Antiretroviral Therapy for the Prevention of HIV-1 Transmission.

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

DOI Link

10.1056/NEJMoa1600693

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

Recommended Citation

Cohen, Myron S.; Chen, Ying Q.; McCauley, Marybeth; Gamble, Theresa; Hosseinipour, Mina C.; Kumarasamy, Nagalingeswaran; Hakim, James G.; Kumwenda, Johnstone; Grinsztejn, Beatriz; Pilotto, Jose H.S.; Godbole, Sheela V.; Chariyalertsak, Suwat; Santos, Breno R.; Mayer, Kenneth H.; Hoffman, Irving F.; Eshleman, Susan H.; Piwowar-Manning, Estelle; Cottle, Leslie; Zhang, Xinyi C.; Makhema, Joseph; Mills, Lisa A.; Panchia, Ravindre; Faesen, Sharlaa; Eron, Joseph; Gallant, Joel; Havlir, Diane; Swindells, Susan; Elharrar, Vanessa; Burns, David; Taha, Taha E.; Nielsen-Saines, Karin; Celentano, David D.; Essex, Max; Hudelson, Sarah E.; Redd, Andrew D.; and Fleming, Thomas R., "Antiretroviral Therapy for the Prevention of HIV-1 Transmission." (2016). Journal Articles: Internal Medicine. 4.
https://digitalcommons.unmc.edu/com_internal_articles/4