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RAPID ART program yields clinical benefits in San Francisco
BOSTON – In San Francisco, a citywide program to get all persons with newly diagnosed HIV infections linked to care within 5 working days cut the time to first virologic suppression by more than half and reduced the median time from initiation of care to antiretroviral therapy from nearly 4 weeks to just 1 day, an infectious disease specialist reported.
“We saw significant improvements in time to ART [antiretroviral therapy] initiation and time to first virologic suppression in traditionally vulnerable populations, including racial and ethnic minorities and the homeless. However, disparities remain in some groups,” Oliver Bacon, MD, MPH, of the University of California, San Francisco, and the San Francisco Department of Public Health, said at the Conference on Retroviruses and Opportunistic Infections.
Under the program, all persons with confirmed HIV diagnoses are linked within 5 working days to care, and at the first care visit, have baseline labs collected, receive counseling, and undergo medical and psychosocial assessment. Patients then begin ART with tenofovir and emtricitabine plus either an integrase inhibitor or a boost of darunavir, with the option of a four-drug regimen if the HIV infection was suspected to have occurred while the patient was taking preexposure prophylaxis.
The investigators identified HIV clinics using HIV surveillance data, and trained providers on RAPID procedures with both in-service training and individual provider detailing.
Providers and clinics that agreed to join the program were added to a RAPID provider directory, which was then given to linkage navigators that could use it to identify the optimal HIV clinic for each newly diagnosed patient, according to insurance coverage and psychosocial needs.
The full protocol and RAPID detailing brochure also were made available to clinicians at a website and were distributed at open quarterly consortium meetings.
Dr. Bacon presented HIV case registry data on care outcomes from 2013 to 2016.
In 2013, 93% of all new HIV cases linked to care; in 2016, 97% linked. The proportion of newly diagnosed persons who started on ART also improved, from 78% in 2013 to 81% in 2016. In addition, the proportion of patients who both linked to care within 5 days and were started on ART within 1 day rose from 6% in 2013 to 30% by 2016.
Similar improvements were seen in median time from diagnosis to care, from 8 days in 2013 to 5 in 2016 (–38%); time from the first care visit to ART initiation from 27 days to 1 day, respectively (–96%); time from ART initiation to virologic load below 200 copies/mL from 70 to 38 days (–46%), and time from diagnosis to virologic load below 200 from 134 to 61 days (–54%).
Time from diagnosis to first care visit decreased significantly for males, whites, Hispanics, youth aged 13-29 years, and for those with housing; time from ART to virologic suppression decreased significantly for males, those under age 40 years, whites, Hispanics, Asian/Pacific Islanders, and for those with housing.
It is important to note that 16% of persons diagnosed with HIV in 2016 had not started on ART. “We found no notable sociodemographic differences versus the ART starters, although we did not look at mental illness [or] ... substance use,” Dr. Bacon said.
He acknowledged that the analysis did not address the important question of durability of virologic suppression.
The San Francisco Getting to Zero Consortium is sponsored by Gilead, Janssen, Bristol-Myers Squibb, the City of San Francisco, and by Will Hagerty. Dr. Bacon reported no conflicts of interest to disclose.
SOURCE: Buchbinder SP et al. CROI 2018, Abstract 87.
BOSTON – In San Francisco, a citywide program to get all persons with newly diagnosed HIV infections linked to care within 5 working days cut the time to first virologic suppression by more than half and reduced the median time from initiation of care to antiretroviral therapy from nearly 4 weeks to just 1 day, an infectious disease specialist reported.
“We saw significant improvements in time to ART [antiretroviral therapy] initiation and time to first virologic suppression in traditionally vulnerable populations, including racial and ethnic minorities and the homeless. However, disparities remain in some groups,” Oliver Bacon, MD, MPH, of the University of California, San Francisco, and the San Francisco Department of Public Health, said at the Conference on Retroviruses and Opportunistic Infections.
Under the program, all persons with confirmed HIV diagnoses are linked within 5 working days to care, and at the first care visit, have baseline labs collected, receive counseling, and undergo medical and psychosocial assessment. Patients then begin ART with tenofovir and emtricitabine plus either an integrase inhibitor or a boost of darunavir, with the option of a four-drug regimen if the HIV infection was suspected to have occurred while the patient was taking preexposure prophylaxis.
The investigators identified HIV clinics using HIV surveillance data, and trained providers on RAPID procedures with both in-service training and individual provider detailing.
Providers and clinics that agreed to join the program were added to a RAPID provider directory, which was then given to linkage navigators that could use it to identify the optimal HIV clinic for each newly diagnosed patient, according to insurance coverage and psychosocial needs.
The full protocol and RAPID detailing brochure also were made available to clinicians at a website and were distributed at open quarterly consortium meetings.
Dr. Bacon presented HIV case registry data on care outcomes from 2013 to 2016.
In 2013, 93% of all new HIV cases linked to care; in 2016, 97% linked. The proportion of newly diagnosed persons who started on ART also improved, from 78% in 2013 to 81% in 2016. In addition, the proportion of patients who both linked to care within 5 days and were started on ART within 1 day rose from 6% in 2013 to 30% by 2016.
Similar improvements were seen in median time from diagnosis to care, from 8 days in 2013 to 5 in 2016 (–38%); time from the first care visit to ART initiation from 27 days to 1 day, respectively (–96%); time from ART initiation to virologic load below 200 copies/mL from 70 to 38 days (–46%), and time from diagnosis to virologic load below 200 from 134 to 61 days (–54%).
Time from diagnosis to first care visit decreased significantly for males, whites, Hispanics, youth aged 13-29 years, and for those with housing; time from ART to virologic suppression decreased significantly for males, those under age 40 years, whites, Hispanics, Asian/Pacific Islanders, and for those with housing.
It is important to note that 16% of persons diagnosed with HIV in 2016 had not started on ART. “We found no notable sociodemographic differences versus the ART starters, although we did not look at mental illness [or] ... substance use,” Dr. Bacon said.
He acknowledged that the analysis did not address the important question of durability of virologic suppression.
The San Francisco Getting to Zero Consortium is sponsored by Gilead, Janssen, Bristol-Myers Squibb, the City of San Francisco, and by Will Hagerty. Dr. Bacon reported no conflicts of interest to disclose.
SOURCE: Buchbinder SP et al. CROI 2018, Abstract 87.
BOSTON – In San Francisco, a citywide program to get all persons with newly diagnosed HIV infections linked to care within 5 working days cut the time to first virologic suppression by more than half and reduced the median time from initiation of care to antiretroviral therapy from nearly 4 weeks to just 1 day, an infectious disease specialist reported.
“We saw significant improvements in time to ART [antiretroviral therapy] initiation and time to first virologic suppression in traditionally vulnerable populations, including racial and ethnic minorities and the homeless. However, disparities remain in some groups,” Oliver Bacon, MD, MPH, of the University of California, San Francisco, and the San Francisco Department of Public Health, said at the Conference on Retroviruses and Opportunistic Infections.
Under the program, all persons with confirmed HIV diagnoses are linked within 5 working days to care, and at the first care visit, have baseline labs collected, receive counseling, and undergo medical and psychosocial assessment. Patients then begin ART with tenofovir and emtricitabine plus either an integrase inhibitor or a boost of darunavir, with the option of a four-drug regimen if the HIV infection was suspected to have occurred while the patient was taking preexposure prophylaxis.
The investigators identified HIV clinics using HIV surveillance data, and trained providers on RAPID procedures with both in-service training and individual provider detailing.
Providers and clinics that agreed to join the program were added to a RAPID provider directory, which was then given to linkage navigators that could use it to identify the optimal HIV clinic for each newly diagnosed patient, according to insurance coverage and psychosocial needs.
The full protocol and RAPID detailing brochure also were made available to clinicians at a website and were distributed at open quarterly consortium meetings.
Dr. Bacon presented HIV case registry data on care outcomes from 2013 to 2016.
In 2013, 93% of all new HIV cases linked to care; in 2016, 97% linked. The proportion of newly diagnosed persons who started on ART also improved, from 78% in 2013 to 81% in 2016. In addition, the proportion of patients who both linked to care within 5 days and were started on ART within 1 day rose from 6% in 2013 to 30% by 2016.
Similar improvements were seen in median time from diagnosis to care, from 8 days in 2013 to 5 in 2016 (–38%); time from the first care visit to ART initiation from 27 days to 1 day, respectively (–96%); time from ART initiation to virologic load below 200 copies/mL from 70 to 38 days (–46%), and time from diagnosis to virologic load below 200 from 134 to 61 days (–54%).
Time from diagnosis to first care visit decreased significantly for males, whites, Hispanics, youth aged 13-29 years, and for those with housing; time from ART to virologic suppression decreased significantly for males, those under age 40 years, whites, Hispanics, Asian/Pacific Islanders, and for those with housing.
It is important to note that 16% of persons diagnosed with HIV in 2016 had not started on ART. “We found no notable sociodemographic differences versus the ART starters, although we did not look at mental illness [or] ... substance use,” Dr. Bacon said.
He acknowledged that the analysis did not address the important question of durability of virologic suppression.
The San Francisco Getting to Zero Consortium is sponsored by Gilead, Janssen, Bristol-Myers Squibb, the City of San Francisco, and by Will Hagerty. Dr. Bacon reported no conflicts of interest to disclose.
SOURCE: Buchbinder SP et al. CROI 2018, Abstract 87.
REPORTING FROM CROI
Key clinical point: A program for getting newly diagnosed HIV cases into care and treatment rapidly improved clinical outcomes, including among vulnerable populations.
Major finding: Median time from the first care visit to antiretroviral therapy initiation decreased from 27 days to only 1.
Study details: A retrospective analysis of outcomes from the Rapid ART Program Initiative for HIV Diagnoses.
Disclosures: The San Francisco Getting to Zero Consortium is sponsored by Gilead, Janssen, Bristol-Myers Squibb, the City of San Francisco, and by Will Hagerty. Dr. Bacon disclosed no conflicts of interest.
Source: Buchbinder SP et al. CROI 2018, Abstract 87.
Dolutegravir-based regimen effective in HIV/TB coinfected
BOSTON – In antiretroviral therapy–naive patients with HIV and tuberculosis coinfection, a combination of dolutegravir-based ART and rifampin-based TB therapy was associated with good efficacy and immunological responses through at least 24 weeks, investigators reported.
