Gilead Files Once-daily Integrase Inhibitor Elvitegravir With FDA
This article was originally published in The Pink Sheet Daily
Part of the Quad combination product, stand-alone elvitegravir could open up the integrase inhibitor market. In a study supporting the single-agent NDA, once-daily elvitegravir proved comparable to Merck’s twice-daily blockbuster Isentress, the only commercially available integrase inhibitor.
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Gilead has priced its new 4-in-1 HIV treatment, more commonly referred to as Quad, slightly above the only other integrase inhibitor-based regimen on the market, Merck’s Isentress, but at a 35% premium to its own three-drug combo product, Atripla.
With cost concerns already arising, the sponsor says it is working to ensure the drug is covered by state AIDS Drug Assistance Programs.
Viiv Healthcare/Shionogi’s once-daily, unboosted integrase inhibitor dolutegravir is efficacious and well-tolerated in the first of four Phase III HIV trials to report, a study of treatment-naïve patients. Drug poses a competitive threat to Merck’s blockbuster Isentress and Gilead’s elvitegravir, part of the four-in-one “Quad” pill.