26 April 2012

The CAPRISA 004 Tenofovir Gel Trial was conducted from 2007 to 2010 and included about 1000 women from Durban and Vulindlela, KwaZulu-Natal. The results from this study, which were announced in July 2010 at the International AIDS Conference in Vienna, provided new hope for HIV prevention particularly for women who bear a disproportionate burden of HIV infection especially in Africa. The study showed that tenofovir gel use before and after sex was a safe and effective product that reduced the risk of HIV-infection by 39% overall, and by 54% when used consistently.

Additional research is needed to confirm the CAPRISA 004 findings before this HIV prevention gel can be made widely available. The Follow-on African Consortium for Tenofovir Studies (FACTS) is a crucial study that is currently being undertaken by a consortium of South Africa’s leading HIV researchers and is testing the same dosing regimen (before and after sex) as the CAPRISA 004 trial in 18-40 year-old women. In South Africa alone, this new prevention technology, that enables women to take control of their HIV risk, could avert an estimated 1.3 million new HIV infections and 800,000 AIDS deaths over the next 20 years.

Following the release of the CAPRISA 004 trial results, an international consultation hosted by the World Health Organisation (WHO) and UNAIDS in August 2010 endorsed the ethical need for CAPRISA, and the funders of the CAPRISA 004 trial, to provide the women involved in the trial and their communities with post-trial access to tenofovir gel. Although the efficacy of the gel must still be confirmed, there is an ethical obligation to make the gel available to women, who participated in the CAPRISA 004 trial. CAPRISA and the funders of the CAPRISA 004 trial are committed to meeting this obligation and have secured the funds and the gel for this purpose.

However, before the gel can be provided to study participants, it has to be approved by the Medicines Control Council (MCC). CAPRISA’s application to the MCC in November 2010 to provide post-trial access to the gel, while research to confirm the initial results are underway, has been met with long delays. After 19 months, despite multiple meetings and correspondence with the MCC there is no decision on whether the gel can be provided to women from the study.

CAPRISA fully supports the planned march on Thursday 26 April 2012 in Pietermaritzburg to bring attention to the challenges being faced by South African women to reduce their HIV risk and to study participants who wish to have access to the HIV prevention gel.