AIDS fight enters new phase with prevention pill

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CHICAGO (AP) - Condoms and other safe-sex practices have accomplished only so much. Now the 30-year battle against AIDS is on the verge of a radical new phase, with the government expected to endorse a once-a-day pill to prevent infection with the virus.

Some doctors are already giving patients the drug, Truvada, to ward off infection. But Food and Drug Administration approval would expand that practice and could make the highly expensive medicine more affordable. Truvada costs around $11,000 to $14,000 a year.

Approval seems likely after an FDA advisory panel Thursday endorsed the use of Truvada for prevention.

In the generation-long fight against AIDS, “it’s the first time we have talked about a medication for prevention of HIV,” said Dr. Lisa Sterman of Francisco, who treats HIV-positive patients.

“With this recommendation, we’re nearing a watershed moment in our fight against HIV,” said James Loduca, a spokesman for the San Francisco AIDS Foundation. “We know this isn’t a magic bullet, and it’s not going to be the right prevention strategy for everyone, but it could save thousands of lives in the United States and potentially millions around the world.”

Truvada has been FDA-approved since 2004 for treating people infected with the AIDS virus. Once a drug is on the market, doctors are free to prescribe it for off-label, or unapproved, uses, and that’s what some have been doing in giving Truvada to patients who are healthy but in danger of getting the virus from their partners or through risky sex.

Official FDA backing of the practice would allow Truvada's maker, Gilead Sciences Inc. of Foster City, Calif., to market it for prevention. Approval would also probably lead many more insurance companies to pay for the drug. And by widening the market for Truvada, it could prompt Gilead to lower the price.

An FDA decision is expected by June 15.

The FDA is also considering approving the first over-the-counter HIV test for use at home. Experts said it could help slow the spread of HIV.

An estimated 1.2 million Americans and millions more around the world have HIV. Unless the virus is treated with antiviral drugs, it can turn into full-blown AIDS. Antivirals have made the disease more manageable and allowed patients to live much longer than when the epidemic began in the early 1980s.

Nevertheless, about 50,000 new infections are diagnosed in the U.S. each year, a number that has held steady for about 15 years.

Truvada represents “a pretty radical step, but I think it’s a necessary step,” said Sterman, who prescribes it to infected patients and those who are healthy but at risk. “We’ve come as far as we can with condom use and safe-sex strategies.”

The drug would be recommended for people at high risk of getting the virus, such as gay men with multiple sex partners, prostitutes and people whose partners are infected.

In one U.S. government study of more than 1,200 men and women in Botswana, Truvada lowered the HIV infection risk by about 78 percent. Another larger study in Africa found a slightly lower rate of effectiveness, but researchers say that if used as directed, the pill can be 90 percent effective or higher.

It is available as an HIV treatment in Africa and other poor regions, but Gilead is seeking approval for prevention in the U.S. only, a company spokeswoman said. Some experts have expressed concern that the use of Truvada for prevention could cause shortages in poor countries that desperately need the drug to treat infected people.

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