On Tuesday, Food and Drug Administration reviewers affirmed clinical trial data suggesting the HIV drug Truvada is safe and effective in cutting HIV infection risk when taken daily. The positive review comes ahead of an FDA advisory panel’s meeting on Thursday to discuss whether to approve Truvada for people at high risk of acquiring HIV sexually. The drug from Gilead Sciences already is approved to treat persons infected with HIV.
The panel will take separate votes on approval to market Truvada as an HIV prevention option among:
*gay and bisexual men,
*people in serodiscordant relationships and
*others at risk for acquiring HIV sexually.
Truvada only worked to prevent HIV when taken every day, reviewers emphasized. Adherence to the once-daily pill was less than perfect in clinical trials, which included condom use and HIV counseling, and adherence may be even less ideal in the real world, reviewers said.
Some researchers note that condoms are still the best prevention against HIV, and that a pill is not the same. Some drugs on the horizon also may prove to be better for HIV prevention than Truvada, which has had mixed results for preventing infection in women, critics say. Nonetheless, many advocates say Truvada should be an option, along with condoms, counseling, and other prevention measures.
Side-effects associated with Truvada include dizziness, diarrhea, nausea, and vomiting. More serious adverse events include liver toxicity, bone thinning, and kidney problems.
FDA does not have to follow the advice of its advisory panels, but usually does so.