ARV Drug Use and HIV Drug Resistance Among HIV+ Black MSM
ARV Drug Use and HIV Drug Resistance Among HIV+ Black MSM
Background: HIV Prevention Trials Network (HPTN) 061 enrolled black men who have sex with men in the United States. Some men with low/undetectable HIV RNA had unusual patterns of antiretroviral (ARV) drug use or had drugs detected in the absence of viral suppression. This report includes a comprehensive analysis of ARV drug use and drug resistance among men in HPTN 061 who were not virally suppressed.
Methods: The analysis included 169 men who had viral loads >400 copies per milliliter at enrollment, including 3 with acute infection and 13 with recent infection. By self-report, 88 were previously diagnosed, including 31 in care; 137 men reported no ARV drug use. Samples from these 169 men and 23 seroconverters were analyzed with HIV genotyping and ARV drug assays.
Results: Forty-eight (28%) of the 169 men had ≥1 drug resistance mutation (DRM); 19 (11%) had multiclass resistance. Sixty men (36%) had ≥1 ARV drug detected, 42 (70%) of whom reported no ARV drug use. Nine (23%) of 39 newly infected men had ≥1 DRM; 10 had ≥1 ARV drug detected. Unusual patterns of ARV drugs were detected more frequently in newly diagnosed men than previously diagnosed men. The rate of transmitted drug resistance was 23% based on HIV genotyping and self-reported ARV drug use but was 12% after adjusting for ARV drug detection.
Conclusions: Many men in HPTN 061 had drug-resistant HIV, and many were at risk of acquiring additional DRMs. ARV drug testing revealed unusual patterns of ARV drug use and provided a more accurate estimate of transmitted drug resistance.
In the United States, men who have sex with men (MSM) account for 66% of new HIV infections and over half of those living with HIV. Black MSM are disproportionately affected by the HIV epidemic. The HIV Prevention Trials Network (HPTN) 061 study evaluated the feasibility of a multicomponent intervention to reduce HIV incidence in black MSM and is the largest longitudinal cohort of black MSM in the United States to date. The study enrolled both HIV-uninfected men at a high risk of HIV acquisition and HIV-infected men. HIV incidence in this cohort was 3.0% overall and 5.9% among younger participants (ages 18–30 years).
HPTN 061 provided important information about the HIV epidemic in black MSM. By design, most of the HIV-infected men enrolled in HPTN 061 reported that they were unaware of their HIV status (newly diagnosed) or that they were aware of their status (previously diagnosed) but were not in care. However, 54% of the HIV-infected men who reported that they were newly diagnosed had low or undetectable HIV viral loads at enrollment. Although none of these men reported previous or current antiretroviral (ARV) drug use, ARV drug testing revealed that 78% of these men were on ARV treatment (ART) but chose not to disclose this to study staff. Some men had unusual patterns of ARV drugs detected [e.g., 2 non-nucleoside reverse transcription inhibitors (NNRTIs), an NNRTI with a protease inhibitor (PI), or multiple PIs]. A few men had 1 or 2 nucleoside/nucleotide reverse transcription inhibitors (NRTIs) detected in the absence of an NNRTI or PI, which suggested that they may have been using ARV drugs for pre- or post-exposure prophylaxis (PrEP or PEP). ARV drugs were also detected in some men with low but detectable HIV viral loads (400–1000 copies/mL). This was concerning because exposure to nonsuppressive levels of ARV drugs promotes selection of HIV with drug resistance mutations (DRMs), which can be transmitted to others. These findings indicated the need for further evaluation of ARV drug use and HIV drug resistance among black MSM in the HPTN 061 cohort.
This report presents a comprehensive analysis of ARV drug use and HIV drug resistance among HIV-infected men in the HPTN 061 cohort who were not virally suppressed. By combining ARV drug testing with HIV genotyping, we were able to assess current levels of drug resistance, the risk for increasing drug resistance, and patterns of ARV drug use in this cohort. Inclusion of ARV drug testing in these assessments, rather than relying solely on self-reported ARV drug use, also provided a more accurate estimate of the frequency of transmitted drug resistance (TDR).
