HIV

Over the past decade, data have suggested that antiretroviral therapy (ART) may be associated with an increased risk for adverse pregnancy outcomes, namely, preterm birth (PTB). But a combination of methodologic challenges, demographic gaps, and spotty clinical data has left the question unresolved, especially for pregnant women with HIV who reside in developed countries.

“Given that a lot of the emerging data has come out of resource-limited settings where patient and clinical characteristics are different from developed world settings like the United States, we felt that this was an important question to address,” Kartik Venkatesh, MD, PhD, a high-risk obstetrician and perinatal epidemiologist at the Ohio State Wexner Medical Center, Columbus, told this news organization.

In a prospective cohort study of U.S. women with or at risk for HIV, Dr. Venkatesh and his colleagues found that ART exposure (including highly active antiretroviral therapy [HAART]) was associated with as much as an 80% decline in the likelihood of PTB (defined as birth less than 34 weeks). The study was published in HIV Medicine.
 

24 years of data analyzed

Dr. Venkatesh and his team analyzed self-reported birth data of women with singleton live-born pregnancies enrolled in the ongoing, multicenter, prospective observational Women’s Interagency HIV Study (WIHS) from Oct. 1, 1995, to March 31, 2019.

“We first looked at women with HIV versus without HIV, [who were] matched on many clinical and sociodemographic characteristics and at similarly high risk of some of these obstetrical outcomes like PTB,” explained Dr. Venkatesh. “We then looked at the relative impact of antiretroviral therapy amongst women living with HIV compared to no antiretroviral therapy.”

ART regimens were classified as none, monotherapy, dual therapy, or HAART. (HAART was defined as more than three antiretrovirals, including at least one protease inhibitor [PI], nonnucleoside reverse transcriptase inhibitor, integrase inhibitor, or entry inhibitor.) In this cohort, for 63.5% of women receiving ART, therapy was initiated before pregnancy (mean duration of HAART, 6 years), and most were virally suppressed.

Among the 4,944 women assessed in the WIHS trial, 74% (3,646) had HIV. In total, 383 women had 488 singleton deliveries, including 218 women with HIV (272 deliveries) and 165 without HIV (216 deliveries). Sociodemographics in both cohorts were well matched. For most participants, the mean age was 40-41 years at delivery, most were non-Hispanic Black persons, and the mean pregnancy body mass index was greater than or equal to 29 kg/m2. Of the women with HIV, 33% had chronic hypertension; of those without HIV, 42.1% had chronic hypertension; 4.7% and 5.0%, respectively, had pregestational diabetes.

The findings showed that PTB risk less than 34 weeks was similar between women with (10%) and without (8%) HIV (adjusted risk ratio, 1.30; 95% confidence interval, 0.74-2.31). Among deliveries to women with HIV who were receiving ART, PTB risk less than 34 weeks was lower with HAART (7%), compared with not receiving ART (26%) (aRR, 0.19), as well as with monotherapy or dual therapy (3% vs. no ART) (aRR, 0.12). Notably, 67% of deliveries to women receiving HAART included a PI-containing regimen, but these women were not significantly more likely to have a PTB less than 34 weeks, compared with women taking non-PI HAART regimens (aRR, 2.61; 95% CI, 0.65-10.59). Results were similar for secondary outcomes (PTB less than 28 weeks, less than 37 weeks).
 

Filling in the gaps toward the safest regimen

“This study spans 25 years, so it covers a lot of the history of HIV in pregnancy and is reassuring around using ART in pregnancy,” Shahin Lockman, MD, told this news organization. Dr. Lockman is an associate professor of infectious diseases at Brigham and Women’s Hospital and a co-PI of the Botswana Clinical Trials Unit at the Botswana Harvard AIDS Institute Partnership. She was not involved in the study. “One of the worst things for a mother and for pregnancy outcomes, for the fetus and baby’s health and development, is uncontrolled maternal HIV,’’ she said.

Dr. Lockman also noted potential confounders that drive poor birth outcomes in Southern African women, compared with U.S. women, making comparisons between this and other observational studies difficult. Still, she said that the question is not whether women should be receiving treatment but whether or not there are differences between antiretroviral regimens.

“One of the areas that we did not go deeper into was the subtype of antiretroviral therapy, given the relatively small study numbers [did not] allow us to do a robust analysis,” Dr. Venkatesh said.

Rather, he emphasized that the findings might lend more weight to speculation that immunologic characteristics associated with HIV status and immunotherapy – such as low CD4 cell counts prior to delivery, or duration of HIV infection – may be important drivers of adverse birth outcomes among women with HIV taking ART.

And at least in this cohort, many of these characteristics were similar between the treatment groups.

Both researchers agree that the findings – while reassuring – highlight the importance of collecting robust obstetric and safety data as part of prospective databases of individuals living with HIV, not only in resource-limited settings but also among the domestic U.S. population.

“We’ve learned a lot over the last 10 years,” Dr. Lockman said. “Some regimens (like lopinavir/ritonavir or nevirapine) are associated with significantly worse birth outcomes, whereas efavirenz doesn’t seem to be, or less so, and dolutegravir seems to be associated with even better outcomes. So, I think that where we are moving is to regimens that are the safest.”

Moving forward, Dr. Venkatesh explained, not only should researchers focus on exploring which antiretrovirals are safest in this context but also if the use of preexposure prophylaxis during conception periods affects birth outcomes.

Dr. Venkatesh and Dr. Lockman report no relevant financial relationships.

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

Over the past decade, data have suggested that antiretroviral therapy (ART) may be associated with an increased risk for adverse pregnancy outcomes, namely, preterm birth (PTB). But a combination of methodologic challenges, demographic gaps, and spotty clinical data has left the question unresolved, especially for pregnant women with HIV who reside in developed countries.

“Given that a lot of the emerging data has come out of resource-limited settings where patient and clinical characteristics are different from developed world settings like the United States, we felt that this was an important question to address,” Kartik Venkatesh, MD, PhD, a high-risk obstetrician and perinatal epidemiologist at the Ohio State Wexner Medical Center, Columbus, told this news organization.

In a prospective cohort study of U.S. women with or at risk for HIV, Dr. Venkatesh and his colleagues found that ART exposure (including highly active antiretroviral therapy [HAART]) was associated with as much as an 80% decline in the likelihood of PTB (defined as birth less than 34 weeks). The study was published in HIV Medicine.
 

24 years of data analyzed

Dr. Venkatesh and his team analyzed self-reported birth data of women with singleton live-born pregnancies enrolled in the ongoing, multicenter, prospective observational Women’s Interagency HIV Study (WIHS) from Oct. 1, 1995, to March 31, 2019.

“We first looked at women with HIV versus without HIV, [who were] matched on many clinical and sociodemographic characteristics and at similarly high risk of some of these obstetrical outcomes like PTB,” explained Dr. Venkatesh. “We then looked at the relative impact of antiretroviral therapy amongst women living with HIV compared to no antiretroviral therapy.”

ART regimens were classified as none, monotherapy, dual therapy, or HAART. (HAART was defined as more than three antiretrovirals, including at least one protease inhibitor [PI], nonnucleoside reverse transcriptase inhibitor, integrase inhibitor, or entry inhibitor.) In this cohort, for 63.5% of women receiving ART, therapy was initiated before pregnancy (mean duration of HAART, 6 years), and most were virally suppressed.

Among the 4,944 women assessed in the WIHS trial, 74% (3,646) had HIV. In total, 383 women had 488 singleton deliveries, including 218 women with HIV (272 deliveries) and 165 without HIV (216 deliveries). Sociodemographics in both cohorts were well matched. For most participants, the mean age was 40-41 years at delivery, most were non-Hispanic Black persons, and the mean pregnancy body mass index was greater than or equal to 29 kg/m2. Of the women with HIV, 33% had chronic hypertension; of those without HIV, 42.1% had chronic hypertension; 4.7% and 5.0%, respectively, had pregestational diabetes.

