The U.S. Food and Drug Administration today approved Zepatier (Elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
The most common side effects of Zepatier without ribavirin were fatigue, headache and nausea. The most common side effects of Zepatier with ribavirin were anemia and headache.
Zepatier carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants, generally at or after treatment week eight. Zepatier should not be given to patients with moderate or severe liver impairment.
Zepatier was granted breakthrough therapy designation for the treatment of chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis and for the treatment of chronic HCV genotype 4 infection.