TBD Meeting (2893-20)

Tuberculosis symptoms as defined by the World Health Organization were effective in identifying patients with TB for the purposes of same-day antiretroviral therapy (ART) initiation in patients diagnosed with HIV, according to a pooled study of patients in two clinical trials. Guidelines suggest that patients with one or more TB symptoms be investigated for active TB before initiation of ART.

xrender/Thinkstock

However, more than 80% of patients with TB symptoms did not have the disease and faced a delay of ART initiation, despite the many benefits of same-day ART initiation, according to the study presented online at the Conference on Retroviruses & Opportunistic Infections. This year CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In her presentation, Alana T. Brennan, PhD, of the Boston University School of Public Health discussed the pooled results of 834 patients in the SLATE (Simple Algorithm for Treatment Eligibility) I and SLATE II trials. These two trials, conducted in South Africa and Kenya, respectively, assessed two variations of a simplified algorithm for eligibility for same-day ART initiation.

A total of 834 patients at baseline reported any self-described symptoms of TB using the WHO four-symptom TB screen (cough, fever, weight loss, night sweats). Those patients with any TB symptoms were assessed by sputum samples. The outcomes were prevalence of TB symptoms, TB diagnosis, and treatment.

Among the 834 patients, 493 (60%) reported no symptoms; 215 (26%) reported one to two symptoms, and 120 (14%) reported three to four symptoms. Only 66% of the patients with one to two symptoms were tested for TB; 78% of the patients with three to four symptoms were tested. Of these, only 1% of the patients with one to two symptoms tested positive for TB, and only 2% of the patients with three to four symptoms tested positive, according to Dr. Brennan.

“More than 80% of patients with TB symptoms did not have TB, but faced delay in ART initiation. No same-day [ART] initiators reported adverse events, so we hope that there would be some reconsideration of the requirement of TB testing prior to ART initiation due to any symptom of TB. … A potential consideration of the severity of the symptoms a patient has is necessary,” Dr. Brennan concluded.

Dr. Brennan reported that there were no disclosures.

[email protected]

SOURCE: Brennan AT et al. CROI 2020, Abstract 720.

Tuberculosis symptoms as defined by the World Health Organization were effective in identifying patients with TB for the purposes of same-day antiretroviral therapy (ART) initiation in patients diagnosed with HIV, according to a pooled study of patients in two clinical trials. Guidelines suggest that patients with one or more TB symptoms be investigated for active TB before initiation of ART.

xrender/Thinkstock

However, more than 80% of patients with TB symptoms did not have the disease and faced a delay of ART initiation, despite the many benefits of same-day ART initiation, according to the study presented online at the Conference on Retroviruses & Opportunistic Infections. This year CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In her presentation, Alana T. Brennan, PhD, of the Boston University School of Public Health discussed the pooled results of 834 patients in the SLATE (Simple Algorithm for Treatment Eligibility) I and SLATE II trials. These two trials, conducted in South Africa and Kenya, respectively, assessed two variations of a simplified algorithm for eligibility for same-day ART initiation.

A total of 834 patients at baseline reported any self-described symptoms of TB using the WHO four-symptom TB screen (cough, fever, weight loss, night sweats). Those patients with any TB symptoms were assessed by sputum samples. The outcomes were prevalence of TB symptoms, TB diagnosis, and treatment.

Among the 834 patients, 493 (60%) reported no symptoms; 215 (26%) reported one to two symptoms, and 120 (14%) reported three to four symptoms. Only 66% of the patients with one to two symptoms were tested for TB; 78% of the patients with three to four symptoms were tested. Of these, only 1% of the patients with one to two symptoms tested positive for TB, and only 2% of the patients with three to four symptoms tested positive, according to Dr. Brennan.

“More than 80% of patients with TB symptoms did not have TB, but faced delay in ART initiation. No same-day [ART] initiators reported adverse events, so we hope that there would be some reconsideration of the requirement of TB testing prior to ART initiation due to any symptom of TB. … A potential consideration of the severity of the symptoms a patient has is necessary,” Dr. Brennan concluded.

Dr. Brennan reported that there were no disclosures.

[email protected]

SOURCE: Brennan AT et al. CROI 2020, Abstract 720.

Tuberculosis symptoms as defined by the World Health Organization were effective in identifying patients with TB for the purposes of same-day antiretroviral therapy (ART) initiation in patients diagnosed with HIV, according to a pooled study of patients in two clinical trials. Guidelines suggest that patients with one or more TB symptoms be investigated for active TB before initiation of ART.

xrender/Thinkstock

However, more than 80% of patients with TB symptoms did not have the disease and faced a delay of ART initiation, despite the many benefits of same-day ART initiation, according to the study presented online at the Conference on Retroviruses & Opportunistic Infections. This year CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In her presentation, Alana T. Brennan, PhD, of the Boston University School of Public Health discussed the pooled results of 834 patients in the SLATE (Simple Algorithm for Treatment Eligibility) I and SLATE II trials. These two trials, conducted in South Africa and Kenya, respectively, assessed two variations of a simplified algorithm for eligibility for same-day ART initiation.

A total of 834 patients at baseline reported any self-described symptoms of TB using the WHO four-symptom TB screen (cough, fever, weight loss, night sweats). Those patients with any TB symptoms were assessed by sputum samples. The outcomes were prevalence of TB symptoms, TB diagnosis, and treatment.

Among the 834 patients, 493 (60%) reported no symptoms; 215 (26%) reported one to two symptoms, and 120 (14%) reported three to four symptoms. Only 66% of the patients with one to two symptoms were tested for TB; 78% of the patients with three to four symptoms were tested. Of these, only 1% of the patients with one to two symptoms tested positive for TB, and only 2% of the patients with three to four symptoms tested positive, according to Dr. Brennan.

“More than 80% of patients with TB symptoms did not have TB, but faced delay in ART initiation. No same-day [ART] initiators reported adverse events, so we hope that there would be some reconsideration of the requirement of TB testing prior to ART initiation due to any symptom of TB. … A potential consideration of the severity of the symptoms a patient has is necessary,” Dr. Brennan concluded.

Dr. Brennan reported that there were no disclosures.

[email protected]

SOURCE: Brennan AT et al. CROI 2020, Abstract 720.

Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).

“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”

Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).

Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.

In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.

In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.

For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.

“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.

Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”

The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.

[email protected]

SOURCE: Nabwire F et al. CROI 2020, Abstract 768.

Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).

“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”

Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).

Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.

In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.

In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.

For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.

“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.

Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”

The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.

[email protected]

SOURCE: Nabwire F et al. CROI 2020, Abstract 768.

Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).

“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”

Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).

Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.

In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.

In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.

For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.

“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.

Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”

The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.

[email protected]

SOURCE: Nabwire F et al. CROI 2020, Abstract 768.

The single-tablet antiretroviral regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) was assessed as being noninferior to two dolutegravir (DTG)-containing regimens among adults aged 50 and over living with HIV, according to a new study.

The study pooled data from two phase 3, randomized, double-blind B/F/TAF studies comparing that regimen with DTG-containing regimens for adults living with HIV who were treatment naive. Anthony Mills, MD, a physician in private practice in West Hollywood, Calif., and his associates reported results at the 144-week mark for the two studies in a poster that was presented as part of the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In the two trials, the B/F/TAF regimen was compared with a DTG and abacavir/lamivudine (DTG + ABC/3TC) regimen, as well as with DTG plus emtricitabine/tenofovir alafenamide (DTG + F/TAF). A total of 629 patients were enrolled in the first study, and 645 in the second. Of these, a total of 196 patients were aged 50 years or older. Across all study arms, most participants (73%-92%) were male, and 20%-37% were black or of African descent. Participants identifying as Hispanic or being of Latino ancestry made up 11%-27% of participants.

About 80%-90% of patients had asymptomatic HIV infection at the time of enrollment, with median CD4 counts ranging from 405-534 cells/mcL across study arms. Patients had a median 4.27-4.53 log (base 10) copies/mL at baseline. In both studies, patients had to have at least 500 HIV-1 RNA copies per mL, and couldn’t have known resistance to any of the study drugs.

