Michael A. Polis, MD, MPH
Does preexposure prophylaxis (PrEP) with antiviral medication for uninfected partners prevent HIV-1 transmission in serodiscordant heterosexual couples?
Randomized placebo-controlled trial (Partners Preexposure Prophylaxis [PrEP] Study). ClinicalTrials.gov NCT00557245.
Blinded† (participants, clinicians, data collectors, and outcome assessors).
36 months (placebo treatment stopped early for apparent benefit).
9 sites in Kenya and Uganda.
4758 HIV-1 seronegative partners with HIV-infected partners (heterosexual couples) ≥ 18 years of age (62% of HIV-1–negative partners were men, 97% of couples were married). Seropositive partners had CD4 cell counts ≥ 250 cells/mm3 and were not receiving or meeting local guidelines for antiretroviral therapy at enrollment. Seronegative partners had normal renal function (creatinine clearance ≥ 60 mL/min, and serum creatinine ≤ 1.3 mg/dL for men and ≤ 1.1 mg/dL for women) and were not pregnant, breastfeeding, or infected with hepatitis B virus.
Once-daily oral tenofovir disoproxil fumarate, 300 mg (TDF) (n = 1589); TDF, 300 mg, plus emtricitabine, 200 mg (TDF–FTC) (n = 1583); or placebo (n = 1586). All participants received standard comprehensive HIV-1 prevention services.
Primary outcome was HIV-1 infection. Other outcomes included adverse events and death.
99.5% (modified intention-to-treat analysis excluding participants with HIV-1 RNA detected later by polymerase chain reaction assays in plasma taken at enrollment).
82 partners became infected with HIV-1 during the study. Both TDF and TDF-FTC reduced risk for HIV-1 transmission compared with placebo (Table). TDF and TDF-FTC groups did not differ (P = 0.23). Groups did not differ for adverse events or death (P > 0.24 for all).
Preexposure prophylaxis with oral antiretroviral tenofovir disoproxil fumarate (TDF) and TDF plus emtricitabine reduced transmission of HIV-1 to seronegative partners in serodiscordant heterosexual couples.
Tenofovir disoproxil fumarate (TDF), TDF plus emtricitabine (TDF–FTC), or placebo for prevention of HIV-1 transmission to seronegative partners‡
‡Abbreviations defined in Glossary. RRR, NNT, and CI calculated from event rates in article. Results for modified intention-to-treat population of 4733 couples.
Polis MA. Preexposure prophylaxis reduced HIV-1 spread in serodiscordant heterosexual couples. Ann Intern Med. ;157:JC5–3. doi: 10.7326/0003-4819-157-10-201211200-02003
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Published: Ann Intern Med. 2012;157(10):JC5-3.
HIV, Infectious Disease, Prevention/Screening.
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