FDA Panel Backs HIV Prevention Pill Truvada
A U.S. Food and Drug Administration advisory panel voted on Thursday to recommend Truvada -- currently administered as a treatment for patients who test positive for the human immunodeficiency virus -- as an HIV-prevention measure.
The FDA is scheduled to make its decision on Truvada in the new indication next month. Although the agency is not required to follow the advice of its advisory panel, it typically does.
The panel recommended the drug be approved as a daily pill for healthy people at risk for HIV, which includes people with an HIV-positive partner.
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"I think this is a huge milestone," Dr. Robert Grant, associate director of the Center for AIDS Research at the University of California at San Francisco, who led the panel's research, told CBS News. "I think we are in an era for the first time when we can see the end of the AIDS epidemic."
HIV can cause a failure of the immune system. Some people develop flulike symptoms within a few weeks of being infected, but most show no symptoms, according to the Centers for Disease Control and Prevention. About 25 percent of people infected with HIV do not know it, the CDC said.
There is no cure for HIV infection -- or its final stage, AIDS -- but treatment with a cocktail of medications helps. The average life expectancy of someone infected with HIV is 32 years from the time of entering HIV care if medication is begun early, according to a 2006 study published in Med Care. The later the treatment is started, the shorter life expectancy becomes.
Truvada is a combination of HIV drugs and is taken daily to manage the disease. However, some doctors have already been prescribing the drug off label as a preventative measure. The FDA vote would allow the drug's maker, Gilead Sciences Inc., to market the drug as a prophylactic.
"This is a pretty radical step, but I think it's a necessary step," Dr. Lisa Sterman, a doctor from San Francisco who prescribes the drug off label, told the Boston Globe. "We've come as far as we can with condom use and safe sex strategies."
Administration of the pill regimen costs about $900 per month, but, with insurance, the cost comes down to about a $40 monthly co-payment.
The drug needs to be taken every day to be effective, and the major concern is patient compliance. Clinical-trial participants did not always adhere to a strict regimen, and real-world patients are likely to be even less compliant.
"The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine," Dr. Tom Giordano, a member of the FDA advisory panel who voted in favor of the drug, told CBS News. "I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits."
Complete compliance to a drug regimen is impossible, Karen Haughey, a registered nurse, said during the FDA's public-comment period. "Truvada needs to be taken every day, 100 percent of the time, and my experience as a registered nurse tells me that won't happen," she told the panel. "In my eight years, not one patient that I've cared for has been 100 percent adherent."
The San Francisco AIDS Foundation praised the panel's decision, saying it could help bring an end to the AIDS epidemic.
"With this recommendation, we're nearing a watershed moment in our fight against HIV," James Loduca, a representative of the foundation, told the Boston Globe. "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."
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