Truvada was originally approved by the US Food and Drug Administration in August 2004 for use alongside antiretroviral drugs by those who are HIV-positive. Now, the agency announced that the drug would also be approved for use in individuals who are at a high risk of contracting the virus, making it the first drug approved for HIV preventation.
"Today's approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret Hamburg in a press release yesterday (July 16).
The drug, which can reduce the risk of infection by up to 75 percent, can now be used by anyone engaging in sexual activity with HIV-positive partners. Some groups, however, are concerned that it may provide a false sense of security, and encourage risky behavior. The FDA stresses Truvada should only be used as part of a "comprehensive HIV prevention plan," including condom use, among other things. Furthermore, the drug is much less effective if not taken daily, and there are also worries that if it is not taken correctly, drug-resistant strains of HIV could develop.
As part of the approval, the drug's manufacturer, Gilead Sciences, is required to take samples from people who become infected while taking to the drug to look for signs of resistance. The company also provided an education strategy and promised to offer free condoms and HIV testing vouchers to make sure people are doing all they can to minimize the risk of infection.
While treating the HIV-positive partner is still the primary focus of much HIV research, Tom Giordano, who sat on an FDA advisory panel that recommended the approval in May, thinks this new prevention is still an important step forward. “When you really boil it down, that's going to be a relatively focused population, but it's an important population to treat,” he told the Associated Press.