At week 144, there were no statistically significant differences in virologic outcomes across study arms in the younger or older age subgroups: 81% of the B/F/TAF patients older than 50 years had fewer than 50 copies/mL of HIV-1 RNA, compared with 83% and 88% of the younger DTG/ABC/3TC and DTG + F/TAF groups meeting this mark, respectively.

Results were similar for the patients aged younger than 50 years, with 82%, 84%, and 83% of the B/F/TAF, DTG/ABC/3TC, and DTG + F/TAF groups having fewer than 50 copies/mL of HIV-1 RNA, respectively.

No patients in either age group showed resistance to any components of the treatment regimens. No treatment-emergent resistance was seen in any study participants, and few adverse events occurred. Those that were seen didn’t occur more frequently in older patients, compared with younger patients, and no patients discontinued their treatment because of renal issues.

Bone mineral density (BMD) was only measured in the study that compared B/F/TAF with DTG/ABC/3TC. Hip BMD decreased slightly in both groups, but the changes were comparable between older and younger participants. For both age groups, differences weren’t significant between the B/F/TAF group and those taking DTG/ABC/3TC. Spine density actually increased slightly in older patients taking B/F/TAF, but the difference between this measure and the slight decrease in older patients taking DTG/ABC/3TC was not significant.

Weight increased over time for all groups, ranging from a gain of 3.4 kg at 144 weeks for older patients taking DTG + F/TAF to 5.3 kg for the same regimen in younger patients, but none of the between-group differences were significant.

All fasting lipids rose for each study arm in both older and younger patients. Some of the between-group differences were statistically significant, but “there were no clinically significant differences in median changes from baseline in fasting lipids” among those aged 50 years or older, noted Dr. Mills and associates.

In terms of safety, no study drug-related discontinuations for renal adverse events occurred in either the B/F/TAF or the DTG + F/TAF groups, and the investigators saw no proximal renal tubulopathy.

The estimated glomerular filtration rate (eGFR) was calculated using the Cockroft-Gault equation. All three antiviral regimens were associated with early drops in eGFR, “consistent with inhibition of tubular creatinine secretion via organic cation transporter 2,” noted Dr. Mills and associates.

Other adverse events were rare in all groups in both older and younger patients, without significant differences between therapies.

The study was supported by Gilead Sciences, which also provided support to Dr. Mills. One coauthor is a Gilead employee.

[email protected]

SOURCE: Mills A et al. CROI 2020, Abstract 2886.

The single-tablet antiretroviral regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) was assessed as being noninferior to two dolutegravir (DTG)-containing regimens among adults aged 50 and over living with HIV, according to a new study.

The study pooled data from two phase 3, randomized, double-blind B/F/TAF studies comparing that regimen with DTG-containing regimens for adults living with HIV who were treatment naive. Anthony Mills, MD, a physician in private practice in West Hollywood, Calif., and his associates reported results at the 144-week mark for the two studies in a poster that was presented as part of the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In the two trials, the B/F/TAF regimen was compared with a DTG and abacavir/lamivudine (DTG + ABC/3TC) regimen, as well as with DTG plus emtricitabine/tenofovir alafenamide (DTG + F/TAF). A total of 629 patients were enrolled in the first study, and 645 in the second. Of these, a total of 196 patients were aged 50 years or older. Across all study arms, most participants (73%-92%) were male, and 20%-37% were black or of African descent. Participants identifying as Hispanic or being of Latino ancestry made up 11%-27% of participants.

About 80%-90% of patients had asymptomatic HIV infection at the time of enrollment, with median CD4 counts ranging from 405-534 cells/mcL across study arms. Patients had a median 4.27-4.53 log (base 10) copies/mL at baseline. In both studies, patients had to have at least 500 HIV-1 RNA copies per mL, and couldn’t have known resistance to any of the study drugs.

At week 144, there were no statistically significant differences in virologic outcomes across study arms in the younger or older age subgroups: 81% of the B/F/TAF patients older than 50 years had fewer than 50 copies/mL of HIV-1 RNA, compared with 83% and 88% of the younger DTG/ABC/3TC and DTG + F/TAF groups meeting this mark, respectively.

Results were similar for the patients aged younger than 50 years, with 82%, 84%, and 83% of the B/F/TAF, DTG/ABC/3TC, and DTG + F/TAF groups having fewer than 50 copies/mL of HIV-1 RNA, respectively.

No patients in either age group showed resistance to any components of the treatment regimens. No treatment-emergent resistance was seen in any study participants, and few adverse events occurred. Those that were seen didn’t occur more frequently in older patients, compared with younger patients, and no patients discontinued their treatment because of renal issues.

Bone mineral density (BMD) was only measured in the study that compared B/F/TAF with DTG/ABC/3TC. Hip BMD decreased slightly in both groups, but the changes were comparable between older and younger participants. For both age groups, differences weren’t significant between the B/F/TAF group and those taking DTG/ABC/3TC. Spine density actually increased slightly in older patients taking B/F/TAF, but the difference between this measure and the slight decrease in older patients taking DTG/ABC/3TC was not significant.

Weight increased over time for all groups, ranging from a gain of 3.4 kg at 144 weeks for older patients taking DTG + F/TAF to 5.3 kg for the same regimen in younger patients, but none of the between-group differences were significant.

All fasting lipids rose for each study arm in both older and younger patients. Some of the between-group differences were statistically significant, but “there were no clinically significant differences in median changes from baseline in fasting lipids” among those aged 50 years or older, noted Dr. Mills and associates.

In terms of safety, no study drug-related discontinuations for renal adverse events occurred in either the B/F/TAF or the DTG + F/TAF groups, and the investigators saw no proximal renal tubulopathy.

The estimated glomerular filtration rate (eGFR) was calculated using the Cockroft-Gault equation. All three antiviral regimens were associated with early drops in eGFR, “consistent with inhibition of tubular creatinine secretion via organic cation transporter 2,” noted Dr. Mills and associates.

Other adverse events were rare in all groups in both older and younger patients, without significant differences between therapies.

The study was supported by Gilead Sciences, which also provided support to Dr. Mills. One coauthor is a Gilead employee.

[email protected]

SOURCE: Mills A et al. CROI 2020, Abstract 2886.

The single-tablet antiretroviral regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) was assessed as being noninferior to two dolutegravir (DTG)-containing regimens among adults aged 50 and over living with HIV, according to a new study.

The study pooled data from two phase 3, randomized, double-blind B/F/TAF studies comparing that regimen with DTG-containing regimens for adults living with HIV who were treatment naive. Anthony Mills, MD, a physician in private practice in West Hollywood, Calif., and his associates reported results at the 144-week mark for the two studies in a poster that was presented as part of the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

In the two trials, the B/F/TAF regimen was compared with a DTG and abacavir/lamivudine (DTG + ABC/3TC) regimen, as well as with DTG plus emtricitabine/tenofovir alafenamide (DTG + F/TAF). A total of 629 patients were enrolled in the first study, and 645 in the second. Of these, a total of 196 patients were aged 50 years or older. Across all study arms, most participants (73%-92%) were male, and 20%-37% were black or of African descent. Participants identifying as Hispanic or being of Latino ancestry made up 11%-27% of participants.

About 80%-90% of patients had asymptomatic HIV infection at the time of enrollment, with median CD4 counts ranging from 405-534 cells/mcL across study arms. Patients had a median 4.27-4.53 log (base 10) copies/mL at baseline. In both studies, patients had to have at least 500 HIV-1 RNA copies per mL, and couldn’t have known resistance to any of the study drugs.

At week 144, there were no statistically significant differences in virologic outcomes across study arms in the younger or older age subgroups: 81% of the B/F/TAF patients older than 50 years had fewer than 50 copies/mL of HIV-1 RNA, compared with 83% and 88% of the younger DTG/ABC/3TC and DTG + F/TAF groups meeting this mark, respectively.

Results were similar for the patients aged younger than 50 years, with 82%, 84%, and 83% of the B/F/TAF, DTG/ABC/3TC, and DTG + F/TAF groups having fewer than 50 copies/mL of HIV-1 RNA, respectively.

No patients in either age group showed resistance to any components of the treatment regimens. No treatment-emergent resistance was seen in any study participants, and few adverse events occurred. Those that were seen didn’t occur more frequently in older patients, compared with younger patients, and no patients discontinued their treatment because of renal issues.

