Truvada's FDA approval is being heralded as historic, as it's the first drug ever approved to prevent sexually acquired HIV infection in healthy adults, Reuters reports.
But the drug's price may put it out of reach for many worldwide.
Truvada, made by Gilead Sciences of Foster City, Calif., combines two anti-HIV drugs in a single pill. The FDA had already approved Truvada as part of a multi-drug combo to help treat HIV-infected patients age 12 and older. (Details about the FDA's drug approval process is available here.)
The FDA's new approval, announced Monday, clears the way for doctors to prescribe Truvada to help prevent HIV infection in non-infected adults. Truvada can reduce the risk of HIV infection if it's used daily as part of an overall strategy that includes safe-sex practices, education, and regular HIV testing, according to the FDA.
"We are concerned about risk-taking behavior, however, the (clinical) trials did not bear that out," an FDA director said. "The hope is the right messages will get out and Truvada will be used properly."
Truvada's FDA approval comes after a study that found a 42% reduction in HIV infection rates when Truvada was taken daily. The study involved about 2,500 men who have sex with other men.
Another study involved more than 4,700 heterosexual couples in which one partner had HIV and the other did not. Results showed Truvada reduced the risk of infection by the non-infected partner by 75%, the FDA said in a statement.
Despite the promising results, Truvada's $480-a-year price tag may make it too costly for many in places hit hardest by HIV infection and AIDS, Bloomberg News reports. However, Gilead sells Truvada for as little as $8 a month in some low-income countries, a spokeswoman said.
As a condition for Truvada's FDA approval, Gilead must collect data from anyone for whom Truvada did not work, along with women who become pregnant while taking Truvada, Reuters reports.