute visit,” he said.

Now that we have these data, he said, “we have to build.”

Dr. Palefsky agreed. Very few centers have enough people skilled at performing HRAs to meet the current demand, and it’s not realistic to expect clinicians to perform an HRA every 6 months like the study team did. There need to be algorithms put in place to help practitioners figure out who among their patients living with HIV could benefit from this increased screening, as well as biomarkers to identify HSIL progression and regression without the use of HRA, Dr. Palefsky told attendees. And more clinicians need to be recruited and trained to read HRAs, which can be difficult for the untrained eye to decipher.

Dr. Malebranche added another, more fundamental thing that needs to be built. Dr. Malebranche has worked in HIV clinics where the majority of his patients qualify for insurance under the Ryan White Program and get their medications through the AIDS Drug Assistance Program. While Ryan White programs can provide critical wraparound care, Dr. Malebranche has had to refer out for something like an HRA or cancer treatment. But the people who only access care through such programs may not have coverage with the clinics that perform HRA or that treat cancer. And that’s if they can even find someone to see them.

“If I live in a state like Georgia, which doesn’t have Medicaid expansion and we have people who are uninsured, where do you send them?” Dr. Malebranche asked. “This isn’t theoretical. I ran into this problem when I was working at the AIDS Healthcare Foundation last year. ... This is a call for infrastructure.”

The study was funded by the National Cancer Institute. Dr. Brooks reported no relevant financial relationships. Dr. Palefsky has received consultant fees from Merck, Vir Biotechnology, Virion Therapeutics, and Antiva Bioscience, as well as speaker fees from Merck. Dr. Malebranche has received consulting and advising fees from ViiV Healthcare.

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

Reports based on a press release in October 2021 suggested it, but now the full data tell the story: Early monitoring and treatment of anal high-grade squamous intraepithelial lesions (HSIL) cut risk for anal cancer by 57% in people living with HIV.

“We now show, for the first time, that treatment of anal HSIL is effective in reducing the incidence of anal cancer,” said Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the Anal Neoplasia Clinic at the University of California, San Francisco. “These data should be included in an overall assessment for inclusion of screening for and treating HSIL as standard of care in people living with HIV.”

Dr. Palefsky presented the full results in a special session at the Conference on Retroviruses and Opportunistic Infections, which drew excitement, gratitude, and relief from both researchers and clinicians, who flocked to the session.

But it’s not just people with HIV who will benefit from this research. Dr. Palefsky suggested that the findings should also be considered as guides for other people at high-risk for anal cancer, such as people who are immunocompromised for other reasons, including those with lupus, ulcerative colitis, Crohn’s disease, or cisgender women who have had vulvar or cervical cancer or precancer.

“If we can show efficacy in the most challenging group of all, which are people living with HIV, we think the results can be as good, if not even better, in the other groups at high risk of anal cancer,” Dr. Palefsky said.

But to serve anyone – whether living with HIV or not – infrastructure, algorithms, and workforce training are going be needed to meet the currently unserved people through use of high-resolution anoscopy (HRA) and other screening technology, he said.

Dr. Palefsy and colleagues screened 10,723 people living with HIV being served at 15 clinics nationwide. More than half, 52.2%, had anal HSIL – 53.3% of the cisgender men living with HIV in the trial, 45.8% of the cis women living with HIV, and a full 62.5% of transgender participants.

Those 4,446 participants were split evenly between the treatment arm and the control arm. Those in the treatment arm received treatment for HSIL on their first study visit via one of five options: hyfrecation, office-based electrocautery ablation, infrared coagulation, topical 5-fluorouracil cream, or topical imiquimod. Then, every 6 months after that, they came in for HRA, blood tests, anal Pap smears, and biopsies to check for any lingering or new HSIL. If clinicians found such cells, they received treatment again. If biopsies still showed HSIL and clinician and participant were worried about cancer, they could come in as frequently as every 3 months and receive treatment each time.

The active-monitoring control group still received an anal Pap smear, blood tests, biopsy, and HRA every 6 months – a level of care that is currently not mandated anywhere for people living with HIV, Dr. Palefsky said in an interview. They were also able to come in for more frequent monitoring (every 3 months) if clinicians were worried about cancer.

“Those in both arms would have been getting more attention than if they had not participated in the study,” he said.

In addition, during screening, researchers found that cancer was already present in 17 other people, who skipped the study to go right to treatment.

Participants reflected the demographics of the HIV epidemic in the United States. They were older (median age, 51 years), mostly gay (78%), and cisgender male (80%). Close to half, 42%, were Black, and 16% were Latinx. In addition, cisgender women made up 16% of the participants and transgender people, and nonbinary individuals accounted for more than 3% of the participants. In addition, one in three smoked.

The vast majority of participants had well-controlled HIV and healthy immune systems, though half in each arm had a history of AIDS, defined as lowest-ever CD4 immune cell counts below 200. Today, more than 80% of participants had undetectable viral loads, defined as a viral load less than 50 copies/mL, and another 7% had HIV viral loads below 200. In total, 9.3% in the treatment arm and 10.9% in the control arm had HIV viral loads higher than that. At time of enrollment, CD4 counts were above 600 in each group, indicating healthy immune systems.

Although all participants were there because they had anal HSIL, more than 1 in 10 – 13% – had abnormal cells so extensive that they covered more than half of the anal canal or the perianal region.

Once everyone was enrolled, researchers began monitoring and treatment, looking specifically for 31 cases of cancer – a number the team had determined that they’d need in order to draw any conclusions. Dr. Palefsky didn’t have to wait long. They were still trying to enroll the last 1,000 participants to have the power necessary to reach that number when the cancer diagnoses came in.

Dr. Palefsky told this news organization that the reason for that is unclear. It could be that some of those cases would have resolved on their own, and so the swiftness with which they reached the required number of cancer cases belies their seriousness. It could also be that the particular people who enrolled in this trial were engaging in behaviors that put them at even higher risk for anal cancer than the population of people living with HIV in the United States.

