Epclusa has attained FDA approval as a treatment for chronic hepatitis C. | Courtesy of Shutterstock
+ Regulatory
Amanda Rupp | Jun 29, 2016

Epclusa gains FDA approval to treat chronic hepatitis C

Leaders at the U.S. Food and Drug Administration (FDA) recently approved of Epclusa as a new treatment for adults who have chronic hepatitis C virus (HCV) infections.

Patients can qualify for the treatment regardless of whether they have cirrhosis, or advanced liver disease. People who have moderate to severe cirrhosis -- also called decompensated cirrhosis -- can combine Epclusa with ribavirin.

Epclusa is the first regimen that has been approved to treat all of the six main kinds of HCV genotypes. The treatment is a fixed-dose combination tablet that is comprised of velpatasvir, a new drug, and sofosbuvir, a drug first approved in 2013.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said.

HCV, a viral disease, inflames the liver, which can cause liver failure or reduced liver function. There are an estimated six different HCV strains or genotypes, each of them genetically distinct. Roughly 75 percent of U.S. patients who have HCV have genotype 1. Approximately 20-25 percent of Americans have HCV infections from genotypes 2 or 3, and the remaining few HCV patients have infections from genotypes 4, 5 or 6.

Knowing the kind of genotype that a patient has makes the treatment more effective in targeting the specific infection. This is why Epclusa is unique in its approach to treating HCV.

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