Gilead's $12,000-a-Year HIV Prevention Pill Fails to Win Physician Support

In Boston at this week's 18th Conference on Retroviruses and Opportunistic Infections (CROI), numerous presentations addressed issues surrounding the use of Gilead Science Inc.'s Truvada as an HIV preventative. In late November, researchers reported the results of a study, conducted among healthy men who have sex with men, which showed that taking the AIDS drug reduced the risk of HIV infection by 73 percent among the most adherent participants and by 44 percent overall. The MSM also were provided condoms and counseling.

So far, however, doctors have been reluctant to prescribe Truvada, which costs $12,000 a year and carries a risk of side effects, to their healthy patients.

"We're not seeing people beating down the doors," said Kenneth Mayer, medical research director and co-chair of Boston's Fenway Institute, whose clients include thousands of MSM. Mayer said he knows of no clinic doctor who has prescribed Truvada, which combines emtricitabine and tenofovir, to prevent HIV infection.

Martin Markowitz, clinical director of New York's Aaron Diamond AIDS Research Center, praised the study but added that "it raises more question than it answers. People who can't use a condom, are they likely to take a pill every day? And in the real world, who will pay?"

Presentations at CROI also are exploring other preventive measures, like male circumcision and microbicides, that may be used concurrently with Truvada in some populations, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "It's almost certainly going to be a combination of things that together will have a major impact," he said.

CDC is convening expert panels to discuss how best to introduce Truvada as an HIV preventative. Demonstration projects that would offer the drug to high-risk, uninfected men are under consideration by the National Institutes of Health and the Department of Health and Human Services. Gilead has announced plans to file for US approval of Truvada as an HIV preventative in the first half of this year.

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