The U.S. Food and Drug Administration has approved Vosevi 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 a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.
- Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV.
- Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past.
- The safety and efficacy of Vosevi was evaluated in two Phase 3 clinical trials that enrolled approximately 750 adults without cirrhosis or with mild cirrhosis.
The FDA granted approval of Vosevi to Gilead Sciences Inc.