Dolutegravir-based ART appeared to be comparable to efavirenz-based therapy at viral suppression with a similar safety profile, although the trial was not powered for head-to-head comparison, said Kelly Dooley, MD, of Johns Hopkins University, Baltimore.
“We know that rifampin reduces concentrations of dolutegravir substantially, but that drug interaction can be mitigated by increasing the dose of dolutegravir to twice daily. That information was from a healthy volunteer trial, so we thought it would be important to test HIV/TB cotreatment among patients who have both infections,” she said at the Conference on Retroviruses and Opportunistic Infections.
Dr. Dooley and her colleagues looked at dolutegravir or efavirenz plus rifampin-based TB therapy in the INSPIRING trial.
The ongoing study is a phase 3b, noncomparative, randomized, open-label trial in ART-naive adults with HIV-1 and drug-sensitive TB infections.
In a briefing following her presentation of the data in an oral session, Dr. Dooley explained that the reason for the parallel but noncomparative arms in the trial was that it was primarily designed to see how dolutegravir works in HIV/TB coinfected patients. Enrollment of 113 patients from 37 sites in seven countries took about 2 years, and it would have required significantly more time to enroll the more than 500 patients necessary for an adequately powered comparison trial.
The trial was conducted in Argentina, Brazil, Mexico, Peru, Russia, South Africa, and Thailand. Dr. Dooley presented results from a 24-week interim analysis.
Participants who were on rifampin-based TB therapy for up to 8 weeks were randomized on a 3:2 basis to receive either dolutegravir 50 mg twice daily during and for 2 weeks post-TB therapy, followed by 50 mg once daily (69 patients), or efavirenz 600 mg daily plus two nucleoside reverse transcriptase inhibitors of the investigator’s choice for 52 weeks.
At 24 weeks, the percentage of patients deemed to have virologic success, defined as HIV-1 RNA less than 50 copies/mL, was 81% in the dolutegravir arm and 89% in the efavirenz arm. The respective rates of virologic nonresponse were 10% and 7%. No virologic data were available because of treatment discontinuations or missing information for 9% and 5% of patients, respectively.
The difference in response rates between the arms was due to non–treatment associated withdrawals among patients on dolutegravir, Dr. Dooley said.
Virologic withdrawals for confirmed plasma HIV-1 RNA of 400 copies/mL or more at or after week 24 for two consecutive tests occurred in one patient on dolutegravir and in none on efavirenz. There were no treatment-emergent resistance-associated mutations to any anti-HIV drugs in the dolutegravir group (data not available for the efavirenz group).
Two patients, both in the efavirenz arm, discontinued therapy because of adverse events. TB-associated rates of the immune reconstitution inflammatory syndrome (IRIS) occurred in 4% of patients in each treatment arm. No patients discontinued therapy because of IRIS or liver-related adverse events.
“We think that this study provides evidence that dolutegravir is effective and well tolerated in adults with HIV/TB coinfection who are receiving rifampin-based tuberculosis therapy, and we hope that this will increase the number of options for TB/HIV coinfected patients for whom there are relatively few treatment possibilities,” she concluded.
Dr. Dooley reported research support via her university from ViiV Healthcare, which funded the study.
SOURCE: Dooley K et al. Abstract 33.
BOSTON – In antiretroviral therapy–naive patients with HIV and tuberculosis coinfection, a combination of dolutegravir-based ART and rifampin-based TB therapy was associated with good efficacy and immunological responses through at least 24 weeks, investigators reported.
Dolutegravir-based ART appeared to be comparable to efavirenz-based therapy at viral suppression with a similar safety profile, although the trial was not powered for head-to-head comparison, said Kelly Dooley, MD, of Johns Hopkins University, Baltimore.
“We know that rifampin reduces concentrations of dolutegravir substantially, but that drug interaction can be mitigated by increasing the dose of dolutegravir to twice daily. That information was from a healthy volunteer trial, so we thought it would be important to test HIV/TB cotreatment among patients who have both infections,” she said at the Conference on Retroviruses and Opportunistic Infections.
Dr. Dooley and her colleagues looked at dolutegravir or efavirenz plus rifampin-based TB therapy in the INSPIRING trial.
The ongoing study is a phase 3b, noncomparative, randomized, open-label trial in ART-naive adults with HIV-1 and drug-sensitive TB infections.
In a briefing following her presentation of the data in an oral session, Dr. Dooley explained that the reason for the parallel but noncomparative arms in the trial was that it was primarily designed to see how dolutegravir works in HIV/TB coinfected patients. Enrollment of 113 patients from 37 sites in seven countries took about 2 years, and it would have required significantly more time to enroll the more than 500 patients necessary for an adequately powered comparison trial.
The trial was conducted in Argentina, Brazil, Mexico, Peru, Russia, South Africa, and Thailand. Dr. Dooley presented results from a 24-week interim analysis.
Participants who were on rifampin-based TB therapy for up to 8 weeks were randomized on a 3:2 basis to receive either dolutegravir 50 mg twice daily during and for 2 weeks post-TB therapy, followed by 50 mg once daily (69 patients), or efavirenz 600 mg daily plus two nucleoside reverse transcriptase inhibitors of the investigator’s choice for 52 weeks.
At 24 weeks, the percentage of patients deemed to have virologic success, defined as HIV-1 RNA less than 50 copies/mL, was 81% in the dolutegravir arm and 89% in the efavirenz arm. The respective rates of virologic nonresponse were 10% and 7%. No virologic data were available because of treatment discontinuations or missing information for 9% and 5% of patients, respectively.
The difference in response rates between the arms was due to non–treatment associated withdrawals among patients on dolutegravir, Dr. Dooley said.
Virologic withdrawals for confirmed plasma HIV-1 RNA of 400 copies/mL or more at or after week 24 for two consecutive tests occurred in one patient on dolutegravir and in none on efavirenz. There were no treatment-emergent resistance-associated mutations to any anti-HIV drugs in the dolutegravir group (data not available for the efavirenz group).
Two patients, both in the efavirenz arm, discontinued therapy because of adverse events. TB-associated rates of the immune reconstitution inflammatory syndrome (IRIS) occurred in 4% of patients in each treatment arm. No patients discontinued therapy because of IRIS or liver-related adverse events.
“We think that this study provides evidence that dolutegravir is effective and well tolerated in adults with HIV/TB coinfection who are receiving rifampin-based tuberculosis therapy, and we hope that this will increase the number of options for TB/HIV coinfected patients for whom there are relatively few treatment possibilities,” she concluded.
Dr. Dooley reported research support via her university from ViiV Healthcare, which funded the study.
SOURCE: Dooley K et al. Abstract 33.
BOSTON – In antiretroviral therapy–naive patients with HIV and tuberculosis coinfection, a combination of dolutegravir-based ART and rifampin-based TB therapy was associated with good efficacy and immunological responses through at least 24 weeks, investigators reported.
Dolutegravir-based ART appeared to be comparable to efavirenz-based therapy at viral suppression with a similar safety profile, although the trial was not powered for head-to-head comparison, said Kelly Dooley, MD, of Johns Hopkins University, Baltimore.
“We know that rifampin reduces concentrations of dolutegravir substantially, but that drug interaction can be mitigated by increasing the dose of dolutegravir to twice daily. That information was from a healthy volunteer trial, so we thought it would be important to test HIV/TB cotreatment among patients who have both infections,” she said at the Conference on Retroviruses and Opportunistic Infections.
Dr. Dooley and her colleagues looked at dolutegravir or efavirenz plus rifampin-based TB therapy in the INSPIRING trial.
The ongoing study is a phase 3b, noncomparative, randomized, open-label trial in ART-naive adults with HIV-1 and drug-sensitive TB infections.
In a briefing following her presentation of the data in an oral session, Dr. Dooley explained that the reason for the parallel but noncomparative arms in the trial was that it was primarily designed to see how dolutegravir works in HIV/TB coinfected patients. Enrollment of 113 patients from 37 sites in seven countries took about 2 years, and it would have required significantly more time to enroll the more than 500 patients necessary for an adequately powered comparison trial.
The trial was conducted in Argentina, Brazil, Mexico, Peru, Russia, South Africa, and Thailand. Dr. Dooley presented results from a 24-week interim analysis.
Participants who were on rifampin-based TB therapy for up to 8 weeks were randomized on a 3:2 basis to receive either dolutegravir 50 mg twice daily during and for 2 weeks post-TB therapy, followed by 50 mg once daily (69 patients), or efavirenz 600 mg daily plus two nucleoside reverse transcriptase inhibitors of the investigator’s choice for 52 weeks.
At 24 weeks, the percentage of patients deemed to have virologic success, defined as HIV-1 RNA less than 50 copies/mL, was 81% in the dolutegravir arm and 89% in the efavirenz arm. The respective rates of virologic nonresponse were 10% and 7%. No virologic data were available because of treatment discontinuations or missing information for 9% and 5% of patients, respectively.
The difference in response rates between the arms was due to non–treatment associated withdrawals among patients on dolutegravir, Dr. Dooley said.
Virologic withdrawals for confirmed plasma HIV-1 RNA of 400 copies/mL or more at or after week 24 for two consecutive tests occurred in one patient on dolutegravir and in none on efavirenz. There were no treatment-emergent resistance-associated mutations to any anti-HIV drugs in the dolutegravir group (data not available for the efavirenz group).
Two patients, both in the efavirenz arm, discontinued therapy because of adverse events. TB-associated rates of the immune reconstitution inflammatory syndrome (IRIS) occurred in 4% of patients in each treatment arm. No patients discontinued therapy because of IRIS or liver-related adverse events.
“We think that this study provides evidence that dolutegravir is effective and well tolerated in adults with HIV/TB coinfection who are receiving rifampin-based tuberculosis therapy, and we hope that this will increase the number of options for TB/HIV coinfected patients for whom there are relatively few treatment possibilities,” she concluded.
Dr. Dooley reported research support via her university from ViiV Healthcare, which funded the study.
SOURCE: Dooley K et al. Abstract 33.
REPORTING FROM CROI
Key clinical point:
Major finding: The virologic response rate at 24 weeks with dolutegravir was 81%.
Data source: Randomized noncomparative trial of 113 patients with HIV/TB coinfections in seven countries.
Disclosures: Dr. Dooley reported research support via her university from ViiV Healthcare, which funded the study.
Source: Dooley K et al. Abstract 33.
