AVAC calls for economic and political support for CAPRISA 004 microbicide trial's critical follow-up studies

Sep 4 2010

AVAC today issues a call to action to donors, policy-makers, researchers and advocates to ensure that critical follow-up studies to the landmark CAPRISA 004 microbicide trial receive the economic and political support needed to move forward as quickly as possible. The call comes as a group of microbicide and public health experts have agreed upon a plan for further studies, which are expected to cost $100 million over three years, of which only $58 million has been committed.

"We have an imperative to learn about the effectiveness of 1 percent tenofovir gel, the product tested in CAPRISA 004. If the results are confirmed, we now have an incredible opportunity to translate a clinical trial result into public health impact -- and we should not miss it," said Mitchell Warren, AVAC executive director.

A group of key decision makers met recently in South Africa to develop a comprehensive research agenda to build on the results of the CAPRISA 004 microbicide gel trial. At that meeting, public health officials, researchers, and regulators moved with remarkable speed to develop a consensus plan that calls for a set of studies aimed at confirming the CAPRISA 004 results and developing implementation strategies.

"A plan is in place to move the research forward, and funders and policy makers must now move quickly ensure that it can be implemented as soon as possible," Warren added. "Women in South Africa and around the world are calling for access to this product. We have a moral obligation to quickly and efficiently answer the remaining questions that will tell us if this is an intervention that can be used and how it will need to be implemented."

"These results could lead to one of most exciting breakthroughs in the history of the AIDS epidemic. This microbicide could be an important tool to help women protect themselves from HIV," said Warren. "At the same time that researchers work to confirm the results, we must also ensure that plans are in place to ensure swift regulatory approvals and implementation programs. A safe and effective microbicide must not follow the same slow route to full implementation as the female condom."

The microbicide field has been energized by this result, as has the larger field of biomedical prevention research. We must not lose momentum," Warren added. "There is funding in place for microbicide research and other trials are ongoing, but there is a real risk that the development of 1 percent tenofovir gel will languish without a new infusion of funding specifically targeted to moving this product and dosing strategy forward."

"Knowing that AIDS treatment and other global health priorities are starved for resources, we do not make the call for additional funds for this research lightly," Warren added. "But a relatively small investment in this research agenda has the potential to reap huge rewards in the number of new infections that can be prevented if 1 percent tenfovir proves to be even a partially effective microbicide."

It is critical that as the field moves forward with a research agenda for this strategy, a full and robust HIV prevention research agenda continues and the microbicide pipeline is expanded to ensure the development of additional dosing and delivery methods that will work for more women and men. Several key HIV prevention trials are underway, including other microbicide dosing strategies and formulations, PrEP (testing antiretroviral drugs in oral form), and vaccines. A combination of new HIV prevention interventions, along with scaled up treatment and care programs, are needed to end the AIDS epidemic.

More information about the CAPRISA 004 result and ARV-based prevention is available in AVAC's new publication A Cascade of Hope and Questions: Understanding the Results of CAPRISA 004 available at www.avac.org.