[HTML][HTML] Prevention of HIV-1 infection with early antiretroviral therapy

MS Cohen, YQ Chen, M McCauley… - New England journal …, 2011 - Mass Medical Soc
MS Cohen, YQ Chen, M McCauley, T Gamble, MC Hosseinipour, N Kumarasamy, JG Hakim…
New England journal of medicine, 2011Mass Medical Soc
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 …
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.)
The New England Journal Of Medicine