Or it could be that symptom-based screening is missing a lot of cancers that currently go untreated.

“So perhaps we will be seeing an increase in anal cancer reported in the future compared to the currently reported rates,” he said. “We don’t really know.”

Regardless of the reason for the speed to cases of cancer, the results were definitive: Nine participants were diagnosed with invasive anal cancer in the treatment arm, while 21 were diagnosed with invasive anal cancer in the control arm. That’s a 57% reduction in cancer occurrence between the arms. Or, to put it another way, the rate of anal cancer among people in the treatment arm was 173 per 100,000 people-years. In the active monitoring arm, it was 402 per 100,000 person-years. For context, the overall rate of anal cancer among people living with HIV is 50 per 100,000 person-years. The rate in the general U.S. population is 8 per 100,000 people-years.

The experimental treatment was such a definitive success that the investigators stopped the trial and shifted all participants in the control arm to treatment.
 

‘We have to build’

Before Dr. Palefsky was even done presenting the data, clinicians, people living with HIV, and experts at the session were already brainstorming as to how to get these results into practice.

“These data are what we have long needed to fuel some action on this important problem, including medical cost reimbursement through insurance and increasing the number of persons trained and capable in anal cancer screening,” John Brooks, MD, head of the epidemiology research team at the Centers for Disease Control and Prevention’s division of HIV/AIDS prevention, wrote in the virtual chat.

Jeff Taylor, a member of the ANCHOR advisory board and a person living with HIV who participated in one of the first azidothymidine trials in the late 1980s, responded quickly.

“What kind of advocacy from researchers, HIV clinicians and [people living with HIV] is needed to get this on treatment guidelines, HRA providers trained and certified, and payors to cover this so [people living with HIV] actually have access to lifesaving screening and [treatment]?” Mr. Taylor asked.

It’s a serious challenge. David Malebranche, MD, an Atlanta-based internal medicine physician who specializes in sexual health and HIV, commented in an interview. When he saw the initial press release last year on the ANCHOR findings, his first reaction was: “Thank god. We finally have some data to show what we’ve been trying to get people to do” all along.

But then he wondered, who is going to perform these tests? It’s a fair question. Currently, the wait for an HRA is 6-12 months in many parts of the country. And Dr. Malebranche can’t imagine this being added to his already full plate as a primary care provider.

“If you tell a primary care provider now that they have to do a rectal Pap smear, that’s going to be a problem while you’re also asking them to screen each patient for depression, anxiety, domestic abuse, intimate partner violence, all the healthcare maintenance and all the other screening tests – and then you deal with not only the urgent complaint but then all the complex medical issues on top of that – in a 15-minute or 10-minute visit,” he said.

Now that we have these data, he said, “we have to build.”

Dr. Palefsky agreed. Very few centers have enough people skilled at performing HRAs to meet the current demand, and it’s not realistic to expect clinicians to perform an HRA every 6 months like the study team did. There need to be algorithms put in place to help practitioners figure out who among their patients living with HIV could benefit from this increased screening, as well as biomarkers to identify HSIL progression and regression without the use of HRA, Dr. Palefsky told attendees. And more clinicians need to be recruited and trained to read HRAs, which can be difficult for the untrained eye to decipher.

Dr. Malebranche added another, more fundamental thing that needs to be built. Dr. Malebranche has worked in HIV clinics where the majority of his patients qualify for insurance under the Ryan White Program and get their medications through the AIDS Drug Assistance Program. While Ryan White programs can provide critical wraparound care, Dr. Malebranche has had to refer out for something like an HRA or cancer treatment. But the people who only access care through such programs may not have coverage with the clinics that perform HRA or that treat cancer. And that’s if they can even find someone to see them.

“If I live in a state like Georgia, which doesn’t have Medicaid expansion and we have people who are uninsured, where do you send them?” Dr. Malebranche asked. “This isn’t theoretical. I ran into this problem when I was working at the AIDS Healthcare Foundation last year. ... This is a call for infrastructure.”

The study was funded by the National Cancer Institute. Dr. Brooks reported no relevant financial relationships. Dr. Palefsky has received consultant fees from Merck, Vir Biotechnology, Virion Therapeutics, and Antiva Bioscience, as well as speaker fees from Merck. Dr. Malebranche has received consulting and advising fees from ViiV Healthcare.

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

Reports based on a press release in October 2021 suggested it, but now the full data tell the story: Early monitoring and treatment of anal high-grade squamous intraepithelial lesions (HSIL) cut risk for anal cancer by 57% in people living with HIV.

“We now show, for the first time, that treatment of anal HSIL is effective in reducing the incidence of anal cancer,” said Joel Palefsky, MD, lead investigator of the Anal Cancer/HSIL Outcomes Research (ANCHOR) study and founder/director of the Anal Neoplasia Clinic at the University of California, San Francisco. “These data should be included in an overall assessment for inclusion of screening for and treating HSIL as standard of care in people living with HIV.”

Dr. Palefsky presented the full results in a special session at the Conference on Retroviruses and Opportunistic Infections, which drew excitement, gratitude, and relief from both researchers and clinicians, who flocked to the session.

But it’s not just people with HIV who will benefit from this research. Dr. Palefsky suggested that the findings should also be considered as guides for other people at high-risk for anal cancer, such as people who are immunocompromised for other reasons, including those with lupus, ulcerative colitis, Crohn’s disease, or cisgender women who have had vulvar or cervical cancer or precancer.

“If we can show efficacy in the most challenging group of all, which are people living with HIV, we think the results can be as good, if not even better, in the other groups at high risk of anal cancer,” Dr. Palefsky said.

But to serve anyone – whether living with HIV or not – infrastructure, algorithms, and workforce training are going be needed to meet the currently unserved people through use of high-resolution anoscopy (HRA) and other screening technology, he said.

Dr. Palefsy and colleagues screened 10,723 people living with HIV being served at 15 clinics nationwide. More than half, 52.2%, had anal HSIL – 53.3% of the cisgender men living with HIV in the trial, 45.8% of the cis women living with HIV, and a full 62.5% of transgender participants.

