Michael A. Polis, MD, MPH
Does early antiretroviral therapy (ART) in patients with HIV-1 prevent transmission to uninfected sexual partners and reduce serious clinical events compared with delayed therapy?
Randomized controlled trial (HIV Prevention Trials Network [HPTN] 052). ClinicalTrials.gov NCT00074581.
Unclear allocation concealment.*
Median 1.7 years.
13 sites in Botswana, Kenya, Malawi, South Africa, Zimbabwe, Brazil, India, Thailand, and USA.
1763 HIV-1 serodiscordant couples ≥ 18 years of age (50% of HIV-1–infected patients were men, 97% heterosexual, 94% married, 54% from Africa), who were in a stable relationship for ≥ 3 months, had ≥ 3 episodes of vaginal or anal intercourse in that time, and were willing to disclose HIV test results to their partners. Inclusion criteria for HIV-1–infected partners were CD4 counts 350 to 550 cells/mm3 and no previous ART except for short-term prevention of mother-to-child transmission. HIV-1–infected patients with active tuberculosis were excluded.
Combination ART for HIV-1–infected patients at enrollment (n = 886, early therapy) or delayed after 2 consecutive CD4 cell counts ≤ 250 cells/mm3 or after developing an AIDS-related illness (n = 877, delayed therapy).
Primary outcomes were HIV-1 transmission to the uninfected partner and serious clinical events (death, World Health Organization stage 4 events, severe bacterial infection, or pulmonary tuberculosis) in HIV-1 infected patients. Secondary outcomes included other severe or life-threatening adverse events.
90% (intention-to-treat analysis).
21% of patients in the delayed therapy group began therapy after a median of 42 months. 39 partners became infected with HIV-1; 28 transmissions were virologically linked to the HIV-infected partner. Early therapy reduced HIV-1 transmission and serious clinical events (Table). Groups did not differ for other severe or life-threatening adverse events.
Early antiretroviral therapy for patients with HIV-1 reduced transmission to uninfected sexual partners and serious clinical events more than delayed therapy.
†Abbreviations defined in Glossary. RRR, NNT, and CI calculated from control event rates and hazard ratios in article. Analysis was adjusted for such potential prognostic factors as baseline CD4 count and plasma HIV-1 RNA concentration in the infected partner, and sex.
‡Any transmission regardless of genetic linkage.
§Death, World Health Organization stage 4 events, severe bacterial infections, and pulmonary tuberculosis for HIV-1–infected partners.
Polis MA. Early antiretroviral therapy reduced HIV-1 transmission in serodiscordant couples. Ann Intern Med. ;155:JC6–8. doi: 10.7326/0003-4819-155-12-201112200-02008
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Published: Ann Intern Med. 2011;155(12):JC6-8.
HIV, Infectious Disease.
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