May 10, 2012 -- An FDA advisory panel today recommended approval of the drug Truvada to prevent the spread of HIV infection in high-risk, healthy people.
Since 2004, the drug has been been approved to treat people already infected with HIV, the virus that causes AIDS.
The FDA's Antiviral Drugs Advisory Committee recommended approval for three groups:
Men who have sex with men
Uninfected partners of HIV-positive partners
Others at risk of infection through sexual activity
The yes vote was strongest for the first group, with the panel voting 19-3. For the second group, the panel voted 19-2 with 1 abstention. For the third group, the panel voted 12-8 with 2 abstentions.
The FDA does not have to follow the advice of the advisory panel, but it typically does. A final decision is expected by June 15. Truvada is already used ''off-label" as a preventive drug in high-risk people, such as men who have sex with men.
AIDS activists and doctors have been sharply divided about what FDA approval for healthy people will mean. In some studies, the drug reduced the risk of infection by 75%.
Critics of the decision say an HIV-preventive drug will send the wrong message, leading to the decline of condom use.
Advocates say a preventive drug will be a welcome addition to other measures to reduce the AIDS epidemic. "It's not a panacea, not a blanket answer, but it is one more piece of the prevention puzzle," says William McColl, political director of AIDS United.
The cost of the drug is about $1,100 a month, says Patrick O'Brien of Gilead Sciences, its maker. With insurance, the cost is often a $10 co-pay, he says.
About 1.2 million Americans have HIV, according to the CDC, although 1 in 5 is unaware. About 50,000 people in the U.S. each year are newly infected.
Truvada contains two medicines, Emtriva and Viread. They are combined in one pill. For the treatment of HIV, Truvada is used in combination with other HIV medicines.
The drug works by helping to block a chemical in the body needed for HIV to multiply.
As the advisory committee listened to evidence about the drug, some expressed concerns that people would share the medication. Others wondered if approval for healthy persons would result in a decline in safer sex practices such as condom use.
If people who took the medication got infected anyway, some worried that drug-resistant strains might develop.
Other questions addressed by the expert panel, such as whether to require doctors who prescribe it to receive education about the drug, were not voted on. Nor was the question about how often those who take the preventive drug would get HIV testing.