Posted Wednesday, Dec. 1, 2010, at 11:04 AM
We may be approaching a time when a topical vaginal gel that cuts the overall HIV infection rate by 39 percent will be available to the women who need it most. The results of a successful clinical trial with the gel, which contains the antiretroviral tenofovir, were announced this past July by South African researchers. In late October, the U.S. Food and Drug Administration promised to fast-track its review if a confirmatory study, due for completion in 2013, shows positive results . And this past Monday, the trial’s primary funder, the influential United States Agency for International Development (USAID)*, called together dozens of stakeholders-researchers, funders, advocates, and government officials from the U.S. and South Africa-to begin moving toward licensure and distribution.
HIV is now the leading cause of death for women of reproductive age globally , not least because up to 70 percent of women worldwide have been forced to have unprotected sex. True, condoms provide the best protection against HIV and other sexually transmitted infections. But the fact remains that many women’s best chance for prevention lies not in negotiating condom use, but in their ability to protect themselves by means unknown to their male partners.
The situation is harshest in sub-Saharan Africa, home to 22.5 million people living with HIV-68 percent of the global total. Women there account for nearly 60 percent of all adults living with HIV. While women worldwide are twice as likely to contract HIV through unprotected heterosexual intercourse than men, women 15-24 years of age in several Southern African countries are three times more likely to be infected with HIV than their male peers, primarily due to heterosexual sex with infected partners.
Even given the urgency of the situation, 2014 is the soonest tenofovir gel will become publicly available-and that’s in the earliest and best scenario. The initial data on the gel must be confirmed; the regulatory review processes of South Africa as well the U.S. must be satisfied, and the former’s Medical Control Council is still determining theirs. Finally, there are the public health issues: How best to roll out a product that is meant to supplement, not entirely replace, other safer sex practices?
USAID and its collaborative partners are working on it. Furthermore, there are more clinical trials and preventative products in the pipeline . Late last month, South African researchers announced the results of a successful trial using a widely prescribed antiretroviral combination pill with 2,499 men who have sex with men. The confirmatory study for tenofovir gel will compare its performance with two other oral antiretrovirals (plain old tenofovir and the tenofovir/emtricitabine combo used in the other trial) on nearly 5,000 women. In HIV as in birth control, options matter: it’s not one size fits all. So in addition to testing these three products for effectiveness and safety, the study is also trying to determine which form of prevention women prefer and use correctly. Microbicides, once the purview of grass-roots activists , have taken center stage. And that’s good news for women worldwide.
*Correction, Dec. 1, 2010: The original version of this post used the incorrect acronym for the United States Agency for International Development.