Researchers had been trying to create a pill for years that could help stem the epidemic. Public health advocates said Monday that Truvada represents a major breakthrough, both as a medical therapy and as a means of expanding other preventive measures.
Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug's impact.
The FDA's decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that Americans can use in the privacy of their homes.
The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the U.S., which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. And it's estimated that one-fifth, or about 240,000 people, are unaware that they are infected.
The drug's label carries a warning that people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug, making their disease more difficult to treat. The label also warns of side effects, including kidney and liver problems.
Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are already infected with the virus. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.
Starting in 2010, studies showed that the drug could prevent people from contracting HIV when used as a precautionary measure. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year, another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.
Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval will allow Gilead Sciences to formally market the drug for that use, which could dramatically increase prescriptions.
Gilead Sciences said Monday that it would keep the pill at its current price, nearly $14,000 per year. Even at that price, HIV physicians said the drug could be cost effective if it prevents people from contracting the virus.
The lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.
The decision by the FDA on Truvada follows its approval of the OraQuick test earlier this month. The test, which detects the presence of HIV in saliva collected using a mouth swab and returns a result within 40 minutes, is aimed at people who might not otherwise be tested. The FDA has said the test is not 100 percent accurate.
The Associated Press contributed to this report.