Drug moves toward FDA approval for HIV prevention

WASHINGTON ? A pill that has long been used to treat HIV has moved a step closer to becoming the first drug approved in the U.S. to prevent healthy people from becoming infected with the virus that causes AIDS.

The Food and Drug Administration said Tuesday that Gilead Sciences' Truvada appears to be safe and effective for HIV prevention. It concluded that taking the pill daily could spare users "infection with a serious and life-threatening illness that requires lifelong treatment."

On Thursday, a panel of FDA advisors will vote on whether Truvada should be approved as a preventive treatment for people who are at high risk of contracting the human immunodeficiency virus through sexual intercourse. The FDA is not required to follow the advice of its panels, but usually does.

An estimated 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. No other drugs have been proven to prevent HIV and a vaccine is believed to be decades away.

Gilead Sciences Inc., 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.

Researchers first reported in 2010 that Truvada could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44%, when accompanied by condoms and counseling. Another study found that Truvada reduced infection by 75% in heterosexual couples in which one partner was infected with HIV and the other was not.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. But FDA approval would allow Gilead Sciences to formally market its drug for that use.

Some patient advocacy groups say the drug is an important new option to prevent HIV, alongside condoms, counseling and other measures. Last month, AIDS United and more than a dozen other advocacy groups urged the FDA to approve Truvada.

But support is not unanimous.

Although the FDA is legally barred from considering cost when reviewing drugs, healthcare providers have raised concerns about Truvada's price tag: $900 a month, or nearly $11,000 per year. Medicare and Medicaid, the nation's largest health insurance plans, generally cover drugs approved by the FDA, and analysts expect most large health insurers to follow suit.

In addition, some researchers object that Truvada is not as good a preventive option as condoms, and they say the drug has a mixed record in protecting women.

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