Antiretroviral Therapy for the Prevention of HIV-1 Transmission

作者：Cohen, M. S.^*; Chen, Y. Q.; McCauley, M.; Gamble, T.; Hosseinipour, M. C.; Kumarasamy, N.; Hakim, J. G.; Kumwenda, J.; Grinsztejn, B.; Pilotto, J. H. S.; Godbole, S. V.; Chariyalertsak, S.; Santos, B. R.; Mayer, K. H.; Hoffman, I. F.; Eshleman, S. H.; Piwowar-Manning, E.; Cottle, L.; Zhang, X. C.; Makhema, J.; Mills, L. A.; Panchia, R.; Faesen, S.; Eron, J.; Gallant, J.; Havlir, D.; Swindells, S.; Elharrar, V.; Burns, D.; Taha, T. E.; Nielsen-Saines, K.; Celentano, D. D.; Essex, M.

来源：New England Journal of Medicine, 2016, 375(9): 830-839.

DOI：10.1056/NEJMoa1600693

• RANDOMIZED-TRIAL
• VIRAL LOAD
• HPTN 052
• INFECTION

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.)

• 出版日期2016-9-1
• 单位中国疾病预防控制中心