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Vosevi is a fixed-dose combination product containing sofosbuvir, velpatasvir, and voxilaprevir for the re-treatment of adults with chronic hepatitis C.
In July 2017, the FDA approved Gilead Sciences' Vosevi, a fixed-dose combination product containing sofosbuvir, an HCV NS5B polymerase inhibitor, velpatasvir, an HCV NS5A inhibitor, and voxilaprevir, an HCV NS3/4A protease inhibitor for re-treatment of adults with chronic hepatitis C genotypes 1, 2, 3, 4, 5, or 6.
With its approval, Vosevi became the first antiviral regimen that is indicated for patients who have been previously treated with sofosbuvir or other drugs that inhibit NS5A.
Vosevi is indicated for the treatment of adult patients with HCV genotype 1, 2, 3, 4, 5, or 6 that have previously been treated with an HCV regimen containing an NS5A inhibitor or in patients with genotype 1a or 3 and have previously been treated with a regimen containing sofosbuvir without an NS5A inhibitor.
It can be used in those without cirrhosis or with compensated cirrhosis (Child-Pugh A).
Vosevi is a combination of 3 direct-acting antiviral agents with distinct mechanisms of action. Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication.
Velpatasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication and virion assembly. Voxilaprevir is an inhibitor of the NS3/4A protease, which is necessary for proteolytic cleave for the HCV polyprotein and viral replication.