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FDA Approves Epclusa for Chronic Hepatitis C

Combination drug treats six major strains of hepatitis C virus infection

TUESDAY, June 28, 2016 (HealthDay News) — 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.

Epclusa combines sofosbuvir, FDA-approved in 2013, and the new drug velpatasvir. For patients with moderate-to-severe cirrhosis, Epclusa is approved to be used in combination with ribavirin. Epclusa also is approved for use in patients who haven’t developed cirrhosis, the agency said Tuesday in a news release.

Epclusa was evaluated in clinical trials involving 1,558 patients. 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 amiodarone, could lead to symptomatic bradycardia.

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

Epclusa is produced and marketed by Gilead Sciences, based in Foster City, Calif.

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