Mutation Resistance Could Differentiate Shionogi/ViiV’s Dolutegravir
This article was originally published in Pharmaceutical Approvals Monthly
Full data from the Phase III SPRING-2 trial released at the International AIDS Conference revealed ViiV/Shionogi’s experimental integrase inhibitor dolutegravir had no resistance mutations compared to Merck’s Isentress.
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During an event in New York, the president of the Japan Pharmaceutical Manufacturers Association spoke about the troubles facing the Japanese pharmaceutical industry and the steps that need to be taken to continue competing on a global level. He also addressed the changes happening at the company he heads, Japan’s Shionogi.
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.
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.