Healthy people can protect themselves from the deadly HIV virus if they take Gilead Sciences Inc. (GILD)’s Truvada every day. Whether patients will is an issue dividing AIDS advocates as U.S. regulators weigh approving the pill as the first preventative measure against the disease.
Truvada is safe and effective enough as a preventative medicine, Food and Drug Administration staff concluded in a report yesterday. An advisory panel recommendation for approval, set for debate tomorrow, hinges on who would get the pill and whether patients can be educated on the importance of following through with a prescription.
Doctors say the idea is to get healthy individuals in certain high-risk groups to take a $14,000-a-year pill every day to reduce the estimated 48,000 new U.S. cases of HIV each year. Some advocates say such a medicine to prevent the virus that can be avoided with condoms may encourage unprotected sex and increase infections.
“That’s an issue many of us have talked about for years,” said Mitchell Warren, executive director of AVAC: Global Advocacy for HIV Prevention. “If you have this new option, would you be riskier? There is no evidence to show that that might be the case, but that doesn’t mean it’s not a concern.”
Truvada can reduce the risk of HIV as much as 94 percent for people who took the pill regularly, according to a study cited by the FDA. In other trials, only 10 percent of participants took the medicine as prescribed, and one study was halted after no benefit was gained.