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New HIV PrEP Drug Approved by FDA; Not Tested for All Groups

by Sam Cronin

EDGE Media Network Contributor

Friday October 11, 2019

The Food and Drug Administration approved the use of Descovy as an HIV prevention drug on Thursday. Descovy has been approved as a treatment for those already infected with HIV since 2016, according to Reuters. The drug was developed by Gilead Sciences Inc., makers of Truvada, which has been used to treat those infected with HIV since 2004 and as a preventative drug since 2012. Descovy contains a newer formulation of the drug in Truvada. Its approval comes with a significant caveat, however, in that it is not approved for those who have "receptive vaginal sex," which includes cisgender women and some transgender people.

The New York Times reports that "the drug's maker, Gilead Sciences, tested it only 'in men and transgender women.'" This is a notably limited test group, and raises questions of how the drug may react differently in vaginal tissue versus rectal tissue.

The Times goes on to say that "the F.D.A., in fact, will require Gilead to study the Descovy in cisgender women, company officials said. Gilead is considering a trial in Africa."

The patent for Truvada, the original pre-exposure prophylaxis, or PrEP pill, is close to expiration. In light of this, Reuters reports that "Gilead has said it aims to transition PrEP use from Truvada to Descovy before the older drug loses patent protection, which is expected next year."

The Times indicates that Descovy's patent is set to expire in 2026, which could provide a clue to why Gilead aims to phase out the soon-to-go-generic Truvada from its business. A group called Prep4All Collaboration aims to end the patents for both HIV prevention pills earlier in an effort to drive down the prices of the life-saving drugs and encourage generic versions entering the market.

Additionally, Reuters reports "Descovy was shown in clinical trials to be less toxic than Truvada to the kidneys and bones. But some AIDS advocacy groups question whether it makes sense to prioritize Descovy for PrEP close to the time that cheaper generic versions of Truvada are to become available."

Regardless, Descovy is set to hit the market soon. Check out the official press release from Gilead's website here, including the disclaimers and specific dosing information.

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