Bone mineral density (BMD) was only measured in the study that compared B/F/TAF with DTG/ABC/3TC. Hip BMD decreased slightly in both groups, but the changes were comparable between older and younger participants. For both age groups, differences weren’t significant between the B/F/TAF group and those taking DTG/ABC/3TC. Spine density actually increased slightly in older patients taking B/F/TAF, but the difference between this measure and the slight decrease in older patients taking DTG/ABC/3TC was not significant.

Weight increased over time for all groups, ranging from a gain of 3.4 kg at 144 weeks for older patients taking DTG + F/TAF to 5.3 kg for the same regimen in younger patients, but none of the between-group differences were significant.

All fasting lipids rose for each study arm in both older and younger patients. Some of the between-group differences were statistically significant, but “there were no clinically significant differences in median changes from baseline in fasting lipids” among those aged 50 years or older, noted Dr. Mills and associates.

In terms of safety, no study drug-related discontinuations for renal adverse events occurred in either the B/F/TAF or the DTG + F/TAF groups, and the investigators saw no proximal renal tubulopathy.

The estimated glomerular filtration rate (eGFR) was calculated using the Cockroft-Gault equation. All three antiviral regimens were associated with early drops in eGFR, “consistent with inhibition of tubular creatinine secretion via organic cation transporter 2,” noted Dr. Mills and associates.

Other adverse events were rare in all groups in both older and younger patients, without significant differences between therapies.

The study was supported by Gilead Sciences, which also provided support to Dr. Mills. One coauthor is a Gilead employee.

[email protected]

SOURCE: Mills A et al. CROI 2020, Abstract 2886.

Despite highly effective antiretroviral therapy, HIV still shortens life expectancy by 9 years and healthy life expectancy free of comorbidities 16 years, according to a review of HIV patients and matched controls at Kaiser Permanente facilities in California and the mid-Atlantic states during 2000-2016.

M. Alexander Otto/MDedge News

The good news is that starting antiretroviral therapy (ART) when CD4 counts are 500 cells/mm³ or higher closes the mortality gap. People who do so can expect to live into their mid-80s, the same as people without HIV, and the years they can expect to be free of diabetes and cancer is catching up to uninfected people, although the gap for other comorbidities hasn’t changed and the overall comorbidity gap remains 16 years, according to the report, which was presented at the Conference on Retroviruses & Opportunistic Infections

“We were excited about finding no difference in lifespan for people starting ART with high CD4 counts, but we were surprised by how wide the gap was for the number of comorbidity free years. Greater attention to comorbidity prevention is needed,” said study lead Julia Marcus, PhD, an infectious disease epidemiologist and assistant professor of population medicine at Harvard Medical School, Boston.

The team estimated the average number of total and comorbidity-free years of life remaining at age 21 for 39,000 people with HIV who were matched 1:10 with 387,767 uninfected adults by sex, race/ethnicity, year, and medical center.

Overall, adults with HIV could expect to live until they were 77 years old, versus 86 years for people without HIV, during 2014-2016. It’s a large improvement over the 22 year gap during 2000-2003, when the numbers were 59 versus 81 years, respectively, Dr. Marcus reported at the virtual meeting, which was scheduled to be in Boston, but held online this year because of concerns about spreading the COVID-19 virus.

But the overall comorbidity gap didn’t budge during 2000-2016. People with HIV during 2014-2016 could expect to be comorbidity free until age 36 years, versus 52 years for the general population, the same 16-year difference during 2000-2003, when the numbers were age 32 versus age 48 years.

During 2014-2016, liver disease came 24 years sooner with HIV, and chronic kidney disease 17 years, chronic lung disease 16 years, cancer 9 years, and diabetes and cancer both 8 years sooner. Early ART didn’t narrow the gap for most comorbidities. Dr. Marcus didn’t address the reasons for the differences, except to note that “smoking rates were definitely higher among people with HIV.”

The results weren’t broken down by sex, but the majority of subjects, 88%, were men. The mean age was 41 years, and about half were white, with most of the rest either black or Hispanic. Transmission was among men who have sex with men in 70% of the cases, heterosexual sex in 20%, and IV drug accounted for the rest. Almost a third of the subjects started ART with CD4 counts at or above 500 cells/mm³.

Dr. Marcus said the results are likely generalizable to most insured people with HIV, but also that comorbidity screening might be higher in the HIV population, which could have affected the results.

The work was funded by the National Institutes of Health. Dr. Marcus is an adviser for Gilead.

[email protected]

SOURCE: Marcus JL et al. CROI 2020. Abstract 151.

Despite highly effective antiretroviral therapy, HIV still shortens life expectancy by 9 years and healthy life expectancy free of comorbidities 16 years, according to a review of HIV patients and matched controls at Kaiser Permanente facilities in California and the mid-Atlantic states during 2000-2016.

M. Alexander Otto/MDedge News

The good news is that starting antiretroviral therapy (ART) when CD4 counts are 500 cells/mm³ or higher closes the mortality gap. People who do so can expect to live into their mid-80s, the same as people without HIV, and the years they can expect to be free of diabetes and cancer is catching up to uninfected people, although the gap for other comorbidities hasn’t changed and the overall comorbidity gap remains 16 years, according to the report, which was presented at the Conference on Retroviruses & Opportunistic Infections

“We were excited about finding no difference in lifespan for people starting ART with high CD4 counts, but we were surprised by how wide the gap was for the number of comorbidity free years. Greater attention to comorbidity prevention is needed,” said study lead Julia Marcus, PhD, an infectious disease epidemiologist and assistant professor of population medicine at Harvard Medical School, Boston.

The team estimated the average number of total and comorbidity-free years of life remaining at age 21 for 39,000 people with HIV who were matched 1:10 with 387,767 uninfected adults by sex, race/ethnicity, year, and medical center.

Overall, adults with HIV could expect to live until they were 77 years old, versus 86 years for people without HIV, during 2014-2016. It’s a large improvement over the 22 year gap during 2000-2003, when the numbers were 59 versus 81 years, respectively, Dr. Marcus reported at the virtual meeting, which was scheduled to be in Boston, but held online this year because of concerns about spreading the COVID-19 virus.

But the overall comorbidity gap didn’t budge during 2000-2016. People with HIV during 2014-2016 could expect to be comorbidity free until age 36 years, versus 52 years for the general population, the same 16-year difference during 2000-2003, when the numbers were age 32 versus age 48 years.

During 2014-2016, liver disease came 24 years sooner with HIV, and chronic kidney disease 17 years, chronic lung disease 16 years, cancer 9 years, and diabetes and cancer both 8 years sooner. Early ART didn’t narrow the gap for most comorbidities. Dr. Marcus didn’t address the reasons for the differences, except to note that “smoking rates were definitely higher among people with HIV.”

The results weren’t broken down by sex, but the majority of subjects, 88%, were men. The mean age was 41 years, and about half were white, with most of the rest either black or Hispanic. Transmission was among men who have sex with men in 70% of the cases, heterosexual sex in 20%, and IV drug accounted for the rest. Almost a third of the subjects started ART with CD4 counts at or above 500 cells/mm³.

Dr. Marcus said the results are likely generalizable to most insured people with HIV, but also that comorbidity screening might be higher in the HIV population, which could have affected the results.

The work was funded by the National Institutes of Health. Dr. Marcus is an adviser for Gilead.

[email protected]

SOURCE: Marcus JL et al. CROI 2020. Abstract 151.

Despite highly effective antiretroviral therapy, HIV still shortens life expectancy by 9 years and healthy life expectancy free of comorbidities 16 years, according to a review of HIV patients and matched controls at Kaiser Permanente facilities in California and the mid-Atlantic states during 2000-2016.

M. Alexander Otto/MDedge News

The good news is that starting antiretroviral therapy (ART) when CD4 counts are 500 cells/mm³ or higher closes the mortality gap. People who do so can expect to live into their mid-80s, the same as people without HIV, and the years they can expect to be free of diabetes and cancer is catching up to uninfected people, although the gap for other comorbidities hasn’t changed and the overall comorbidity gap remains 16 years, according to the report, which was presented at the Conference on Retroviruses & Opportunistic Infections

“We were excited about finding no difference in lifespan for people starting ART with high CD4 counts, but we were surprised by how wide the gap was for the number of comorbidity free years. Greater attention to comorbidity prevention is needed,” said study lead Julia Marcus, PhD, an infectious disease epidemiologist and assistant professor of population medicine at Harvard Medical School, Boston.

