FDA Approves New Hep C Treatment

The FDA has approved Epclusa—a fixed-dose combination of sofosbuvir and velpatasvir—for the treatment of adult patients with chronic hepatitis C virus (HCV) with and without cirrhosis.

In patients with moderate to severe cirrhosis, Epclusa is approved for use in combination with ribavirin.
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The safety and efficacy of the drug were evaluated in 3 Phase III clinical trials of 1558 participants without cirrhosis or with compensated cirrhosis. Overall, 95-99% of patients receiving Epclusa were free of virus detected in the blood at 12 weeks after the conclusion of treatment.

In another trial involving 267 participants with moderate to severe cirrhosis, 94% of the 87 receiving Epclusa and ribavirin were free of virus detected in the blood at 12 weeks after conclusion of treatment.

The most common side effects included headache and fatigue. The drug also carries a warning of serious slowing of the heart rate and cases requiring pacemaker intervention reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral.

—Michael Potts

Reference:

FDA. FDA approves Epclusa for treatment of chronic Hepatitis C virus infection [press release]. June 28, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm.