WASHINGTON -- A pill that has long been used to treat HIV has moved one step closer to becoming the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.
The Food and Drug Administration said Tuesday that Gilead Sciences Inc.'s Truvada appears to be safe and effective for HIV prevention. It concluded that taking the pill daily could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment."
On Thursday a panel of FDA advisers will consider the review when it votes on whether Truvada should be approved as a preventive treatment for people who are at high risk of contracting HIV through sexual intercourse. The FDA is not required to follow the advice of its panels, but it usually does.
About 1.2 million Americans have HIV, which attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off infections. If Truvada is approved, it would be a major breakthrough in the 30-year campaign against the AIDS epidemic. There have been no other drugs proven to prevent HIV and a vaccine is believed to be decades away.
Gilead Sciences, based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication 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 have reduced symptoms and are far less likely to develop AIDS.
"Thirty years into the epidemic we can't dismiss any new options," James Loduca, a spokesman for the San Francisco AIDS Foundation, said in an interview.
FDA reviewers said Tuesday that patients who are using the pill as a preventive measure must be diligent about taking it every day.
Some patient advocacy groups say the drug is an important new option to prevent HIV, alongside condoms, counseling, and other measures.
But support for FDA approval is not unanimous.
Although the FDA is legally barred from considering cost when reviewing drugs, health-care providers have raised concerns about Truvada's price: $900 a month, or just under $11,000 a year. Medicare and Medicaid generally cover drugs approved by the FDA, and analysts expect most large health insurers to follow suit.
Michael Weinstein, president of the AIDS Healthcare Foundation, said approval and prescription of Truvada as a preventive may lead to less condom use and more infections, as well as increased resistance to the drug.
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