The findings showed that PTB risk less than 34 weeks was similar between women with (10%) and without (8%) HIV (adjusted risk ratio, 1.30; 95% confidence interval, 0.74-2.31). Among deliveries to women with HIV who were receiving ART, PTB risk less than 34 weeks was lower with HAART (7%), compared with not receiving ART (26%) (aRR, 0.19), as well as with monotherapy or dual therapy (3% vs. no ART) (aRR, 0.12). Notably, 67% of deliveries to women receiving HAART included a PI-containing regimen, but these women were not significantly more likely to have a PTB less than 34 weeks, compared with women taking non-PI HAART regimens (aRR, 2.61; 95% CI, 0.65-10.59). Results were similar for secondary outcomes (PTB less than 28 weeks, less than 37 weeks).
 

Filling in the gaps toward the safest regimen

“This study spans 25 years, so it covers a lot of the history of HIV in pregnancy and is reassuring around using ART in pregnancy,” Shahin Lockman, MD, told this news organization. Dr. Lockman is an associate professor of infectious diseases at Brigham and Women’s Hospital and a co-PI of the Botswana Clinical Trials Unit at the Botswana Harvard AIDS Institute Partnership. She was not involved in the study. “One of the worst things for a mother and for pregnancy outcomes, for the fetus and baby’s health and development, is uncontrolled maternal HIV,’’ she said.

Dr. Lockman also noted potential confounders that drive poor birth outcomes in Southern African women, compared with U.S. women, making comparisons between this and other observational studies difficult. Still, she said that the question is not whether women should be receiving treatment but whether or not there are differences between antiretroviral regimens.

“One of the areas that we did not go deeper into was the subtype of antiretroviral therapy, given the relatively small study numbers [did not] allow us to do a robust analysis,” Dr. Venkatesh said.

Rather, he emphasized that the findings might lend more weight to speculation that immunologic characteristics associated with HIV status and immunotherapy – such as low CD4 cell counts prior to delivery, or duration of HIV infection – may be important drivers of adverse birth outcomes among women with HIV taking ART.

And at least in this cohort, many of these characteristics were similar between the treatment groups.

Both researchers agree that the findings – while reassuring – highlight the importance of collecting robust obstetric and safety data as part of prospective databases of individuals living with HIV, not only in resource-limited settings but also among the domestic U.S. population.

“We’ve learned a lot over the last 10 years,” Dr. Lockman said. “Some regimens (like lopinavir/ritonavir or nevirapine) are associated with significantly worse birth outcomes, whereas efavirenz doesn’t seem to be, or less so, and dolutegravir seems to be associated with even better outcomes. So, I think that where we are moving is to regimens that are the safest.”

Moving forward, Dr. Venkatesh explained, not only should researchers focus on exploring which antiretrovirals are safest in this context but also if the use of preexposure prophylaxis during conception periods affects birth outcomes.

Dr. Venkatesh and Dr. Lockman report no relevant financial relationships.

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

Over the past decade, data have suggested that antiretroviral therapy (ART) may be associated with an increased risk for adverse pregnancy outcomes, namely, preterm birth (PTB). But a combination of methodologic challenges, demographic gaps, and spotty clinical data has left the question unresolved, especially for pregnant women with HIV who reside in developed countries.

“Given that a lot of the emerging data has come out of resource-limited settings where patient and clinical characteristics are different from developed world settings like the United States, we felt that this was an important question to address,” Kartik Venkatesh, MD, PhD, a high-risk obstetrician and perinatal epidemiologist at the Ohio State Wexner Medical Center, Columbus, told this news organization.

In a prospective cohort study of U.S. women with or at risk for HIV, Dr. Venkatesh and his colleagues found that ART exposure (including highly active antiretroviral therapy [HAART]) was associated with as much as an 80% decline in the likelihood of PTB (defined as birth less than 34 weeks). The study was published in HIV Medicine.
 

24 years of data analyzed

Dr. Venkatesh and his team analyzed self-reported birth data of women with singleton live-born pregnancies enrolled in the ongoing, multicenter, prospective observational Women’s Interagency HIV Study (WIHS) from Oct. 1, 1995, to March 31, 2019.

“We first looked at women with HIV versus without HIV, [who were] matched on many clinical and sociodemographic characteristics and at similarly high risk of some of these obstetrical outcomes like PTB,” explained Dr. Venkatesh. “We then looked at the relative impact of antiretroviral therapy amongst women living with HIV compared to no antiretroviral therapy.”

ART regimens were classified as none, monotherapy, dual therapy, or HAART. (HAART was defined as more than three antiretrovirals, including at least one protease inhibitor [PI], nonnucleoside reverse transcriptase inhibitor, integrase inhibitor, or entry inhibitor.) In this cohort, for 63.5% of women receiving ART, therapy was initiated before pregnancy (mean duration of HAART, 6 years), and most were virally suppressed.

Among the 4,944 women assessed in the WIHS trial, 74% (3,646) had HIV. In total, 383 women had 488 singleton deliveries, including 218 women with HIV (272 deliveries) and 165 without HIV (216 deliveries). Sociodemographics in both cohorts were well matched. For most participants, the mean age was 40-41 years at delivery, most were non-Hispanic Black persons, and the mean pregnancy body mass index was greater than or equal to 29 kg/m2. Of the women with HIV, 33% had chronic hypertension; of those without HIV, 42.1% had chronic hypertension; 4.7% and 5.0%, respectively, had pregestational diabetes.

The findings showed that PTB risk less than 34 weeks was similar between women with (10%) and without (8%) HIV (adjusted risk ratio, 1.30; 95% confidence interval, 0.74-2.31). Among deliveries to women with HIV who were receiving ART, PTB risk less than 34 weeks was lower with HAART (7%), compared with not receiving ART (26%) (aRR, 0.19), as well as with monotherapy or dual therapy (3% vs. no ART) (aRR, 0.12). Notably, 67% of deliveries to women receiving HAART included a PI-containing regimen, but these women were not significantly more likely to have a PTB less than 34 weeks, compared with women taking non-PI HAART regimens (aRR, 2.61; 95% CI, 0.65-10.59). Results were similar for secondary outcomes (PTB less than 28 weeks, less than 37 weeks).
 

Filling in the gaps toward the safest regimen

“This study spans 25 years, so it covers a lot of the history of HIV in pregnancy and is reassuring around using ART in pregnancy,” Shahin Lockman, MD, told this news organization. Dr. Lockman is an associate professor of infectious diseases at Brigham and Women’s Hospital and a co-PI of the Botswana Clinical Trials Unit at the Botswana Harvard AIDS Institute Partnership. She was not involved in the study. “One of the worst things for a mother and for pregnancy outcomes, for the fetus and baby’s health and development, is uncontrolled maternal HIV,’’ she said.

Dr. Lockman also noted potential confounders that drive poor birth outcomes in Southern African women, compared with U.S. women, making comparisons between this and other observational studies difficult. Still, she said that the question is not whether women should be receiving treatment but whether or not there are differences between antiretroviral regimens.

“One of the areas that we did not go deeper into was the subtype of antiretroviral therapy, given the relatively small study numbers [did not] allow us to do a robust analysis,” Dr. Venkatesh said.

Rather, he emphasized that the findings might lend more weight to speculation that immunologic characteristics associated with HIV status and immunotherapy – such as low CD4 cell counts prior to delivery, or duration of HIV infection – may be important drivers of adverse birth outcomes among women with HIV taking ART.

And at least in this cohort, many of these characteristics were similar between the treatment groups.

Both researchers agree that the findings – while reassuring – highlight the importance of collecting robust obstetric and safety data as part of prospective databases of individuals living with HIV, not only in resource-limited settings but also among the domestic U.S. population.

“We’ve learned a lot over the last 10 years,” Dr. Lockman said. “Some regimens (like lopinavir/ritonavir or nevirapine) are associated with significantly worse birth outcomes, whereas efavirenz doesn’t seem to be, or less so, and dolutegravir seems to be associated with even better outcomes. So, I think that where we are moving is to regimens that are the safest.”

Moving forward, Dr. Venkatesh explained, not only should researchers focus on exploring which antiretrovirals are safest in this context but also if the use of preexposure prophylaxis during conception periods affects birth outcomes.

Dr. Venkatesh and Dr. Lockman report no relevant financial relationships.

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

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

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

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

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

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

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

Heterosexuals with HIV have lower CD4 counts at diagnosis than their gay and bisexual male peers, according to an analysis of more than 300,000 people living with HIV globally.

