2011•New England Journal of MedicineOpen access
Prevention of HIV-1 Infection with Early Antiretroviral Therapy
Myron S. Cohen, Ying Qing Chen, Marybeth McCauley, Theresa Gamble, Mina C. Hosseinipour, Nagalingeswaran Kumarasamy, James Gita Hakim, Johnstone Kumwenda, Beatriz Gilda Jegerhorn Grinsztejn, José Henrique Pilotto, Sheela Godbole, Sanjay Madhav Mehendale, Suwat Chariyalertsak, Breno Riegel Santos, Kenneth Hugh Mayer, Irving Hoffman, Susan H. Eshleman, Estelle Piwowar‐Manning, Lei Wang, Joseph M. Makhema, Lisa A. Mills, Guy de Bruyn, Ian Sanne, Joseph J. Eron, Joel E. Gallant, Diane V. Havlir, Susan Swindells, Heather Jane Ribaudo, Vanessa Elharrar, David Burns, Taha E. Taha, Karin Nielsen‐Saines, David D. Celentano, Max Essex, Thomas R. Fleming
Open full text 7,006 citations
Abstract
BACKGROUND: Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. METHODS: In nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death. RESULTS: As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01). CONCLUSIONS: The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).
Open-access reader