The team estimated the average number of total and comorbidity-free years of life remaining at age 21 for 39,000 people with HIV who were matched 1:10 with 387,767 uninfected adults by sex, race/ethnicity, year, and medical center.

Overall, adults with HIV could expect to live until they were 77 years old, versus 86 years for people without HIV, during 2014-2016. It’s a large improvement over the 22 year gap during 2000-2003, when the numbers were 59 versus 81 years, respectively, Dr. Marcus reported at the virtual meeting, which was scheduled to be in Boston, but held online this year because of concerns about spreading the COVID-19 virus.

But the overall comorbidity gap didn’t budge during 2000-2016. People with HIV during 2014-2016 could expect to be comorbidity free until age 36 years, versus 52 years for the general population, the same 16-year difference during 2000-2003, when the numbers were age 32 versus age 48 years.

During 2014-2016, liver disease came 24 years sooner with HIV, and chronic kidney disease 17 years, chronic lung disease 16 years, cancer 9 years, and diabetes and cancer both 8 years sooner. Early ART didn’t narrow the gap for most comorbidities. Dr. Marcus didn’t address the reasons for the differences, except to note that “smoking rates were definitely higher among people with HIV.”

The results weren’t broken down by sex, but the majority of subjects, 88%, were men. The mean age was 41 years, and about half were white, with most of the rest either black or Hispanic. Transmission was among men who have sex with men in 70% of the cases, heterosexual sex in 20%, and IV drug accounted for the rest. Almost a third of the subjects started ART with CD4 counts at or above 500 cells/mm³.

Dr. Marcus said the results are likely generalizable to most insured people with HIV, but also that comorbidity screening might be higher in the HIV population, which could have affected the results.

The work was funded by the National Institutes of Health. Dr. Marcus is an adviser for Gilead.

[email protected]

SOURCE: Marcus JL et al. CROI 2020. Abstract 151.

At the end of 6 months of low-dose pomalidomide (Pomalyst), more than half of men who have sex with men had partial or complete clearance of long-standing, grade 3 anal lesions from human papillomavirus, irrespective of HIV status; the number increased to almost two-thirds when they were checked at 12 months, according to a 26-subject study said in video presentation of his research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

“Therapy induced durable and continuous clearance of anal HSIL [high-grade squamous intraepithelial lesions]. Further study in HPV-associated premalignancy is warranted to follow up this small, single arm study,” said study lead Mark Polizzotto, MD, PhD, head of the therapeutic and vaccine research program at the Kirby Institute in Sydney.

HPV anal lesions, and subsequent HSIL and progression to anal cancer, are prevalent among men who have sex with men. The risk increases with chronic lesions and concomitant HIV infection.

Pomalidomide is potentially a less painful alternative to options such as freezing and laser ablation, and it may have a lower rate of recurrence, but it’s expensive. Copays range upward from $5,000 for a month supply, according to GoodRx. Celgene, the maker of the drug, offers financial assistance.

Pomalidomide is a derivative of thalidomide that’s approved for multiple myeloma and also has shown effect against a viral lesion associated with HIV, Kaposi sarcoma. The drug is a T-cell activator, and since T-cell activation also is key to spontaneous anal HSIL clearance, Dr. Polizzotto and team wanted to take a look to see if it could help, he said.

The men in the study were at high risk for progression to anal cancer. With a median lesion duration of more than 3 years, and at least one case out past 7 years, spontaneous clearance wasn’t in the cards. The lesions were all grade 3 HSIL, which means severe dysplasia, and more than half of the subjects had HPV genotype 16, and the rest had other risky genotypes. Ten subjects also had HIV, which also increases the risk of anal cancer.

Pomalidomide was given in back-to-back cycles for 6 months, each consisting of 2 mg orally for 3 weeks, then 1 week off, along with a thrombolytic, usually aspirin, given the black box warning of blood clots. The dose was half the 5-mg cycle for Kaposi’s.

The overall response rate – complete clearance or a partial clearance of at least a 50% on high-resolution anoscopy – was 50% at 6 months (12/24), including four complete responses (4/15, 27%) in subjects without HIV, as well as four in the HIV group (4/9, 44%).

On follow-up at month 12, “we saw something we did not expect. Strikingly, with no additional therapy in the interim, we saw a deepening of response in a number of subjects.” The overall response rate climbed to 63% (15/24), including 33% complete response in the HIV-free group (5/15) and HIV-positive group (3/9).

Some did lose their response in the interim, however, and the study team is working to figure out if it was do to a recurrence or a new infection.

A general pattern of immune activation on treatment, including increased systemic CD4+ T-cell responses to HPV during therapy, supported the investigator’s hunch of an immunologic mechanism of action, Dr. Polizzotto said.

There were four instances of grade 3 neutropenia over eight treatment cycles, and one possibly related angina attack, but other than that, adverse reactions were generally mild and self-limited, mostly to grade 1 or 2 neutropenia, constipation, fatigue, and rash, with no idiosyncratic reactions in the HIV group or loss of viral suppression, and no discontinuations because of side effects.

The men in the study were aged 40-50 years, with a median age of 54 years; all but one were white. The median lesion involved a quarter of the anal ring, but sometimes more than half.

The work was funded by the Cancer Institute of New South Wales, the Australian National Health and Medical Research Council, and Celgene. Dr. Polizzotto disclosed patents with Celgene and research funding from the company.

[email protected]

SOURCE: Polizzotto M et al. CROI 2020. Abstract 70

At the end of 6 months of low-dose pomalidomide (Pomalyst), more than half of men who have sex with men had partial or complete clearance of long-standing, grade 3 anal lesions from human papillomavirus, irrespective of HIV status; the number increased to almost two-thirds when they were checked at 12 months, according to a 26-subject study said in video presentation of his research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

“Therapy induced durable and continuous clearance of anal HSIL [high-grade squamous intraepithelial lesions]. Further study in HPV-associated premalignancy is warranted to follow up this small, single arm study,” said study lead Mark Polizzotto, MD, PhD, head of the therapeutic and vaccine research program at the Kirby Institute in Sydney.

HPV anal lesions, and subsequent HSIL and progression to anal cancer, are prevalent among men who have sex with men. The risk increases with chronic lesions and concomitant HIV infection.

Pomalidomide is potentially a less painful alternative to options such as freezing and laser ablation, and it may have a lower rate of recurrence, but it’s expensive. Copays range upward from $5,000 for a month supply, according to GoodRx. Celgene, the maker of the drug, offers financial assistance.

Pomalidomide is a derivative of thalidomide that’s approved for multiple myeloma and also has shown effect against a viral lesion associated with HIV, Kaposi sarcoma. The drug is a T-cell activator, and since T-cell activation also is key to spontaneous anal HSIL clearance, Dr. Polizzotto and team wanted to take a look to see if it could help, he said.

The men in the study were at high risk for progression to anal cancer. With a median lesion duration of more than 3 years, and at least one case out past 7 years, spontaneous clearance wasn’t in the cards. The lesions were all grade 3 HSIL, which means severe dysplasia, and more than half of the subjects had HPV genotype 16, and the rest had other risky genotypes. Ten subjects also had HIV, which also increases the risk of anal cancer.

Pomalidomide was given in back-to-back cycles for 6 months, each consisting of 2 mg orally for 3 weeks, then 1 week off, along with a thrombolytic, usually aspirin, given the black box warning of blood clots. The dose was half the 5-mg cycle for Kaposi’s.

The overall response rate – complete clearance or a partial clearance of at least a 50% on high-resolution anoscopy – was 50% at 6 months (12/24), including four complete responses (4/15, 27%) in subjects without HIV, as well as four in the HIV group (4/9, 44%).

On follow-up at month 12, “we saw something we did not expect. Strikingly, with no additional therapy in the interim, we saw a deepening of response in a number of subjects.” The overall response rate climbed to 63% (15/24), including 33% complete response in the HIV-free group (5/15) and HIV-positive group (3/9).

Some did lose their response in the interim, however, and the study team is working to figure out if it was do to a recurrence or a new infection.