“It was quite a startling finding for us, because it’s now telling everybody, ‘Look, if you have MSM [men who have sex with men] coming into your clinic, expect CD4 counts at diagnosis to be higher than if the person got the infection as a heterosexual,’” Narendra Dixit, PhD, senior fellow at the Indian Institute of Science’s Centre for Biosystems Science and Engineering, Bangalore, India, said in an interview.

And that means, he said, that the pattern may appear in local clinics.

“If they find that there are differences in the CD4 counts between heterosexuals and MSMs, they should not be surprised anymore,” he said.

Dr. Dixit proposed that the reason for this may be that the viruses transmitted among heterosexuals are more virulent, but the study didn’t provide evidence of that.
 

Immune health at HIV diagnosis

In this study, which was published online March 10 in PLOS Pathogens, Dr. Dixit and colleague Anathu James, PhD, a data scientist and an epidemiologist at the Indian Institute of Science, culled data from 337,119 people captured in studies in the United Kingdom, the United States, Europe, Australia, and China. For all participants, CD4 counts were drawn at the time of diagnosis and before starting HIV treatment. Dr. Dixit and Dr. James then divided the studies by HIV transmission group – gay and bisexual men versus heterosexuals – and then averaged CD4 counts in each study.

Then they created a mathematical model to estimate how quickly each group might progress to an AIDS-defining illness, given those initial CD4 counts.

What they found was that the mean CD4 count was consistently higher in the gay and bisexual males than in the heterosexuals, no matter where they lived. For instance, mean CD4 counts at diagnosis were a mean of 437 cells/mm³ among gay and bisexual men in one European cohort, compared to a mean of 307 among heterosexuals. In the U.S. data, the mean CD4 count for gay and bisexual men was 390, compared to 314 among heterosexuals. In China, the same held true: Gay men had a mean CD4 count of 368 cells/mm³; heterosexuals had a mean CD4 count of 270.

This remained true when they only looked at people between the ages of 13 and 29 years in the United States or whether they were younger than 40 in Europe and Australia. In Europe and Australia, though, heterosexual women younger than 40 had higher CD4 counts than either straight or gay men. But this difference did not reach statistical significance, and gay men had higher CD4 counts overall when the investigators didn’t segregate the data by age group.

“We were stunned,” Dr. Dixit told this news organization. “People never thought there could be a difference in the CD4 counts just because the mode of transmission is different – or, in this case, because the risk groups are different.”

There was no difference, though, in viral load at diagnosis.

In their mathematical model on progression to AIDS, the investigators estimated that these lower CD4 counts at diagnosis would lead to a progression to AIDS that was 19% higher for straight people than for gay and bisexual men. What this implies for practice is less clear. Right now, Dr. Dixit hopes the data will be used to conduct molecular analysis of HIV strains in heterosexuals and gay and bisexual men to see if the HIV circulating in straight communities is different – and perhaps more virulent – than the HIV circulating among gay and bisexual men. Previous research has suggested that CD4 counts can be used as a proxy for virulence.

Dr. Dixit’s mathematical model follows recent news of a highly virulent strain of HIV that’s been present in the Netherlands for decades. “More virulent” in that case meant that it was more highly transmissible and led to higher viral loads and a quicker decline of the immune CD4 cells. So when news of Dr. Dixit’s study went out, it was accompanied by a press release stating as fact that “HIV-1 infections are more virulent when transmitted through penile-vaginal intercourse.” The study’s title states that HIV is “more virulent” in heterosexuals.

But this study doesn’t actually show that, said virology researcher Timothy Henrich, MD, associate professor of medicine at the University of California, San Francisco, in an interview. In the Netherlands study, investigators took the additional step of analyzing HIV genomes. But this was not done in the recent PLOS Pathogens study.

“This was essentially a large meta-analysis of multiple large cohorts across many different countries,” said Dr. Henrich, who was not involved in the study. “There was no in-depth sequence analysis to say, ‘Oh yeah, this is because of a difference in the viruses that are being transmitted.’ If I were reviewing this paper, I probably would have said, ‘This is an interesting observation, but please don’t go overboard in your conclusions.’”

The study made Dr. Henrich want to know more. For instance, what method did each study use to determine CD4 counts? Did they control for the length of time since acquisition? Dr. Henrich said that if they didn’t differentiate between acute infection and chronic infection, he wasn’t sure what conclusions could be drawn from the data. Dr. Dixit told this news organization that they used the plateau level – the point after acute infection when CD4 counts settle into a consistent level. But it’s unclear how far from HIV acquisition each of the people in these studies was.

What Dr. Henrich does know, he said, is that big data are going to continue to change how we think about and investigate HIV transmission and virulence and what it could mean for clinical practice. The National Institutes of Health, for instance, will soon require all researchers receiving their funding to make their raw data publicly available soon after publication.

“We’re going to see a lot more of these large studies going forward,” he said. And if molecular analyses bear out Dr. Dixit’s conclusion – which he called “a big if” – “maybe we could use this study as a way” to do this work in the future.

The study was funded by DBT Network and the Wellcome Trust India Alliance Senior Fellowship. Dr. Dixit has disclosed no relevant financial relationships. Dr. Henrich is conducting studies funded in whole or in part by Merck and Gilead Sciences.

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

Heterosexuals with HIV have lower CD4 counts at diagnosis than their gay and bisexual male peers, according to an analysis of more than 300,000 people living with HIV globally.

“It was quite a startling finding for us, because it’s now telling everybody, ‘Look, if you have MSM [men who have sex with men] coming into your clinic, expect CD4 counts at diagnosis to be higher than if the person got the infection as a heterosexual,’” Narendra Dixit, PhD, senior fellow at the Indian Institute of Science’s Centre for Biosystems Science and Engineering, Bangalore, India, said in an interview.

And that means, he said, that the pattern may appear in local clinics.

“If they find that there are differences in the CD4 counts between heterosexuals and MSMs, they should not be surprised anymore,” he said.

Dr. Dixit proposed that the reason for this may be that the viruses transmitted among heterosexuals are more virulent, but the study didn’t provide evidence of that.
 

Immune health at HIV diagnosis

In this study, which was published online March 10 in PLOS Pathogens, Dr. Dixit and colleague Anathu James, PhD, a data scientist and an epidemiologist at the Indian Institute of Science, culled data from 337,119 people captured in studies in the United Kingdom, the United States, Europe, Australia, and China. For all participants, CD4 counts were drawn at the time of diagnosis and before starting HIV treatment. Dr. Dixit and Dr. James then divided the studies by HIV transmission group – gay and bisexual men versus heterosexuals – and then averaged CD4 counts in each study.

Then they created a mathematical model to estimate how quickly each group might progress to an AIDS-defining illness, given those initial CD4 counts.

What they found was that the mean CD4 count was consistently higher in the gay and bisexual males than in the heterosexuals, no matter where they lived. For instance, mean CD4 counts at diagnosis were a mean of 437 cells/mm³ among gay and bisexual men in one European cohort, compared to a mean of 307 among heterosexuals. In the U.S. data, the mean CD4 count for gay and bisexual men was 390, compared to 314 among heterosexuals. In China, the same held true: Gay men had a mean CD4 count of 368 cells/mm³; heterosexuals had a mean CD4 count of 270.

This remained true when they only looked at people between the ages of 13 and 29 years in the United States or whether they were younger than 40 in Europe and Australia. In Europe and Australia, though, heterosexual women younger than 40 had higher CD4 counts than either straight or gay men. But this difference did not reach statistical significance, and gay men had higher CD4 counts overall when the investigators didn’t segregate the data by age group.

“We were stunned,” Dr. Dixit told this news organization. “People never thought there could be a difference in the CD4 counts just because the mode of transmission is different – or, in this case, because the risk groups are different.”

There was no difference, though, in viral load at diagnosis.

In their mathematical model on progression to AIDS, the investigators estimated that these lower CD4 counts at diagnosis would lead to a progression to AIDS that was 19% higher for straight people than for gay and bisexual men. What this implies for practice is less clear. Right now, Dr. Dixit hopes the data will be used to conduct molecular analysis of HIV strains in heterosexuals and gay and bisexual men to see if the HIV circulating in straight communities is different – and perhaps more virulent – than the HIV circulating among gay and bisexual men. Previous research has suggested that CD4 counts can be used as a proxy for virulence.