Those 4,446 participants were split evenly between the treatment arm and the control arm. Those in the treatment arm received treatment for HSIL on their first study visit via one of five options: hyfrecation, office-based electrocautery ablation, infrared coagulation, topical 5-fluorouracil cream, or topical imiquimod. Then, every 6 months after that, they came in for HRA, blood tests, anal Pap smears, and biopsies to check for any lingering or new HSIL. If clinicians found such cells, they received treatment again. If biopsies still showed HSIL and clinician and participant were worried about cancer, they could come in as frequently as every 3 months and receive treatment each time.

The active-monitoring control group still received an anal Pap smear, blood tests, biopsy, and HRA every 6 months – a level of care that is currently not mandated anywhere for people living with HIV, Dr. Palefsky said in an interview. They were also able to come in for more frequent monitoring (every 3 months) if clinicians were worried about cancer.

“Those in both arms would have been getting more attention than if they had not participated in the study,” he said.

In addition, during screening, researchers found that cancer was already present in 17 other people, who skipped the study to go right to treatment.

Participants reflected the demographics of the HIV epidemic in the United States. They were older (median age, 51 years), mostly gay (78%), and cisgender male (80%). Close to half, 42%, were Black, and 16% were Latinx. In addition, cisgender women made up 16% of the participants and transgender people, and nonbinary individuals accounted for more than 3% of the participants. In addition, one in three smoked.

The vast majority of participants had well-controlled HIV and healthy immune systems, though half in each arm had a history of AIDS, defined as lowest-ever CD4 immune cell counts below 200. Today, more than 80% of participants had undetectable viral loads, defined as a viral load less than 50 copies/mL, and another 7% had HIV viral loads below 200. In total, 9.3% in the treatment arm and 10.9% in the control arm had HIV viral loads higher than that. At time of enrollment, CD4 counts were above 600 in each group, indicating healthy immune systems.

Although all participants were there because they had anal HSIL, more than 1 in 10 – 13% – had abnormal cells so extensive that they covered more than half of the anal canal or the perianal region.

Once everyone was enrolled, researchers began monitoring and treatment, looking specifically for 31 cases of cancer – a number the team had determined that they’d need in order to draw any conclusions. Dr. Palefsky didn’t have to wait long. They were still trying to enroll the last 1,000 participants to have the power necessary to reach that number when the cancer diagnoses came in.

Dr. Palefsky told this news organization that the reason for that is unclear. It could be that some of those cases would have resolved on their own, and so the swiftness with which they reached the required number of cancer cases belies their seriousness. It could also be that the particular people who enrolled in this trial were engaging in behaviors that put them at even higher risk for anal cancer than the population of people living with HIV in the United States.

Or it could be that symptom-based screening is missing a lot of cancers that currently go untreated.

“So perhaps we will be seeing an increase in anal cancer reported in the future compared to the currently reported rates,” he said. “We don’t really know.”

Regardless of the reason for the speed to cases of cancer, the results were definitive: Nine participants were diagnosed with invasive anal cancer in the treatment arm, while 21 were diagnosed with invasive anal cancer in the control arm. That’s a 57% reduction in cancer occurrence between the arms. Or, to put it another way, the rate of anal cancer among people in the treatment arm was 173 per 100,000 people-years. In the active monitoring arm, it was 402 per 100,000 person-years. For context, the overall rate of anal cancer among people living with HIV is 50 per 100,000 person-years. The rate in the general U.S. population is 8 per 100,000 people-years.

The experimental treatment was such a definitive success that the investigators stopped the trial and shifted all participants in the control arm to treatment.
 

‘We have to build’

Before Dr. Palefsky was even done presenting the data, clinicians, people living with HIV, and experts at the session were already brainstorming as to how to get these results into practice.

“These data are what we have long needed to fuel some action on this important problem, including medical cost reimbursement through insurance and increasing the number of persons trained and capable in anal cancer screening,” John Brooks, MD, head of the epidemiology research team at the Centers for Disease Control and Prevention’s division of HIV/AIDS prevention, wrote in the virtual chat.

Jeff Taylor, a member of the ANCHOR advisory board and a person living with HIV who participated in one of the first azidothymidine trials in the late 1980s, responded quickly.

“What kind of advocacy from researchers, HIV clinicians and [people living with HIV] is needed to get this on treatment guidelines, HRA providers trained and certified, and payors to cover this so [people living with HIV] actually have access to lifesaving screening and [treatment]?” Mr. Taylor asked.

It’s a serious challenge. David Malebranche, MD, an Atlanta-based internal medicine physician who specializes in sexual health and HIV, commented in an interview. When he saw the initial press release last year on the ANCHOR findings, his first reaction was: “Thank god. We finally have some data to show what we’ve been trying to get people to do” all along.

But then he wondered, who is going to perform these tests? It’s a fair question. Currently, the wait for an HRA is 6-12 months in many parts of the country. And Dr. Malebranche can’t imagine this being added to his already full plate as a primary care provider.

“If you tell a primary care provider now that they have to do a rectal Pap smear, that’s going to be a problem while you’re also asking them to screen each patient for depression, anxiety, domestic abuse, intimate partner violence, all the healthcare maintenance and all the other screening tests – and then you deal with not only the urgent complaint but then all the complex medical issues on top of that – in a 15-minute or 10-minute visit,” he said.

Now that we have these data, he said, “we have to build.”

Dr. Palefsky agreed. Very few centers have enough people skilled at performing HRAs to meet the current demand, and it’s not realistic to expect clinicians to perform an HRA every 6 months like the study team did. There need to be algorithms put in place to help practitioners figure out who among their patients living with HIV could benefit from this increased screening, as well as biomarkers to identify HSIL progression and regression without the use of HRA, Dr. Palefsky told attendees. And more clinicians need to be recruited and trained to read HRAs, which can be difficult for the untrained eye to decipher.

