HIV Breakthrough: Gel Helps Prevent Infection

An antiretroviral drug formulated into a vaginal microbicide gel cut HIV incidence among women by up to 50 percent after 12 months, South African researchers reported today. Investigators with the Center for the AIDS Program of Research in South Africa presented their findings at the 18th International AIDS Conference in Vienna.

The double-blind, randomized controlled trial enrolled 889 HIV-negative heterosexual women from the Durban area. Half received a tenofovir-spiked gel and were told to use it 12 hours before sex and as soon as possible within twelve hours afterwards. The other half received a placebo. After 2.5 years, 38 women using the tenofovir gel had acquired HIV, compared with 60 of the placebo users.

In high adherers (>80 percent adherence), HIV incidence was 54 percent lower than for women in the placebo arm (P=0.025). Those 50 percent to 80 percent adherent had a 38 percent reduction, compared with just 28 percent for women who were less than 50 percent compliant. Compared with the placebo, tenofovir gel reduced HIV infection by an estimated 50 percent at 12 months, and 39 percent after 2.5 years. Tenofovir gel seemed safe, with only mild diarrhea slightly more common among users.

In South Africa, such a gel could avert 1.3 infections and 826,000 deaths over two decades, said Dr. Salim Abdool Karim, the South African researcher who led the study. However, further studies are needed to confirm the gel's safety and efficacy, he said. A second trial now underway compares it with a placebo and will take a couple more years to complete.

In the United States, a microbicide would need to be at least 80 percent effective in order to be licensed, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. However, other countries face different epidemics and may decide differently about the level of protection necessary.

If the gel's safety and efficacy are confirmed by other studies, the World Health Organization will work to accelerate access to it, said Dr. Margaret Chan, the agency's director-general.

The full study, "Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women," was published with free access in Science Express (2010;doi:10.1126/science.1193748).

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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