Dr. Dixit’s mathematical model follows recent news of a highly virulent strain of HIV that’s been present in the Netherlands for decades. “More virulent” in that case meant that it was more highly transmissible and led to higher viral loads and a quicker decline of the immune CD4 cells. So when news of Dr. Dixit’s study went out, it was accompanied by a press release stating as fact that “HIV-1 infections are more virulent when transmitted through penile-vaginal intercourse.” The study’s title states that HIV is “more virulent” in heterosexuals.

But this study doesn’t actually show that, said virology researcher Timothy Henrich, MD, associate professor of medicine at the University of California, San Francisco, in an interview. In the Netherlands study, investigators took the additional step of analyzing HIV genomes. But this was not done in the recent PLOS Pathogens study.

“This was essentially a large meta-analysis of multiple large cohorts across many different countries,” said Dr. Henrich, who was not involved in the study. “There was no in-depth sequence analysis to say, ‘Oh yeah, this is because of a difference in the viruses that are being transmitted.’ If I were reviewing this paper, I probably would have said, ‘This is an interesting observation, but please don’t go overboard in your conclusions.’”

The study made Dr. Henrich want to know more. For instance, what method did each study use to determine CD4 counts? Did they control for the length of time since acquisition? Dr. Henrich said that if they didn’t differentiate between acute infection and chronic infection, he wasn’t sure what conclusions could be drawn from the data. Dr. Dixit told this news organization that they used the plateau level – the point after acute infection when CD4 counts settle into a consistent level. But it’s unclear how far from HIV acquisition each of the people in these studies was.

What Dr. Henrich does know, he said, is that big data are going to continue to change how we think about and investigate HIV transmission and virulence and what it could mean for clinical practice. The National Institutes of Health, for instance, will soon require all researchers receiving their funding to make their raw data publicly available soon after publication.

“We’re going to see a lot more of these large studies going forward,” he said. And if molecular analyses bear out Dr. Dixit’s conclusion – which he called “a big if” – “maybe we could use this study as a way” to do this work in the future.

The study was funded by DBT Network and the Wellcome Trust India Alliance Senior Fellowship. Dr. Dixit has disclosed no relevant financial relationships. Dr. Henrich is conducting studies funded in whole or in part by Merck and Gilead Sciences.

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

Heterosexuals with HIV have lower CD4 counts at diagnosis than their gay and bisexual male peers, according to an analysis of more than 300,000 people living with HIV globally.

“It was quite a startling finding for us, because it’s now telling everybody, ‘Look, if you have MSM [men who have sex with men] coming into your clinic, expect CD4 counts at diagnosis to be higher than if the person got the infection as a heterosexual,’” Narendra Dixit, PhD, senior fellow at the Indian Institute of Science’s Centre for Biosystems Science and Engineering, Bangalore, India, said in an interview.

And that means, he said, that the pattern may appear in local clinics.

“If they find that there are differences in the CD4 counts between heterosexuals and MSMs, they should not be surprised anymore,” he said.

Dr. Dixit proposed that the reason for this may be that the viruses transmitted among heterosexuals are more virulent, but the study didn’t provide evidence of that.
 

Immune health at HIV diagnosis

In this study, which was published online March 10 in PLOS Pathogens, Dr. Dixit and colleague Anathu James, PhD, a data scientist and an epidemiologist at the Indian Institute of Science, culled data from 337,119 people captured in studies in the United Kingdom, the United States, Europe, Australia, and China. For all participants, CD4 counts were drawn at the time of diagnosis and before starting HIV treatment. Dr. Dixit and Dr. James then divided the studies by HIV transmission group – gay and bisexual men versus heterosexuals – and then averaged CD4 counts in each study.

Then they created a mathematical model to estimate how quickly each group might progress to an AIDS-defining illness, given those initial CD4 counts.

What they found was that the mean CD4 count was consistently higher in the gay and bisexual males than in the heterosexuals, no matter where they lived. For instance, mean CD4 counts at diagnosis were a mean of 437 cells/mm³ among gay and bisexual men in one European cohort, compared to a mean of 307 among heterosexuals. In the U.S. data, the mean CD4 count for gay and bisexual men was 390, compared to 314 among heterosexuals. In China, the same held true: Gay men had a mean CD4 count of 368 cells/mm³; heterosexuals had a mean CD4 count of 270.

This remained true when they only looked at people between the ages of 13 and 29 years in the United States or whether they were younger than 40 in Europe and Australia. In Europe and Australia, though, heterosexual women younger than 40 had higher CD4 counts than either straight or gay men. But this difference did not reach statistical significance, and gay men had higher CD4 counts overall when the investigators didn’t segregate the data by age group.

“We were stunned,” Dr. Dixit told this news organization. “People never thought there could be a difference in the CD4 counts just because the mode of transmission is different – or, in this case, because the risk groups are different.”

There was no difference, though, in viral load at diagnosis.

In their mathematical model on progression to AIDS, the investigators estimated that these lower CD4 counts at diagnosis would lead to a progression to AIDS that was 19% higher for straight people than for gay and bisexual men. What this implies for practice is less clear. Right now, Dr. Dixit hopes the data will be used to conduct molecular analysis of HIV strains in heterosexuals and gay and bisexual men to see if the HIV circulating in straight communities is different – and perhaps more virulent – than the HIV circulating among gay and bisexual men. Previous research has suggested that CD4 counts can be used as a proxy for virulence.

Dr. Dixit’s mathematical model follows recent news of a highly virulent strain of HIV that’s been present in the Netherlands for decades. “More virulent” in that case meant that it was more highly transmissible and led to higher viral loads and a quicker decline of the immune CD4 cells. So when news of Dr. Dixit’s study went out, it was accompanied by a press release stating as fact that “HIV-1 infections are more virulent when transmitted through penile-vaginal intercourse.” The study’s title states that HIV is “more virulent” in heterosexuals.

But this study doesn’t actually show that, said virology researcher Timothy Henrich, MD, associate professor of medicine at the University of California, San Francisco, in an interview. In the Netherlands study, investigators took the additional step of analyzing HIV genomes. But this was not done in the recent PLOS Pathogens study.

“This was essentially a large meta-analysis of multiple large cohorts across many different countries,” said Dr. Henrich, who was not involved in the study. “There was no in-depth sequence analysis to say, ‘Oh yeah, this is because of a difference in the viruses that are being transmitted.’ If I were reviewing this paper, I probably would have said, ‘This is an interesting observation, but please don’t go overboard in your conclusions.’”

The study made Dr. Henrich want to know more. For instance, what method did each study use to determine CD4 counts? Did they control for the length of time since acquisition? Dr. Henrich said that if they didn’t differentiate between acute infection and chronic infection, he wasn’t sure what conclusions could be drawn from the data. Dr. Dixit told this news organization that they used the plateau level – the point after acute infection when CD4 counts settle into a consistent level. But it’s unclear how far from HIV acquisition each of the people in these studies was.

What Dr. Henrich does know, he said, is that big data are going to continue to change how we think about and investigate HIV transmission and virulence and what it could mean for clinical practice. The National Institutes of Health, for instance, will soon require all researchers receiving their funding to make their raw data publicly available soon after publication.

“We’re going to see a lot more of these large studies going forward,” he said. And if molecular analyses bear out Dr. Dixit’s conclusion – which he called “a big if” – “maybe we could use this study as a way” to do this work in the future.

The study was funded by DBT Network and the Wellcome Trust India Alliance Senior Fellowship. Dr. Dixit has disclosed no relevant financial relationships. Dr. Henrich is conducting studies funded in whole or in part by Merck and Gilead Sciences.

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

Testing is ongoing after more than 4,600 veterans who had received care at the Carl Vinson Veterans Affairs Medical Center in Dublin, Georgia, were alerted that they may have been exposed to HIV, hepatitis B, and hepatitis C. The exposure was due to improperly sterilized equipment. At least some of the patients have tested positive, but the facility has not indicated the number, the diseases, or whether the infections were the result of the exposure.

A mid-January internal review at the hospital found that not all steps were being followed in the procedures for sterilizing equipment between patients. Patients who had dentistry, endoscopy, urology, podiatry, optometry, or surgical procedures in 2021 may have been exposed to blood-borne pathogens.

