FDA Approves Gilead’s Vosevi Combination for Hepatitis C

July 21, 2017

The FDA approved Gilead’s Vosevi antiviral combination for chronic hepatitis C virus in genotypes 1-6.

Vosevi is a fixed-dose tablet containing two previously approved drugs — sofosbuvir and velpatasvir —as well as the new drug voxilaprevir. Approved in patients with mild or no liver disease, Vosevi is the first treatment for patients previously treated with sofosbuvir or other drugs for HCV that inhibit the protein NS5A.

Vosevi was evaluated in two Phase III clinical trials enrolling approximately 750 adults, comparing 12 weeks of treatment with placebo or with sofosbuvir and velpatasvir alone. Both trials showed 96 percent of patients that received Vosevi had no virus detected in the blood after finishing treatment. The FDA previously granted Vosevi priority review and a Breakthrough Therapy designation.

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