Hospital urine screening reduces TB deaths in HIV+ adults
BOSTON – Urine-based screening for tuberculosis added to standard sputum-based screening can reduce the risk of TB-associated deaths among hospitalized patients with advanced HIV compared with sputum-based screening alone, results of a randomized trial indicate.
Among 2,574 hospitalized HIV-positive patients, the rate of death at 56 days, the primary endpoint, was 21.1% for patients screened with standard-of-care sputum testing using the Xpert MTB/RIF assay, compared with 18.3% for patients screened with sputum testing and urine-sample testing by the Xpert MTB/RIF and the Determine TB-LAM urine dipstick test, reported Ankur Gupta-Wright, MBBS, MRCP, from the London School of Hygiene and Tropical Medicine.
“For every 100 patients who are HIV-positive admitted to hospital, with screening for TB using new urine-based testing in addition to sputum testing we can diagnose approximately seven extra TB case, and save approximately three lives,” he said at a briefing following his presentation of the data in a late-breaking oral abstract session.
“The findings our trial support the use of urine-based TB screening, and we hope to change how we screen for TB in HIV-positive admissions in the hospital in places with high burden of HIV and TB,” he said, speaking on behalf of colleagues in the STAMP Study.
HIV-related TB caused an estimated 400,000 deaths worldwide in 2016, and is responsible for between 32% and 67% of deaths in HIV-positive adults admit to hospitals in Africa. Yet half of all of those cases of TB are undiagnosed at the time of death, he said.
Urine based screens are easily obtained and have good diagnostic yield for disseminated TB, which is common in patients with advanced HIV, he said.
To see whether adding urine screening could increase TB diagnosis and treatment and reduce TB deaths among hospitalized HIV+ patients, the investigators enrolled 2,600 unselected HIV+ adults admitted to hospitals in South Africa and Malawi. Patients less than 18 years of age, those who had been treated for TB with the last 12 months or had received TB prophylaxis with isoniazid within the last 6 months were excluded, leaving a sample size of 2,574.
The patients were randomly assigned to standard-of-care Xpert MTB/RIF sputum screening either alone or with the addition of the two urine-based screens already described.
The overall absolute difference in risk of death at 56 days was -2.8% favoring urine screening (P = .074). As noted, this difference was only significant among patients with CD4 counts below 100/uL. Among these patients, mortality rates for nonurine screened versus screened were 35.7% vs. 28.8%, respectively (P = .036).
Baseline hemoglobin below 8 g/dl and TB suspected at admission were also predictive of better outcomes with the addition of urine-based screening.
An analysis of time to death stratified by baseline CD4 cell count also showed the advantage of urine screening for the sickest patients, with an adjusted hazard ratio for patients with CD4 counts below 100 of 0.77 (P = .047).
The urine-based screening also lead to significantly more microbiologically confirmed and clinically diagnosed TB, and more TB treatment (P less than .001 for each).
A separate cost analysis, presented in a scientific poster (CROI 2018 Abstract 1117LB), showed that the incremental cost-effectiveness ratios for the urine-based intervention were $490 per year of life save in Malawi, and $850 per year of life saved in South Africa.
The study was funded by UK AID, the UK Medical Research Council, and the Wellcome Trust. Dr. Gupta-Wright reported having no conflicts of interest to disclose.
SOURCE: Gupta-Wright, A et al. CROI 2018, Abstract 38LB.
BOSTON – Urine-based screening for tuberculosis added to standard sputum-based screening can reduce the risk of TB-associated deaths among hospitalized patients with advanced HIV compared with sputum-based screening alone, results of a randomized trial indicate.
Among 2,574 hospitalized HIV-positive patients, the rate of death at 56 days, the primary endpoint, was 21.1% for patients screened with standard-of-care sputum testing using the Xpert MTB/RIF assay, compared with 18.3% for patients screened with sputum testing and urine-sample testing by the Xpert MTB/RIF and the Determine TB-LAM urine dipstick test, reported Ankur Gupta-Wright, MBBS, MRCP, from the London School of Hygiene and Tropical Medicine.
“For every 100 patients who are HIV-positive admitted to hospital, with screening for TB using new urine-based testing in addition to sputum testing we can diagnose approximately seven extra TB case, and save approximately three lives,” he said at a briefing following his presentation of the data in a late-breaking oral abstract session.
“The findings our trial support the use of urine-based TB screening, and we hope to change how we screen for TB in HIV-positive admissions in the hospital in places with high burden of HIV and TB,” he said, speaking on behalf of colleagues in the STAMP Study.
HIV-related TB caused an estimated 400,000 deaths worldwide in 2016, and is responsible for between 32% and 67% of deaths in HIV-positive adults admit to hospitals in Africa. Yet half of all of those cases of TB are undiagnosed at the time of death, he said.
Urine based screens are easily obtained and have good diagnostic yield for disseminated TB, which is common in patients with advanced HIV, he said.
To see whether adding urine screening could increase TB diagnosis and treatment and reduce TB deaths among hospitalized HIV+ patients, the investigators enrolled 2,600 unselected HIV+ adults admitted to hospitals in South Africa and Malawi. Patients less than 18 years of age, those who had been treated for TB with the last 12 months or had received TB prophylaxis with isoniazid within the last 6 months were excluded, leaving a sample size of 2,574.
The patients were randomly assigned to standard-of-care Xpert MTB/RIF sputum screening either alone or with the addition of the two urine-based screens already described.
The overall absolute difference in risk of death at 56 days was -2.8% favoring urine screening (P = .074). As noted, this difference was only significant among patients with CD4 counts below 100/uL. Among these patients, mortality rates for nonurine screened versus screened were 35.7% vs. 28.8%, respectively (P = .036).
Baseline hemoglobin below 8 g/dl and TB suspected at admission were also predictive of better outcomes with the addition of urine-based screening.
An analysis of time to death stratified by baseline CD4 cell count also showed the advantage of urine screening for the sickest patients, with an adjusted hazard ratio for patients with CD4 counts below 100 of 0.77 (P = .047).
The urine-based screening also lead to significantly more microbiologically confirmed and clinically diagnosed TB, and more TB treatment (P less than .001 for each).
A separate cost analysis, presented in a scientific poster (CROI 2018 Abstract 1117LB), showed that the incremental cost-effectiveness ratios for the urine-based intervention were $490 per year of life save in Malawi, and $850 per year of life saved in South Africa.
The study was funded by UK AID, the UK Medical Research Council, and the Wellcome Trust. Dr. Gupta-Wright reported having no conflicts of interest to disclose.
SOURCE: Gupta-Wright, A et al. CROI 2018, Abstract 38LB.
BOSTON – Urine-based screening for tuberculosis added to standard sputum-based screening can reduce the risk of TB-associated deaths among hospitalized patients with advanced HIV compared with sputum-based screening alone, results of a randomized trial indicate.
Among 2,574 hospitalized HIV-positive patients, the rate of death at 56 days, the primary endpoint, was 21.1% for patients screened with standard-of-care sputum testing using the Xpert MTB/RIF assay, compared with 18.3% for patients screened with sputum testing and urine-sample testing by the Xpert MTB/RIF and the Determine TB-LAM urine dipstick test, reported Ankur Gupta-Wright, MBBS, MRCP, from the London School of Hygiene and Tropical Medicine.
“For every 100 patients who are HIV-positive admitted to hospital, with screening for TB using new urine-based testing in addition to sputum testing we can diagnose approximately seven extra TB case, and save approximately three lives,” he said at a briefing following his presentation of the data in a late-breaking oral abstract session.
“The findings our trial support the use of urine-based TB screening, and we hope to change how we screen for TB in HIV-positive admissions in the hospital in places with high burden of HIV and TB,” he said, speaking on behalf of colleagues in the STAMP Study.
HIV-related TB caused an estimated 400,000 deaths worldwide in 2016, and is responsible for between 32% and 67% of deaths in HIV-positive adults admit to hospitals in Africa. Yet half of all of those cases of TB are undiagnosed at the time of death, he said.
Urine based screens are easily obtained and have good diagnostic yield for disseminated TB, which is common in patients with advanced HIV, he said.
To see whether adding urine screening could increase TB diagnosis and treatment and reduce TB deaths among hospitalized HIV+ patients, the investigators enrolled 2,600 unselected HIV+ adults admitted to hospitals in South Africa and Malawi. Patients less than 18 years of age, those who had been treated for TB with the last 12 months or had received TB prophylaxis with isoniazid within the last 6 months were excluded, leaving a sample size of 2,574.
The patients were randomly assigned to standard-of-care Xpert MTB/RIF sputum screening either alone or with the addition of the two urine-based screens already described.
The overall absolute difference in risk of death at 56 days was -2.8% favoring urine screening (P = .074). As noted, this difference was only significant among patients with CD4 counts below 100/uL. Among these patients, mortality rates for nonurine screened versus screened were 35.7% vs. 28.8%, respectively (P = .036).
Baseline hemoglobin below 8 g/dl and TB suspected at admission were also predictive of better outcomes with the addition of urine-based screening.
An analysis of time to death stratified by baseline CD4 cell count also showed the advantage of urine screening for the sickest patients, with an adjusted hazard ratio for patients with CD4 counts below 100 of 0.77 (P = .047).
The urine-based screening also lead to significantly more microbiologically confirmed and clinically diagnosed TB, and more TB treatment (P less than .001 for each).
A separate cost analysis, presented in a scientific poster (CROI 2018 Abstract 1117LB), showed that the incremental cost-effectiveness ratios for the urine-based intervention were $490 per year of life save in Malawi, and $850 per year of life saved in South Africa.
The study was funded by UK AID, the UK Medical Research Council, and the Wellcome Trust. Dr. Gupta-Wright reported having no conflicts of interest to disclose.
SOURCE: Gupta-Wright, A et al. CROI 2018, Abstract 38LB.
REPORTING FROM CROI
Key clinical point: Adding urine screening for TB to sputum screening in hospitalized HIV+ patients can reduce risk for death from TB.
Major finding: Among patients with CD4 counts below 100/uL, the 56-day mortality rates was of 35.7% with sputum screening alone vs. 28.8% for combined urine and sputum screening.
Data source: Randomized pragmatic trial in 2,574 HIV+ hospitalized adults in Malawi and South Africa.
Disclosures: The study was funded by UK AID, the UK Medical Research Council, and the Wellcome Trust. Dr. Gupta-Wright reported having no conflicts of interest to disclose.
Source: Gupta-Wright A et al. CROI 2018, Abstract 38LB.
Looking to increase PrEP uptake
BOSTON – More than 1.1 million Americans are at substantial risk for HIV and would benefit from preexposure prophylaxis (PrEP), but only 90,000 prescriptions were filled by retail or mail-order pharmacies in the United States from Sept. 2015 to August 2016, according to the Centers for Disease Control and Prevention.
The CDC estimated that 500,340 blacks in the United States have indications for preexposure prophylaxis, but only about 7,000 (less than 1%) filled a prescription during that time. Among an estimated 282,260 Hispanics who might benefit, just about 7,600 (3%) filled prescriptions. Uptake was a bit higher among whites: about 42,000 prescriptions among 303,230 at-risk people (14%).
PrEP uptake might be particularly low among black and Hispanic people because, in addition to the well-known disparities in health care access and other issues: “There’s a stigma with being gay: ‘If I’m taking this drug, does that mean I’m gay?’ ” Dr. Smith said.
To address the problem, “get more serious about HIV testing. You want to find people who are positive, who need to be on treatment. The second step is to find ways to collect risk-behavior data.” That could be as simple as having the nurse ask a few extra questions before the office visit, or adding a few questions to the intake form, she said at the Conference On Retroviruses And Opportunistic Infections.
“You are trying to help patients acknowledge that they are engaging in behaviors that might have exposed them to HIV, and providers need to be able to hear the answers. One of the problems we have is providers who say ‘my patients aren’t like that,’ or ‘this person is married; I don’t need to ask them.’” Another easy way to find at-risk patients is to look at STD history. If a patient has had syphilis, or two episodes of gonorrhea in the past year, you “need to talk to them about PrEP,” she said.
For black and Hispanic patients, “it’s a higher index of suspicion. For example, you take blood pressure in all your patients, but you are also aware that hypertension is more common in African Americans. So if you’re rushed, you are still going to do a blood pressure in African American patients, but maybe not in the young white jogger; you get that next time.” Especially in high-prevalence HIV settings, “every patient should be aware of PrEP. It should be part of the conversation with everybody,” she said.
The CDC used national pharmacy data and estimates of risky behavior to draw its conclusions. Commercial pharmacies account for maybe 90% of all PrEP prescriptions, so the data slightly underestimate the true use numbers. The more than 1.1 million people included an estimated 813,970 gay and bisexual men, 258,080 heterosexuals, and 72,510 intravenous drug users. The ultimate goal of the work is target PrEP interventions where they are needed most. The agency plans to release state-by-state data soon.
CDC funded the work. Dr. Smith didn’t have any disclosures.
SOURCE: Smith DK et al. 2018 CROI, Abstract 86.
BOSTON – More than 1.1 million Americans are at substantial risk for HIV and would benefit from preexposure prophylaxis (PrEP), but only 90,000 prescriptions were filled by retail or mail-order pharmacies in the United States from Sept. 2015 to August 2016, according to the Centers for Disease Control and Prevention.
The CDC estimated that 500,340 blacks in the United States have indications for preexposure prophylaxis, but only about 7,000 (less than 1%) filled a prescription during that time. Among an estimated 282,260 Hispanics who might benefit, just about 7,600 (3%) filled prescriptions. Uptake was a bit higher among whites: about 42,000 prescriptions among 303,230 at-risk people (14%).
PrEP uptake might be particularly low among black and Hispanic people because, in addition to the well-known disparities in health care access and other issues: “There’s a stigma with being gay: ‘If I’m taking this drug, does that mean I’m gay?’ ” Dr. Smith said.
To address the problem, “get more serious about HIV testing. You want to find people who are positive, who need to be on treatment. The second step is to find ways to collect risk-behavior data.” That could be as simple as having the nurse ask a few extra questions before the office visit, or adding a few questions to the intake form, she said at the Conference On Retroviruses And Opportunistic Infections.
“You are trying to help patients acknowledge that they are engaging in behaviors that might have exposed them to HIV, and providers need to be able to hear the answers. One of the problems we have is providers who say ‘my patients aren’t like that,’ or ‘this person is married; I don’t need to ask them.’” Another easy way to find at-risk patients is to look at STD history. If a patient has had syphilis, or two episodes of gonorrhea in the past year, you “need to talk to them about PrEP,” she said.
For black and Hispanic patients, “it’s a higher index of suspicion. For example, you take blood pressure in all your patients, but you are also aware that hypertension is more common in African Americans. So if you’re rushed, you are still going to do a blood pressure in African American patients, but maybe not in the young white jogger; you get that next time.” Especially in high-prevalence HIV settings, “every patient should be aware of PrEP. It should be part of the conversation with everybody,” she said.
The CDC used national pharmacy data and estimates of risky behavior to draw its conclusions. Commercial pharmacies account for maybe 90% of all PrEP prescriptions, so the data slightly underestimate the true use numbers. The more than 1.1 million people included an estimated 813,970 gay and bisexual men, 258,080 heterosexuals, and 72,510 intravenous drug users. The ultimate goal of the work is target PrEP interventions where they are needed most. The agency plans to release state-by-state data soon.
CDC funded the work. Dr. Smith didn’t have any disclosures.
SOURCE: Smith DK et al. 2018 CROI, Abstract 86.
BOSTON – More than 1.1 million Americans are at substantial risk for HIV and would benefit from preexposure prophylaxis (PrEP), but only 90,000 prescriptions were filled by retail or mail-order pharmacies in the United States from Sept. 2015 to August 2016, according to the Centers for Disease Control and Prevention.
The CDC estimated that 500,340 blacks in the United States have indications for preexposure prophylaxis, but only about 7,000 (less than 1%) filled a prescription during that time. Among an estimated 282,260 Hispanics who might benefit, just about 7,600 (3%) filled prescriptions. Uptake was a bit higher among whites: about 42,000 prescriptions among 303,230 at-risk people (14%).
PrEP uptake might be particularly low among black and Hispanic people because, in addition to the well-known disparities in health care access and other issues: “There’s a stigma with being gay: ‘If I’m taking this drug, does that mean I’m gay?’ ” Dr. Smith said.
To address the problem, “get more serious about HIV testing. You want to find people who are positive, who need to be on treatment. The second step is to find ways to collect risk-behavior data.” That could be as simple as having the nurse ask a few extra questions before the office visit, or adding a few questions to the intake form, she said at the Conference On Retroviruses And Opportunistic Infections.
“You are trying to help patients acknowledge that they are engaging in behaviors that might have exposed them to HIV, and providers need to be able to hear the answers. One of the problems we have is providers who say ‘my patients aren’t like that,’ or ‘this person is married; I don’t need to ask them.’” Another easy way to find at-risk patients is to look at STD history. If a patient has had syphilis, or two episodes of gonorrhea in the past year, you “need to talk to them about PrEP,” she said.
For black and Hispanic patients, “it’s a higher index of suspicion. For example, you take blood pressure in all your patients, but you are also aware that hypertension is more common in African Americans. So if you’re rushed, you are still going to do a blood pressure in African American patients, but maybe not in the young white jogger; you get that next time.” Especially in high-prevalence HIV settings, “every patient should be aware of PrEP. It should be part of the conversation with everybody,” she said.
The CDC used national pharmacy data and estimates of risky behavior to draw its conclusions. Commercial pharmacies account for maybe 90% of all PrEP prescriptions, so the data slightly underestimate the true use numbers. The more than 1.1 million people included an estimated 813,970 gay and bisexual men, 258,080 heterosexuals, and 72,510 intravenous drug users. The ultimate goal of the work is target PrEP interventions where they are needed most. The agency plans to release state-by-state data soon.
CDC funded the work. Dr. Smith didn’t have any disclosures.
SOURCE: Smith DK et al. 2018 CROI, Abstract 86.
REPORTING FROM CROI
Key clinical point: To know if patients need PrEP, you first have to ask about at-risk behaviors.
Major finding: About 500,340 blacks have indications for preexposure prophylaxis (PrEP), but only about 7,000 filled a prescription from Sept. 2015-August 2016.
Study details: The findings are based on pharmacy data and estimates of risky behavior.
Disclosures: CDC funded the work. The lead investigator didn’t have any disclosures.
Source: Smith DK et al. 2018 CROI, Abstract 86.
‘Clean and sober’ ex-prisoners have better HIV suppression
BOSTON – Prisoners living with HIV who have drug- or alcohol-abuse disorders and are given extended-release naltrexone prior to release are significantly more likely to have improved viral suppression at 6 months, compared with fellow HIV+ prisoners who do not, investigators in two parallel clinical trials reported.
“A medication that can be used for reduction of alcohol and opiate use could also help stabilize patients coming out of prison and jail, and help maintain or achieve viral suppression,” said Sandra Springer, MD, from Yale University, New Haven, Conn.
“The United States incarcerates more individuals than any other country in the world, and our prevalence rates in prison of HIV are three times greater, and if we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population that has significant substance-use disorders, in particular opiate- and alcohol-use disorders,” she said at a briefing following her presentation of the data in an oral abstract session.
Dr. Springer and her colleagues had shown in a previous study that, although 59% of HIV-positive prisoners treated with ART while incarcerated attained viral suppression, the percentage who retained suppression dropped to 18% just 3 months after they were released. The investigators also found that relapse to drug and alcohol use occurs quickly after release, and that relapses are associated with loss of viral suppression.
In the studies reported at CROI 2018, Dr. Springer and her colleagues evaluated the effects of treatment with XR-NTX on HIV viral suppression among HIV-positive prisoners and jail detainees with either opioid-use disorders (NEW HOPE study) or alcohol-use disorders (INSPIRE study) after they are released to the community.
Both studies were double-blind, placebo-controlled, randomized trials. Detainees were recruited, enrolled, and randomized while imprisoned to receive either placebo or XR-NTX in six monthly injections, with the first performed in prison, and the subsequent five injections performed in the community.
The participants were all HIV-seropositive prisoners aged 18 years or older returning to communities in Connecticut and western Massachusetts who met DSM-IV criteria for either alcohol- or opioid-use disorder.
The investigators found that among opioid users in NEW HOPE, viral suppression levels (fewer than 50 copies/mL) improved from 37.9% at baseline to 60.6% at 6 months among 66 individuals who received XR-NTX (P = .002). In contrast, viral suppression among 27 placebo users dropped from 55.6% at baseline to 40.7%, although this decline was not statistically significant.
In multivariate analysis controlling for treatment arm, cocaine-use disorder, homelessness, or number of injections received, the only significant predictor for viral suppression at 6 months was XR-NTX vs. placebo (odds ratio, 2.90; P = .043). There were no serious adverse events in this study.
Among those with alcohol-use disorders in the INSPIRE study, the changes in viral suppression were similar to those in the NEW HOPE study, improving from 31% at baseline to 56.7% at 6 months among 67 participants in the XR-NTX arm (P = .001), compared with a decline from 42% to 30.3% among 33 participants in the placebo arm, although again this difference was not significant.
In the INSPIRE study, significant predictors of viral suppression at 6 months included naltrexone XR (OR, 4.54; P = .009), three or more injections (OR, 6.34; P = .001), white vs. black or Hispanic (OR, 5.37; P = .040), and alcohol improvement score, a composite measure of drinking parameters (OR, 1.43; P =.033).
Dr. Springer said in the briefing that inclusion criteria in the studies were broad enough to allow overlap between alcohol-use and drug-use disorders,
She emphasized that persons living with HIV who have drug- or alcohol-use disorders and are being released from incarcerations should be strongly considered for antiopioid and/or antialcohol pharmacotherapy in addition to ART.
The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
SOURCE: Springer S et al. CROI Abstract 96
BOSTON – Prisoners living with HIV who have drug- or alcohol-abuse disorders and are given extended-release naltrexone prior to release are significantly more likely to have improved viral suppression at 6 months, compared with fellow HIV+ prisoners who do not, investigators in two parallel clinical trials reported.
“A medication that can be used for reduction of alcohol and opiate use could also help stabilize patients coming out of prison and jail, and help maintain or achieve viral suppression,” said Sandra Springer, MD, from Yale University, New Haven, Conn.
“The United States incarcerates more individuals than any other country in the world, and our prevalence rates in prison of HIV are three times greater, and if we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population that has significant substance-use disorders, in particular opiate- and alcohol-use disorders,” she said at a briefing following her presentation of the data in an oral abstract session.
Dr. Springer and her colleagues had shown in a previous study that, although 59% of HIV-positive prisoners treated with ART while incarcerated attained viral suppression, the percentage who retained suppression dropped to 18% just 3 months after they were released. The investigators also found that relapse to drug and alcohol use occurs quickly after release, and that relapses are associated with loss of viral suppression.
In the studies reported at CROI 2018, Dr. Springer and her colleagues evaluated the effects of treatment with XR-NTX on HIV viral suppression among HIV-positive prisoners and jail detainees with either opioid-use disorders (NEW HOPE study) or alcohol-use disorders (INSPIRE study) after they are released to the community.
Both studies were double-blind, placebo-controlled, randomized trials. Detainees were recruited, enrolled, and randomized while imprisoned to receive either placebo or XR-NTX in six monthly injections, with the first performed in prison, and the subsequent five injections performed in the community.
The participants were all HIV-seropositive prisoners aged 18 years or older returning to communities in Connecticut and western Massachusetts who met DSM-IV criteria for either alcohol- or opioid-use disorder.
The investigators found that among opioid users in NEW HOPE, viral suppression levels (fewer than 50 copies/mL) improved from 37.9% at baseline to 60.6% at 6 months among 66 individuals who received XR-NTX (P = .002). In contrast, viral suppression among 27 placebo users dropped from 55.6% at baseline to 40.7%, although this decline was not statistically significant.
In multivariate analysis controlling for treatment arm, cocaine-use disorder, homelessness, or number of injections received, the only significant predictor for viral suppression at 6 months was XR-NTX vs. placebo (odds ratio, 2.90; P = .043). There were no serious adverse events in this study.
Among those with alcohol-use disorders in the INSPIRE study, the changes in viral suppression were similar to those in the NEW HOPE study, improving from 31% at baseline to 56.7% at 6 months among 67 participants in the XR-NTX arm (P = .001), compared with a decline from 42% to 30.3% among 33 participants in the placebo arm, although again this difference was not significant.
In the INSPIRE study, significant predictors of viral suppression at 6 months included naltrexone XR (OR, 4.54; P = .009), three or more injections (OR, 6.34; P = .001), white vs. black or Hispanic (OR, 5.37; P = .040), and alcohol improvement score, a composite measure of drinking parameters (OR, 1.43; P =.033).
Dr. Springer said in the briefing that inclusion criteria in the studies were broad enough to allow overlap between alcohol-use and drug-use disorders,
She emphasized that persons living with HIV who have drug- or alcohol-use disorders and are being released from incarcerations should be strongly considered for antiopioid and/or antialcohol pharmacotherapy in addition to ART.
The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
SOURCE: Springer S et al. CROI Abstract 96
BOSTON – Prisoners living with HIV who have drug- or alcohol-abuse disorders and are given extended-release naltrexone prior to release are significantly more likely to have improved viral suppression at 6 months, compared with fellow HIV+ prisoners who do not, investigators in two parallel clinical trials reported.
“A medication that can be used for reduction of alcohol and opiate use could also help stabilize patients coming out of prison and jail, and help maintain or achieve viral suppression,” said Sandra Springer, MD, from Yale University, New Haven, Conn.
“The United States incarcerates more individuals than any other country in the world, and our prevalence rates in prison of HIV are three times greater, and if we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population that has significant substance-use disorders, in particular opiate- and alcohol-use disorders,” she said at a briefing following her presentation of the data in an oral abstract session.
Dr. Springer and her colleagues had shown in a previous study that, although 59% of HIV-positive prisoners treated with ART while incarcerated attained viral suppression, the percentage who retained suppression dropped to 18% just 3 months after they were released. The investigators also found that relapse to drug and alcohol use occurs quickly after release, and that relapses are associated with loss of viral suppression.
In the studies reported at CROI 2018, Dr. Springer and her colleagues evaluated the effects of treatment with XR-NTX on HIV viral suppression among HIV-positive prisoners and jail detainees with either opioid-use disorders (NEW HOPE study) or alcohol-use disorders (INSPIRE study) after they are released to the community.
Both studies were double-blind, placebo-controlled, randomized trials. Detainees were recruited, enrolled, and randomized while imprisoned to receive either placebo or XR-NTX in six monthly injections, with the first performed in prison, and the subsequent five injections performed in the community.
The participants were all HIV-seropositive prisoners aged 18 years or older returning to communities in Connecticut and western Massachusetts who met DSM-IV criteria for either alcohol- or opioid-use disorder.
The investigators found that among opioid users in NEW HOPE, viral suppression levels (fewer than 50 copies/mL) improved from 37.9% at baseline to 60.6% at 6 months among 66 individuals who received XR-NTX (P = .002). In contrast, viral suppression among 27 placebo users dropped from 55.6% at baseline to 40.7%, although this decline was not statistically significant.
In multivariate analysis controlling for treatment arm, cocaine-use disorder, homelessness, or number of injections received, the only significant predictor for viral suppression at 6 months was XR-NTX vs. placebo (odds ratio, 2.90; P = .043). There were no serious adverse events in this study.
Among those with alcohol-use disorders in the INSPIRE study, the changes in viral suppression were similar to those in the NEW HOPE study, improving from 31% at baseline to 56.7% at 6 months among 67 participants in the XR-NTX arm (P = .001), compared with a decline from 42% to 30.3% among 33 participants in the placebo arm, although again this difference was not significant.
In the INSPIRE study, significant predictors of viral suppression at 6 months included naltrexone XR (OR, 4.54; P = .009), three or more injections (OR, 6.34; P = .001), white vs. black or Hispanic (OR, 5.37; P = .040), and alcohol improvement score, a composite measure of drinking parameters (OR, 1.43; P =.033).
Dr. Springer said in the briefing that inclusion criteria in the studies were broad enough to allow overlap between alcohol-use and drug-use disorders,
She emphasized that persons living with HIV who have drug- or alcohol-use disorders and are being released from incarcerations should be strongly considered for antiopioid and/or antialcohol pharmacotherapy in addition to ART.
The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
SOURCE: Springer S et al. CROI Abstract 96
REPORTING FROM CROI
Key clinical point: Among the HIV-positive prison population, drug and alcohol use are predictors for lower viral suppression rates.
Major finding: Viral suppression levels at 6 months were significantly higher among HIV+ drug or alcohol abusers treated with monthly naltrexone extended release.
Data source: Prospective, double-blind randomized trials in 93 HIV+ prisoners with opioid-use disorder (NEW HOPE) and 100 with alcohol-use disorder (INSPIRE).
Disclosures: The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
Source: Springer S et al. CROI, Abstract 96.
Raltegravir not associated with IRIS in African trial
BOSTON – A randomized trial in sub-Saharan Africa found no evidence that first-line raltegravir (Isentress)triggers immune reconstitution syndrome in HIV patients.
It’s an important finding because raltegravir and other integrase inhibitors are replacing nonnucleoside reverse-transcriptase inhibitors (NNRTIs) as first-line treatments for HIV. There have been a few reports from observational studies that among severely immunocompromised, the rapid drop in viral load (VL) with the drugs might trigger immune reconstitution syndrome (IRIS), an exaggerated, dysfunctional, and sometimes fatal response to pathogens as the immune system begins to recover.
The 1,805 subjects in those four countries – a few children, but mostly adults – started the trial with median baseline CD4 counts of 37 cells/mcL and VLs of 249,770 copies/mL; 903 were randomized to standard treatment with two nucleoside reverse transcriptase inhibitors plus one NNRTI (Efavirenz), while 902 were randomized to the same regimen but with raltegravir during the first 12 weeks.
As expected, VLs came down very fast in the raltegravir group to a mean of only 80 copies/mL at 4 weeks, vs. a mean of 480 copies/mL in the standard treatment arm.
After a median of about a month, 225 fatal and 113 nonfatal IRIS events (adjudicated by a review committee blinded to randomization) occurred in 9.9% of patients in the raltegravir arm and 9.5% of patients on standard treatment, a nonsignificant difference (P = .79). IRIS was fatal in 4% of raltegravir patients and 3.4% of standard-care patients, also a nonsignificant difference (P = .54).
In both groups, TB-IRIS occurred in about 6%, cryptococcal-IRIS in about 2%, and IRIS of unknown etiology in about 2%. Also in both groups, IRIS risk was highest among older subjects as well as those who went into treatment with particularly low CD4 counts or tuberculosis (TB).