In response, the VA sent teams from other hospitals to help, including a team from the Augusta Veterans Affairs Medical Center to reprocess all equipment and staff from VA facilities in Atlanta, South Carolina, and Alabama to provide personnel training. All staff at Carl Vinson Veterans Affairs Medical Center have since been retrained on all current guidelines.

The hospital says it’s still testing exposed veterans. Hospital spokesperson James Huckfeldt told a Macon-based newspaper, The Telegraph, that veterans with positive test results will undergo additional testing to determine whether the transmission is new or preexisting. “The findings from the additional testing will be used to accurately diagnose any impacted veterans and ensure that they receive appropriate medical treatment,” he said.

Manuel M. Davila, director of the hospital, sent letters to the patients at risk, alerting them to the exposure. “We sincerely apologize and accept responsibility for this mistake and are taking steps to prevent it from happening in the future,” Davilla wrote. “This event is unacceptable to us as well, and we want to work with you to correct the situation and ensure your safety and well-being. Because your safety is important to us and because we want to honor your trust in us, we want you to know that when concerns are raised over our processes or procedures, we take immediate steps to stop everything and make sure things are.”

Davilla reassured the veterans that “we are confident that the risk of infectious disease is very low.”

The Carl Vinson Medical Center has set up a communication center to answer questions for veterans: (478) 274-5400.

Testing is ongoing after more than 4,600 veterans who had received care at the Carl Vinson Veterans Affairs Medical Center in Dublin, Georgia, were alerted that they may have been exposed to HIV, hepatitis B, and hepatitis C. The exposure was due to improperly sterilized equipment. At least some of the patients have tested positive, but the facility has not indicated the number, the diseases, or whether the infections were the result of the exposure.

A mid-January internal review at the hospital found that not all steps were being followed in the procedures for sterilizing equipment between patients. Patients who had dentistry, endoscopy, urology, podiatry, optometry, or surgical procedures in 2021 may have been exposed to blood-borne pathogens.

In response, the VA sent teams from other hospitals to help, including a team from the Augusta Veterans Affairs Medical Center to reprocess all equipment and staff from VA facilities in Atlanta, South Carolina, and Alabama to provide personnel training. All staff at Carl Vinson Veterans Affairs Medical Center have since been retrained on all current guidelines.

The hospital says it’s still testing exposed veterans. Hospital spokesperson James Huckfeldt told a Macon-based newspaper, The Telegraph, that veterans with positive test results will undergo additional testing to determine whether the transmission is new or preexisting. “The findings from the additional testing will be used to accurately diagnose any impacted veterans and ensure that they receive appropriate medical treatment,” he said.

Manuel M. Davila, director of the hospital, sent letters to the patients at risk, alerting them to the exposure. “We sincerely apologize and accept responsibility for this mistake and are taking steps to prevent it from happening in the future,” Davilla wrote. “This event is unacceptable to us as well, and we want to work with you to correct the situation and ensure your safety and well-being. Because your safety is important to us and because we want to honor your trust in us, we want you to know that when concerns are raised over our processes or procedures, we take immediate steps to stop everything and make sure things are.”

Davilla reassured the veterans that “we are confident that the risk of infectious disease is very low.”

The Carl Vinson Medical Center has set up a communication center to answer questions for veterans: (478) 274-5400.

Testing is ongoing after more than 4,600 veterans who had received care at the Carl Vinson Veterans Affairs Medical Center in Dublin, Georgia, were alerted that they may have been exposed to HIV, hepatitis B, and hepatitis C. The exposure was due to improperly sterilized equipment. At least some of the patients have tested positive, but the facility has not indicated the number, the diseases, or whether the infections were the result of the exposure.

A mid-January internal review at the hospital found that not all steps were being followed in the procedures for sterilizing equipment between patients. Patients who had dentistry, endoscopy, urology, podiatry, optometry, or surgical procedures in 2021 may have been exposed to blood-borne pathogens.

In response, the VA sent teams from other hospitals to help, including a team from the Augusta Veterans Affairs Medical Center to reprocess all equipment and staff from VA facilities in Atlanta, South Carolina, and Alabama to provide personnel training. All staff at Carl Vinson Veterans Affairs Medical Center have since been retrained on all current guidelines.

The hospital says it’s still testing exposed veterans. Hospital spokesperson James Huckfeldt told a Macon-based newspaper, The Telegraph, that veterans with positive test results will undergo additional testing to determine whether the transmission is new or preexisting. “The findings from the additional testing will be used to accurately diagnose any impacted veterans and ensure that they receive appropriate medical treatment,” he said.

Manuel M. Davila, director of the hospital, sent letters to the patients at risk, alerting them to the exposure. “We sincerely apologize and accept responsibility for this mistake and are taking steps to prevent it from happening in the future,” Davilla wrote. “This event is unacceptable to us as well, and we want to work with you to correct the situation and ensure your safety and well-being. Because your safety is important to us and because we want to honor your trust in us, we want you to know that when concerns are raised over our processes or procedures, we take immediate steps to stop everything and make sure things are.”

Davilla reassured the veterans that “we are confident that the risk of infectious disease is very low.”

The Carl Vinson Medical Center has set up a communication center to answer questions for veterans: (478) 274-5400.

Infectious disease specialist and humanitarian, Paul Edward Farmer, MD, PhD, who cofounded Partners In Health, died suddenly on Feb. 21. To celebrate his life, this news organization interviewed Serena Koenig, MD, MPH, who met Dr. Farmer when she was an internal medicine resident at Brigham and Women’s Hospital. Dr. Koenig had worked closely with Dr. Farmer ever since they met.

Q. Can you please share one of your best memories of Dr. Farmer?

Dr. Serena Koenig: There are so many memories it is hard to choose. One that was very formative for me occurred during one of my first trips to Haiti, in 2001. Paul and some other incredible colleagues at Partners IN Health (PIH) had started the HIV Equity Initiative, which was one of the first programs in the world to provide free, comprehensive treatment for HIV. This was at the time when millions of people in Africa were dying of HIV and many experts said it was not feasible to treat HIV in a poor country, because it was too complicated and expensive. Paul took me on some home visits with patients who had what he called the Lazarus effect, coming back from death’s door from advanced AIDS to vigorous health on antiretroviral therapy. I had just started working in Haiti with Paul and PIH, and I felt the enormous magnitude of what he was doing.

Q. What aspects of him and his work do you find most admirable?

Dr. Koenig: I most admired Paul’s humanity, his belief that every person matters and has the right to high-quality health care, and his vision of global health equity.

He said: “The idea that some lives matter less is the root of all that is wrong with the world.” Paul lived this philosophy. He has spoken extensively about harms of socialization for scarcity on behalf of those who are poor, leading policy makers to decisions regarding the feasibility of treating some diseases, but not others.

He said in an interview with the Harvard Gazette in 2018: “The most compelling thing to fight socialization for scarcity on behalf of others is health system strengthening. Health systems that integrate prevention and quality care.”

A few weeks ago, I asked him his thoughts about the high-level resources we have invested in some patients who have needed specialty care over the years, and he said: “No way that we should waste all of our emotional energy responding only to those constant, nagging critics that it’s not cost effective, not feasible, not sustainable, not even prudent. Because you know what they would have done if it was their child or family member.”
 

Q. When did you first meet Dr. Farmer, and what inspired you to work with him?

Dr. Koenig: When I was an internal medicine resident at the Brigham, Paul and I bonded over the care of one of my clinic patients who I followed very closely, and who was admitted to his inpatient service.

Like everyone else who has worked with Paul, I was touched by his kindness and warmth.

A couple of years later, he asked me to help him raise money to bring a young man named Wilnot from Haiti to the Brigham for an aortic valve replacement. After we raised the money, he asked me to go to Haiti to help Wilnot get his medical visa and to escort him to Boston.

That short trip to Haiti had an enormous impact on my life. I was shattered to see the poverty that the people of Haiti were enduring – and in a country a short plane flight from Miami.

Shortly after this, Paul asked me to help him find treatment for another patient, a young boy named John, who presented with neck masses that were later diagnosed as nasopharyngeal carcinoma.

It took us some time to make the diagnosis and then to arrange free care at Mass General.

