Guest blog post by Salim S. Abdool Karim & Quarraisha Abdool Karim
Co-Principal Investigators of the CAPRISA 004 Tenofovir Gel trial
On July 20, we announced, on behalf of our research team from the Centre for the AIDS Programme of Research (CAPRISA) in Durban, South Africa, that a microbicide gel—containing the antiretroviral drug tenofovir—reduces a woman’s chances of acquiring HIV by 39% and the genital herpes virus by 51%. Women who used the gel most consistently showed 54% protection against HIV infection. Now, for the first time in nearly three decades of research, we have a new technology, one that women can use and control, to prevent the sexual transmission of HIV.
All of us who have a stake in HIV prevention—scientists, policy-makers, international and community advocates and funders—now have greater impetus to accelerate the research on the use of antiretroviral based strategies for prevention. More than half a dozen trials are currently investigating oral or vaginal formulations of antiretroviral drugs. Many of these will be completed within the next two or three years, and other trials are urgently needed to corroborate and extend the results of the CAPRISA 004 trial. Specifically, additional safety information on use of tenofovir gel in pregnant women, women with hepatitis B virus infection, in women younger than 18 years and in women with renal impairment would be helpful to ease scale-up and wide-spread implementation with the eventual objective of regulatory licensure, a goal which may be another 3-5 years away.
There are many challenges as we consider the next steps including the nature of the additional research required, the considerations in designing future implementation, plans to investigate methods of reducing cost of the gel and local manufacturing, etc. A laudable first step is the joint leadership of UNAIDS and WHO, with financial support from UNAIDS, WHO and USAID, in organizing a consultation of major stakeholders in late August, which is being hosted by the South African government, on the next steps for tenofovir gel. The task of preparing for future implementation in a timely fashion, is daunting. The potential of wide scale delivery of antiretroviral products for prevention will provide many challenges to scientists, public health practitioners, policy-makers and communities in considering the logistics of providing access to the most vulnerable populations. It will not be simple: the task raises enormous ethical, medical, and economic challenges. Small scale model implementation studies need to be initiated now to provide valuable information and guidance for expanding the future delivery of a topical or oral antiretroviral based prevention to national levels.
We are in the midst of a global economic downturn and competing priorities have diverted resources that might have expedited research on antiretroviral strategies for prevention. Governments, communities, funders, and health experts must work together to ensure that this new way of preventing HIV attains regulatory licensure expeditiously and becomes readily available and accessible to women globally as soon as possible thereafter.


























