Iris Chen1, Matthew B Connor, William Clarke, Mark A Marzinke, Vanessa Cummings, Autumn Breaud, Jessica M Fogel, Oliver Laeyendecker, Sheldon D Fields, Deborah Donnell, Sam Griffith, Hyman M Scott, Steven Shoptaw, Carlos del Rio, Manya Magnus, Sharon Mannheimer, Darrell P Wheeler, Kenneth H Mayer, Beryl A Koblin, Susan H Eshleman. 1. *Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; †Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ‡Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, MD; §Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; ‖College of Nursing and Health Sciences, Florida International University, Miami, FL; ¶Department of Global Health, University of Washington, Seattle, WA; #Science Facilitation Department, FHI 360, Durham, NC; **Bridge HIV, San Francisco Department of Public Health, San Francisco, CA; ††Department of Family Medicine, University of California Los Angeles, Los Angeles, CA; ‡‡Department of Global Health, Emory University Rollins School of Public Health, Atlanta, GA; §§Department of Epidemiology and Biostatistics, The George Washington University, Washington, DC; ‖‖Department of Medicine, Harlem Hospital, Mailman School of Public Health, Columbia University, New York, NY; ¶¶Graduate School of Social Work, Loyola University Chicago, Chicago, IL; ##Division of Fenway Health, The Fenway Institute, Boston, MA; ***Infectious Disease Division, Beth Israel Deaconess Medical Center, Boston, MA; †††Department of Medicine, Harvard Medical School, Boston, MA; and ‡‡‡Laboratory of Infectious Disease Prevention, Lindsley F. Kimball Research Institute, New York Blood Center, New York, NY.
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.
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.
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