FDA Approves Truvada For HIV Prevention
BY HIV Plus Editors
July 16 2012 4:26 PM ET
The Food and Drug Administration has approved Truvada for use in reducing the risk of sexual transmission of HIV.
Truvada can be used as a Pre-exposure Prophylaxis, commonly known as PrEP. The FDA recommended Monday that Truvada, which is also an antiretrovial medication, be used "in combination with safer sex practices to prevent sexually acquired HIV infection in adults at high risk. They warned, however, that Truvada alone, even when taken daily, cannot be a substitute for safe sex practices.
"Today’s approval marks an important milestone in our fight against HIV," FDA Commissioner Margaret A. Hamburg, M.D. said in a statement. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
A study to evaluate the effectiveness of Truvada as PrEP involved a sampling of 2,499 HIV-negative men and transgender women who have sex with men with evidence of high risk behavior for HIV infection such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status, a high number of sex partners, and exchange of sex for commodities. The study showed Truvada was effective in reducing the risk of HIV infection by 42% versus the placebo. Another study of 4,758 heterosexual couples where one partner is HIV-negative and the other is HIV-positive showed a 75% reduction of risk versus the placebo.
"For the first time, there is now a pill that can be prescribed to HIV-negative individuals at increased vulnerability for contracting the virus that can significantly reduce their risk of infection," Moises Agosto of the National Minority AIDS Council said Monday.
Agosto warns, however, that Truvada is by no means a panacea and is only effective when used in conjunction with traditional prevention and risk reduction strategies, such as condom usage." "Anti-retroviral medications, like Truvada, are extremely powerful drugs with the potential for serious side effects," Agosto continued. "As such, PrEP should only be used by individuals who are highly vulnerable to HIV infection, including those in sero-discordant couples, sex workers and gay men. Its efficacy is also directly related to an individual’s adherence to a regimen, and should only be used by those who can commit to taking it regularly. Finally, use of PrEP by individuals who may already be HIV-positive could increase the risk of drug resistance." House Minority Leader Nancy Pelosi hailed the announcement in a statement Monday, and said she awaits the day that "AIDS is nothing but a terrible, terrible memory."
"The FDA’s historic decision to approve use of an antiretroviral drug for HIV prevention by individuals at high-risk of infection provides us with an effective new weapon in our fight against HIV/AIDS," she added. "We must employ each and every strategy that reduces the chances of acquiring HIV as part of a comprehensive approach to save lives in the United States and around the world. It’s a source of pride to me and my constituents that some of this groundbreaking research was conducted at San Francisco’s Gladstone Institutes."
Michael Weinstein of the AIDS Healthcare Foundation see the FDA's approval of Truvada without a precursory HIV test as a "wreckless" move that "will ultimately set back years of HIV prevention efforts." He added, "From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support. And while FDA recommends a negative HIV test prior to use of Truvada as PrEP and states that use by people with an ‘…unknown or HIV positive status…’ is ‘contraindicated,’ it in no way actually requires HIV testing in any manner—just strengthening of the ‘Boxed Warning’ on Gilead’s packaging."
The announcement comes just two weeks after the FDA approved at-home rapid HIV tests.