This update contains a link to AVAC’s new publication, Understanding the results of CAPRISA 004. CAPRISA 004 is the landmark trial of the microbicide 1% tenofovir gel, the results of which were released in July 2010. It found that 1% tenofovir gel reduced HIV-negative women’s risk of HIV infection by an estimated 39 percent overall. AVAC’s new document provides key context for next steps regarding the development of the microbicide 1% tenofovir gel and describes many of the issues that advocates should be monitoring and engaging with in the months to come.
This is the second volume in our Cascade of Hope and Questions series about ARV-based prevention. Volume One, Anticipating the results of ARV-based prevention trials, was released in July 2010, before the CAPRISA 004 data were released. It can be downloaded at avac.org/CAPRISA004 along with a range of other materials related to the trial.
As Understanding the results of CAPRISA 004 explains, there is an urgent need for work on follow-up research on 1% tenofovir gel, regulatory pathways for potential introduction and microbicide pipeline expansion. Community input is needed on each of these issues, which must be addressed simultaneously.
There is a need for clear leadership to execute such a coordinated, comprehensive agenda. Advocates must hold donors, research entities and government leaders accountable for action both in South Africa, where CAPRISA 004 took place, and in every other setting where 1% tenofovir gel could potentially play a role as a new HIV prevention tool. The CAPRISA 004 data show the impact the gel could have in reducing women’s risk of infection via vaginal sex. Additional information is needed on safety and effectiveness of the gel among populations such as adolescents, pregnant women and others. There is also a need to continue evaluation of 1% tenofovir gel for anal sex.
Many of these issues will be discussed at a meeting taking place on August 25th and 26th in Johannesburg. This consultation is co-sponsored by WHO and UNAIDS and hosted by the South African Department of Science and Technology with support from USAID. Advocates will need to track outcomes from this meeting and hold relevant stakeholders accountable for next steps. AVAC will provide an update on these issues following the consultation.
In the coming months, AVAC will release Volume 3 in the Cascade of Hope and Questions series. It will focus on anticipating the results of oral PrEP trials including the iPrEx trial evaluating tenofovir/emtricitabine, also known as Truvada, in gay men and other men who have sex with men. Volume Four, to be released in early 2011, will focus on understanding all of the ARV-based prevention trial data to date.
AVAC is working with its partners on a range of stakeholder consultations in East and Southern Africa among other settings. If you or your organization would like to find out more about our upcoming dialogues and/or arrange for a conference call or webinar on CAPRISA 004 and its implications for your community, please let us know at email@example.com!