A general pattern of immune activation on treatment, including increased systemic CD4+ T-cell responses to HPV during therapy, supported the investigator’s hunch of an immunologic mechanism of action, Dr. Polizzotto said.

There were four instances of grade 3 neutropenia over eight treatment cycles, and one possibly related angina attack, but other than that, adverse reactions were generally mild and self-limited, mostly to grade 1 or 2 neutropenia, constipation, fatigue, and rash, with no idiosyncratic reactions in the HIV group or loss of viral suppression, and no discontinuations because of side effects.

The men in the study were aged 40-50 years, with a median age of 54 years; all but one were white. The median lesion involved a quarter of the anal ring, but sometimes more than half.

The work was funded by the Cancer Institute of New South Wales, the Australian National Health and Medical Research Council, and Celgene. Dr. Polizzotto disclosed patents with Celgene and research funding from the company.

[email protected]

SOURCE: Polizzotto M et al. CROI 2020. Abstract 70

At the end of 6 months of low-dose pomalidomide (Pomalyst), more than half of men who have sex with men had partial or complete clearance of long-standing, grade 3 anal lesions from human papillomavirus, irrespective of HIV status; the number increased to almost two-thirds when they were checked at 12 months, according to a 26-subject study said in video presentation of his research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

“Therapy induced durable and continuous clearance of anal HSIL [high-grade squamous intraepithelial lesions]. Further study in HPV-associated premalignancy is warranted to follow up this small, single arm study,” said study lead Mark Polizzotto, MD, PhD, head of the therapeutic and vaccine research program at the Kirby Institute in Sydney.

HPV anal lesions, and subsequent HSIL and progression to anal cancer, are prevalent among men who have sex with men. The risk increases with chronic lesions and concomitant HIV infection.

Pomalidomide is potentially a less painful alternative to options such as freezing and laser ablation, and it may have a lower rate of recurrence, but it’s expensive. Copays range upward from $5,000 for a month supply, according to GoodRx. Celgene, the maker of the drug, offers financial assistance.

Pomalidomide is a derivative of thalidomide that’s approved for multiple myeloma and also has shown effect against a viral lesion associated with HIV, Kaposi sarcoma. The drug is a T-cell activator, and since T-cell activation also is key to spontaneous anal HSIL clearance, Dr. Polizzotto and team wanted to take a look to see if it could help, he said.

The men in the study were at high risk for progression to anal cancer. With a median lesion duration of more than 3 years, and at least one case out past 7 years, spontaneous clearance wasn’t in the cards. The lesions were all grade 3 HSIL, which means severe dysplasia, and more than half of the subjects had HPV genotype 16, and the rest had other risky genotypes. Ten subjects also had HIV, which also increases the risk of anal cancer.

Pomalidomide was given in back-to-back cycles for 6 months, each consisting of 2 mg orally for 3 weeks, then 1 week off, along with a thrombolytic, usually aspirin, given the black box warning of blood clots. The dose was half the 5-mg cycle for Kaposi’s.

The overall response rate – complete clearance or a partial clearance of at least a 50% on high-resolution anoscopy – was 50% at 6 months (12/24), including four complete responses (4/15, 27%) in subjects without HIV, as well as four in the HIV group (4/9, 44%).

On follow-up at month 12, “we saw something we did not expect. Strikingly, with no additional therapy in the interim, we saw a deepening of response in a number of subjects.” The overall response rate climbed to 63% (15/24), including 33% complete response in the HIV-free group (5/15) and HIV-positive group (3/9).

Some did lose their response in the interim, however, and the study team is working to figure out if it was do to a recurrence or a new infection.

A general pattern of immune activation on treatment, including increased systemic CD4+ T-cell responses to HPV during therapy, supported the investigator’s hunch of an immunologic mechanism of action, Dr. Polizzotto said.

There were four instances of grade 3 neutropenia over eight treatment cycles, and one possibly related angina attack, but other than that, adverse reactions were generally mild and self-limited, mostly to grade 1 or 2 neutropenia, constipation, fatigue, and rash, with no idiosyncratic reactions in the HIV group or loss of viral suppression, and no discontinuations because of side effects.

The men in the study were aged 40-50 years, with a median age of 54 years; all but one were white. The median lesion involved a quarter of the anal ring, but sometimes more than half.

The work was funded by the Cancer Institute of New South Wales, the Australian National Health and Medical Research Council, and Celgene. Dr. Polizzotto disclosed patents with Celgene and research funding from the company.

[email protected]

SOURCE: Polizzotto M et al. CROI 2020. Abstract 70

Increased visceral fat predicts both the presence of hepatic fibrosis in HIV patients with nonalcoholic fatty liver disease and also its progression, according to a report at the Conference on Retroviruses & Opportunistic Infections.

Among 58 people with NAFLD and well-controlled HIV, mostly men, a “striking 43% had evidence of fibrosis” on liver biopsy, a quarter with severe stage 3 fibrosis. Visceral fat content on MRI predicted fibrosis (284 cm² among fibrotic patients vs. 212 cm² among nonfibrotic patients, P = .005), but body mass index (BMI), waist circumference, subcutaneous fat, and hepatic fat content did not, said investigators led by Lindsay Fourman, MD, an attending physician at the Neuroendocrine & Pituitary Tumor Clinical Center at Massachusetts General Hospital, Boston.

Among 24 subjects with a second liver biopsy a year later, 38% had fibrosis progression, more than half from no fibrosis at baseline. Baseline visceral fat (306 cm² among progressors versus 212 cm², P = .04) again predicted progression, after adjustment for baseline BMI, hepatic fat content, and NAFLD activity score.

For every 25 cm² rise in baseline visceral fat, the team found a 40% increased odds of fibrosis progression (P = .03). Body mass index was stable among subjects, so progression was not related to sudden weight gain. Dr. Fourman noted that people with HIV can have normal BMIs, but still significant accumulation of visceral fat.

The mean rate of progression was 0.2 stages per year. “To put this into perspective, the rate of fibrosis progression among NAFLD in the general population has been quoted to be about 0.03 stages per year.” Among HIV patients, it’s “more than sixfold higher,” she said in a video presentation of her research at the meeting, which was presented online this year. CROI organizers chose to hold a virtual meeting due to concerns about the spread of COVID-19.

Overall, visceral adiposity is “a novel clinical predictor of accelerated” progression in people with HIV. “Therapies to reduce visceral fat may be particularly effective in HIV-associated NAFLD,” she said.

The findings come from a trial of one such therapy, the growth hormone releasing hormone analogue tesamorelin (Egrifta). It’s approved for reduction of excess abdominal fat in HIV patients with lipodystrophy. Dr. Fourman and her colleagues recently reported a more than 30% reduction in liver fat, versus placebo, among HIV patients with NAFLD after a year of treatment, and a lower rate of fibrosis progression at 10.5% versus 37.5% (Lancet HIV. 2019 Dec;6[12]:e821-30).

In their follow-up study reported at the meeting, people with fibrosis at baseline also had higher NAFLD activity scores (3.6 points vs. 2.0 points; P < .0001), as well as higher ALT (41 U/L vs. 23 U/L, P = .002) and AST levels (44 U/L vs. 24 U/L; P = .0003).

Baseline BMI, liver fat content, NAFLD activity score, liver enzymes, waist circumference, CD4 count, and HIV duration, a median of 16 years in the study, did not predict progression, but activity scores, hemoglobin A_1C, and C-reactive protein increased as fibrosis progressed.

“We really can’t speak from our own data” if HIV regimens might have had a role in progression. Sixty-two percent of the subjects were on integrase inhibitors, and integrase inhibitors are associated with weight gain, but their effect on visceral weight gain is unclear, plus BMIs were stable. Also, there was no difference in HIV regimens among the more than 100 people screened for the study between those with NAFDL and those without.

The subjects were 54 years old, on average. The average liver fat content at baseline was about 14%, and average baseline BMI just over 30 kg/m². In addition to the 62% on integrase inhibitors, 40% were on nonnucleoside reverse transcriptase inhibitors, and 24% were on protease inhibitors.

The work was funded by the National Institutes of Health. Dr. Fourman is a paid consultant to Theratechnologies, maker of tesamorelin.

[email protected]

SOURCE: Fourman LT et al. CROI 2020, Abstract 128

Increased visceral fat predicts both the presence of hepatic fibrosis in HIV patients with nonalcoholic fatty liver disease and also its progression, according to a report at the Conference on Retroviruses & Opportunistic Infections.

Among 58 people with NAFLD and well-controlled HIV, mostly men, a “striking 43% had evidence of fibrosis” on liver biopsy, a quarter with severe stage 3 fibrosis. Visceral fat content on MRI predicted fibrosis (284 cm² among fibrotic patients vs. 212 cm² among nonfibrotic patients, P = .005), but body mass index (BMI), waist circumference, subcutaneous fat, and hepatic fat content did not, said investigators led by Lindsay Fourman, MD, an attending physician at the Neuroendocrine & Pituitary Tumor Clinical Center at Massachusetts General Hospital, Boston.

Among 24 subjects with a second liver biopsy a year later, 38% had fibrosis progression, more than half from no fibrosis at baseline. Baseline visceral fat (306 cm² among progressors versus 212 cm², P = .04) again predicted progression, after adjustment for baseline BMI, hepatic fat content, and NAFLD activity score.

For every 25 cm² rise in baseline visceral fat, the team found a 40% increased odds of fibrosis progression (P = .03). Body mass index was stable among subjects, so progression was not related to sudden weight gain. Dr. Fourman noted that people with HIV can have normal BMIs, but still significant accumulation of visceral fat.

The mean rate of progression was 0.2 stages per year. “To put this into perspective, the rate of fibrosis progression among NAFLD in the general population has been quoted to be about 0.03 stages per year.” Among HIV patients, it’s “more than sixfold higher,” she said in a video presentation of her research at the meeting, which was presented online this year. CROI organizers chose to hold a virtual meeting due to concerns about the spread of COVID-19.

Overall, visceral adiposity is “a novel clinical predictor of accelerated” progression in people with HIV. “Therapies to reduce visceral fat may be particularly effective in HIV-associated NAFLD,” she said.

The findings come from a trial of one such therapy, the growth hormone releasing hormone analogue tesamorelin (Egrifta). It’s approved for reduction of excess abdominal fat in HIV patients with lipodystrophy. Dr. Fourman and her colleagues recently reported a more than 30% reduction in liver fat, versus placebo, among HIV patients with NAFLD after a year of treatment, and a lower rate of fibrosis progression at 10.5% versus 37.5% (Lancet HIV. 2019 Dec;6[12]:e821-30).

In their follow-up study reported at the meeting, people with fibrosis at baseline also had higher NAFLD activity scores (3.6 points vs. 2.0 points; P < .0001), as well as higher ALT (41 U/L vs. 23 U/L, P = .002) and AST levels (44 U/L vs. 24 U/L; P = .0003).

Baseline BMI, liver fat content, NAFLD activity score, liver enzymes, waist circumference, CD4 count, and HIV duration, a median of 16 years in the study, did not predict progression, but activity scores, hemoglobin A_1C, and C-reactive protein increased as fibrosis progressed.

“We really can’t speak from our own data” if HIV regimens might have had a role in progression. Sixty-two percent of the subjects were on integrase inhibitors, and integrase inhibitors are associated with weight gain, but their effect on visceral weight gain is unclear, plus BMIs were stable. Also, there was no difference in HIV regimens among the more than 100 people screened for the study between those with NAFDL and those without.

The subjects were 54 years old, on average. The average liver fat content at baseline was about 14%, and average baseline BMI just over 30 kg/m². In addition to the 62% on integrase inhibitors, 40% were on nonnucleoside reverse transcriptase inhibitors, and 24% were on protease inhibitors.

The work was funded by the National Institutes of Health. Dr. Fourman is a paid consultant to Theratechnologies, maker of tesamorelin.

[email protected]

SOURCE: Fourman LT et al. CROI 2020, Abstract 128

Increased visceral fat predicts both the presence of hepatic fibrosis in HIV patients with nonalcoholic fatty liver disease and also its progression, according to a report at the Conference on Retroviruses & Opportunistic Infections.

Among 58 people with NAFLD and well-controlled HIV, mostly men, a “striking 43% had evidence of fibrosis” on liver biopsy, a quarter with severe stage 3 fibrosis. Visceral fat content on MRI predicted fibrosis (284 cm² among fibrotic patients vs. 212 cm² among nonfibrotic patients, P = .005), but body mass index (BMI), waist circumference, subcutaneous fat, and hepatic fat content did not, said investigators led by Lindsay Fourman, MD, an attending physician at the Neuroendocrine & Pituitary Tumor Clinical Center at Massachusetts General Hospital, Boston.

Among 24 subjects with a second liver biopsy a year later, 38% had fibrosis progression, more than half from no fibrosis at baseline. Baseline visceral fat (306 cm² among progressors versus 212 cm², P = .04) again predicted progression, after adjustment for baseline BMI, hepatic fat content, and NAFLD activity score.

For every 25 cm² rise in baseline visceral fat, the team found a 40% increased odds of fibrosis progression (P = .03). Body mass index was stable among subjects, so progression was not related to sudden weight gain. Dr. Fourman noted that people with HIV can have normal BMIs, but still significant accumulation of visceral fat.

The mean rate of progression was 0.2 stages per year. “To put this into perspective, the rate of fibrosis progression among NAFLD in the general population has been quoted to be about 0.03 stages per year.” Among HIV patients, it’s “more than sixfold higher,” she said in a video presentation of her research at the meeting, which was presented online this year. CROI organizers chose to hold a virtual meeting due to concerns about the spread of COVID-19.

Overall, visceral adiposity is “a novel clinical predictor of accelerated” progression in people with HIV. “Therapies to reduce visceral fat may be particularly effective in HIV-associated NAFLD,” she said.

The findings come from a trial of one such therapy, the growth hormone releasing hormone analogue tesamorelin (Egrifta). It’s approved for reduction of excess abdominal fat in HIV patients with lipodystrophy. Dr. Fourman and her colleagues recently reported a more than 30% reduction in liver fat, versus placebo, among HIV patients with NAFLD after a year of treatment, and a lower rate of fibrosis progression at 10.5% versus 37.5% (Lancet HIV. 2019 Dec;6[12]:e821-30).

In their follow-up study reported at the meeting, people with fibrosis at baseline also had higher NAFLD activity scores (3.6 points vs. 2.0 points; P < .0001), as well as higher ALT (41 U/L vs. 23 U/L, P = .002) and AST levels (44 U/L vs. 24 U/L; P = .0003).

Baseline BMI, liver fat content, NAFLD activity score, liver enzymes, waist circumference, CD4 count, and HIV duration, a median of 16 years in the study, did not predict progression, but activity scores, hemoglobin A_1C, and C-reactive protein increased as fibrosis progressed.

“We really can’t speak from our own data” if HIV regimens might have had a role in progression. Sixty-two percent of the subjects were on integrase inhibitors, and integrase inhibitors are associated with weight gain, but their effect on visceral weight gain is unclear, plus BMIs were stable. Also, there was no difference in HIV regimens among the more than 100 people screened for the study between those with NAFDL and those without.

The subjects were 54 years old, on average. The average liver fat content at baseline was about 14%, and average baseline BMI just over 30 kg/m². In addition to the 62% on integrase inhibitors, 40% were on nonnucleoside reverse transcriptase inhibitors, and 24% were on protease inhibitors.

The work was funded by the National Institutes of Health. Dr. Fourman is a paid consultant to Theratechnologies, maker of tesamorelin.

[email protected]

SOURCE: Fourman LT et al. CROI 2020, Abstract 128

The first randomized trial to see if a short course of a direct-acting antiviral works as well for acute hepatitis C virus (HCV) infection as the standard 12-week course was stopped early after it became clear that it did not, according to a report at the Conference on Retroviruses & Opportunistic Infections.

In the end, 6 weeks of sofosbuvir-velpatasvir (Epclusa) “was inferior” to 12 weeks, said investigators led by Gail Matthews, MD, PhD, an associate professor in the Viral Hepatitis Clinical Research Program at the Kirby Institute, in Sydney, New South Wales, Australia.

Guidelines recommend 12 weeks of direct-acting antiviral treatment, but a few observational studies have suggested that 6 weeks might be enough. Since that would make it easier for physicians and patients, and would save money, Dr. Matthews and her team set out to resolve the uncertainty with a randomized trial.