When I returned to Haiti with two PIH colleagues to help John get a visa and escort him back to Boston, we found that John’s condition was much worse. We ended up medically evacuating him to Boston, because he was too sick for a commercial flight.

Tracy Kidder wrote about this heartbreaking experience in the book “Mountains Beyond Mountains.”

Throughout all of these experiences, I was deeply impressed with Paul’s commitment to do whatever it took to provide the best care for patients, as if they were members of his own family. He said “Tout Moun Se Moun” (Haitian Creole for “every person is a person”), and I could tell that he meant it.
 

Q. How did you collaborate with him professionally?

Dr. Koenig: I spent the first few years after residency working with Paul and Partners In Health. Initially, I served as a liaison between PIH in Haiti and the Brigham, bringing several more patients to Boston for care, and arranging specialty surgical trips to Haiti.

Later, when HIV funding became available from the Global Fund for HIV, Tuberculosis, and Malaria, I moved to rural Haiti to provide treatment for patients with HIV and/or TB at one of the first PIH expansion sites. We treated many patients with advanced stages of HIV and/or TB, and many of them recovered remarkably quickly with antiretroviral therapy.

When I returned to Boston to complete an infectious disease fellowship I switched my focus to conducting clinical research to improve HIV and TB treatment outcomes. Paul emailed his mentor and friend, Jean “Bill” Pape, the director of a Haitian NGO called GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections), which is an internationally celebrated center of excellence in HIV-related research and clinical care, to ask if I could collaborate with them.

Ever since that time, I have been based between the Brigham’s division of global health equity, which was led by Paul, and GHESKIO.

Paul was very supportive of our research, which aims to improve health service delivery and treatment regimens for HIV and TB.
 

Q. What lessons do you think other physicians can learn from him?

Dr. Koenig: As Joia Mukherjee, chief medical officer of Partners In Health, has said, Paul left us a roadmap. He wrote many books, and he was very eloquent in expressing his philosophy about equity and justice in numerous interviews. This is relevant not only for international sites, but in the United States as well, with our major disparities in health outcomes by race, geography, and socioeconomic status.

No one will be able to replace Paul, but he left us with a vision of what is achievable.

Dr. Koenig is associate physician, Brigham and Women’s Hospital, Boston, with faculty appointments in the divisions of global health equity and infectious diseases. She is also associate professor at Harvard Medical School.

Infectious disease specialist and humanitarian, Paul Edward Farmer, MD, PhD, who cofounded Partners In Health, died suddenly on Feb. 21. To celebrate his life, this news organization interviewed Serena Koenig, MD, MPH, who met Dr. Farmer when she was an internal medicine resident at Brigham and Women’s Hospital. Dr. Koenig had worked closely with Dr. Farmer ever since they met.

Q. Can you please share one of your best memories of Dr. Farmer?

Dr. Serena Koenig: There are so many memories it is hard to choose. One that was very formative for me occurred during one of my first trips to Haiti, in 2001. Paul and some other incredible colleagues at Partners IN Health (PIH) had started the HIV Equity Initiative, which was one of the first programs in the world to provide free, comprehensive treatment for HIV. This was at the time when millions of people in Africa were dying of HIV and many experts said it was not feasible to treat HIV in a poor country, because it was too complicated and expensive. Paul took me on some home visits with patients who had what he called the Lazarus effect, coming back from death’s door from advanced AIDS to vigorous health on antiretroviral therapy. I had just started working in Haiti with Paul and PIH, and I felt the enormous magnitude of what he was doing.

Q. What aspects of him and his work do you find most admirable?

Dr. Koenig: I most admired Paul’s humanity, his belief that every person matters and has the right to high-quality health care, and his vision of global health equity.

He said: “The idea that some lives matter less is the root of all that is wrong with the world.” Paul lived this philosophy. He has spoken extensively about harms of socialization for scarcity on behalf of those who are poor, leading policy makers to decisions regarding the feasibility of treating some diseases, but not others.

He said in an interview with the Harvard Gazette in 2018: “The most compelling thing to fight socialization for scarcity on behalf of others is health system strengthening. Health systems that integrate prevention and quality care.”

A few weeks ago, I asked him his thoughts about the high-level resources we have invested in some patients who have needed specialty care over the years, and he said: “No way that we should waste all of our emotional energy responding only to those constant, nagging critics that it’s not cost effective, not feasible, not sustainable, not even prudent. Because you know what they would have done if it was their child or family member.”
 

Q. When did you first meet Dr. Farmer, and what inspired you to work with him?

Dr. Koenig: When I was an internal medicine resident at the Brigham, Paul and I bonded over the care of one of my clinic patients who I followed very closely, and who was admitted to his inpatient service.

Like everyone else who has worked with Paul, I was touched by his kindness and warmth.

A couple of years later, he asked me to help him raise money to bring a young man named Wilnot from Haiti to the Brigham for an aortic valve replacement. After we raised the money, he asked me to go to Haiti to help Wilnot get his medical visa and to escort him to Boston.

That short trip to Haiti had an enormous impact on my life. I was shattered to see the poverty that the people of Haiti were enduring – and in a country a short plane flight from Miami.

Shortly after this, Paul asked me to help him find treatment for another patient, a young boy named John, who presented with neck masses that were later diagnosed as nasopharyngeal carcinoma.

It took us some time to make the diagnosis and then to arrange free care at Mass General.

When I returned to Haiti with two PIH colleagues to help John get a visa and escort him back to Boston, we found that John’s condition was much worse. We ended up medically evacuating him to Boston, because he was too sick for a commercial flight.

Tracy Kidder wrote about this heartbreaking experience in the book “Mountains Beyond Mountains.”

Throughout all of these experiences, I was deeply impressed with Paul’s commitment to do whatever it took to provide the best care for patients, as if they were members of his own family. He said “Tout Moun Se Moun” (Haitian Creole for “every person is a person”), and I could tell that he meant it.
 

Q. How did you collaborate with him professionally?

Dr. Koenig: I spent the first few years after residency working with Paul and Partners In Health. Initially, I served as a liaison between PIH in Haiti and the Brigham, bringing several more patients to Boston for care, and arranging specialty surgical trips to Haiti.

Later, when HIV funding became available from the Global Fund for HIV, Tuberculosis, and Malaria, I moved to rural Haiti to provide treatment for patients with HIV and/or TB at one of the first PIH expansion sites. We treated many patients with advanced stages of HIV and/or TB, and many of them recovered remarkably quickly with antiretroviral therapy.

When I returned to Boston to complete an infectious disease fellowship I switched my focus to conducting clinical research to improve HIV and TB treatment outcomes. Paul emailed his mentor and friend, Jean “Bill” Pape, the director of a Haitian NGO called GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections), which is an internationally celebrated center of excellence in HIV-related research and clinical care, to ask if I could collaborate with them.

Ever since that time, I have been based between the Brigham’s division of global health equity, which was led by Paul, and GHESKIO.

Paul was very supportive of our research, which aims to improve health service delivery and treatment regimens for HIV and TB.
 

Q. What lessons do you think other physicians can learn from him?

Dr. Koenig: As Joia Mukherjee, chief medical officer of Partners In Health, has said, Paul left us a roadmap. He wrote many books, and he was very eloquent in expressing his philosophy about equity and justice in numerous interviews. This is relevant not only for international sites, but in the United States as well, with our major disparities in health outcomes by race, geography, and socioeconomic status.

No one will be able to replace Paul, but he left us with a vision of what is achievable.

Dr. Koenig is associate physician, Brigham and Women’s Hospital, Boston, with faculty appointments in the divisions of global health equity and infectious diseases. She is also associate professor at Harvard Medical School.

Infectious disease specialist and humanitarian, Paul Edward Farmer, MD, PhD, who cofounded Partners In Health, died suddenly on Feb. 21. To celebrate his life, this news organization interviewed Serena Koenig, MD, MPH, who met Dr. Farmer when she was an internal medicine resident at Brigham and Women’s Hospital. Dr. Koenig had worked closely with Dr. Farmer ever since they met.

