The Food and Drug Administration in July approved the prescription drug Truvada for use in HIV prevention, making it the first medication OK’d for preventing, not just treating, HIV. Truvada is already widely used to treat HIV, but studies have indicated that it can help keep people from contracting the virus. The FDA approved its use by HIV-negative people who are at high risk of acquiring HIV.
“Today’s approval marks an important milestone in our fight against HIV,” said FDA commissioner Margaret Hamburg, MD. “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.”
The FDA is changing the warning literature boxed with Truvada to emphasize that those using it for prevention need to be confirmed as HIV-negative and tested for the virus every three months. The agency is also starting a training and education program to help doctors inform their patients about the necessity of adhering to the recommended dose, engaging in safer-sex practices, receiving counseling, and getting tested regularly as well as their small but real risk of still contracting HIV while on the drug.
Some doctors have already been prescribing Truvada off-label for prevention to the HIV-negative partner of an HIV-positive person, but they did so at their own discretion. FDA approval now allows its maker, Gilead Sciences, to explicitly market the drug for the purpose of prevention. Truvada, a combination of the drugs Emtriva (emtricitabine) and Viread (tenofovir), is one of the class of drugs called nucleoside reverse transcriptase inhibitors, so called for the way in which it suppresses replication of HIV in infected people.
AIDS activists and service providers were not universally enthusiastic about Truvada’s approval for preventive use, expressing concerns about adherence, side effects, and declining condom use. Michael Weinstein, president of the Los Angeles–based AIDS Healthcare Foundation, issued a statement calling the action “completely reckless and a move that will ultimately set back years of HIV prevention efforts.”
Numerous others, however, said Truvada for prevention is a necessary additional weapon in the fight against HIV. It “won’t end AIDS by itself, but we certainly can’t end the HIV epidemic without it,” San Francisco AIDS Foundation spokesman James Loduca told the San Francisco Chronicle