European Commission grants marketing authorization for Gilead’s Epclusa (sofosbuvir/velpatasvir) for the treatment of all genotypes of chronic hepatitis C

8 July 2016 - Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis C virus infection and is Gilead’s third sofosbuvir-based treatment.

Gilead Sciences today announced that the European Commission has granted marketing authorization for Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.

View Gilead Sciences' press release

Michael Wonder

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Michael Wonder