Final results of the HIV prevention study VOICE are published in NEJM

Original Article:

Researchers who conducted VOICE, a major HIV prevention trial involving more than 5,000 women in Africa, describe the study’s primary results in this week’s issue of the New England Journal of Medicine (NEJM), outlining in detail how the three products tested were safe but overall not effective in preventing HIV.

The study also reports the degree to which women did not use the products daily as instructed, with tests of blood indicating that just three months into the trial a majority of study participants were not using their assigned product – either an antiretroviral (ARV) tablet (tenofovir or Truvada®) or a vaginal gel (tenofovir gel). Such tests would have detected the presence of drug had there been recent use of a study product. For many women, drug was not detected in any blood sample taken at any time during the study, suggesting they may have never used the products at all.

Tenofovir and Truvada are both approved for the treatment of HIV when used in combination with other ARVs. Tenofovir (tenofovir disoproxil fumarate, or TDF) is known by the brand name Viread®. Truvada is the brand name for a tablet containing both tenofovir and emtricitabine. In July 2012, the U.S. Food and Drug Administration approved the use of Truvada also for HIV prevention (pre-exposure prophylaxis, or PrEP) based largely on the results of two pivotal trials in two different populations – the iPrEx study in 2,500 men who have sex with men (MSM), and the Partners PrEP Study involving 4,758 serodiscordant heterosexual couples in whom one partner is HIV-infected. These and other studies have shown Truvada is more effective when used consistently. Indeed, as with VOICE, Truvada was not effective in the FEM-PrEP Study of 2,119 women in whom adherence was very low.

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