The FDA has approved Merck's elbasvir and grazoprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotypes 1 and 4 infections.
The FDA has approved Merck’s elbasvir and grazoprevir (Zepatier) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections.
“Today’s approval provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release.
In trials involving 1373 participants with HCV genotype 1 or 4, the patients received the drug with or without ribavirin once daily for 12 or 16 weeks.
The sustained virologic response rates in patients ranged from 94% to 97% in genotype 1-infected patients and from 97% to 100% in genotype 4-infected patients.
Genotype 1 is the most common type, while genotype 4 is one of the least common types.
The most common adverse effects associated with Zepatier without ribavirin were fatigue, headache, and nausea.
Anemia and headache were the most common adverse effects among patients who took Zepatier with ribavirin.
Zepatier should not be prescribed to patients with moderate or severe liver impairment.