Q. Can you please share one of your best memories of Dr. Farmer?

Dr. Serena Koenig: There are so many memories it is hard to choose. One that was very formative for me occurred during one of my first trips to Haiti, in 2001. Paul and some other incredible colleagues at Partners IN Health (PIH) had started the HIV Equity Initiative, which was one of the first programs in the world to provide free, comprehensive treatment for HIV. This was at the time when millions of people in Africa were dying of HIV and many experts said it was not feasible to treat HIV in a poor country, because it was too complicated and expensive. Paul took me on some home visits with patients who had what he called the Lazarus effect, coming back from death’s door from advanced AIDS to vigorous health on antiretroviral therapy. I had just started working in Haiti with Paul and PIH, and I felt the enormous magnitude of what he was doing.

Q. What aspects of him and his work do you find most admirable?

Dr. Koenig: I most admired Paul’s humanity, his belief that every person matters and has the right to high-quality health care, and his vision of global health equity.

He said: “The idea that some lives matter less is the root of all that is wrong with the world.” Paul lived this philosophy. He has spoken extensively about harms of socialization for scarcity on behalf of those who are poor, leading policy makers to decisions regarding the feasibility of treating some diseases, but not others.

He said in an interview with the Harvard Gazette in 2018: “The most compelling thing to fight socialization for scarcity on behalf of others is health system strengthening. Health systems that integrate prevention and quality care.”

A few weeks ago, I asked him his thoughts about the high-level resources we have invested in some patients who have needed specialty care over the years, and he said: “No way that we should waste all of our emotional energy responding only to those constant, nagging critics that it’s not cost effective, not feasible, not sustainable, not even prudent. Because you know what they would have done if it was their child or family member.”
 

Q. When did you first meet Dr. Farmer, and what inspired you to work with him?

Dr. Koenig: When I was an internal medicine resident at the Brigham, Paul and I bonded over the care of one of my clinic patients who I followed very closely, and who was admitted to his inpatient service.

Like everyone else who has worked with Paul, I was touched by his kindness and warmth.

A couple of years later, he asked me to help him raise money to bring a young man named Wilnot from Haiti to the Brigham for an aortic valve replacement. After we raised the money, he asked me to go to Haiti to help Wilnot get his medical visa and to escort him to Boston.

That short trip to Haiti had an enormous impact on my life. I was shattered to see the poverty that the people of Haiti were enduring – and in a country a short plane flight from Miami.

Shortly after this, Paul asked me to help him find treatment for another patient, a young boy named John, who presented with neck masses that were later diagnosed as nasopharyngeal carcinoma.

It took us some time to make the diagnosis and then to arrange free care at Mass General.

When I returned to Haiti with two PIH colleagues to help John get a visa and escort him back to Boston, we found that John’s condition was much worse. We ended up medically evacuating him to Boston, because he was too sick for a commercial flight.

Tracy Kidder wrote about this heartbreaking experience in the book “Mountains Beyond Mountains.”

Throughout all of these experiences, I was deeply impressed with Paul’s commitment to do whatever it took to provide the best care for patients, as if they were members of his own family. He said “Tout Moun Se Moun” (Haitian Creole for “every person is a person”), and I could tell that he meant it.
 

Q. How did you collaborate with him professionally?

Dr. Koenig: I spent the first few years after residency working with Paul and Partners In Health. Initially, I served as a liaison between PIH in Haiti and the Brigham, bringing several more patients to Boston for care, and arranging specialty surgical trips to Haiti.

Later, when HIV funding became available from the Global Fund for HIV, Tuberculosis, and Malaria, I moved to rural Haiti to provide treatment for patients with HIV and/or TB at one of the first PIH expansion sites. We treated many patients with advanced stages of HIV and/or TB, and many of them recovered remarkably quickly with antiretroviral therapy.

When I returned to Boston to complete an infectious disease fellowship I switched my focus to conducting clinical research to improve HIV and TB treatment outcomes. Paul emailed his mentor and friend, Jean “Bill” Pape, the director of a Haitian NGO called GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections), which is an internationally celebrated center of excellence in HIV-related research and clinical care, to ask if I could collaborate with them.

Ever since that time, I have been based between the Brigham’s division of global health equity, which was led by Paul, and GHESKIO.

Paul was very supportive of our research, which aims to improve health service delivery and treatment regimens for HIV and TB.
 

Q. What lessons do you think other physicians can learn from him?

Dr. Koenig: As Joia Mukherjee, chief medical officer of Partners In Health, has said, Paul left us a roadmap. He wrote many books, and he was very eloquent in expressing his philosophy about equity and justice in numerous interviews. This is relevant not only for international sites, but in the United States as well, with our major disparities in health outcomes by race, geography, and socioeconomic status.

No one will be able to replace Paul, but he left us with a vision of what is achievable.

Dr. Koenig is associate physician, Brigham and Women’s Hospital, Boston, with faculty appointments in the divisions of global health equity and infectious diseases. She is also associate professor at Harvard Medical School.

Antiretroviral therapy (ART) regimens provide long-lasting suppression of HIV replication and have helped people with HIV live healthier lives for decades.  

Today's ART regimens are associated with fewer serious and intolerable adverse effects than those used in the past, but weight gain remains a concern in clinical practice. 

In this ReCAP, Dr David Wohl, from the University of North Carolina at Chapel Hill, reports on the relationship between ART and weight gain, as well as the implications of excessive weight gain in HIV management. 

He shares data from multiple studies, including the ADVANCE trial, which offer insight on how different HIV therapies affect patient weight. 

Dr Wohl also discusses the steps clinicians should take if weight gain does occur in people who are on HIV therapy.  

--

Professor of Medicine; Medical Director, UNC COVID-19 Vaccine Clinic, COVID-19 Monoclonal Antibody Infusion Clinic, University of North Carolina at Chapel Hill 

David Wohl, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Gilead; ViiV; Janssen; Merck 

Serve(d) as a speaker or a member of a speakers bureau for: Gilead 

Received research grant from: Gilead; Merck; ViiV 

Antiretroviral therapy (ART) regimens provide long-lasting suppression of HIV replication and have helped people with HIV live healthier lives for decades.  

Today's ART regimens are associated with fewer serious and intolerable adverse effects than those used in the past, but weight gain remains a concern in clinical practice. 

In this ReCAP, Dr David Wohl, from the University of North Carolina at Chapel Hill, reports on the relationship between ART and weight gain, as well as the implications of excessive weight gain in HIV management. 

He shares data from multiple studies, including the ADVANCE trial, which offer insight on how different HIV therapies affect patient weight. 

Dr Wohl also discusses the steps clinicians should take if weight gain does occur in people who are on HIV therapy.  

--

Professor of Medicine; Medical Director, UNC COVID-19 Vaccine Clinic, COVID-19 Monoclonal Antibody Infusion Clinic, University of North Carolina at Chapel Hill 

David Wohl, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Gilead; ViiV; Janssen; Merck 

Serve(d) as a speaker or a member of a speakers bureau for: Gilead 

Received research grant from: Gilead; Merck; ViiV 

Antiretroviral therapy (ART) regimens provide long-lasting suppression of HIV replication and have helped people with HIV live healthier lives for decades.  

Today's ART regimens are associated with fewer serious and intolerable adverse effects than those used in the past, but weight gain remains a concern in clinical practice. 

In this ReCAP, Dr David Wohl, from the University of North Carolina at Chapel Hill, reports on the relationship between ART and weight gain, as well as the implications of excessive weight gain in HIV management. 

He shares data from multiple studies, including the ADVANCE trial, which offer insight on how different HIV therapies affect patient weight. 

Dr Wohl also discusses the steps clinicians should take if weight gain does occur in people who are on HIV therapy.  

--

Professor of Medicine; Medical Director, UNC COVID-19 Vaccine Clinic, COVID-19 Monoclonal Antibody Infusion Clinic, University of North Carolina at Chapel Hill 

David Wohl, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Gilead; ViiV; Janssen; Merck 

Serve(d) as a speaker or a member of a speakers bureau for: Gilead 

Received research grant from: Gilead; Merck; ViiV 

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.

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.

The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2022.

In a policy statement published online Feb. 17 in Pediatrics, the AAP said the updated recommendations differ little from those released last year by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

“The only significant change this year was to add the dengue vaccine to the schedule,” Sean T. O’Leary, MD, MPH, vice chair of the AAP’s 2021-2022 Committee on Infectious Diseases and a coauthor of the statement, told this news organization. “But that is really only relevant for children living in endemic areas, primarily Puerto Rico but some other smaller U.S .territories as well.”

