Antiretroviral therapy that reduces viral replication could limit the transmission of
human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.
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.
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 earlytherapy
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).
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.)
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