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Antiretroviral Therapy for the Prevention of HIV-1 Transmission.


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 .).

SUBMITTER: Cohen MS 

PROVIDER: S-EPMC5049503 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Antiretroviral Therapy for the Prevention of HIV-1 Transmission.

Cohen Myron S MS   Chen Ying Q YQ   McCauley Marybeth M   Gamble Theresa T   Hosseinipour Mina C MC   Kumarasamy Nagalingeswaran N   Hakim James G JG   Kumwenda Johnstone J   Grinsztejn Beatriz B   Pilotto Jose H S JH   Godbole Sheela V SV   Chariyalertsak Suwat S   Santos Breno R BR   Mayer Kenneth H KH   Hoffman Irving F IF   Eshleman Susan H SH   Piwowar-Manning Estelle E   Cottle Leslie L   Zhang Xinyi C XC   Makhema Joseph J   Mills Lisa A LA   Panchia Ravindre R   Faesen Sharlaa S   Eron Joseph J   Gallant Joel J   Havlir Diane D   Swindells Susan S   Elharrar Vanessa V   Burns David D   Taha Taha E TE   Nielsen-Saines Karin K   Celentano David D DD   Essex Max M   Hudelson Sarah E SE   Redd Andrew D AD   Fleming Thomas R TR  

The New England journal of medicine 20160718 9


<h4>Background</h4>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.<h4>Me  ...[more]

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