FDA panel recommends approval of prophylactic use of HIV prevention drug

An influential advisory panel of the Food and Drug Administration has endorsed Truvada after the drug was shown to prevent HIV infection in healthy people.

It recommended prescribing the pill preventatively to people at high risk of contracting the virus. A final decision is expected next month, but if the FDA goes along with the recommendation, it won’t be without a degree of controversy.

Dr. Kenneth Mayer, medical research director at Fenway Health in Boston and a professor at Harvard Medical School, likened the pill to contraception, rather than a vaccine that grants immunity from a disease. Mayer said the big controversy then becomes first, the cost, but second and primarily, this may give people who are currently using condoms to prevent HIV infection to abandon those efforts.

“Our feeling is that with more than 50,000 new infections per year in the U.S. and more than 2 million across the globe every year, new HIV infections, having a tool like this is extremely important,” Mayer said.

There’s also concern that beyond simply giving people a reason not to take all practical measures to avoid infection, it might actually encourage high-risk behaviors.

“It’s really important for any physicians to educate the patient before offering this as a tool for prevention,” Mayer said. “This isn’t something that will be available over the counter, so it means that there has to be a clinical encounter beforehand and that has to lead to a discussion.”

The drug was tested among two different sets of at-risk groups prior to the FDA panel recommending its widespread use: men who have sex with other men at different locations around the globe, as well as heterosexual men and women living in Africa. Both groups have a statistically higher risk of contracting HIV than the average population.

Mayer said that in the study, condoms, when used consistently and correctly, remained the most effective means of preventing HIV. This pill would aim to serve people who, for certain reason, don’t want to continue using condoms.

“This is highly effective, particularly if people are highly adherent. It’s not going to work if people don’t take the pill,” Mayer said. “It really presumes that people have to do what they’re doing before they start this regimen.”