US nod for Gilead’s pan-genotypic hep C pill

US regulators have waved through Gilead’s Vosevi allowing the drug’s use to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs - sofosbuvir and velpatasvir - and new drug voxilaprevir. It is the first treatment cleared by the US Food and Drug Administration for patients who have already received the direct-acting antiviral drug sofosbuvir or other NS5A inhibitors, providing a new option for those whose previous treatment has been unsuccessful. For patients who require re-treatment, there remains an unmet clinical need for an effective and well-tolerated option,” noted Ira Jacobson, chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Vosevi clinical trials.