Zepatier (pronounced ZEP-ah-teer), taken with or without ribavirin, was approved by the U.S. Food and Drug Administration (FDA) yesterday for the treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4 and little or no liver damage (Child-Pugh A).
Yesterday’s Press Releases about Zepatier’s FDA Approval
- The FDA’s News Release about the treatment’s approval
- The Press Release about the approval by Merck, Zepatier’s developer
Zepatier is an all-oral, short-course (12 or 16 weeks), interferon-free hep C treatment that can be taken with or without ribavirin. The treatment is a pill taken once-daily that is made up of two direct-acting antivirals, grazoprevir and elbasvir.
In clinical trials, Zepatier (with or without ribavirin) cured an overall 94% – 97% of patients with hep C genotype 1, and 97% – 100% of hep C genotype 4 patients.
Zepatier in Canada
On January 22nd, Health Canada approved Zepatier for use in Canada for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring). In Canada, it was approved for use with or without ribavirin and with or without Sovaldi.