“Basically, the increase in IRIS was not there. We believe these results can be extrapolated across the class of integrase inhibitors. This provides great reassurance,” especially given the prospect of first-line integrase inhibitors in developing countries, where patients tend to present with more advanced disease, said lead investigator Diana Gibb, MD, an epidemiology professor and researcher at the University College London at the Conference on Retroviruses and Opportunistic Infections.
The wrinkle in the findings was that “we didn’t see any benefit to adding raltegravir to the first 12 weeks of treatment. Everyone thought that by [driving] down the viral load faster, you might get less disease progression, and so fewer deaths. We didn’t see any difference at all. The mortality was identical at 24 weeks [around 10.5% in both arms] and at 48 weeks [around 12.5%]. The same if you looked at” severe AIDS complications, she said.
Fast, steep declines in VL “might not necessarily translate” to clinical benefit, Dr. Gibb said.
What did make a difference was IRIS prophylaxis.
The study included a second randomization at baseline, 906 subjects were randomized to enhanced prophylaxis with isoniazid, fluconazole, azithromycin, trimethoprim-sulfamethoxazole, and single-dose albendazole (Albenza); 899 others were randomized to standard prophylaxis with trimethoprim-sulfamethoxazole alone (N Engl J Med. 2017 Jul 20;377[3]:233-45).
Enhanced prophylaxis nearly halved the incidence of IRIS from 12% to 7.4%, and significantly reduced deaths at 48 weeks from 14.4% to 11% (P = .04).
“Patients with very low CD4 counts and high viral loads are the patients where this enhanced protocol package would be useful,” Dr. Gibb said.
The median age in the trial was 36 years; 4% of the subjects were 5-17 years old. Just over half the subjects were male.
The work was supported by the U.K. Department for International Development, the Wellcome Trust, and others. Dr. Gibb didn’t have any disclosures.
SOURCE: Gibb D et al. CROI, Abstract 23.
BOSTON – A randomized trial in sub-Saharan Africa found no evidence that first-line raltegravir (Isentress)triggers immune reconstitution syndrome in HIV patients.
It’s an important finding because raltegravir and other integrase inhibitors are replacing nonnucleoside reverse-transcriptase inhibitors (NNRTIs) as first-line treatments for HIV. There have been a few reports from observational studies that among severely immunocompromised, the rapid drop in viral load (VL) with the drugs might trigger immune reconstitution syndrome (IRIS), an exaggerated, dysfunctional, and sometimes fatal response to pathogens as the immune system begins to recover.
The 1,805 subjects in those four countries – a few children, but mostly adults – started the trial with median baseline CD4 counts of 37 cells/mcL and VLs of 249,770 copies/mL; 903 were randomized to standard treatment with two nucleoside reverse transcriptase inhibitors plus one NNRTI (Efavirenz), while 902 were randomized to the same regimen but with raltegravir during the first 12 weeks.
As expected, VLs came down very fast in the raltegravir group to a mean of only 80 copies/mL at 4 weeks, vs. a mean of 480 copies/mL in the standard treatment arm.
After a median of about a month, 225 fatal and 113 nonfatal IRIS events (adjudicated by a review committee blinded to randomization) occurred in 9.9% of patients in the raltegravir arm and 9.5% of patients on standard treatment, a nonsignificant difference (P = .79). IRIS was fatal in 4% of raltegravir patients and 3.4% of standard-care patients, also a nonsignificant difference (P = .54).
In both groups, TB-IRIS occurred in about 6%, cryptococcal-IRIS in about 2%, and IRIS of unknown etiology in about 2%. Also in both groups, IRIS risk was highest among older subjects as well as those who went into treatment with particularly low CD4 counts or tuberculosis (TB).
“Basically, the increase in IRIS was not there. We believe these results can be extrapolated across the class of integrase inhibitors. This provides great reassurance,” especially given the prospect of first-line integrase inhibitors in developing countries, where patients tend to present with more advanced disease, said lead investigator Diana Gibb, MD, an epidemiology professor and researcher at the University College London at the Conference on Retroviruses and Opportunistic Infections.
The wrinkle in the findings was that “we didn’t see any benefit to adding raltegravir to the first 12 weeks of treatment. Everyone thought that by [driving] down the viral load faster, you might get less disease progression, and so fewer deaths. We didn’t see any difference at all. The mortality was identical at 24 weeks [around 10.5% in both arms] and at 48 weeks [around 12.5%]. The same if you looked at” severe AIDS complications, she said.
Fast, steep declines in VL “might not necessarily translate” to clinical benefit, Dr. Gibb said.
What did make a difference was IRIS prophylaxis.
The study included a second randomization at baseline, 906 subjects were randomized to enhanced prophylaxis with isoniazid, fluconazole, azithromycin, trimethoprim-sulfamethoxazole, and single-dose albendazole (Albenza); 899 others were randomized to standard prophylaxis with trimethoprim-sulfamethoxazole alone (N Engl J Med. 2017 Jul 20;377[3]:233-45).
Enhanced prophylaxis nearly halved the incidence of IRIS from 12% to 7.4%, and significantly reduced deaths at 48 weeks from 14.4% to 11% (P = .04).
“Patients with very low CD4 counts and high viral loads are the patients where this enhanced protocol package would be useful,” Dr. Gibb said.
The median age in the trial was 36 years; 4% of the subjects were 5-17 years old. Just over half the subjects were male.
The work was supported by the U.K. Department for International Development, the Wellcome Trust, and others. Dr. Gibb didn’t have any disclosures.
SOURCE: Gibb D et al. CROI, Abstract 23.
BOSTON – A randomized trial in sub-Saharan Africa found no evidence that first-line raltegravir (Isentress)triggers immune reconstitution syndrome in HIV patients.
It’s an important finding because raltegravir and other integrase inhibitors are replacing nonnucleoside reverse-transcriptase inhibitors (NNRTIs) as first-line treatments for HIV. There have been a few reports from observational studies that among severely immunocompromised, the rapid drop in viral load (VL) with the drugs might trigger immune reconstitution syndrome (IRIS), an exaggerated, dysfunctional, and sometimes fatal response to pathogens as the immune system begins to recover.
The 1,805 subjects in those four countries – a few children, but mostly adults – started the trial with median baseline CD4 counts of 37 cells/mcL and VLs of 249,770 copies/mL; 903 were randomized to standard treatment with two nucleoside reverse transcriptase inhibitors plus one NNRTI (Efavirenz), while 902 were randomized to the same regimen but with raltegravir during the first 12 weeks.
As expected, VLs came down very fast in the raltegravir group to a mean of only 80 copies/mL at 4 weeks, vs. a mean of 480 copies/mL in the standard treatment arm.
After a median of about a month, 225 fatal and 113 nonfatal IRIS events (adjudicated by a review committee blinded to randomization) occurred in 9.9% of patients in the raltegravir arm and 9.5% of patients on standard treatment, a nonsignificant difference (P = .79). IRIS was fatal in 4% of raltegravir patients and 3.4% of standard-care patients, also a nonsignificant difference (P = .54).
In both groups, TB-IRIS occurred in about 6%, cryptococcal-IRIS in about 2%, and IRIS of unknown etiology in about 2%. Also in both groups, IRIS risk was highest among older subjects as well as those who went into treatment with particularly low CD4 counts or tuberculosis (TB).
“Basically, the increase in IRIS was not there. We believe these results can be extrapolated across the class of integrase inhibitors. This provides great reassurance,” especially given the prospect of first-line integrase inhibitors in developing countries, where patients tend to present with more advanced disease, said lead investigator Diana Gibb, MD, an epidemiology professor and researcher at the University College London at the Conference on Retroviruses and Opportunistic Infections.
The wrinkle in the findings was that “we didn’t see any benefit to adding raltegravir to the first 12 weeks of treatment. Everyone thought that by [driving] down the viral load faster, you might get less disease progression, and so fewer deaths. We didn’t see any difference at all. The mortality was identical at 24 weeks [around 10.5% in both arms] and at 48 weeks [around 12.5%]. The same if you looked at” severe AIDS complications, she said.
Fast, steep declines in VL “might not necessarily translate” to clinical benefit, Dr. Gibb said.
What did make a difference was IRIS prophylaxis.
The study included a second randomization at baseline, 906 subjects were randomized to enhanced prophylaxis with isoniazid, fluconazole, azithromycin, trimethoprim-sulfamethoxazole, and single-dose albendazole (Albenza); 899 others were randomized to standard prophylaxis with trimethoprim-sulfamethoxazole alone (N Engl J Med. 2017 Jul 20;377[3]:233-45).
Enhanced prophylaxis nearly halved the incidence of IRIS from 12% to 7.4%, and significantly reduced deaths at 48 weeks from 14.4% to 11% (P = .04).
“Patients with very low CD4 counts and high viral loads are the patients where this enhanced protocol package would be useful,” Dr. Gibb said.
The median age in the trial was 36 years; 4% of the subjects were 5-17 years old. Just over half the subjects were male.
The work was supported by the U.K. Department for International Development, the Wellcome Trust, and others. Dr. Gibb didn’t have any disclosures.
SOURCE: Gibb D et al. CROI, Abstract 23.
REPORTING FROM CROI
Key clinical point: Amid concern to the contrary, integrase inhibitors might not trigger IRIS in the severely immunocompromised.
Major finding: IRIS events – 225 fatal and 113 nonfatal – occurred in 9.9% of patients in the raltegravir arm and 9.5% of patients on standard treatment (P = .79).
Study details: Randomized trial with 1,805 subjects
Disclosures: The work was supported by the U.K. Department for International Development, the Wellcome Trust, and others. The lead investigator had no disclosures.
Source: Gibb D et al. CROI, Abstract 23.
HIV diagnosis at home and same-day ART start tied to better outcomes
BOSTON – Diagnosing HIV infections in the home and starting persons who tested positive on antiretroviral therapy on the same day significantly increased the likelihood that the HIV-positive individuals would show up at a clinic for care within 3 months of diagnosis. It also improved their odds for having viral suppression at 12 months, compared with those who tested positive but were referred to a clinic for starting ART therapy, the standard of care.
Among 278 residents of the southern African nation of Lesotho, 68.8% of those randomized to an intervention in which they were offered same-day, home-based ART initiation and were given a 30-day supply of medication had linked to care by 3 months of follow-up, compared with 43.1% of those who were diagnosed and then referred to a health care facility to be started on ART, reported Niklaus D. Labhardt, MD, from the Swiss Tropical and Public Health Institute in Basel, and his colleagues.
