Epclusa Clinical Development Timeline
Chronicle of the development and FDA review of Gilead’s fixed-dose combination of sofosbuvir and velpatasvir for hepatitis C.
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Drug Review Profile of the pan-genotypic HCV treatment shows agency staff debating whether fixed-dose combination's strong efficacy in certain genotype 3 patients could be further maximized by adding ribavirin.
US FDA cited strong efficacy, good safety of Gilead's Harvoni and AbbVie's Viekira Pak in rescinding breakthrough therapy designation for the sofosbuvir/velpatasvir fixed-dose combination in hepatitis C patients with genotype 1 infection.
FDA staff who participated in the review of Gilead’s pan-genotypic hepatitis C drug.