FDA Panel Supports New Drug Descovy as PrEP for Some
On Wednesday, August 7, an FDA advisory panel voted 16-2 in favor of allowing the use of Gilead Sciences, Inc.’s combination drug Descovy to reduce the risk of sexually transmitted HIV in cisgender men and transgender women who have sex with men. Descovy is a combination of emtricitabine and tenofovir alafenamide and is already used to treat chronic HIV.
This panel vote does not, however, mean that Descovy will immediately be available for use as PrEP. For one thing, the FDA has yet to make a final decision on whether to approve Descovy for PrEP. While the agency usually follows the advice of its advisory panels, it is not bound to do so.
For instance, regarding the approval of Descovy as PrEP for cisgender women, according to an August 6 report in www.medpagetoday.com, “The FDA had encouraged Gilead to conduct a dedicated efficacy trial of F/TAF in cisgender women at high risk for HIV infection, but the company chose not to incur the expense. Instead it gambled that the FDA would agree to accept an ‘extrapolation’ strategy based on two phase I pharmacokinetic studies to be presented at the Wednesday meeting, collectively indicating that F/TAF will be as effective as F/TDF, approvals for which include cisgender women.” The FDA rejected Gilead’s argument, saying that there was not enough data to support the use of Descovy by cisgender women. The panel voted 10-8 against approving Descovy for cisgender women. Conducted by Gilead, the DISCOVER trial is assessing the safety and efficacy of Descovy as PrEP in cisgender men and transgender women who have sex with men; the trial is not assessing cisgender women nor transgender men who have sex with men.
Some patient advocacy groups oppose the launch of Descovy as PrEP. Primarily, they cite the U.S. launch next September of a generic version of Truvada, the currently approved PrEP, Truvada, which could lower patient costs significantly.
And, of course, there is the financial side of the story. The panel’s recommendation is welcome news for Gilead, as Truvada, its third best-selling HIV drug, faces loss of exclusivity in the United States, beginning next year, as its patent expires. Due to its approval for use as PrEP, sales of Truvada grew 15% last year, according to Reuters. Gilead hopes that Descovy will help it retain its Truvada patient base after the drug goes off-patent.
Gilead, and we, await the FDA’s final decision.
—Reporting by Hank Trout
Hank Trout, Senior Editor, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a forty-year resident of San Francisco, where he lives with his fiancé Rick. Follow him on Twitter @HankTroutWriter.