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. Gilead tried to make a case for approval in women based on pharmacokinetic data, but the lack of clinical data in cisgender women was a major issue during the FDA advisory committee review. Panelists did not mince words in expressing their disappointment with Gilead and the FDA in allowing the Descovy application to advance so far without any clinical data in cisgender women
