FDA delays Truvada decision

The FDA has put off by three months its decision on whether the Gilead Sciences ($GILD) drug Truvada can be used as the first preventative HIV treatment, but analysts don't see it as a sign of trouble.

The FDA decision to take some extra time to review Gilead's proposals for keeping the drug from being abused, "just delays the inevitable," Ira Loss, an analyst with Washington Analysis, tells Bloomberg. He is confident the drug will be approved as the first treatment for people who are not infected but who are at high risk of getting the disease, like partners of HIV patients. The target date is now Sept. 14.

When an advisory panel last month recommended the treatment, some members focused on concerns in the HIV care community that some high-risk users might see Truvada as their shield against infection and stop other important preventions, like using condoms. There is also a concern some will not be conscientious about taking the drug daily and so develop resistance for a drug they will need if they do get infected, The Washington Post reports. Gilead has said it will offer education, free HIV testing and condoms, among other things, to increase the chances the drug will be used appropriately.

The data on its effectiveness is impressive. The Post reports that studies sponsored by Gilead show if taken every day, the drug mitigates infection risk by more than 90%. The drug is expensive and the numbers at risk are significant, but some doctors already prescribe Truvada for high risk patients and so analysts are not expecting approval will do a lot for Gilead's bottom line. Many think that Quad, the first single tablet, once-daily drug that delivers an integrase inhibitor, is more important to keeping Gilead as the leader in HIV treatments. An FDA panel in May also recommended the FDA approve Quad as a treatment for those already infected but who have not yet received treatment. An agency decision on it is expected by Aug. 27.

- read the Bloomberg story
- here's the Washington Post piece

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