Dr. Malebranche added another, more fundamental thing that needs to be built. Dr. Malebranche has worked in HIV clinics where the majority of his patients qualify for insurance under the Ryan White Program and get their medications through the AIDS Drug Assistance Program. While Ryan White programs can provide critical wraparound care, Dr. Malebranche has had to refer out for something like an HRA or cancer treatment. But the people who only access care through such programs may not have coverage with the clinics that perform HRA or that treat cancer. And that’s if they can even find someone to see them.

“If I live in a state like Georgia, which doesn’t have Medicaid expansion and we have people who are uninsured, where do you send them?” Dr. Malebranche asked. “This isn’t theoretical. I ran into this problem when I was working at the AIDS Healthcare Foundation last year. ... This is a call for infrastructure.”

The study was funded by the National Cancer Institute. Dr. Brooks reported no relevant financial relationships. Dr. Palefsky has received consultant fees from Merck, Vir Biotechnology, Virion Therapeutics, and Antiva Bioscience, as well as speaker fees from Merck. Dr. Malebranche has received consulting and advising fees from ViiV Healthcare.

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

The recent news that a third person has been “cured” of HIV through a unique transplant of stem cells has given hope for a larger-scale way to beat back the HIV epidemic that has plagued the world for decades.

But while this case is certainly cause for celebration, experts involved in the effort say we are still a long way from a universal cure.

Researcher Yvonne Bryson, MD, chief of pediatric infectious diseases at the University of California, Los Angeles, told those attending the Conference on Retroviruses and Opportunistic Infections that this case is special. The patient was a woman living with HIV who is multiracial. The previous two patients were men: one white, one Latinx.

The woman in this case was given transplants of stem cells and umbilical cord blood to treat leukemia. The treatment not only sent her cancer into remission, but her HIV as well.

The success of this case suggests that cord stem cell transplants should be considered to produce remission and cure for those with HIV who also have cancers and other diseases, the researchers said.

While the news was met with excitement in the scientific community, the approach will not be available universally, since the transplants were all done to treat cancers in the three HIV-infected patients. Overall, Dr. Bryson estimates that about 50 people per year may benefit from this procedure. 

Even so, other experts say the approach could provide insight into other ways to find cures. And Dr. Bryson says it opens up options for more diverse populations.

“A bone marrow transplant is not a viable large-scale strategy for curing HIV, but it does present a proof of concept that HIV can be cured,” said Sharon Lewin, MD, president-elect of the International AIDS Society. “It also further strengthens using gene therapy as a viable strategy for an HIV cure.”

The woman needed a stem cell transplant after being diagnosed with leukemia. The stem cell transplant technique used was also novel, Dr. Bryson said. The medical team used a combination of adult stem cells from a relative’s blood and umbilical cord blood from a cord-blood bank that had a rare mutation that makes the immune system resistant to HIV.

In the previous two cases of HIV cures after transplants, both patients were treated with stem cell transplants, with the same mutation, but from bone marrow transplants, a more difficult procedure. And no cord blood was used for those.

The combination of adult cells and cord-blood cells proved to be the ticket to success. Using the adult cells provides a kind of bridge that helps until the cord blood takes over, the researchers said. By day 100 after the transplant, Dr. Bryson said, the woman basically had a new immune system.

HIV remained undetectable in T cells and in bone marrow. And 37 months after the transplant, the woman stopped taking the antiretroviral treatment commonly given to treat HIV infection.

‘’She is currently clinically well,” Dr. Bryson said. Her cancer is in remission.
 

Case histories: Three patients

The woman, who is middle-aged, has requested privacy, asking that neither her age nor other details be released. But the researchers did provide some background on her medical history and her route back to health. She was diagnosed with HIV in 2013 and began treatment with antiretroviral therapy (ART). Four years after her HIV diagnosis, she developed high-risk acute myelogenous leukemia. The transplant was done to treat that.

Her recovery was much less bumpy than that of the previous two patients, the researchers said. She left the hospital 17 days after the transplant. She didn’t have serious complications like the first two, who developed a condition that occurs when donor bone marrow or stem cells attack the recipient.

“This case also suggests that it’s the transplant of HIV-resistant cells that was key to achieving a cure here,” said Dr. Lewin. The first patient who had HIV remission after a stem cell transplant, a White man, stayed in remission for 12 years and was termed cured. But he died of leukemia in September 2020. The other, a Latinx man, has been in remission for more than 30 months.
 

HIV statistics, ethnic/racial burdens

In the United States, about 1.2 million people have HIV, according to HIV.gov. Thirteen percent of those who have it do not know they have it. In 2019, 34,800 new infections were diagnosed.

Certain ethnic and racial groups are more affected by HIV than others, given their proportions in the U.S. population, federal statistics suggest. In 2019, for instance, African Americans were 13% of the U.S. population but 40% of those with HIV. Hispanics/Latinx represented 18.5% of the total population but 25% of those diagnosed with HIV.

Disparities also affect women unequally, with Black women disproportionately affected, compared to women of other ethnic and racial groups. Annual HIV infections remained stable overall among Black women from 2015 to 2019, but the rate of new HIV infections among Black women is 11 times that of White women and 4 times that of Latinx, according to federal statistics.
 

Expert perspective, reactions

Vincent Marconi, MD, professor of infectious diseases at Emory University, Atlanta, whose research focuses on disparities in HIV treatment responses, called the news “an exciting development for the cure agenda. This is the first woman to have been cured for at least 14 months, and they used cord blood, which could allow for potentially less toxic regimens and fewer adverse effects.”

Although the approach, meant to be used to treat the cancers, will not be widely available, he said that ‘’it does provide insight into somewhat related alternative models of cure involving gene therapy.”

Meanwhile, Dr. Marconi and other researchers are focusing on the concept of long-term HIV remission if a cure is not possible. Among the strategies under study are gene editing and immune-based treatments. HIV remission is generally defined as having an HIV viral load that is not detectable after stopping treatment.

