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Antiretroviral Treatment for Prevention of HIV Transmission
Myron S. Cohen, M.D.1, Ying Q. Chen, Ph.D.2, Marybeth McCauley, M.P.H. 3, Theresa Gamble, Ph.D.3, Mina C. Hosseinipour, M.D.1, Nagalingeswaran Kumarasamy, M.B., B.S.4, James G. Hakim, M.D.5, Johnstone Kumwenda, F.R.C.P.6, Beatriz Grinsztejn, M.D.7, Jose H.S. Pilotto, M.D.8, Sheela V. Godbole, M.D.9, Suwat Chariyalertsak, M.D.10, Breno R. Santos, M.D.11, Kenneth H. Mayer, M.D.12, Irving F. Hoffman, P.A.1, Susan H. Eshleman, M.D., Ph.D.13, Estelle Piwowar-Manning, M.T. (ASCP)13, Leslie Cottle, B.S.14, Xinyi Cindy Zhang, Ph.D.15, Joseph Makhema, M.B., B. Ch.16, Lisa A. Mills, M.D.17, Ravindre Panchia, M.B., B.Ch.18, Sharlaa Faesen, M.B., B.Ch.19, Joseph Eron, M.D.1, Joel Gallant, M.D.20, Diane Havlir, M.D.21, Susan Swindells, M.B., B.S.22, Vanessa Elharrar, M.D.23, David Burns, M.D.23, Taha E. Taha, M.B., B.S.24, Karin Nielsen-Saines, M.D.25, David D. Celentano, Sc.D.26, Max Essex, D.V.M.27, Sarah E. Hudelson, B.S.13, Andrew D. Redd, Ph.D. 28,29, and Thomas R. Fleming, Ph.D.30, for the HPTN 052 Study Team*
1Dept. of Medicine, Univ. of North Carolina at Chapel Hill, Chapel Hill, NC; 2Vaccine and Infectious Disease Division and Public Health Science Division, Fred Hutchinson Cancer Research Center, Seattle, WA; 3FHI 360, Washington, DC; 4Y.R. Gaitonade Center for AIDS Research and Education, Chennai, India; 5University of Zimbabwe, Harare, Zimbabwe; 6College of Medicine-Johns Hopkins Project, Blantyre, Malawi; 7Instituto de Pesquisa Clinica Evandro Chagas, Rio de Janeiro, Brazil; 8Hospital Geral de Nova Iguacu and Laboratorio de AIDS e Imunologia Molecular-IOC/Fiocruz, Rio de Janeiro, Brazil; 9National AIDS Research Institute (ICMR), Pune, India; 10Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand; 11Servico de Infectologia, Hospital Nossa Senhora da Conceicao/GHC, Porto Alegre, Brazil; 12Fenway Institute,Boston, MA; 13Dept. of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; 14SCHARP, Fred Hutchinson Cancer Research Center, Seattle, WA; 15Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; 16Botswana Harvard Aids Institute, Gaborone, Botswana; 17CDC Division of HIV/AIDS Prevention/KEMRI-CDC Research and Public Health Collaboration HIV Research Branch, Kisumu, Kenya; 18Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa; 19Clinical HIV Research Unit, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 20Southwest CARE Center, Santa Fe, NM; 21University of California San Francisco, San Francisco, CA; 22University of Nebraska Medical Center, Omaha, NE: 23Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD; 24Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; 25Division of Infectious Diseases, David Geffen UCLA School of Medicine, Los Angeles, CA; 26Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; 27Harvard School of Public Health, Boston, MA; 28Dept. of Medicine, Johns Hopkins Univ. School of Medicine, Baltimore, MD; 29Laboratory of Immunoregulation, NIAID, NIH, Bethesda, MD; 30Department of Biostatistics, University of Washington, Seattle, WA.
Interim analysis of the HIV Prevention Trials Network (HPTN) 052 trial demonstrated that antiretroviral therapy (ART) prevented >96% of linked HIV-1 infections in serodiscordant couples. ART was then offered to all HIV-infected index participants; the study included pre-planned follow-up for >5 years to assess the durability of ART for HIV prevention.
HIV-infected participants were randomized to early or delayed treatment arms. In the early ART arm, 866 study participants started ART at enrollment (CD4 count 350-550 cells/mm3). In the delayed ART arm, 877study participants started ART after two consecutive CD4 cell counts fell between 200 and 250 cells/mm3 or if they developed an AIDS-defining illness. The primary study endpoint was genetically-linked partner HIV infections.
Index participants were followed for 10,131 person-years (PYs); partners were followed for 8,509 PYs. Seventy-eight partner infections were observed during the trial (annual incidence: 0.9%, 95% confidence intervals [CI]: 0.7-1.1%); viral linkage status was determined for 72 (92.3%) of the partner infections. Twenty-six infections were unlinked (14 in the early ART arm; 12 in the delayed ART arm; incidence: 0.3%, 95% CI: 0.2-0.4%) and 46 infections were linked (3 in the early ART arm, 43 in the delayed ART arm; incidence: 0.5%, 95% CI: 0.4-0.7%). Relative to delayed ART, early ART prevented 93% of linked HIV infections (hazard ratio: 0.07, 95% CI: 0.02-0.22). No linked infections were observed when the index participant was stably suppressed on ART.
ART use led to a sustained decrease in sexual transmission of partner associated genetically-linked HIV. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.)
Originally Appeared in The New England Journal of Medicine online on July 17, 2016.
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