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SILVER SPRING (Maryland) - The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers yesterday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.
In a series of votes, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner.
The FDA is not required to follow the panel's advice, though it usually does. A final decision is expected by June 15.
Gilead Sciences, based in Foster City, California, has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe it as part of a drug cocktail to repress the virus.
While panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted a number of concerns created by the first drug to prevent HIV. In particular, the panel debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug's effectiveness in women, who have shown much lower rates of protection in studies.
Panelists struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who did not take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.
"The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine," said Dr Tom Giordano of Baylor College of Medicine, who voted in favour of the drug. "I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits."
Panelists stressed that people should be tested to make sure they do not have HIV before starting therapy with 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. The experts grappled with how to protect patients while avoiding hurdles that could discourage them from seeking treatment.
"If we put up too many hoops to jump through, there will be people who don't make it through those hoops," said Daniel Raymond, the panel's patient representative.
Truvada's groundbreaking preventive ability has exposed stark disagreements on prevention among those in the HIV community. While Truvada's supporters say the drug is an important new option, critics worry that the drug could give users a false sense of security, and encourage risky behavior.
During the meeting's public comment period, FDA panelists heard from more than two dozen doctors, nurses and patients who said patients would not take the drug as recommended - every day, in addition to using condoms.
Mr Nick Literski, a federal worker in Seattle, has been taking Truvada for HIV prevention for more than a year. His partner is HIV-infected and his doctor prescribes the drug as a precautionary measure, even though it is not yet FDA-approved for that use. Literski pays a US$40 monthly co-pay for the once-daily pill.
FDA approval of the drug for prevention would be "a huge step forward" in the fight against AIDS, he said in an interview yesterday. But he said rejection would be devastating, threatening gay relationships like his that involve one partner who is HIV infected and one who is not.
"Many HIV-positive men end up ending their relationships with HIV-negative men out of fear of infecting their partner," Mr Literski said, and he worried about that happening to him before he started using Truvada. AP
