Gilead Gets FDA Approval For Epclusa (Sofosbuvir/Velpatasvir) for All Genotypes Of Chronic Hepatitis C Treatment

Gilead Sciences, Inc. GILD revealed Tuesday that the Food and Drug Administration has approved its Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg). According to the company, this was the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

Gilead disclosed that Epclusa is also the first single tablet regimen that got approval for the treatment of patients with HCV genotype 2 and 3, without the requirement for ribavirin. The drug maker added that Epclusa for 12 weeks was approved 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 company's president and CEO, John Milligan, commented, "Today's approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens. As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible."

Similarly, Chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Epclusa clinical trials, had this to say, "The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype."

He added, "Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens."