FDA favors first drug for HIV prevention
Federal drug regulators on Tuesday affirmed landmark study results showing that a popular HIV-fighting pill can also help healthy people avoid contracting the virus that causes AIDS in the first place. While the pill appears safe and effective for prevention, scientists stressed that it only works when taken on a daily basis.
The Food and Drug Administration will hold a meeting Thursday to discuss whether Truvada should be approved for people who are at risks of contracting HIV through sexual intercourse. The agency’s positive review posted Tuesday suggests the daily pill will become the first drug approved to prevent HIV infection in high-risk patients.
FDA reviewers conclude that taking Truvada pre-emptively could spare patients “infection with a serious and life-threatening illness that requires lifelong treatment.”
Despite the positive results, reviewers said that patients must be diligent about taking the pill every day. Adherence to the medication was less than perfect in clinical trials, and reviewers said that patients in the real world may forget to take their medication even more than those in clinical studies.
First announced in 2010, Truvada’s preventive ability was hailed as a breakthrough in the 30-year campaign against the AIDS epidemic.
Because Truvada is already on the market to manage HIV, some doctors currently prescribe it as a preventive measure. FDA approval would allow the drugmaker Gilead Sciences to formally market its drug for the new use.