Dengue fever also is endemic in American Samoa and the U.S. Virgin Islands.

Notably, a new section has been added on routine recommendations for use of the Dengvaxia vaccine.

The 2022 policy statement addresses regular immunization of children from birth to 18 years and catch-up vaccination for those aged 4 months to 18 years. In addition to the AAP, multiple complementary physician and nurse organizations have approved the updates. The ACIP schedule is revised annually to reflect current recommendations on vaccines licensed by the U.S. Food and Drug Administration.

Most of the other changes this year involve minor updates to clarify language or improve usability. “CDC and AAP are always working to make the schedule as user-friendly as possible, with improvements made every year,” Dr. O’Leary, professor of pediatric infectious diseases at the University of Colorado at Denver, Aurora, said.

In terms of physician acceptance, he added, “I don’t think any of the changes would be considered controversial.”

Among other updates and clarifications:

• For Haemophilus influenzae type b (Hib) vaccination, the text now includes recommendations for the hexavalent Vaxelis vaccine (diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B) for both routine and catch-up vaccination.
• For hepatitis A, the relevant note has been updated to clarify the age for routine vaccination.
• For human papillomavirus (HPV), the note now clarifies when an HPV series is complete with no additional dose recommended.
• The special situations section has been amended to specify which persons with immunocompromising conditions such as HIV should receive three doses of HPV vaccine regardless of age at initial vaccination.
• For measles, mumps, and rubella, routine vaccination now includes recommendations on the combination measles, mumps, rubella, and varicella vaccine.
• For meningococcal serogroup A, C, W, and Y vaccines, the augmented text explains when these can be simultaneously administered with serogroup B meningococcal vaccines, preferably at different anatomic sites. The language for the dosing schedule for Menveo vaccination in infants also has been clarified.
• In the catch-up immunization schedule for late-starting children aged 4 months to 18 years, the text on Hib has been changed so that the minimum interval between dose two and dose three now refers to Vaxelis, while reference to the discontinued Comvax (Hib-Hep B) vaccine has been removed.

As in other years, graphic changes have been made to table coloration and layout to improve accessibility. And as before, the 2022 childhood and adolescent immunization schedule has been updated to ensure consistency between its format and that of the 2022 adult immunization schedules.

The AAP committee stressed that clinically significant adverse events after immunization should be reported to the Vaccine Adverse Event Reporting System.

The full 2022 schedule can be found on the CDC’s website.

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

The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2022.

In a policy statement published online Feb. 17 in Pediatrics, the AAP said the updated recommendations differ little from those released last year by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

“The only significant change this year was to add the dengue vaccine to the schedule,” Sean T. O’Leary, MD, MPH, vice chair of the AAP’s 2021-2022 Committee on Infectious Diseases and a coauthor of the statement, told this news organization. “But that is really only relevant for children living in endemic areas, primarily Puerto Rico but some other smaller U.S .territories as well.”

Dengue fever also is endemic in American Samoa and the U.S. Virgin Islands.

Notably, a new section has been added on routine recommendations for use of the Dengvaxia vaccine.

The 2022 policy statement addresses regular immunization of children from birth to 18 years and catch-up vaccination for those aged 4 months to 18 years. In addition to the AAP, multiple complementary physician and nurse organizations have approved the updates. The ACIP schedule is revised annually to reflect current recommendations on vaccines licensed by the U.S. Food and Drug Administration.

Most of the other changes this year involve minor updates to clarify language or improve usability. “CDC and AAP are always working to make the schedule as user-friendly as possible, with improvements made every year,” Dr. O’Leary, professor of pediatric infectious diseases at the University of Colorado at Denver, Aurora, said.

In terms of physician acceptance, he added, “I don’t think any of the changes would be considered controversial.”

Among other updates and clarifications:

• For Haemophilus influenzae type b (Hib) vaccination, the text now includes recommendations for the hexavalent Vaxelis vaccine (diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B) for both routine and catch-up vaccination.
• For hepatitis A, the relevant note has been updated to clarify the age for routine vaccination.
• For human papillomavirus (HPV), the note now clarifies when an HPV series is complete with no additional dose recommended.
• The special situations section has been amended to specify which persons with immunocompromising conditions such as HIV should receive three doses of HPV vaccine regardless of age at initial vaccination.
• For measles, mumps, and rubella, routine vaccination now includes recommendations on the combination measles, mumps, rubella, and varicella vaccine.
• For meningococcal serogroup A, C, W, and Y vaccines, the augmented text explains when these can be simultaneously administered with serogroup B meningococcal vaccines, preferably at different anatomic sites. The language for the dosing schedule for Menveo vaccination in infants also has been clarified.
• In the catch-up immunization schedule for late-starting children aged 4 months to 18 years, the text on Hib has been changed so that the minimum interval between dose two and dose three now refers to Vaxelis, while reference to the discontinued Comvax (Hib-Hep B) vaccine has been removed.

As in other years, graphic changes have been made to table coloration and layout to improve accessibility. And as before, the 2022 childhood and adolescent immunization schedule has been updated to ensure consistency between its format and that of the 2022 adult immunization schedules.

The AAP committee stressed that clinically significant adverse events after immunization should be reported to the Vaccine Adverse Event Reporting System.

The full 2022 schedule can be found on the CDC’s website.

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

The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2022.

In a policy statement published online Feb. 17 in Pediatrics, the AAP said the updated recommendations differ little from those released last year by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

“The only significant change this year was to add the dengue vaccine to the schedule,” Sean T. O’Leary, MD, MPH, vice chair of the AAP’s 2021-2022 Committee on Infectious Diseases and a coauthor of the statement, told this news organization. “But that is really only relevant for children living in endemic areas, primarily Puerto Rico but some other smaller U.S .territories as well.”

Dengue fever also is endemic in American Samoa and the U.S. Virgin Islands.

Notably, a new section has been added on routine recommendations for use of the Dengvaxia vaccine.

The 2022 policy statement addresses regular immunization of children from birth to 18 years and catch-up vaccination for those aged 4 months to 18 years. In addition to the AAP, multiple complementary physician and nurse organizations have approved the updates. The ACIP schedule is revised annually to reflect current recommendations on vaccines licensed by the U.S. Food and Drug Administration.

Most of the other changes this year involve minor updates to clarify language or improve usability. “CDC and AAP are always working to make the schedule as user-friendly as possible, with improvements made every year,” Dr. O’Leary, professor of pediatric infectious diseases at the University of Colorado at Denver, Aurora, said.

In terms of physician acceptance, he added, “I don’t think any of the changes would be considered controversial.”

Among other updates and clarifications:

• For Haemophilus influenzae type b (Hib) vaccination, the text now includes recommendations for the hexavalent Vaxelis vaccine (diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B) for both routine and catch-up vaccination.
• For hepatitis A, the relevant note has been updated to clarify the age for routine vaccination.
• For human papillomavirus (HPV), the note now clarifies when an HPV series is complete with no additional dose recommended.
• The special situations section has been amended to specify which persons with immunocompromising conditions such as HIV should receive three doses of HPV vaccine regardless of age at initial vaccination.
• For measles, mumps, and rubella, routine vaccination now includes recommendations on the combination measles, mumps, rubella, and varicella vaccine.
• For meningococcal serogroup A, C, W, and Y vaccines, the augmented text explains when these can be simultaneously administered with serogroup B meningococcal vaccines, preferably at different anatomic sites. The language for the dosing schedule for Menveo vaccination in infants also has been clarified.
• In the catch-up immunization schedule for late-starting children aged 4 months to 18 years, the text on Hib has been changed so that the minimum interval between dose two and dose three now refers to Vaxelis, while reference to the discontinued Comvax (Hib-Hep B) vaccine has been removed.

As in other years, graphic changes have been made to table coloration and layout to improve accessibility. And as before, the 2022 childhood and adolescent immunization schedule has been updated to ensure consistency between its format and that of the 2022 adult immunization schedules.

The AAP committee stressed that clinically significant adverse events after immunization should be reported to the Vaccine Adverse Event Reporting System.

The full 2022 schedule can be found on the CDC’s website.

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