Abstract and Introduction
Abstract
Background: HIV Prevention Trials Network (HPTN) 061 enrolled black men who have sex with men in the United States. Some men with low/undetectable HIV RNA had unusual patterns of antiretroviral (ARV) drug use or had drugs detected in the absence of viral suppression. This report includes a comprehensive analysis of ARV drug use and drug resistance among men in HPTN 061 who were not virally suppressed.
Methods: The analysis included 169 men who had viral loads >400 copies per milliliter at enrollment, including 3 with acute infection and 13 with recent infection. By self-report, 88 were previously diagnosed, including 31 in care; 137 men reported no ARV drug use. Samples from these 169 men and 23 seroconverters were analyzed with HIV genotyping and ARV drug assays.
Results: Forty-eight (28%) of the 169 men had ≥1 drug resistance mutation (DRM); 19 (11%) had multiclass resistance. Sixty men (36%) had ≥1 ARV drug detected, 42 (70%) of whom reported no ARV drug use. Nine (23%) of 39 newly infected men had ≥1 DRM; 10 had ≥1 ARV drug detected. Unusual patterns of ARV drugs were detected more frequently in newly diagnosed men than previously diagnosed men. The rate of transmitted drug resistance was 23% based on HIV genotyping and self-reported ARV drug use but was 12% after adjusting for ARV drug detection.
Conclusions: Many men in HPTN 061 had drug-resistant HIV, and many were at risk of acquiring additional DRMs. ARV drug testing revealed unusual patterns of ARV drug use and provided a more accurate estimate of transmitted drug resistance.
Introduction
In the United States, men who have sex with men (MSM) account for 66% of new HIV infections and over half of those living with HIV. Black MSM are disproportionately affected by the HIV epidemic. The HIV Prevention Trials Network (HPTN) 061 study evaluated the feasibility of a multicomponent intervention to reduce HIV incidence in black MSM and is the largest longitudinal cohort of black MSM in the United States to date. The study enrolled both HIV-uninfected men at a high risk of HIV acquisition and HIV-infected men. HIV incidence in this cohort was 3.0% overall and 5.9% among younger participants (ages 18–30 years).
HPTN 061 provided important information about the HIV epidemic in black MSM. By design, most of the HIV-infected men enrolled in HPTN 061 reported that they were unaware of their HIV status (newly diagnosed) or that they were aware of their status (previously diagnosed) but were not in care. However, 54% of the HIV-infected men who reported that they were newly diagnosed had low or undetectable HIV viral loads at enrollment. Although none of these men reported previous or current antiretroviral (ARV) drug use, ARV drug testing revealed that 78% of these men were on ARV treatment (ART) but chose not to disclose this to study staff. Some men had unusual patterns of ARV drugs detected [e.g., 2 non-nucleoside reverse transcription inhibitors (NNRTIs), an NNRTI with a protease inhibitor (PI), or multiple PIs]. A few men had 1 or 2 nucleoside/nucleotide reverse transcription inhibitors (NRTIs) detected in the absence of an NNRTI or PI, which suggested that they may have been using ARV drugs for pre- or post-exposure prophylaxis (PrEP or PEP). ARV drugs were also detected in some men with low but detectable HIV viral loads (400–1000 copies/mL). This was concerning because exposure to nonsuppressive levels of ARV drugs promotes selection of HIV with drug resistance mutations (DRMs), which can be transmitted to others. These findings indicated the need for further evaluation of ARV drug use and HIV drug resistance among black MSM in the HPTN 061 cohort.
This report presents a comprehensive analysis of ARV drug use and HIV drug resistance among HIV-infected men in the HPTN 061 cohort who were not virally suppressed. By combining ARV drug testing with HIV genotyping, we were able to assess current levels of drug resistance, the risk for increasing drug resistance, and patterns of ARV drug use in this cohort. Inclusion of ARV drug testing in these assessments, rather than relying solely on self-reported ARV drug use, also provided a more accurate estimate of the frequency of transmitted drug resistance (TDR).
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