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ViiV Thinks It May Get All-Gender Approval For Cabotegravir For PrEP

 
• By Joseph Haas

Final data comparing cabotegravir to Truvada for HIV prophylaxis confirms superiority. ViiV says treatment data in women may enable an all-gender approval that eluded Gilead with Descovy.

PrEp tablet. Vector pre-exposure prophylaxis blue pill developed to prevent HIV epidemic.
ViiV hopes it will join Gilead in the HIV PrEP space with cabotegravir

With a 66% greater effect, ViiV Healthcare’s next-generation integrase inhibitor cabotegravir has demonstrated superiority to Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) in HIV pre-exposure prophylaxis (PrEP) and is poised for regulatory approval. Viiv is hoping to come to market with clearance for all genders, avoiding a limitation placed on the most recent PrEP approval by the US Food and Drug Administration.

While the first PrEP approval, for Gilead’s Truvada, in 2012 allowed for use in all genders, Gilead received a narrower claim for its follow-on, Descovy (emtricitabine/tenofovir alafenamide), to only men and transgender women – the population studied in its clinical trial. The company is designing a study in cisgender women in hopes of adding that population to Descovy labeling

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