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

The recent news that a third person has been “cured” of HIV through a unique transplant of stem cells has given hope for a larger-scale way to beat back the HIV epidemic that has plagued the world for decades.

But while this case is certainly cause for celebration, experts involved in the effort say we are still a long way from a universal cure.

Researcher Yvonne Bryson, MD, chief of pediatric infectious diseases at the University of California, Los Angeles, told those attending the Conference on Retroviruses and Opportunistic Infections that this case is special. The patient was a woman living with HIV who is multiracial. The previous two patients were men: one white, one Latinx.

The woman in this case was given transplants of stem cells and umbilical cord blood to treat leukemia. The treatment not only sent her cancer into remission, but her HIV as well.

The success of this case suggests that cord stem cell transplants should be considered to produce remission and cure for those with HIV who also have cancers and other diseases, the researchers said.

While the news was met with excitement in the scientific community, the approach will not be available universally, since the transplants were all done to treat cancers in the three HIV-infected patients. Overall, Dr. Bryson estimates that about 50 people per year may benefit from this procedure. 

Even so, other experts say the approach could provide insight into other ways to find cures. And Dr. Bryson says it opens up options for more diverse populations.

“A bone marrow transplant is not a viable large-scale strategy for curing HIV, but it does present a proof of concept that HIV can be cured,” said Sharon Lewin, MD, president-elect of the International AIDS Society. “It also further strengthens using gene therapy as a viable strategy for an HIV cure.”

The woman needed a stem cell transplant after being diagnosed with leukemia. The stem cell transplant technique used was also novel, Dr. Bryson said. The medical team used a combination of adult stem cells from a relative’s blood and umbilical cord blood from a cord-blood bank that had a rare mutation that makes the immune system resistant to HIV.

In the previous two cases of HIV cures after transplants, both patients were treated with stem cell transplants, with the same mutation, but from bone marrow transplants, a more difficult procedure. And no cord blood was used for those.

The combination of adult cells and cord-blood cells proved to be the ticket to success. Using the adult cells provides a kind of bridge that helps until the cord blood takes over, the researchers said. By day 100 after the transplant, Dr. Bryson said, the woman basically had a new immune system.

HIV remained undetectable in T cells and in bone marrow. And 37 months after the transplant, the woman stopped taking the antiretroviral treatment commonly given to treat HIV infection.

‘’She is currently clinically well,” Dr. Bryson said. Her cancer is in remission.
 

Case histories: Three patients

The woman, who is middle-aged, has requested privacy, asking that neither her age nor other details be released. But the researchers did provide some background on her medical history and her route back to health. She was diagnosed with HIV in 2013 and began treatment with antiretroviral therapy (ART). Four years after her HIV diagnosis, she developed high-risk acute myelogenous leukemia. The transplant was done to treat that.

Her recovery was much less bumpy than that of the previous two patients, the researchers said. She left the hospital 17 days after the transplant. She didn’t have serious complications like the first two, who developed a condition that occurs when donor bone marrow or stem cells attack the recipient.

“This case also suggests that it’s the transplant of HIV-resistant cells that was key to achieving a cure here,” said Dr. Lewin. The first patient who had HIV remission after a stem cell transplant, a White man, stayed in remission for 12 years and was termed cured. But he died of leukemia in September 2020. The other, a Latinx man, has been in remission for more than 30 months.
 

HIV statistics, ethnic/racial burdens

In the United States, about 1.2 million people have HIV, according to HIV.gov. Thirteen percent of those who have it do not know they have it. In 2019, 34,800 new infections were diagnosed.

Certain ethnic and racial groups are more affected by HIV than others, given their proportions in the U.S. population, federal statistics suggest. In 2019, for instance, African Americans were 13% of the U.S. population but 40% of those with HIV. Hispanics/Latinx represented 18.5% of the total population but 25% of those diagnosed with HIV.

Disparities also affect women unequally, with Black women disproportionately affected, compared to women of other ethnic and racial groups. Annual HIV infections remained stable overall among Black women from 2015 to 2019, but the rate of new HIV infections among Black women is 11 times that of White women and 4 times that of Latinx, according to federal statistics.
 

Expert perspective, reactions

Vincent Marconi, MD, professor of infectious diseases at Emory University, Atlanta, whose research focuses on disparities in HIV treatment responses, called the news “an exciting development for the cure agenda. This is the first woman to have been cured for at least 14 months, and they used cord blood, which could allow for potentially less toxic regimens and fewer adverse effects.”

Although the approach, meant to be used to treat the cancers, will not be widely available, he said that ‘’it does provide insight into somewhat related alternative models of cure involving gene therapy.”

Meanwhile, Dr. Marconi and other researchers are focusing on the concept of long-term HIV remission if a cure is not possible. Among the strategies under study are gene editing and immune-based treatments. HIV remission is generally defined as having an HIV viral load that is not detectable after stopping treatment.

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

The recent news that a third person has been “cured” of HIV through a unique transplant of stem cells has given hope for a larger-scale way to beat back the HIV epidemic that has plagued the world for decades.

But while this case is certainly cause for celebration, experts involved in the effort say we are still a long way from a universal cure.

Researcher Yvonne Bryson, MD, chief of pediatric infectious diseases at the University of California, Los Angeles, told those attending the Conference on Retroviruses and Opportunistic Infections that this case is special. The patient was a woman living with HIV who is multiracial. The previous two patients were men: one white, one Latinx.

The woman in this case was given transplants of stem cells and umbilical cord blood to treat leukemia. The treatment not only sent her cancer into remission, but her HIV as well.

The success of this case suggests that cord stem cell transplants should be considered to produce remission and cure for those with HIV who also have cancers and other diseases, the researchers said.

While the news was met with excitement in the scientific community, the approach will not be available universally, since the transplants were all done to treat cancers in the three HIV-infected patients. Overall, Dr. Bryson estimates that about 50 people per year may benefit from this procedure. 

Even so, other experts say the approach could provide insight into other ways to find cures. And Dr. Bryson says it opens up options for more diverse populations.

