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Final data confirm PrEP reduced risk for HIV in heterosexual couples
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SEATTLE — Once-daily tenofovir and combination emtricitabine/tenofovir reduced the risk for HIV infection in heterosexual men and women with a partner who is HIV-positive, according to researchers from the University of Washington.
The three-arm randomized trial of antiretroviral therapy pre-exposure prophylaxis (PrEP) included heterosexual couples from Kenya and Uganda in which one of the partners was HIV-positive and the other was HIV-negative. The HIV-negative partners received once-daily tenofovir (Viread, Gilead Sciences), once-daily combination emtricitabine/tenofovir (Truvada, Gilead Sciences) or placebo, and they were followed for as long as 36 months.
“In July 2011, the independent Data and Safety Monitoring Board, upon reviewing the data, recommended that these results be publicly reported, and that those in the placebo arm receive treatment,” researcher Jared Baeten, MD, PhD, associate professor of global health at the University of Washington, told Infectious Disease News. “These final data confirm that pre-exposure prophylaxis provide definitive protection against HIV infection among those at high risk for infection.”
A total of 4,758 couples were enrolled, and in 62% of these pairs, the male partner was HIV-positive. By analyzing monthly pill count, the adherence to the study medication was 97%. Among post-randomization HIV infections, 17 participants were assigned tenofovir, 13 emtricitabine/tenofovir and 52 a placebo.
Among those assigned tenofovir, the risk for HIV was reduced by 67% (P<.0001). Among those assigned emtricitabine/tenofovir, the risk for HIV was reduced by 75% (P<.0001). There was no significant difference in the protection between tenofovir and emtricitabine/tenofovir.
“In addition, resistance to treatment was rare and only occurred in two out of eight individuals who were infected at randomization,” Baeten said. “One developed the K65R mutation and one developed the M184V mutation. Among the 27 participants who acquired HIV after randomization, none developed these mutations.”
The rates of adverse effects were similar across all arms. The PrEP was associated with increased gastrointestinal symptoms, primarily within the first month, and only among about 10% of participants.
For more information:
- Baeten J. #29. Presented at: 19th Conference on Retroviruses and Opportunistic Infections; March 3-8, 2012; Seattle.
Disclosures: The researchers report no relevant financial disclosures.
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