Gilead Sciences Inc. (GILD)’s HIV drug Truvada won the backing of a U.S. advisory panel as the first medicine to keep healthy people from getting the virus through sexual activity.
The panel of doctors, researchers and patients voted that Truvada, currently marketed to treat those infected with HIV, is safe and effective as a form of prevention in high-risk individuals, including gay men whose partners have the disease. The Food and Drug Administration is expected to decide by June 15 and doesn’t have to follow the panel’s recommendation.
AIDS advocates have debated whether a drug to prevent the virus will be used appropriately. Opponents said the pill may give users a false sense of security and could increase risky behavior. Supporters say it’s a needed tool to reduce infections. A majority of advisers said the risk of misuse or developing resistance didn’t outweigh the potential benefit.
“This matters so much. We have got to get this out there,” said Nancy Padian, a member of the panel and an adjunct professor at University of California, Berkeley.
People taking Truvada for prevention should be regularly tested for HIV to make sure they don’t become infected, in which case the virus could develop a resistance to the drug, panel members said.
New methods of prevention are needed to decrease the number of new infections, said Susan Buchbinder, director of AIDS research at the San Francisco Department of Public Health. She said condoms fail at least 1 percent of time and cause sexual dysfunction in as many as 30 percent of men.
“The only way we are going to end the epidemic is through a combination approach,” Buchbinder told the panel meeting yesterday at FDA’s headquarters in White Oak, Maryland. “What we need are new treatments and prevention strategies to have a major impact on the US epidemic.”
The number of people infected with HIV rose to 34 million worldwide in 2009. The virus that leads to AIDS, once a death sentence, can be reduced to low levels in the blood with use of combination antiviral medicines such as Truvada. In the U.S., the number of HIV infections has been little changed at about 50,000 new infections in recent years and has been increasing among gay and bi-sexual men.
The $14,000-a-year drug is aimed at an estimated 415,000 Americans who are among those at high risk for contracting HIV from sexual activity, according to the Atlanta-based Centers for Disease Control and Prevention. These include people whose spouses or partners have the disease, as well as gay men who had more than two partners in the past year and didn’t wear condoms during sex.
Truvada, approved in 2004 for treating HIV infected patients, makes it harder for the virus to multiply. It can reduce the risk of HIV as much as 94 percent for people who took the pill regularly, according to a study cited by the FDA. In other trials, only 10 percent of participants took the medicine as prescribed, and one study was halted after no benefit was gained.
The committee heard from 43 supporters and opponents at yesterday’s meeting to review the use of the drug as a preventative.
Sal Guillen, an HIV testing counselor with an HIV-positive partner, told the panel he wouldn’t take Truvada as a form of pre-exposure prophylaxis, or PrEP, because of concerns over the side effects and efficacy. He thinks the drug as a form of prevention may lead to more risky behavior by people who don’t understand the importance of taking it every day.
“I must say, when I heard about PrEP I got a little excited and thought maybe we wouldn’t have to use condoms,” Guillen said. “I wish that Truvada was the magic pill, but I don’t think it is yet.”
Supporters of approval said that condoms aren’t enough to reduce new infections. They said the FDA should give doctors and their patients an option to decide if the treatment is right for them.
“We need new tools to fight this epidemic that are used as part of a comprehensive approach,” said Chris Collins, director of public policy for amfAR, The Foundation for AIDS Research, a New York-based nonprofit group that funds HIV research. “I don’t think we should be limiting available to a product based on assumptions about the behavior of some.”
Gilead said it will give educational material to doctors and patients about proper use of the drug. The company will also offer free HIV testing and condoms and an assistance program to cover the cost for people without prescription drug coverage, said Andrew Cheng, Gilead’s senior vice president for HIV therapeutic and development operations.
The committee said they want mechanisms in place to make sure infected people don’t get the drug for prevention. If Truvada is used alone, rather than in combination with another AIDS treatment in an infected person, the virus can develop a resistance to the drug. Panel members said they weren’t comfortable relying on doctors to ensure people have a negative HIV test before prescribing Truvada.
“The harm here is huge,” said Judith Feinberg, an infectious disease doctor at the University of Cincinnati College of Medicine. “You become resistant and you don’t know you’re HIV positive and you go infect another 10 people.”
Truvada, Gilead’s second-leading product, generated 2011 sales of $2.88 million. An experimental pill, called Quad, which combines four company drugs, will be reviewed today by the FDA advisory panel.
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