FDA panel ...

FDA panel endorses pill to prevent HIV infection

Final say on Truvada likely by mid-June

May 12, 2012 

CHICAGO -- Condoms and other safe-sex practices 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 already are giving patients the drug, Truvada, to ward off infection. But Food and Drug Administration approval would expand that practice and could make the expensive medicine more affordable. Truvada costs $11,000-$14,000 a year.

The lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.

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

"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."

Since 2004, Truvada has been FDA-approved for treating people infected with AIDS. 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 of Foster City, Calif., to market it for prevention. Approval probably would spur many more insurance companies to pay for the drug. And widening the market for Truvada could prompt Gilead to lower the price.

An FDA decision is expected by June 15.

In one U.S. government study of more than 1,200 men and women in Botswana, Truvada lowered the HIV infection risk about 78%. 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% effective or higher.

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 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 Dr. Lisa Sterman of San Francisco, who treats HIV patients. She prescribes the drug 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 FDA also is considering approving the first over-the-counter HIV test for use at home.

FDA reviewers said Friday that the OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted online. But they also raised concerns about the accuracy of the test, a mouth swab that returns results in about 20 minutes.

Public health experts estimate one-fifth of the 1.2 million HIV carriers in the U.S. -- about 240,000 people -- are not aware they are infected.