“A bone marrow transplant is not a viable large-scale strategy for curing HIV, but it does present a proof of concept that HIV can be cured,” said Sharon Lewin, MD, president-elect of the International AIDS Society. “It also further strengthens using gene therapy as a viable strategy for an HIV cure.”

The woman needed a stem cell transplant after being diagnosed with leukemia. The stem cell transplant technique used was also novel, Dr. Bryson said. The medical team used a combination of adult stem cells from a relative’s blood and umbilical cord blood from a cord-blood bank that had a rare mutation that makes the immune system resistant to HIV.

In the previous two cases of HIV cures after transplants, both patients were treated with stem cell transplants, with the same mutation, but from bone marrow transplants, a more difficult procedure. And no cord blood was used for those.

The combination of adult cells and cord-blood cells proved to be the ticket to success. Using the adult cells provides a kind of bridge that helps until the cord blood takes over, the researchers said. By day 100 after the transplant, Dr. Bryson said, the woman basically had a new immune system.

HIV remained undetectable in T cells and in bone marrow. And 37 months after the transplant, the woman stopped taking the antiretroviral treatment commonly given to treat HIV infection.

‘’She is currently clinically well,” Dr. Bryson said. Her cancer is in remission.
 

Case histories: Three patients

The woman, who is middle-aged, has requested privacy, asking that neither her age nor other details be released. But the researchers did provide some background on her medical history and her route back to health. She was diagnosed with HIV in 2013 and began treatment with antiretroviral therapy (ART). Four years after her HIV diagnosis, she developed high-risk acute myelogenous leukemia. The transplant was done to treat that.

Her recovery was much less bumpy than that of the previous two patients, the researchers said. She left the hospital 17 days after the transplant. She didn’t have serious complications like the first two, who developed a condition that occurs when donor bone marrow or stem cells attack the recipient.

“This case also suggests that it’s the transplant of HIV-resistant cells that was key to achieving a cure here,” said Dr. Lewin. The first patient who had HIV remission after a stem cell transplant, a White man, stayed in remission for 12 years and was termed cured. But he died of leukemia in September 2020. The other, a Latinx man, has been in remission for more than 30 months.
 

HIV statistics, ethnic/racial burdens

In the United States, about 1.2 million people have HIV, according to HIV.gov. Thirteen percent of those who have it do not know they have it. In 2019, 34,800 new infections were diagnosed.

Certain ethnic and racial groups are more affected by HIV than others, given their proportions in the U.S. population, federal statistics suggest. In 2019, for instance, African Americans were 13% of the U.S. population but 40% of those with HIV. Hispanics/Latinx represented 18.5% of the total population but 25% of those diagnosed with HIV.

Disparities also affect women unequally, with Black women disproportionately affected, compared to women of other ethnic and racial groups. Annual HIV infections remained stable overall among Black women from 2015 to 2019, but the rate of new HIV infections among Black women is 11 times that of White women and 4 times that of Latinx, according to federal statistics.
 

Expert perspective, reactions

Vincent Marconi, MD, professor of infectious diseases at Emory University, Atlanta, whose research focuses on disparities in HIV treatment responses, called the news “an exciting development for the cure agenda. This is the first woman to have been cured for at least 14 months, and they used cord blood, which could allow for potentially less toxic regimens and fewer adverse effects.”

Although the approach, meant to be used to treat the cancers, will not be widely available, he said that ‘’it does provide insight into somewhat related alternative models of cure involving gene therapy.”

Meanwhile, Dr. Marconi and other researchers are focusing on the concept of long-term HIV remission if a cure is not possible. Among the strategies under study are gene editing and immune-based treatments. HIV remission is generally defined as having an HIV viral load that is not detectable after stopping treatment.

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

Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

Early initiation of the antiviral oseltamivir (Tamiflu) reduces the risk for death in patients hospitalized with community-acquired pneumonia (CAP) but patients have to be tested for influenza first and that is not happening often enough, a large observational cohort of adult patients indicates.

“Early testing allows for early treatment, and we found that early treatment was associated with reduced mortality so testing patients during the flu season is crucial,” senior author Michael Rothberg, MD, MPH, of the Cleveland Clinic said in an interview.

“Even during the flu season, most patients with CAP in our study went untested for influenza [even though] those who received early oseltamivir exhibited lower 14-day in-hospital case fatality ... suggesting more widespread testing might improve patient outcomes,” the authors added.

The study was published online Feb. 5, 2022, in the journal CHEST.
 

Premier database

Data from the Premier Database – a hospital discharge database with information from over 600 hospitals in the United States – were analyzed between July 2010 and June 2015. Microbiological laboratory data was provided by 179 hospitals. “For each year, we evaluated the total percentage of patients tested for influenza A/B within 3 days of hospitalization,” lead author Abhishek Deshpande, MD, PhD, Cleveland Clinic, and colleagues explained.

A total of 166,268 patients with CAP were included in the study, among which only about one-quarter were tested for influenza. Some 11.5% tested positive for the flu, the authors noted. Testing did increase from 15.4% in 2010 to 35.6% in 2015 and it was higher at close to 29% during the influenza season, compared with only about 8% during the summer months.

Patients who were tested for influenza were younger at age 66.6 years, compared with untested patients, who were 70 years of age (P < .001). Tested patients were also less likely to have been admitted from a nursing facility (P < .001), were less likely to have been hospitalized in the preceding 6 months (P < .001) and have fewer comorbidities than those who were not tested (P < .001).

“Both groups had similar illness severities on admission,” the authors observed, “but patients who were tested were less likely to die in the hospital within 14 days,” the authors reported – at 6.7% versus 10.9% for untested patients (P < .001).

More than 80% of patients who tested positive for influenza received an antibacterial on day 1 of their admission, compared with virtually all those who were either not tested or who tested negative, the investigators added (P < .001). The mean duration of antibacterial therapy among patients with a bacterial coinfection was not influenced by influenza test results.

