The U.S. Food and Drug Administration approved Monday a Gilead Sciences Inc.GILD +1.66% HIV drug for use in certain healthy people to help prevent them from contracting the virus that causes AIDS.
The move, which was expected, marks a milestone in the three-decade effort to prevent HIV and AIDS. Truvada was previously approved for use in combination with other drugs to treat HIV. The new approval marks the first time the FDA has approved a drug to prevent HIV infection. The approval allows Truvada to be used in people who are considered at high risk of becoming infected with HIV, such as those who have an HIV-infected partner.
The FDA said Truvada, a pill taken daily, is to be used in combination with safe-sex practices, such as condom use, to cut the risk of sexually acquired HIV infection in adults. The agency said doctors need to test patients to make sure they are HIV-negative before prescribing Truvada and do follow-up testing every three months. The use of Truvada alone in a person who might become infected with HIV won't treat the virus effectively.
Truvada is a combination of two medicines that make it harder for HIV to multiply in the body. Wall Street analysts said approval of Truvada as a prevention tool is unlikely to add much to the product's sales because it is already being used for this purpose in limited cases, such as when heterosexual couples with one HIV-positive partner try to conceive a child.
Gilead said it has developed FDA-approved materials to educate doctors and patients about how to appropriately use Truvada and will provide vouchers for free HIV testing and condoms.
In May, a federal advisory panel voted to support the expanded use of Truvada in gay and bisexual men and heterosexual couples in which one partner is HIV negative.
In the U.S., about 1.2 million people are infected with HIV and about 50,000 new infections are diagnosed each year, a level that has been stable for the past decade. Medical experts said additional approaches are needed to lower the rate of new infections but were divided on whether Truvada should be approved.
One big concern is whether healthy people would adhere to pill's daily-dose regimen, which is necessary for it to work, and whether the use of the medicine might prompt people to drop other prevention measures such as condom use.
While two federally funded clinical studies submitted by Gilead in support of Truvada showed it could substantially lower a person's risk of contracting HIV, another study looking at Truvada for prevention was stopped last year because too few people were taking the medicine properly to show whether it might work.
The AIDS Healthcare Foundation, a global AIDS organization that provides medical care and services to HIV-infected people, called the FDA's approval of Truvada for HIV prevention "reckless" and criticized the agency for not requiring proof of a negative-HIV test in users. In March, the group had filed a petition with the agency urging it to reject Truvada's application, citing concerns about drug side effects, the nearly $14,000 annual cost of the drug and the difficulty of sticking with a daily pill regimen.
The FDA said possible serious side effects were kidney problems and bone loss but that these weren't common. The less serious but more common side effects were nausea, abdominal pain and diarrhea, the agency said.