Antiretroviral Drug Use and HIV Drug Resistance Among HIV-Infected Black Men Who Have Sex With Men

Abstract

BACKGROUND 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/mL at enrollment, including three 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 multi-class 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 (TDR) 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 TDR.

Evaluation of a Multidrug Assay for Monitoring Adherence to a Regimen for HIV Preexposure Prophylaxis in a Clinical Study, HIV Prevention Trials Network 073

“…In most cases, the drugs detected were consistent with ART regimens recommended at the time of the study. Many of the men for whom drugs were detected did not demonstrate viral suppression and many were using unusual combinations of drugs, which likely contributed to the high frequency of drug resistance observed in that cohort (19). Unusual patterns of ARV drug use were also detected among seroconverters in the HPTN 061 cohort (19).…”

“…Many of the men for whom drugs were detected did not demonstrate viral suppression and many were using unusual combinations of drugs, which likely contributed to the high frequency of drug resistance observed in that cohort (19). Unusual patterns of ARV drug use were also detected among seroconverters in the HPTN 061 cohort (19). In another study (HPTN 064 [2009 to 2010]), we found unusual patterns of ARV drug use among HIV-uninfected women in the United States who were at increased risk of HIV acquisition (20,29).…”

“…When data are collected by self-report, some individuals may forget when they took the drugs, and others may choose to provide socially desirable answers (27). In a clinical trial setting, enrollment criteria and other features of the trial design may inadvertently encourage some participants not to disclose knowledge of their HIV status or ARV drug use (19,28). ARV drug testing provides an objective biomedical measure of ARV drug use.…”

“…This allowed us to explore whether the men enrolled in HPTN 073 were using any other ARV drugs. In a previous study, we analyzed ARV drug use among HIV-infected men in the HPTN 061 study (2009 to 2011), which enrolled 1,553 Black MSM in six cities in the United States, including the three sites in HPTN 073 (19,21). At the time when HPTN 061 was performed, there were no ARV drugs approved for PrEP for sexual HIV transmission.…”

“…We previously developed a qualitative method based on high-resolution mass spectrometry (HRMS) (18) that is less costly than LC-MS/MS methods. That assay detected 15 or 16 ARV drugs in three drug classes (19)(20)(21). The multidrug assay was recently modified to detect 20 ARV drugs in five drug classes (22).…”