In a major press release at the International Aids Conference in Vienna today, published simultaneously in Science, South African researchers claimed a significant advance in prevention of HIV infection using a microbicide.
From the Commentary in Science Express by Jon Cohen:
For the first time ever, a vaginal gel has unequivocally blocked the transmission of HIV.
In a trial that involved nearly 900 South African women, those who received a vaginal gel that contains an anti-HIV drug had a 39% lower chance of becoming infected by the virus than those who received a placebo. …
More than 30 randomized controlled studies of microbicides, vaccines, and drugs to date have failed to thwart sexual transmission of HIV or have yielded such marginal success that researchers wound up hotly debating the data for years after the trials were complete. But there’s no ambiguity about the data from this new microbicide study reported today online in Science and in a presentation at the 18th International AIDS Conference in Vienna: Of the 444 women who received a placebo gel, 60 became infected with HIV versus 38 infections in the 445 women who received the microbicide. The result was statistically significant, and no serious side effects occurred. “It’s a moment we’ve been waiting for 2 decades,” says epidemiologist Quarraisha Abdool Karim, who, with her husband, Salim Abdool Karim, headed the study, known as CAPRISA 004.
Published online 19 July 2009; 10.1126/science.329.5990.374
This truly is good news – both for the HIV/AIDS research and treatment community, who have needed a shot in the arm recently, and for women in developing countries who often have little choice in how or when they have sex.
From the paper in Science:
Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women
Quarraisha Abdool Karim et al., Published Online July 19, 2010
Science DOI: 10.1126/science.1193748
The CAPRISA 004 trial assessed effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445) with placebo gel (n = 444) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years, i.e., person time of study observation (38/680.6 women-years), compared to 9.1 per 100 women-years (60/660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence >80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence <50%), the HIV incidence reduction was 38% and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.
Note my bolding above: while the results were encouraging overall, they were especially good where adherence to the protocol was high. Moreover, it appears as though tenofovir administered externally does not get into the blood in sufficient amounts to cause infecting virus to develop resistance to any noticeable degree. As an added bonus, the treatment appeared to reduce the incidence of herpevirus as well.
To paraphrase someone far more famous, this is only the end of the beginning of the fight against HIV and AIDS: this is not the answer; it is merely an indication that this is a strategy that may work – in the absence of a vaccine – to protect people from infection.
But so nice that it came from South Africa….