In what has been described as a "major breakthrough", the daily use of an antiretroviral drug therapy has been revealed to dramatically reduce new infections in HIV-negative gay and bisexual men. The results of clinical trials involving Truvada, a combination of tenofovir and emtricitabine, open a new line of attack in HIV protection and prevention known as pre-exposure prophylaxis (PrEP).
In the study, published Tuesday by the New England Journal of Medicine, researchers found that the hundreds of gay men randomly assigned to take the drugs were 44 percent less likely to get infected than the equal number assigned to take a placebo. But when only the men whose blood tests showed they had taken their pill faithfully every day were considered, the pill was more than 90 percent effective, said Dr. Anthony S. Fauci, head of the division of the National Institutes of Health, which paid for the study along with the Bill and Melinda Gates Foundation. "That’s huge," Dr. Fauci said.
The large study, nicknamed iPrEx, included nearly 2,500 men in six countries and was coordinated by the Gladstone Institutes of the University of California, San Francisco. The results are the best news in the AIDS field in years, even better than this summer’s revelation that a vaginal microbicide protected 39 percent of all the women testing it and 54 percent of those who used it faithfully.
The study found even higher rates of effectiveness, up to 73 percent, among men who adhered most closely to the daily drug regimen.
The clinical trials only tested the results of "pre-exposure prophylaxis" among men who have sex with men. The results may not apply to other transmission modes, such as male-female sex, injection. But experts say PrEP is a breakthrough because it's a new form of protection available to men, especially those who cannot use condoms because they are sex workers, in prison, under pressure from partners or lose their inhibitions when using drugs. The new form of protection "does not involve getting permission from the other partner, and that’s important," said Phill Wilson, president of the Black AIDS Institute, who describes PrEP as a "one of the most promising prevention tools on the horizon."
Wilson adds: "But we want to caution people from misinterpreting the results. Condom use and decreasing sexual partners remain the most effective way for gay and bisexual men to protect against HIV infection. PrEP should only be an additional tool."
The new data is especially critical in the Black community because Black gay/bisexual men "continue to be hard hit by HIV/AIDS," Wiilson adds. New data from the Centers for Disease Control show almost one in three Black men who have sex with men are HIV positive. More than 60 percent are not aware of their HIV status.