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VOICE trial: Microbicide gel may have stopped two out of three HIV infections – in the women who used it
Gus Cairns, 2015-02-09 10:10:00
The final published paper on the VOICE trial in women in three African countries mainly reinforces what conference presentations have already shown: this ambitious trial failed to demonstrate the effectiveness of either oral pre-exposure prophylaxis (PrEP) or of a tenofovir-containing vaginal microbicide gel, and the reason for this was that only 25-30% of women actually used the study product, despite 88% claiming they used it.
There was one crumb of comfort for the researchers: in women randomised to use tenofovir microbicide gel, there was a 66% reduction in HIV infection in women who actually did use it. However, as the researchers themselves admit, the gel users were not a random sample of trial participants, and could have been at less risk of HIV. So the actual efficacy of the gel may have been lower.
The main results of the VOICE trial were reported by Aidsmap in 2013 when they were presented at the CROI conference in Atlanta. Briefly, roughly 5000 trial participants from South Africa, Uganda and Zimbabwe were randomised into five groups of just under 1000 each. These five groups were given to take or use daily:
- a tenofovir pill plus a placebo (dummy) tenofovir/emtricitabine (Truvada) pill
- a Truvada pill plus a placebo tenofovir pil
- two placebo pills
- a vaginal microbicide gel containing 1% tenofovir
- a placebo microbicide gel.
Retention in the trial was excellent, with 91% of women completing follow-up visits, and adherence appeared to be excellent too with 86% adherence reported on the basis of women's returns of empty pill boxes and gel applicators.
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