Title | Antiretroviral Therapy for the Prevention of HIV-1 Transmission |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Cohen, MS, Chen, YQ, McCauley, M, Gamble, T, Hosseinipour, MC, Kumarasamy, N, Hakim, JG, Kumwenda, J, Grinsztejn, B, Pilotto, JH, Godbole, SV, Chariyalertsak, S, Santos, BR, Mayer, KH, Hoffman, IF, Eshleman, SH, Piwowar-Manning, E, Cottle, L, Zhang, XC, Makhema, J, Mills, LA, Panchia, R, Faesen, S, Eron, J, Gallant, J, Havlir, D, Swindells, S, Elharrar, V, Burns, D, Taha, TE, Nielsen-Saines, K, Celentano, DD, Essex, M, Hudelson, SE, Redd, AD, Fleming, TR |
Journal | N Engl J Med |
Volume | 375 |
Pagination | 830-9 |
Date Published | Sep 01 |
ISBN Number | 0028-4793 |
Accession Number | 27424812 |
Keywords | *HIV-1/genetics, *Sexual Partners, Adult, Anti-Retroviral Agents/*therapeutic use, Disease Transmission, Infectious/*prevention & control, Female, Follow-Up Studies, HIV Infections/prevention & control/*transmission, HIV Seropositivity, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Middle Aged, Risk, Young Adult |
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 .). |
PMCID | PMC5049503 |