However, among those who tested positive for influenza, almost 60% received oseltamivir on day 1 whereas roughly 30% received treatment on day 2 or later. In fact, almost all patients who received early oseltamivir were tested for influenza on day 1, the investigators pointed out. Patients who received early oseltamivir had a 25% lower risk of death within the first 14 days in hospital at an adjusted odds ratio of 0.75 (95% confidence interval, 0.59-0.96).

Early initiation of the antiviral also reduced the risk of requiring subsequent ICU care by 36% at an aOR of 0.64; invasive mechanical ventilation by 46% at an aOR of 0.54, and the need for vasopressor therapy by 47% at an aOR of 0.53. All results were within the 95% confidence levels.

Early use of antiviral therapy also reduced both the length of hospital stay and the cost of that stay by 12%.
 

ATS-IDSA guidelines

As Dr. Deshpande noted, the American Thoracic Society and the Infectious Diseases Society of America guidelines recommend testing and empiric treatment of influenza in patients hospitalized with CAP. “Testing more inpatients especially during the flu season can reduce other diagnostic testing and improve antimicrobial stewardship,” Deshpande noted.

Thus, while the rate of testing for influenza did increase over the 5-year study interval, “there is substantial room for improvement,” he added, as a positive test clearly does trigger the need for intervention. As Dr. Deshpande also noted, the past two influenza seasons have been mild, but influenza activity has again picked up lately again in many parts of the United States.

With the COVID-19 pandemic overwhelming influenza over the past few years, “differentiating between the two based on symptoms alone can be challenging,” he acknowledged, “and clinicians will need to test and treat accordingly.” This is particularly important given that this study clearly indicates that early treatment with an antiviral can lower the risk of short-term mortality in hospitalized CAP patients.

One limitation of the study was the lack of data on time of symptom onset, which may be an important confounder of the effect of oseltamivir on outcomes, the authors point out. Asked to comment on the findings, Barbara Jones, MD, University of Utah Health, Salt Lake City, noted that timely antivirals for patients with influenza are highly effective at mitigating severe disease and are thus strongly recommended by practice guidelines.

“However, it is hard for clinicians to keep influenza on the radar and change testing and treatment approaches according to the season and prevalence [of influenza infections],” she said in an interview. “This is an important study that highlights this challenge.

“We need a better understanding of the solutions that have been effective at improving influenza recognition and treatment, possibly by studying facilities that perform well at this process,” she said.

Dr. Deshpande reported receiving research funding to his institution from the Clorox Company and consultant fees from Merck.

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

Early initiation of the antiviral oseltamivir (Tamiflu) reduces the risk for death in patients hospitalized with community-acquired pneumonia (CAP) but patients have to be tested for influenza first and that is not happening often enough, a large observational cohort of adult patients indicates.

“Early testing allows for early treatment, and we found that early treatment was associated with reduced mortality so testing patients during the flu season is crucial,” senior author Michael Rothberg, MD, MPH, of the Cleveland Clinic said in an interview.

“Even during the flu season, most patients with CAP in our study went untested for influenza [even though] those who received early oseltamivir exhibited lower 14-day in-hospital case fatality ... suggesting more widespread testing might improve patient outcomes,” the authors added.

The study was published online Feb. 5, 2022, in the journal CHEST.
 

Premier database

Data from the Premier Database – a hospital discharge database with information from over 600 hospitals in the United States – were analyzed between July 2010 and June 2015. Microbiological laboratory data was provided by 179 hospitals. “For each year, we evaluated the total percentage of patients tested for influenza A/B within 3 days of hospitalization,” lead author Abhishek Deshpande, MD, PhD, Cleveland Clinic, and colleagues explained.

A total of 166,268 patients with CAP were included in the study, among which only about one-quarter were tested for influenza. Some 11.5% tested positive for the flu, the authors noted. Testing did increase from 15.4% in 2010 to 35.6% in 2015 and it was higher at close to 29% during the influenza season, compared with only about 8% during the summer months.

Patients who were tested for influenza were younger at age 66.6 years, compared with untested patients, who were 70 years of age (P < .001). Tested patients were also less likely to have been admitted from a nursing facility (P < .001), were less likely to have been hospitalized in the preceding 6 months (P < .001) and have fewer comorbidities than those who were not tested (P < .001).

“Both groups had similar illness severities on admission,” the authors observed, “but patients who were tested were less likely to die in the hospital within 14 days,” the authors reported – at 6.7% versus 10.9% for untested patients (P < .001).

More than 80% of patients who tested positive for influenza received an antibacterial on day 1 of their admission, compared with virtually all those who were either not tested or who tested negative, the investigators added (P < .001). The mean duration of antibacterial therapy among patients with a bacterial coinfection was not influenced by influenza test results.

However, among those who tested positive for influenza, almost 60% received oseltamivir on day 1 whereas roughly 30% received treatment on day 2 or later. In fact, almost all patients who received early oseltamivir were tested for influenza on day 1, the investigators pointed out. Patients who received early oseltamivir had a 25% lower risk of death within the first 14 days in hospital at an adjusted odds ratio of 0.75 (95% confidence interval, 0.59-0.96).

Early initiation of the antiviral also reduced the risk of requiring subsequent ICU care by 36% at an aOR of 0.64; invasive mechanical ventilation by 46% at an aOR of 0.54, and the need for vasopressor therapy by 47% at an aOR of 0.53. All results were within the 95% confidence levels.

Early use of antiviral therapy also reduced both the length of hospital stay and the cost of that stay by 12%.
 

ATS-IDSA guidelines

As Dr. Deshpande noted, the American Thoracic Society and the Infectious Diseases Society of America guidelines recommend testing and empiric treatment of influenza in patients hospitalized with CAP. “Testing more inpatients especially during the flu season can reduce other diagnostic testing and improve antimicrobial stewardship,” Deshpande noted.

