Authors

Myron S. Cohen, University of North Carolina at Chapel Hill
Ying Q. Chen, University of North Carolina at Chapel Hill
Marybeth McCauley, FHI 360, Washington, DC
Theresa Gamble, FHI 360, Durham, NC
Mina C. Hosseinipour, University of North Carolina at Chapel Hill
Nagalingeswaran Kumarasamy, Gaitonde Center for AIDS Research and Education
James G. Hakim, University of Zimbabwe
Johnstone Kumwenda, College of Medicine-Johns Hopkins Project
Beatriz Grinsztejn, Instituto de Pesquisa Clinica Evandro Chagas
Jose H.S. Pilotto, Hospital Geral de Nova Iguacu and Laboratorio de AIDS e Imunologia Molecular-IOC/Fiocruz
Sheela V. Godbole, National AIDS Research Institute
Suwat Chariyalertsak, Chiang Mai University
Breno R. Santos, Hospital Nossa Senhora da Conceicao/GHC, Porto Alegre
Kenneth H. Mayer, Fenway Institute
Irving F. Hoffman, University of North Carolina at Chapel Hill
Susan H. Eshleman, Johns Hopkins University School of Medicine
Estelle Piwowar-Manning, Johns Hopkins University School of Medicine
Leslie Cottle, University of North Carolina at Chapel Hill
Xinyi C. Zhang, University of North Carolina at Chapel Hill
Joseph Makhema, Botswana Harvard AIDS Institute
Lisa A. Mills, Centers for Disease Control and Prevention
Ravindre Panchia, University of the Witwatersrand, Johannesburg
Sharlaa Faesen, University of the Witwatersrand, Johannesburg
Joseph Eron, University of North Carolina at Chapel Hill
Joel Gallant, Southwest CARE Center
Diane Havlir, University of California, San Francisco
Susan Swindells, University of Nebraska Medical CenterFollow
Vanessa Elharrar, National Institutes of Health
David Burns, National Institutes of Health
Taha E. Taha, Bloomberg School of Public Health
Karin Nielsen-Saines, David Geffen UCLA School of Medicine
David D. Celentano, Johns Hopkins Bloomberg School of Public Health
Max Essex, Harvard School of Public Health
Sarah E. Hudelson, Johns Hopkins University School of Medicine
Andrew D. Redd, National Institutes of Health
Thomas R. Fleming, University of Washington - Seattle Campus

Document Type

Article

Journal Title

The New England journal of medicine

Publication Date

Fall 9-1-2016

Volume

375

Abstract

BACKGROUND: An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.

METHODS: We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis.

RESULTS: Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant.

CONCLUSIONS: The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581 .).

MeSH Headings

Adult, Anti-Retroviral Agents, Disease Transmission, Infectious, Female, Follow-Up Studies, HIV Infections, HIV Seropositivity, HIV-1, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Middle Aged, Risk, Sexual Partners, Young Adult

ISSN

1533-4406

Rights

"From [The New England journal of medicine,Cohen MS, Chen YQ, McCauley M, et al. Antiretroviral Therapy for the Prevention of HIV-1 Transmission, 375, 830-9. Copyright © (2016) Massachusetts Medical Society. Reprinted with permission. http://www.nejm.org/doi/full/10.1056/NEJMoa1600693#t=article

Included in

Primary Care Commons

COinS