Enrollment was halted short of the 250 target because of an “unacceptably high” relapse rate of 9.7% among 93 people randomized to 6 weeks of sofosbuvir-velpatasvir versus 2% among 99 subjects randomized to the standard 12-week regimen. All the relapse patients except for one in the 12-week arm were more than 95% adherent to treatment, she at the meeting, which was scheduled to be in Boston, but was held online this year because of concerns about spreading the COVID-19 virus.

There were 17 treatment failures (18.3%) in the short arm: two deaths, three reinfections, three lost to follow-up, and the nine relapses 12 weeks out from the end of treatment. There were eight failures (8%) in the long arm, including two reinfections, two lost to follow-up, and the two relapses, but no deaths. Excluding patients with no virologic reason for failure, Dr. Matthews said, “we see the difference in the two arms even more clearly,” with viral RNA undetectable in 98% of the 12-week patients – which is in keeping with label data – versus 89% in the short arm.

The groups were well balanced. Almost all the subjects were men and the majority were white; the median age was 43 years. Almost two-thirds had a primary infection at baseline and HCV genotype 1 a/b was the most common in both groups. Patients had been infected for a year or less, with a median of 25 weeks.

The majority of subjects picked up the virus through homosexual sex, but about 20% by injection drug use. Over two-thirds had well-controlled HIV. There were no treatment related discontinuations, and all the relapsed patients were successfully treated with subsequent therapy, Dr. Matthews said.

The study was conducted in the United States, Europe, Canada, New Zealand, and Australia, and funded by the National Institutes of Health. Dr. Matthews reported research grants to her institution form Abbvie and Gilead, maker of Epclusa.

[email protected]

SOURCE: Matthews G. CROI 2020 abstract 121.

The first randomized trial to see if a short course of a direct-acting antiviral works as well for acute hepatitis C virus (HCV) infection as the standard 12-week course was stopped early after it became clear that it did not, according to a report at the Conference on Retroviruses & Opportunistic Infections.

In the end, 6 weeks of sofosbuvir-velpatasvir (Epclusa) “was inferior” to 12 weeks, said investigators led by Gail Matthews, MD, PhD, an associate professor in the Viral Hepatitis Clinical Research Program at the Kirby Institute, in Sydney, New South Wales, Australia.

Guidelines recommend 12 weeks of direct-acting antiviral treatment, but a few observational studies have suggested that 6 weeks might be enough. Since that would make it easier for physicians and patients, and would save money, Dr. Matthews and her team set out to resolve the uncertainty with a randomized trial.

Enrollment was halted short of the 250 target because of an “unacceptably high” relapse rate of 9.7% among 93 people randomized to 6 weeks of sofosbuvir-velpatasvir versus 2% among 99 subjects randomized to the standard 12-week regimen. All the relapse patients except for one in the 12-week arm were more than 95% adherent to treatment, she at the meeting, which was scheduled to be in Boston, but was held online this year because of concerns about spreading the COVID-19 virus.

There were 17 treatment failures (18.3%) in the short arm: two deaths, three reinfections, three lost to follow-up, and the nine relapses 12 weeks out from the end of treatment. There were eight failures (8%) in the long arm, including two reinfections, two lost to follow-up, and the two relapses, but no deaths. Excluding patients with no virologic reason for failure, Dr. Matthews said, “we see the difference in the two arms even more clearly,” with viral RNA undetectable in 98% of the 12-week patients – which is in keeping with label data – versus 89% in the short arm.

The groups were well balanced. Almost all the subjects were men and the majority were white; the median age was 43 years. Almost two-thirds had a primary infection at baseline and HCV genotype 1 a/b was the most common in both groups. Patients had been infected for a year or less, with a median of 25 weeks.

The majority of subjects picked up the virus through homosexual sex, but about 20% by injection drug use. Over two-thirds had well-controlled HIV. There were no treatment related discontinuations, and all the relapsed patients were successfully treated with subsequent therapy, Dr. Matthews said.

The study was conducted in the United States, Europe, Canada, New Zealand, and Australia, and funded by the National Institutes of Health. Dr. Matthews reported research grants to her institution form Abbvie and Gilead, maker of Epclusa.

[email protected]

SOURCE: Matthews G. CROI 2020 abstract 121.

The first randomized trial to see if a short course of a direct-acting antiviral works as well for acute hepatitis C virus (HCV) infection as the standard 12-week course was stopped early after it became clear that it did not, according to a report at the Conference on Retroviruses & Opportunistic Infections.

In the end, 6 weeks of sofosbuvir-velpatasvir (Epclusa) “was inferior” to 12 weeks, said investigators led by Gail Matthews, MD, PhD, an associate professor in the Viral Hepatitis Clinical Research Program at the Kirby Institute, in Sydney, New South Wales, Australia.

Guidelines recommend 12 weeks of direct-acting antiviral treatment, but a few observational studies have suggested that 6 weeks might be enough. Since that would make it easier for physicians and patients, and would save money, Dr. Matthews and her team set out to resolve the uncertainty with a randomized trial.

Enrollment was halted short of the 250 target because of an “unacceptably high” relapse rate of 9.7% among 93 people randomized to 6 weeks of sofosbuvir-velpatasvir versus 2% among 99 subjects randomized to the standard 12-week regimen. All the relapse patients except for one in the 12-week arm were more than 95% adherent to treatment, she at the meeting, which was scheduled to be in Boston, but was held online this year because of concerns about spreading the COVID-19 virus.

There were 17 treatment failures (18.3%) in the short arm: two deaths, three reinfections, three lost to follow-up, and the nine relapses 12 weeks out from the end of treatment. There were eight failures (8%) in the long arm, including two reinfections, two lost to follow-up, and the two relapses, but no deaths. Excluding patients with no virologic reason for failure, Dr. Matthews said, “we see the difference in the two arms even more clearly,” with viral RNA undetectable in 98% of the 12-week patients – which is in keeping with label data – versus 89% in the short arm.

The groups were well balanced. Almost all the subjects were men and the majority were white; the median age was 43 years. Almost two-thirds had a primary infection at baseline and HCV genotype 1 a/b was the most common in both groups. Patients had been infected for a year or less, with a median of 25 weeks.

The majority of subjects picked up the virus through homosexual sex, but about 20% by injection drug use. Over two-thirds had well-controlled HIV. There were no treatment related discontinuations, and all the relapsed patients were successfully treated with subsequent therapy, Dr. Matthews said.

The study was conducted in the United States, Europe, Canada, New Zealand, and Australia, and funded by the National Institutes of Health. Dr. Matthews reported research grants to her institution form Abbvie and Gilead, maker of Epclusa.

[email protected]

SOURCE: Matthews G. CROI 2020 abstract 121.

A simple, quick point-of-care urine test for tenofovir adherence, similar to an OTC-pregnancy test, has an accuracy of 99.6% versus laboratory testing, according to a report at the Conference on Retroviruses & Opportunistic Infections.

A few drops of urine yield results in 5 minutes, and tell if patients have been taking tenofovir, a key component of HIV preexposure prophylaxis (PrEP) medications, within the previous 4-7 days. Abbott Rapid Diagnostics is gearing up to market the test widely in the United States, and it won’t be very expensive, according to lead investigator Matthew Spinelli, MD, a clinical fellow and HIV/AIDS researcher at the University of California, San Francisco.

It’s an alternative to the usual approach, measuring tenofovir levels in hair, blood, or urine by liquid chromatography and mass spectrometry. That approach is expensive and requires trained personnel, and the results can take a while. Dr. Spinelli and colleagues saw the need for a quicker, easier way for use in the clinic, since real-time adherence results are most likely to make a difference, he said at the meeting, which was scheduled to be in Boston, but was held online instead this year because of concerns about spreading the COVID-19 virus.

Self-report, meanwhile, is notoriously unreliable. Over 90% of people in two previous PrEP studies said they were taking their medications, but only about a quarter had tenofovir in their plasma.

The investigators identified a tenofovir antibody in urine that could be read by enzyme-linked immunosorbent assay (ELISA), and validated it for adherence accuracy against liquid chromatography and mass spectrometry; they then put the antibody on a test strip to create a lateral flow immunoassay.

