FDA Approves HCV Combination Therapy for all Major Genotypes
The US Food and Drug Administration (FDA) has approved Epclusa®, Gilead’s new combination therapy for adults with chronic hepatitis C viral (HCV) infection, for all six major genotypes of the virus. Epclusa pairs an existing therapy, sofosbuvir, with a new drug known as velpatasvir. The new therapy is indicated for chronic HCV patients both with and without cirrhosis.It is administered orally through a fixed-dose tablet.
The safety and efficacy of sofosbuvir/velpatasvir were demonstrated through four clinical trials. Three of those trials included 1,558 HCV patients with either mild or no cirrhosis. Of those, 95% to 99% of patients taking the new combination therapy had no detectable virus in their bloodstream after 12 weeks of treatment. In the fourth trial, 87 HCV patients with moderate-to-severe cirrhosis received sofosbuvir/velpatasvir along with ribavirin. After 12 weeks of treatment, 94% of that group showed no detectable virus in the bloodstream. Headache and fatigue were the most common adverse events observed in the clinical trials.
“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in an agency news release.
Source: Medscape news, June 28, 2016