U.S. Food and Drug Administration advisers on Thursday endorsed the use of the drug Truvada as a means to help prevent HIV infection in healthy people at high risk of contracting the AIDS-causing virus.
In a series of votes that could lead to a major new weapon in the fight against AIDS, the FDA advisers recommended approval of the daily pill for healthy, at-risk individuals, including gay and bisexual men and heterosexual couples with one HIV-infected person, the Associated Press reported.
The FDA is not bound to follow the recommendations of its advisory panels, but it typically does so. A final decision is expected by mid-June.
A report released earlier this week by the FDA suggested that scientists believe the drug is safe and effective. It has been available since 2004 to treat people already infected with HIV.
But there are potential drawbacks to using the medication as a way to try to prevent HIV infection. Truvada — which combines two HIV-fighting drugs, tenofovir (Viread) and emtricitabine (Emtriva) — is very expensive and may cause side effects. And although doctors can already prescribe it to people trying to avoid HIV infection, critics contend it’s too early to officially allow it to be promoted for that use.
On the other hand, those who support marketing the drug as a preventive agent say it can help high-risk people avoid the disease, especially if they don’t use condoms or if they want an added layer of protection.
“I don’t see it as a panacea, but it’s an option, and that’s important,” said Dr. Kenneth Mayer, an AIDS specialist and medical research director of The Fenway Institute at Fenway Health in Boston. “Some people won’t use a condom, but will say, ‘if you give me another option, I’ll use that.’”
Truvada works to combat HIV from replicating in the body’s cells. Mayer explained that in someone who is not yet infected but is exposed to HIV, the drug may prevent the virus from reproducing even if it has already invaded cells. As a result, he said, “the virus cannot start turning the newly exposed person’s body into a ‘factory’ to produce more HIV particles.”