Epclusa Approved for Chronic Hepatitis C
TUESDAY, June 28, 2016 -- The combination drug Epclusa has been approved by the U.S. Food and Drug Administration to treat the six major strains of chronic hepatitis C virus (HCV).
Epclusa combines sofosbuvir, FDA-approved in 2013, and the new drug velpatasvir. For people with moderate-to-severe cirrhosis (chronic liver disease), Epclusa is approved to be used in combination with the drug ribavirin. Epclusa also is approved for use in people who haven't developed cirrhosis, the agency said Tuesday in a news release.
HCV causes liver inflammation and diminished liver function. Some 75 percent of Americans with the disease have genotype 1, although there are five other strains. The disease typically becomes chronic, leading to possible complications including bleeding, yellowing of the skin and eyes (jaundice), abdominal fluid accumulation and liver cancer. It could lead to death.
Epclusa was evaluated in clinical trials involving more than 1,500 people. Up to 99 percent of participants given the drug had no virus detected in the blood 12 weeks after treatment, the FDA said.
The most common side effects reported were headache and fatigue.
The drug's label warns that Epclusa, when used with certain other drugs including the heart medication amiodarone, could lead to symptomatic bradycardia, a serious slowing of the heart, the FDA said.
Epclusa is produced and marketed by Gilead Sciences, based in Foster City, Calif.
The FDA has more about this approval.
Posted: June 2016