FDA, Gilead And HIV Prevention-In-A-Pill?

via Pharmalot, by Ed Silverman


The debate over whether the FDA should approve an existing AIDS medication for preventing the spread of HIV has ratcheted up as more than a dozen advocacy groups are urging the agency to accelerate its review process and not wait for data about heterosexuals. The move comes just one month after one prominent advocacy group urged the FDA not to approve Truvada, which is sold by Gilead Sciences, for prevention, or as pre-exposure prophylaxis, for any group.

In a letter to the FDA and Gilead, the groups say that approval is needed as soon as possible in order to provide protection to gay and bisexual men and transgender women. And they cited data from a study released last November that found that men and transgender women who have sex with men and received a daily dose of Truvada, along with condoms and safe sex counseling, had an average of 42 percent fewer HIV infections than those who received only condoms and counseling (read here).

In fact, three PrEP trials have shown evidence that using Truvada or Gilead’s Viread, which is a component of Truvada, reduced the risk of infections. The other trials examined use by heterosexual men and women, and a so-called partners trial that looked at couples in which one partner is HIV-negative and the other is HIV-positive.But the advoacy groups complain that before results of the heterosexual study were released, the FDA and Gilead were believed to be ready to proceed with a review of PrEP for men who have sex with men, or MSM. And to them, delay means more infections.

Read the rest.

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