“This easy addition to the current practice of home-based testing has the potential to improve practice sub-Saharan African when it will become part of future guidelines and policies,” he said at a media briefing following his presentation of the data in an oral abstract session.
Results from the study were simultaneously published online in JAMA.
Although home-based testing for HIV by trained workers has become common in remote areas such as northern Lesotho, those who test positive may be lost to care and become reservoirs of infection in their communities.
In fact, only 33% of those who test positive at home take the necessary steps to receive care and start on lifelong viral suppression therapy, and “two out of three who tested positive actually remain without ART,” Dr, Labhardt said.
Compressing the testing-to-ART cascade into a single day as a means of getting more patients to start on ART has been accomplished successfully in the clinic, but never before in the home-based setting, he noted.
To see whether same-day ART initiation could be accomplished in the field, Dr. Labhardt and his colleagues designed a multicenter, randomized trial in 278 individuals aged 18 years and older from 268 households. The participants who tested HIV positive and were ART naive were chosen from among 6,655 households in rural villages and 17 urban areas in Lesotho who took part in a home-based testing program.
After giving consent, the participants were randomly assigned to either the same-day or standard of care groups.
In the same-day group, participants were offered home-based ART initiation, given a 1-month supply of drugs, and instructed to visit a specified health facility in 2-4 weeks for their first check-up and refill. The patients were scheduled for additional follow-up visits at 1.5, 3, 6, 9, and 12 months.
In the standard-of-care group, patients received posttest counseling at home and were given an appointment to their nearest health facility within the next 4 weeks; once they were linked to care, they were required to make at least two additional visits for testing prior to starting on ART. Once they started ART, they were given monthly follow-up and drug-refill appointments.
The absolute difference in 3-month linkage rates between the same-day and standard-of-care groups was 25.6% (P = .001), and the difference in 12-month viral suppression rates was 16% (P less than .007).
Retention of care, looking only at those patients who continued visits at their assigned clinics, also was significantly better among patients in the same-day group throughout the study (P = .009).
The investigators acknowledged that the study was limited by being restricted to a rural setting with a very high prevalence of HIV and that they did not have information about the possible development of drug-resistant virus among patients who started on same-day therapy but did not complete the health care link. In addition, there was only limited information available about those patients who neither linked to care or dropped out.
Dr. Labhardt said at the briefing that the same-day intervention could likely be successfully implemented in similar settings in other parts rural Africa with high HIV prevalence.
The study was funded by the Swiss National Science Foundation, Stiftung für Infektiologie beider Basel, and the Gottfried and Julia Bangerter-Rhyner Stiftung. Dr Labhardt reported support from the Stiftung für Infektiologie beider Basel and the Gottfried and Julia Bangerter-Rhyner Foundation and travel support to medical conferences from Gilead Sciences Switzerland Sarl. No other author reported disclosures.
SOURCE: Labhardt ND et al. JAMA. 2018 Mar 1. doi: 10.1001/jama.2018.1818.
BOSTON – Diagnosing HIV infections in the home and starting persons who tested positive on antiretroviral therapy on the same day significantly increased the likelihood that the HIV-positive individuals would show up at a clinic for care within 3 months of diagnosis. It also improved their odds for having viral suppression at 12 months, compared with those who tested positive but were referred to a clinic for starting ART therapy, the standard of care.
Among 278 residents of the southern African nation of Lesotho, 68.8% of those randomized to an intervention in which they were offered same-day, home-based ART initiation and were given a 30-day supply of medication had linked to care by 3 months of follow-up, compared with 43.1% of those who were diagnosed and then referred to a health care facility to be started on ART, reported Niklaus D. Labhardt, MD, from the Swiss Tropical and Public Health Institute in Basel, and his colleagues.
“This easy addition to the current practice of home-based testing has the potential to improve practice sub-Saharan African when it will become part of future guidelines and policies,” he said at a media briefing following his presentation of the data in an oral abstract session.
Results from the study were simultaneously published online in JAMA.
Although home-based testing for HIV by trained workers has become common in remote areas such as northern Lesotho, those who test positive may be lost to care and become reservoirs of infection in their communities.
In fact, only 33% of those who test positive at home take the necessary steps to receive care and start on lifelong viral suppression therapy, and “two out of three who tested positive actually remain without ART,” Dr, Labhardt said.
Compressing the testing-to-ART cascade into a single day as a means of getting more patients to start on ART has been accomplished successfully in the clinic, but never before in the home-based setting, he noted.
To see whether same-day ART initiation could be accomplished in the field, Dr. Labhardt and his colleagues designed a multicenter, randomized trial in 278 individuals aged 18 years and older from 268 households. The participants who tested HIV positive and were ART naive were chosen from among 6,655 households in rural villages and 17 urban areas in Lesotho who took part in a home-based testing program.
After giving consent, the participants were randomly assigned to either the same-day or standard of care groups.
In the same-day group, participants were offered home-based ART initiation, given a 1-month supply of drugs, and instructed to visit a specified health facility in 2-4 weeks for their first check-up and refill. The patients were scheduled for additional follow-up visits at 1.5, 3, 6, 9, and 12 months.
In the standard-of-care group, patients received posttest counseling at home and were given an appointment to their nearest health facility within the next 4 weeks; once they were linked to care, they were required to make at least two additional visits for testing prior to starting on ART. Once they started ART, they were given monthly follow-up and drug-refill appointments.
The absolute difference in 3-month linkage rates between the same-day and standard-of-care groups was 25.6% (P = .001), and the difference in 12-month viral suppression rates was 16% (P less than .007).
Retention of care, looking only at those patients who continued visits at their assigned clinics, also was significantly better among patients in the same-day group throughout the study (P = .009).
The investigators acknowledged that the study was limited by being restricted to a rural setting with a very high prevalence of HIV and that they did not have information about the possible development of drug-resistant virus among patients who started on same-day therapy but did not complete the health care link. In addition, there was only limited information available about those patients who neither linked to care or dropped out.
Dr. Labhardt said at the briefing that the same-day intervention could likely be successfully implemented in similar settings in other parts rural Africa with high HIV prevalence.
The study was funded by the Swiss National Science Foundation, Stiftung für Infektiologie beider Basel, and the Gottfried and Julia Bangerter-Rhyner Stiftung. Dr Labhardt reported support from the Stiftung für Infektiologie beider Basel and the Gottfried and Julia Bangerter-Rhyner Foundation and travel support to medical conferences from Gilead Sciences Switzerland Sarl. No other author reported disclosures.
SOURCE: Labhardt ND et al. JAMA. 2018 Mar 1. doi: 10.1001/jama.2018.1818.
BOSTON – Diagnosing HIV infections in the home and starting persons who tested positive on antiretroviral therapy on the same day significantly increased the likelihood that the HIV-positive individuals would show up at a clinic for care within 3 months of diagnosis. It also improved their odds for having viral suppression at 12 months, compared with those who tested positive but were referred to a clinic for starting ART therapy, the standard of care.
Among 278 residents of the southern African nation of Lesotho, 68.8% of those randomized to an intervention in which they were offered same-day, home-based ART initiation and were given a 30-day supply of medication had linked to care by 3 months of follow-up, compared with 43.1% of those who were diagnosed and then referred to a health care facility to be started on ART, reported Niklaus D. Labhardt, MD, from the Swiss Tropical and Public Health Institute in Basel, and his colleagues.
“This easy addition to the current practice of home-based testing has the potential to improve practice sub-Saharan African when it will become part of future guidelines and policies,” he said at a media briefing following his presentation of the data in an oral abstract session.
Results from the study were simultaneously published online in JAMA.
Although home-based testing for HIV by trained workers has become common in remote areas such as northern Lesotho, those who test positive may be lost to care and become reservoirs of infection in their communities.
In fact, only 33% of those who test positive at home take the necessary steps to receive care and start on lifelong viral suppression therapy, and “two out of three who tested positive actually remain without ART,” Dr, Labhardt said.
Compressing the testing-to-ART cascade into a single day as a means of getting more patients to start on ART has been accomplished successfully in the clinic, but never before in the home-based setting, he noted.
To see whether same-day ART initiation could be accomplished in the field, Dr. Labhardt and his colleagues designed a multicenter, randomized trial in 278 individuals aged 18 years and older from 268 households. The participants who tested HIV positive and were ART naive were chosen from among 6,655 households in rural villages and 17 urban areas in Lesotho who took part in a home-based testing program.
After giving consent, the participants were randomly assigned to either the same-day or standard of care groups.
In the same-day group, participants were offered home-based ART initiation, given a 1-month supply of drugs, and instructed to visit a specified health facility in 2-4 weeks for their first check-up and refill. The patients were scheduled for additional follow-up visits at 1.5, 3, 6, 9, and 12 months.
In the standard-of-care group, patients received posttest counseling at home and were given an appointment to their nearest health facility within the next 4 weeks; once they were linked to care, they were required to make at least two additional visits for testing prior to starting on ART. Once they started ART, they were given monthly follow-up and drug-refill appointments.
The absolute difference in 3-month linkage rates between the same-day and standard-of-care groups was 25.6% (P = .001), and the difference in 12-month viral suppression rates was 16% (P less than .007).
Retention of care, looking only at those patients who continued visits at their assigned clinics, also was significantly better among patients in the same-day group throughout the study (P = .009).
The investigators acknowledged that the study was limited by being restricted to a rural setting with a very high prevalence of HIV and that they did not have information about the possible development of drug-resistant virus among patients who started on same-day therapy but did not complete the health care link. In addition, there was only limited information available about those patients who neither linked to care or dropped out.
Dr. Labhardt said at the briefing that the same-day intervention could likely be successfully implemented in similar settings in other parts rural Africa with high HIV prevalence.
The study was funded by the Swiss National Science Foundation, Stiftung für Infektiologie beider Basel, and the Gottfried and Julia Bangerter-Rhyner Stiftung. Dr Labhardt reported support from the Stiftung für Infektiologie beider Basel and the Gottfried and Julia Bangerter-Rhyner Foundation and travel support to medical conferences from Gilead Sciences Switzerland Sarl. No other author reported disclosures.
SOURCE: Labhardt ND et al. JAMA. 2018 Mar 1. doi: 10.1001/jama.2018.1818.
REPORTING FROM CROI
Key clinical point: A home-based HIV diagnosis and same-day antiretroviral therapy initiation program may improve outcomes in rural areas.