Thus, while the rate of testing for influenza did increase over the 5-year study interval, “there is substantial room for improvement,” he added, as a positive test clearly does trigger the need for intervention. As Dr. Deshpande also noted, the past two influenza seasons have been mild, but influenza activity has again picked up lately again in many parts of the United States.

With the COVID-19 pandemic overwhelming influenza over the past few years, “differentiating between the two based on symptoms alone can be challenging,” he acknowledged, “and clinicians will need to test and treat accordingly.” This is particularly important given that this study clearly indicates that early treatment with an antiviral can lower the risk of short-term mortality in hospitalized CAP patients.

One limitation of the study was the lack of data on time of symptom onset, which may be an important confounder of the effect of oseltamivir on outcomes, the authors point out. Asked to comment on the findings, Barbara Jones, MD, University of Utah Health, Salt Lake City, noted that timely antivirals for patients with influenza are highly effective at mitigating severe disease and are thus strongly recommended by practice guidelines.

“However, it is hard for clinicians to keep influenza on the radar and change testing and treatment approaches according to the season and prevalence [of influenza infections],” she said in an interview. “This is an important study that highlights this challenge.

“We need a better understanding of the solutions that have been effective at improving influenza recognition and treatment, possibly by studying facilities that perform well at this process,” she said.

Dr. Deshpande reported receiving research funding to his institution from the Clorox Company and consultant fees from Merck.

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

Early initiation of the antiviral oseltamivir (Tamiflu) reduces the risk for death in patients hospitalized with community-acquired pneumonia (CAP) but patients have to be tested for influenza first and that is not happening often enough, a large observational cohort of adult patients indicates.

“Early testing allows for early treatment, and we found that early treatment was associated with reduced mortality so testing patients during the flu season is crucial,” senior author Michael Rothberg, MD, MPH, of the Cleveland Clinic said in an interview.

“Even during the flu season, most patients with CAP in our study went untested for influenza [even though] those who received early oseltamivir exhibited lower 14-day in-hospital case fatality ... suggesting more widespread testing might improve patient outcomes,” the authors added.

The study was published online Feb. 5, 2022, in the journal CHEST.
 

Premier database

Data from the Premier Database – a hospital discharge database with information from over 600 hospitals in the United States – were analyzed between July 2010 and June 2015. Microbiological laboratory data was provided by 179 hospitals. “For each year, we evaluated the total percentage of patients tested for influenza A/B within 3 days of hospitalization,” lead author Abhishek Deshpande, MD, PhD, Cleveland Clinic, and colleagues explained.

A total of 166,268 patients with CAP were included in the study, among which only about one-quarter were tested for influenza. Some 11.5% tested positive for the flu, the authors noted. Testing did increase from 15.4% in 2010 to 35.6% in 2015 and it was higher at close to 29% during the influenza season, compared with only about 8% during the summer months.

Patients who were tested for influenza were younger at age 66.6 years, compared with untested patients, who were 70 years of age (P < .001). Tested patients were also less likely to have been admitted from a nursing facility (P < .001), were less likely to have been hospitalized in the preceding 6 months (P < .001) and have fewer comorbidities than those who were not tested (P < .001).

“Both groups had similar illness severities on admission,” the authors observed, “but patients who were tested were less likely to die in the hospital within 14 days,” the authors reported – at 6.7% versus 10.9% for untested patients (P < .001).

More than 80% of patients who tested positive for influenza received an antibacterial on day 1 of their admission, compared with virtually all those who were either not tested or who tested negative, the investigators added (P < .001). The mean duration of antibacterial therapy among patients with a bacterial coinfection was not influenced by influenza test results.

However, among those who tested positive for influenza, almost 60% received oseltamivir on day 1 whereas roughly 30% received treatment on day 2 or later. In fact, almost all patients who received early oseltamivir were tested for influenza on day 1, the investigators pointed out. Patients who received early oseltamivir had a 25% lower risk of death within the first 14 days in hospital at an adjusted odds ratio of 0.75 (95% confidence interval, 0.59-0.96).

Early initiation of the antiviral also reduced the risk of requiring subsequent ICU care by 36% at an aOR of 0.64; invasive mechanical ventilation by 46% at an aOR of 0.54, and the need for vasopressor therapy by 47% at an aOR of 0.53. All results were within the 95% confidence levels.

Early use of antiviral therapy also reduced both the length of hospital stay and the cost of that stay by 12%.
 

ATS-IDSA guidelines

As Dr. Deshpande noted, the American Thoracic Society and the Infectious Diseases Society of America guidelines recommend testing and empiric treatment of influenza in patients hospitalized with CAP. “Testing more inpatients especially during the flu season can reduce other diagnostic testing and improve antimicrobial stewardship,” Deshpande noted.

Thus, while the rate of testing for influenza did increase over the 5-year study interval, “there is substantial room for improvement,” he added, as a positive test clearly does trigger the need for intervention. As Dr. Deshpande also noted, the past two influenza seasons have been mild, but influenza activity has again picked up lately again in many parts of the United States.

With the COVID-19 pandemic overwhelming influenza over the past few years, “differentiating between the two based on symptoms alone can be challenging,” he acknowledged, “and clinicians will need to test and treat accordingly.” This is particularly important given that this study clearly indicates that early treatment with an antiviral can lower the risk of short-term mortality in hospitalized CAP patients.

One limitation of the study was the lack of data on time of symptom onset, which may be an important confounder of the effect of oseltamivir on outcomes, the authors point out. Asked to comment on the findings, Barbara Jones, MD, University of Utah Health, Salt Lake City, noted that timely antivirals for patients with influenza are highly effective at mitigating severe disease and are thus strongly recommended by practice guidelines.

“However, it is hard for clinicians to keep influenza on the radar and change testing and treatment approaches according to the season and prevalence [of influenza infections],” she said in an interview. “This is an important study that highlights this challenge.

“We need a better understanding of the solutions that have been effective at improving influenza recognition and treatment, possibly by studying facilities that perform well at this process,” she said.

Dr. Deshpande reported receiving research funding to his institution from the Clorox Company and consultant fees from Merck.

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

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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