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New HIV prevention pill could save lives

May 20
21:33 2012

CHICAGO: A pill to prevent HIV infection is already being given to some healthy people, but without U.S. government approval, it remains out of reach and too costly for many who need it.
Doctors, patients and advocates say that would change if the Food and Drug Administration takes a landmark step and allows the pill, Truvada, to be marketed for prevention. The drug has been used for some time as a treatment for those already infected with the AIDS virus.
“This is a pretty radical step, but I think it’s a necessary step,” said Dr. Lisa Sterman of San Francisco, who prescribes the drug for already infected patients and those who are healthy but at risk of getting the virus from their partners or through risky sex.
“We’ve come as far as we can with condom use and safe sex strategies,” Sterman said.
A panel of advisers to the Food and Drug Administration have endorsed using Truvada as a preventive.
In the 30-year battle against AIDS, “it’s the first time we have talked about a medication for prevention of HIV,” Sterman said.
An estimated 1.2 million Americans have HIV, with many more worldwide. AIDS can develop unless the virus is treated with antiviral drugs. The success of such medicines has helped make the disease more manageable and allows patients to live much longer than when the epidemic began 30 years ago.
Doctors are allowed to prescribe Truvada “off-label” for prevention, but FDA approval would formally allow the pill’s maker, Gilead Sciences, to market it for that use. The FDA usually follows advisers’ recommendations, and a decision is expected by June 15.
Studies have shown that daily use of Truvada is highly effective at preventing HIV infections.
Some Truvada prevention studies took place in Africa, and the drug is available as an HIV treatment there and in poor nations elsewhere, but Gilead is seeking approval for using it for prevention in the United States only, a company spokeswoman said.
A September editorial in the medical journal Lancet raised concerns about using HIV treatments for prevention when many HIV-infected people globally lack access to effective treatments.
James Loduca, a spokesman for the San Francisco AIDS Foundation, praised the advisory panel’s action.
“With this recommendation, we’re nearing a watershed moment in our fight against HIV,” Loduca said. “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.”
The panel’s action “is a huge step forward,” said Nick Literski, a federal worker who has been taking Truvada for HIV prevention for more than a year. His partner has the AIDS virus.
Using the drug for prevention “is really allowing people to make educated choices about their health,” Literski said.
Not everyone in the HIV community is so excited about using Truvada for prevention.
Michael Weinstein, president of the AIDS Healthcare Foundation, is among the most vocal opponents. His Los Angeles-based group bills itself as the nation’s largest provider of medical care for HIV and AIDS, and Weinstein’s main concern is that patients won’t take the drug as directed – a pill a day plus the use of condoms. Misuse could create drug-resistant HIV strains, and lead to more infections.
The FDA panelists acknowledged that concern and said people should be tested to make sure they don’t have HIV before starting Truvada. Patients who already have the virus and begin taking Truvada could develop a resistance to the drug, making their disease even more difficult to treat.
Justin Terry-Smith, a writer with HIV, has different concerns. He took Truvada for four years to suppress his infection. He said he has friends with the AIDS virus who can’t find the drug, and he worries that making it widely available for prevention could result in shortages and pose problems for patients who need it for treatment.
“There has to much more production of this drug for this to actually go forward,” he said.
Sterman said approval of Truvada for prevention would be unlikely to lead to shortages because the drug would be recommended only for people at high risk for getting the virus.
“I don’t think demand for it is going to be that high,” she said.
Truvada’s costs are another concern. But supporters of the drug note that the lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.
“It’s much more cost-effective to prevent a new infection than it is to treat someone for their lifetime,” Loduca said. “Of course the ultimate goal is a vaccine and a cure, but we’re many years away from that.” -AP



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