After hearing the presentation, moderator Susan Buchbinder, MD, director of HIV prevention research at the San Francisco Department of Public Health, called the work “important” and said it “really has the possibility of opening up a lot of new kinds of studies and new kinds of intervention for both prevention and treatment.”

Dr. Spinelli and colleagues pitted the test strip against their laboratory-based ELISA test using 684 stored urine samples from 324 men and women in disoproxil fumarate/emtricitabine (Truvada) PrEP projects in Africa and the United States.

Overall, the 505 samples that were positive for tenofovir in the lab test were also positive on the urine strip, yielding 100% sensitivity. Of the 179 negative samples on the lab test, 176 were also negative with the strip, yielding a specificity of 98.3%. The results calculated into nearly perfect accuracy.

“We believe that” the urine test strip “is ready for field testing,” and that “point-of-care adherence testing” will be a boon to both PrEP and HIV treatment. A negative test, for instance, would signal the need for immediate counseling, and the patient would still be in the office to hear it. For HIV, high adherence but also high viral load would signal the need for resistance testing, Dr. Spinelli said.

A white-coat effect is possible; people might take their medication when they know they have an upcoming doctor’s appointment. “We will need to evaluate for [that] with additional studies” comparing point-of-care testing with longer-term metrics, such as drug levels in hair, he said.

The study was published to coincide with Dr. Spinelli’s report (J Acquir Immune Defic Syndr. 2020 Mar 10. doi: 10.1097/QAI.0000000000002322).

The funding source wasn’t reported. Dr. Spinelli had no disclosures. Two investigators were Abbott employees.

[email protected]

SOURCE: Spinelli MA et al. 2020 CROI abstract 91.

A simple, quick point-of-care urine test for tenofovir adherence, similar to an OTC-pregnancy test, has an accuracy of 99.6% versus laboratory testing, according to a report at the Conference on Retroviruses & Opportunistic Infections.

A few drops of urine yield results in 5 minutes, and tell if patients have been taking tenofovir, a key component of HIV preexposure prophylaxis (PrEP) medications, within the previous 4-7 days. Abbott Rapid Diagnostics is gearing up to market the test widely in the United States, and it won’t be very expensive, according to lead investigator Matthew Spinelli, MD, a clinical fellow and HIV/AIDS researcher at the University of California, San Francisco.

It’s an alternative to the usual approach, measuring tenofovir levels in hair, blood, or urine by liquid chromatography and mass spectrometry. That approach is expensive and requires trained personnel, and the results can take a while. Dr. Spinelli and colleagues saw the need for a quicker, easier way for use in the clinic, since real-time adherence results are most likely to make a difference, he said at the meeting, which was scheduled to be in Boston, but was held online instead this year because of concerns about spreading the COVID-19 virus.

Self-report, meanwhile, is notoriously unreliable. Over 90% of people in two previous PrEP studies said they were taking their medications, but only about a quarter had tenofovir in their plasma.

The investigators identified a tenofovir antibody in urine that could be read by enzyme-linked immunosorbent assay (ELISA), and validated it for adherence accuracy against liquid chromatography and mass spectrometry; they then put the antibody on a test strip to create a lateral flow immunoassay.

After hearing the presentation, moderator Susan Buchbinder, MD, director of HIV prevention research at the San Francisco Department of Public Health, called the work “important” and said it “really has the possibility of opening up a lot of new kinds of studies and new kinds of intervention for both prevention and treatment.”

Dr. Spinelli and colleagues pitted the test strip against their laboratory-based ELISA test using 684 stored urine samples from 324 men and women in disoproxil fumarate/emtricitabine (Truvada) PrEP projects in Africa and the United States.

Overall, the 505 samples that were positive for tenofovir in the lab test were also positive on the urine strip, yielding 100% sensitivity. Of the 179 negative samples on the lab test, 176 were also negative with the strip, yielding a specificity of 98.3%. The results calculated into nearly perfect accuracy.

“We believe that” the urine test strip “is ready for field testing,” and that “point-of-care adherence testing” will be a boon to both PrEP and HIV treatment. A negative test, for instance, would signal the need for immediate counseling, and the patient would still be in the office to hear it. For HIV, high adherence but also high viral load would signal the need for resistance testing, Dr. Spinelli said.

A white-coat effect is possible; people might take their medication when they know they have an upcoming doctor’s appointment. “We will need to evaluate for [that] with additional studies” comparing point-of-care testing with longer-term metrics, such as drug levels in hair, he said.

The study was published to coincide with Dr. Spinelli’s report (J Acquir Immune Defic Syndr. 2020 Mar 10. doi: 10.1097/QAI.0000000000002322).

The funding source wasn’t reported. Dr. Spinelli had no disclosures. Two investigators were Abbott employees.

[email protected]

SOURCE: Spinelli MA et al. 2020 CROI abstract 91.

A simple, quick point-of-care urine test for tenofovir adherence, similar to an OTC-pregnancy test, has an accuracy of 99.6% versus laboratory testing, according to a report at the Conference on Retroviruses & Opportunistic Infections.

A few drops of urine yield results in 5 minutes, and tell if patients have been taking tenofovir, a key component of HIV preexposure prophylaxis (PrEP) medications, within the previous 4-7 days. Abbott Rapid Diagnostics is gearing up to market the test widely in the United States, and it won’t be very expensive, according to lead investigator Matthew Spinelli, MD, a clinical fellow and HIV/AIDS researcher at the University of California, San Francisco.

It’s an alternative to the usual approach, measuring tenofovir levels in hair, blood, or urine by liquid chromatography and mass spectrometry. That approach is expensive and requires trained personnel, and the results can take a while. Dr. Spinelli and colleagues saw the need for a quicker, easier way for use in the clinic, since real-time adherence results are most likely to make a difference, he said at the meeting, which was scheduled to be in Boston, but was held online instead this year because of concerns about spreading the COVID-19 virus.

Self-report, meanwhile, is notoriously unreliable. Over 90% of people in two previous PrEP studies said they were taking their medications, but only about a quarter had tenofovir in their plasma.

The investigators identified a tenofovir antibody in urine that could be read by enzyme-linked immunosorbent assay (ELISA), and validated it for adherence accuracy against liquid chromatography and mass spectrometry; they then put the antibody on a test strip to create a lateral flow immunoassay.

After hearing the presentation, moderator Susan Buchbinder, MD, director of HIV prevention research at the San Francisco Department of Public Health, called the work “important” and said it “really has the possibility of opening up a lot of new kinds of studies and new kinds of intervention for both prevention and treatment.”

Dr. Spinelli and colleagues pitted the test strip against their laboratory-based ELISA test using 684 stored urine samples from 324 men and women in disoproxil fumarate/emtricitabine (Truvada) PrEP projects in Africa and the United States.

Overall, the 505 samples that were positive for tenofovir in the lab test were also positive on the urine strip, yielding 100% sensitivity. Of the 179 negative samples on the lab test, 176 were also negative with the strip, yielding a specificity of 98.3%. The results calculated into nearly perfect accuracy.

“We believe that” the urine test strip “is ready for field testing,” and that “point-of-care adherence testing” will be a boon to both PrEP and HIV treatment. A negative test, for instance, would signal the need for immediate counseling, and the patient would still be in the office to hear it. For HIV, high adherence but also high viral load would signal the need for resistance testing, Dr. Spinelli said.

A white-coat effect is possible; people might take their medication when they know they have an upcoming doctor’s appointment. “We will need to evaluate for [that] with additional studies” comparing point-of-care testing with longer-term metrics, such as drug levels in hair, he said.

The study was published to coincide with Dr. Spinelli’s report (J Acquir Immune Defic Syndr. 2020 Mar 10. doi: 10.1097/QAI.0000000000002322).

The funding source wasn’t reported. Dr. Spinelli had no disclosures. Two investigators were Abbott employees.

[email protected]

SOURCE: Spinelli MA et al. 2020 CROI abstract 91.

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

[email protected]

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

[email protected]

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

[email protected]

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

[email protected]

SOURCE: Jao J et al. CROI 2020, Poster 00772.

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

[email protected]

SOURCE: Jao J et al. CROI 2020, Poster 00772.

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

[email protected]

SOURCE: Jao J et al. CROI 2020, Poster 00772.