Truvada up for FDA debate as HIV preventive

Should an HIV treatment become a prophylactic? That's the question an FDA panel will address later this week, when it considers the data on forestalling HIV infection with Gilead Sciences' ($GILD) Truvada. As The Wall Street Journal notes, it's the first time a drugmaker has asked the FDA to approve preventive use of an HIV drug--and if it's approved, would mark a major turning point in AIDS-fighting efforts.

On the face of it, preventing HIV infection with a drug seems a no-brainer, provided the drug is effective for that use. This, too, is debatable, and the panel will certainly do so. The indication would be for prevention in high-risk patients, and holding the line on those infections could make a dent in case numbers.

But the worry is that patients in the real world wouldn't take Truvada as directed; there are the usual concerns about simple adherence problems, such as forgetting a dose, but also the affordability problem, given that Truvada costs $14,000 a year. Then there's another potential problem: Would these patients then see themselves as bulletproof, and stop using routine safe-sex measures, i.e., condoms?

And then there's the other side of the story: Some AIDS-prevention advocates worry that denying Truvada this use will quash other prevention-related research. So, the FDA panel will have plenty to sift through. And lots of time to listen: There's an extended public comment period, precisely because of the controversy.

- read the WSJ piece
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