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VOICE trial's disappointing result poses big questions for PrEP
Gus Cairns, 2013-03-04 16:10:00

The failure of one of the largest trials yet conducted of HIV drug-based prevention methods poses questions for how to turn vaginal microbicides and oral pre-exposure prophylaxis (PrEP) into methods people can actually use, the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013) in Atlanta heard today.

The VOICE trial randomised 5029 women from three sites in South Africa, two in Zimbabwe and one in Uganda, although Durban in South Africa, with 3110 enrolled, provided more than half the participants. The women were randomised to use one of three prevention methods or two placebos (dummy methods):

  • daily Truvada (tenofovir plus emtricitabine) as PrEP;
  • daily tenofovir as PrEP;
  • a daily placebo pill looking like Truvada;
  • a tenofovir-containing gel, similar to that used in the CAPRISA 004 study, to be used as a vaginal microbicide;
  • an inert gel as a placebo microbicide.

The tenofovir oral PrEP arm, and the tenofovir vaginal gel and placebo arms of the trial were stopped due to futility in September and November 2011 respectively. ('Futility' means that the trial's data and safety monitoring board, which sees who is receiving treatment and who is receiving placebo, realised that there was no possibility that continuing the trial would produce a positive result.) The Truvada PrEP and placebo-pill arms, however, were continued.

But the conference heard today that Truvada had also not proven effective in preventing HIV and that therefore all three methods had proved no better than placebo.

Source:1