Replication Researcher: Eric Djimeu
Original Paper Title: Prevention of HIV-1 Infection with Early Antiretroviral Therapy.
Original Researchers: Myron S. Cohen, Ying Q. Chen, Marybeth McCauley, Theresa Gamble, Mina C. Hosseinipour, Nagalingeswaran Kumarasamy, James G. Hakim, Johnstone Kumwenda, Beatriz Grinsztejn, Jose H.S. Pilotto, Sheela V. Godbole, Sanjay Mehendale, Suwat Chariyalertsak, Breno R. Santos, Kenneth H. Mayer, Irving F. Hoffman, Susan H. Eshleman, Estelle Piwowar-Manning, Lei Wang, Joseph Makhema, Lisa A. Mills, Guy de Bruyn, Ian Sanne, Joseph Eron, Joel Gallant, Diane Havlir, Susan Swindells, Heather Ribaudo, Vanessa Elharrar, David Burns, Taha E. Taha, Karin Nielsen-Saines, David Celentano, Max Essex and Thomas R. Fleming.
Original Publication: New England Journal of Medicine
Replication Plan: Not Applicable
Current Status: Replication plan published
The Original Study
Several observational studies have reported that the early use of antiretroviral therapy by patients diagnosed with HIV decreases rates of HIV acquisition among their sexual partners. This study evaluates the impact of early antiretroviral therapy on HIV acquisition among serodiscordant couples from nine countries. Specifically, half of 1723 serodiscordant coupes in which HIV-1–infected participants had a CD4 count of 350 to 550 cells per cubic millimeter were randomly assigned to receive antiretroviral therapy immediately (early therapy) while the other half received antiretroviral therapy after a decline in their CD4 count (250 cells per cubic millimeter) or after the onset of HIV-1–related symptoms (delayed therapy). The primary outcome of interest was the link between HIV-1 transmission to HIV-1 negative partners. In order to determine the impact of early therapy, the authors used the Kaplan–Meier method to calculate event-free probabilities and person-year analysis for incidence rate for a given year. They also used Cox regression to estimate relative risks and adjusted for potential prognostic factors. Finally, they used chi-square tests to compare the frequencies of adverse events. The study concluded that early initiation of antiretroviral therapy reduces rates of sexual transmission of HIV-1 and clinical events in HIV negative partners