Major finding: 12-month rates of viral suppression were 50.4% for patients started on ART on the day of a home-based diagnosis, vs. 34.3% for those referred to a clinic for ART.
Data source: Randomized, controlled trial with 278 residents of northern Lesotho who tested positive in home-based HIV testing program.
Disclosures: The study was funded by the Swiss National Science Foundation, Stiftung für Infektiologie beider Basel, and the Gottfried und Julia Bangerter-Rhyner Stiftung. Dr. Labhardt reported support from the Stiftung für Infektiologie beider Basel and the Gottfried and Julia Bangerter-Rhyner and travel support to medical conferences from Gilead Sciences Switzerland Sarl. No other author reported disclosures.
Source: Labhardt ND et al. JAMA. 2018 Mar 1. doi: 10.1001/jama.2018.1818.
Hair tracks HIV antiretroviral adherence
BOSTON – Hair is the key to knowing if patients have been taking their HIV antiretrovirals. In fact, hair levels were the strongest independent predictor of virologic control in a major trial of HIV-positive, treatment-naive patients that compared atazanavir, darunavir, and raltegravir-based regimens. Virologic success was similar in all three arms, but the raltegravir regimen was better tolerated than the protease inhibitor arms (Ann Intern Med. 2014 Oct 7;161[7]:461-71).
Because patient self-reporting is notoriously unreliable, the investigators checked hair for adherence. The results for 599 participants followed for a median of 217 weeks were reported at the Conference on Retroviruses and Opportunistic Infections. Hair samples were collected at weeks 4, 8, 16, and then quarterly; concentrations of the three drugs were measured by liquid chromatography-tandem mass spectrometry.
Rates of virologic failure were 26%, 6%, and 3% for patients with hair levels in the lowest, middle, and highest tertiles, respectively. Lower hair antiretroviral (ARV) levels strongly predicted virologic failure (hazard ratio for every twofold decrease in hair level 1.69, 95% confidence interval, 1.43-2.04, P less than .001). Results were consistent across drugs and for each drug individually.
Patients with ARV hair levels in the lowest tertile were 6.8 times more likely to fail than were patients in the highest tertile. The actual level that was considered low depended on the drug.
Meanwhile, self-reported adherence – a median of 100% in each arm – barely correlated with actual ARV levels (Pearson’s r 0.15).
In the end, “hair levels were the strongest independent predictor of how you did,” said lead investigator Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco, General Hospital.
Testing for hair levels is already a part of clinical care at UCSF, which has a hair analysis lab. In one case, a 21-year-old man seroconverted after saying he was taking pre-exposure prophylaxis (PrEP) perfectly. After a check of his hair, it turned out that he was, but had caught a drug-resistant virus. Another patient who seroconverted on PrEP turned out to have missed some doses a few months before.
Ideally, hair testing could be used early on to provide extra help to patients who prove to have trouble with adherence. Text messaging – as long as the doctor actually responds – is effective, but so is just bringing people in and asking them how they needed to be helped, Dr. Gandhi said.
All that’s required for testing is a small bit of hair from the back of the head, cut close to the scalp. It’s easy and quick, but even so, acceptance was only 55% in the trial. “Where it seems to not be accepted in this country is in men who have sex with men.” Sometimes patients worry about their hairstyle, but “it isn’t very disruptive because it’s a very small amount of hair,” she said.
Bleaching is the only hair treatment that seems to affect ARV levels, reducing them. Short hair is fine, but it keeps less of a record over time. In general, “hair levels are more helpful in PrEP than in treatment, because in treatment we need a real time point of care test” for adherence, Dr. Gandhi said; her team has come up with a urine screen for tenofovir that looks promising.
The mean age in the study was 38 years. About a third of the subjects were women, and a third were black. The findings were similar for men and women.
The drugs in the trial were provided by their manufacturers. Dr. Gandhi had no relevant disclosures.
SOURCE: Gandhi M et al. Abstract 24.
BOSTON – Hair is the key to knowing if patients have been taking their HIV antiretrovirals. In fact, hair levels were the strongest independent predictor of virologic control in a major trial of HIV-positive, treatment-naive patients that compared atazanavir, darunavir, and raltegravir-based regimens. Virologic success was similar in all three arms, but the raltegravir regimen was better tolerated than the protease inhibitor arms (Ann Intern Med. 2014 Oct 7;161[7]:461-71).
Because patient self-reporting is notoriously unreliable, the investigators checked hair for adherence. The results for 599 participants followed for a median of 217 weeks were reported at the Conference on Retroviruses and Opportunistic Infections. Hair samples were collected at weeks 4, 8, 16, and then quarterly; concentrations of the three drugs were measured by liquid chromatography-tandem mass spectrometry.
Rates of virologic failure were 26%, 6%, and 3% for patients with hair levels in the lowest, middle, and highest tertiles, respectively. Lower hair antiretroviral (ARV) levels strongly predicted virologic failure (hazard ratio for every twofold decrease in hair level 1.69, 95% confidence interval, 1.43-2.04, P less than .001). Results were consistent across drugs and for each drug individually.
Patients with ARV hair levels in the lowest tertile were 6.8 times more likely to fail than were patients in the highest tertile. The actual level that was considered low depended on the drug.
Meanwhile, self-reported adherence – a median of 100% in each arm – barely correlated with actual ARV levels (Pearson’s r 0.15).
In the end, “hair levels were the strongest independent predictor of how you did,” said lead investigator Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco, General Hospital.
Testing for hair levels is already a part of clinical care at UCSF, which has a hair analysis lab. In one case, a 21-year-old man seroconverted after saying he was taking pre-exposure prophylaxis (PrEP) perfectly. After a check of his hair, it turned out that he was, but had caught a drug-resistant virus. Another patient who seroconverted on PrEP turned out to have missed some doses a few months before.
Ideally, hair testing could be used early on to provide extra help to patients who prove to have trouble with adherence. Text messaging – as long as the doctor actually responds – is effective, but so is just bringing people in and asking them how they needed to be helped, Dr. Gandhi said.
All that’s required for testing is a small bit of hair from the back of the head, cut close to the scalp. It’s easy and quick, but even so, acceptance was only 55% in the trial. “Where it seems to not be accepted in this country is in men who have sex with men.” Sometimes patients worry about their hairstyle, but “it isn’t very disruptive because it’s a very small amount of hair,” she said.
Bleaching is the only hair treatment that seems to affect ARV levels, reducing them. Short hair is fine, but it keeps less of a record over time. In general, “hair levels are more helpful in PrEP than in treatment, because in treatment we need a real time point of care test” for adherence, Dr. Gandhi said; her team has come up with a urine screen for tenofovir that looks promising.
The mean age in the study was 38 years. About a third of the subjects were women, and a third were black. The findings were similar for men and women.
The drugs in the trial were provided by their manufacturers. Dr. Gandhi had no relevant disclosures.
SOURCE: Gandhi M et al. Abstract 24.
BOSTON – Hair is the key to knowing if patients have been taking their HIV antiretrovirals. In fact, hair levels were the strongest independent predictor of virologic control in a major trial of HIV-positive, treatment-naive patients that compared atazanavir, darunavir, and raltegravir-based regimens. Virologic success was similar in all three arms, but the raltegravir regimen was better tolerated than the protease inhibitor arms (Ann Intern Med. 2014 Oct 7;161[7]:461-71).
Because patient self-reporting is notoriously unreliable, the investigators checked hair for adherence. The results for 599 participants followed for a median of 217 weeks were reported at the Conference on Retroviruses and Opportunistic Infections. Hair samples were collected at weeks 4, 8, 16, and then quarterly; concentrations of the three drugs were measured by liquid chromatography-tandem mass spectrometry.
Rates of virologic failure were 26%, 6%, and 3% for patients with hair levels in the lowest, middle, and highest tertiles, respectively. Lower hair antiretroviral (ARV) levels strongly predicted virologic failure (hazard ratio for every twofold decrease in hair level 1.69, 95% confidence interval, 1.43-2.04, P less than .001). Results were consistent across drugs and for each drug individually.
Patients with ARV hair levels in the lowest tertile were 6.8 times more likely to fail than were patients in the highest tertile. The actual level that was considered low depended on the drug.
Meanwhile, self-reported adherence – a median of 100% in each arm – barely correlated with actual ARV levels (Pearson’s r 0.15).
In the end, “hair levels were the strongest independent predictor of how you did,” said lead investigator Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco, General Hospital.
Testing for hair levels is already a part of clinical care at UCSF, which has a hair analysis lab. In one case, a 21-year-old man seroconverted after saying he was taking pre-exposure prophylaxis (PrEP) perfectly. After a check of his hair, it turned out that he was, but had caught a drug-resistant virus. Another patient who seroconverted on PrEP turned out to have missed some doses a few months before.
Ideally, hair testing could be used early on to provide extra help to patients who prove to have trouble with adherence. Text messaging – as long as the doctor actually responds – is effective, but so is just bringing people in and asking them how they needed to be helped, Dr. Gandhi said.
All that’s required for testing is a small bit of hair from the back of the head, cut close to the scalp. It’s easy and quick, but even so, acceptance was only 55% in the trial. “Where it seems to not be accepted in this country is in men who have sex with men.” Sometimes patients worry about their hairstyle, but “it isn’t very disruptive because it’s a very small amount of hair,” she said.
Bleaching is the only hair treatment that seems to affect ARV levels, reducing them. Short hair is fine, but it keeps less of a record over time. In general, “hair levels are more helpful in PrEP than in treatment, because in treatment we need a real time point of care test” for adherence, Dr. Gandhi said; her team has come up with a urine screen for tenofovir that looks promising.
The mean age in the study was 38 years. About a third of the subjects were women, and a third were black. The findings were similar for men and women.
The drugs in the trial were provided by their manufacturers. Dr. Gandhi had no relevant disclosures.
SOURCE: Gandhi M et al. Abstract 24.
AT CROI
Key clinical point: Hair is a solid alternative to blood, urine, and self-report for HIV drug adherence.
Major finding: Virologic failure was 6,8 times more likely among subjects with antiretroviral hair levels in the lowest tertile, compared with those in the highest tertile.
Study details: Phase 3 trial with 599 subjects.
Disclosures: The drugs in the trial were provided by their manufacturers. The lead investigator had no relevant disclosures.
Source: Gandhi M et al. Abstract 24.
