Gilead secures EC marketing authorization for Epclusa to treat all genotypes of chronic hepatitis C

The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks can now be used 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).

The drug maker said that SOF/VEL is the first single tablet regimen approved to treat patients with HCV genotype 2 and 3, without the RBV requirement.

The company added that physicians also have the options to consider the inclusion of RBV for genotype 3 infected patients with compensated cirrhosis.

SOF/VEL, which is built on the foundation of sofosbuvir, provides a tolerable option which is protease inhibitor free and ribavirin free.

Gilead Sciences president and CEO John Milligan said: “The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected.

“The European approval of SOF/VEL reflects our continued focus to bring a cure to all infected patients across the region and we look forward to working with physicians, healthcare providers and governments to make it available as quickly as possible.”

SOF/VEL is the company’s third sofosbuvir-based treatment to secure marketing authorization from the EC for the treatment of chronic HCV infection.

The US Food and Drug Administration recently approved Epclusa to treat adults with genotype 1-6 chronic HCV infection.