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CROI 2013: Pre-exposure prophylaxis fails to protect women from HIV in African study

Dr Jeanne Marrazo from the University of Seattle, presented data today on the results of VOICE (Vaginal and Oral Interventions to Control the Epidemic), a randomized, placebo-controlled study of pre-exposure prophylaxis (PrEP) in women assessing the safety and efficacy of daily oral tenofovir, daily oral tenofovir-emtricitabine or daily 1% tenofovir vaginal gel. Over 5,000 women from South Africa, Uganda and Zimbabwe were randomized to one of five arms. Retention in the study was high with over 90% of participants completing the study. Self-reported condom use was also high (85%). HIV incidence was high and reported at 5.7%. Unfortunately none of the PrEP modalities resulted in reduced incidence of HIV. In fact, women taking tenofovir alone were almost 50% more likely to become HIV positive, although this was not statistically significant. These results are thought to be a consequence of extremely low rates of adherence to study drugs and vaginal gel. Less than a third of participants had detectible study drug during quarterly plasma samples despite reporting high adherence to the study drugs or vaginal gel. The results underscore the critical issue with PrEP: that of needing to ensure high levels of adherence to agents, and also the need to develop long acting preparations of PrEP as noted in the presentations on the development of long acting parenteral preparations and monthly application of intravaginal rings.

Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito Taljaard M, Piper J, Gomez Feliciano K, Chirenje M. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine or vaginal tenofovir gel in the VOICE study (MTN 003). Presented March 4, 2013 at the 20th CROI, Atlanta, GA. Oral Abstract 26LB

Source: Reporting from Atlanta for PRN News: Anita Radix, MD, MPH