Tuesday, June 21, 2011

New Hope for HIV?

Johannesburg, South Africa – Researchers, advocates, funders and pharmaceutical companies’ representatives gathered in Johannesburg, South Africa to prepare and plan for the implementation of 1% Tenofovir Gel. The meeting that ran on 13 and 14 June 2011 is a follow up to a similar meeting, “next steps 1% Tenofovir Gel,” meeting held in South Africa last year. The August 2010 meeting came subsequent to the historic results of the CAPRISA 004 trial released early in July 2010 at the International AIDS Conference at Vienna, Austria. The study results showed that 1% tenofovir gel reduced the risk of HIV infection in women by 39% compared with placebo (control arm), and by 54% in the women who reported more consistent gel use.

The purpose of this high-level indaba was to indentify priority actions to ensure rapid expansion and availability of 1% tenofovir gel following licensure and to inform normative guidance on use of the gel in high HIV incidence countries and settings. The meeting seeks also to identify key contextual issues related to product introduction and implementation that will guide product roll out strategies.
Players in the HIV prevention field are concerned about outlining current plans for market authorization, manufacturing and supply; synthesise and build on existing knowledge on microbicides and other health innovations particularly related to sexual and reproductive health, including family planning.

Follow up studies currently ongoing will provide parallel comparisons of oral and topically applied antiretroviral strategies for prevention of HIV infection in women. One such study, the MTN 003 (Microbicides Trials Network), VOICE (Vaginal & Oral Interventions to Control the Epidemic) is a phase IIb safety and effectiveness study of 1% tenofovir gel, tenofovir tablet, Truvada tablet for prevention of HIV infection in women. This study is being rolled out at sites in South Africa, Uganda and Zimbabwe with a target sample size approximately 5000 women.

The Zimbabwe arm of the study has enrolled 600 women at sites in Chitungwiza's Zengeza Clinic, Seke South and Harare at the Spilhaus Clinic, Harare Central Hospital. The sites under the auspices of the UZ-UCSF are part of the larger effort to bring much needed HIV prevention empowerment hope for many women who make up the majority of people living with HIV.

The WHO/UNAIDS meeting was being attended by close to 60 delegates form USAID, WHO, UNAIDS, and various research institutions,advocacy groups and government representatives. Conspicuous with their absence were Ministry of Health officials from Zimbabwe, where a reasonably sized population is part of the trials. The meeting was fully sponsored by UNAIDS, WHO and USAID.

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