FDA: New Hepatitis C Drug Approved

The FDA has approved Zepatier (elbasvir and grazoprevir), with or without ribavirin, for the treatment of chronic hepatitis C virus genotypes 1 and 4.

The safety and efficacy of the drug were tested in clinical trials of 1373 individuals with hepatitis c genotypes 1 or 4 without cirrhosis. Those who revieved Zepatier achieved sustained virologic response between 94% and 97% in genotype 1 and 97% to 100% in genotype 4.

The most common side effects of Zepatier were fatigue, headache, nausea, and anemia. The drug also carries a box warning of liver enzyme elevations in 1% of clinical trial participants at or around week 8 of the trials. Zepatier should not be used in patients with moderate to severe liver impairment.

—Michael Potts

Reference:

FDA. FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4 [press release]. January 28, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm.