AIDS Drug Truvada Says May Prevent Virus That Causes The Disease
WASHINGTON — 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.”
One study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was HIV infected and the other was not.
The FDA’s panel of advisers will take separate votes on whether Truvada should be approved for:
- gay and bisexual men
- -men or women in relationships with HIV-positive partners
- -other people at risk of acquiring HIV through sexual activity
Foster City, Calif.-based Gilead Sciences Inc. has marketed Truvada since 2004. The drug is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe the medications as part of a drug cocktail that makes it harder for the virus to reproduce. Patients with low viral levels are far less likely to develop AIDS.
Side effects with Truvada include diarrhea, dizziness, nausea and vomiting. More serious problems can include liver toxicity, kidney problems and bone thinning.
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Source by Associated Press