June 11, 2012
The Food and Drug Administration is delaying by three months a decision on whether to approve the HIV treatment Truvada to prevent HIV infection. According to a spokesperson with Gilead Sciences, its manufacturer, FDA needs time to review a new plan to limit the drug's risks to healthy people.
If approved, Truvada would become the first drug marketed for the prevention of HIV. FDA now is expected to make a decision by September 14.
In May, an FDA advisory committee recommended approval of Truvada for HIV prevention in specific high-risk groups, including men who have sex with men, and partners of those infected. FDA advisors' concerns included that men taking the drug would stop using condoms and that healthy people would not take the drug daily as prescribed.
An HIV testing plan to ensure that those who are getting Truvada for prevention are HIV-negative also is "pivotal," said Mitchell Warren, of the AIDS advocacy group AVAC. He added: "Gilead has said they will provide free HIV testing" to potential users of Truvada. Interim CDC guidelines state that anyone who might use Truvada for prevention must first be tested.
Michael Weinstein, president of the AIDS Healthcare Foundation, applauded the delay. "From the beginning, we believe there was a rush to judgment by government officials and others in favor of ... approval, despite decidedly mixed studies" regarding the drug's effectiveness, he said.
Studies have shown that taken daily, Truvada reduces the risk of infection by more than 90 percent. One study was stopped early because women were not taking Truvada as prescribed and so were not protected. Side-effects can include intestinal discomfort and diarrhea and, in rare cases, liver damage.