Merck’s New Treatment for HCV Genotypes 1 and 4 approved by FDA

A new treatment for hepatitis C (HCV) genotypes 1 and 4, Zepatier (elbasvir and grazoprevir) with or without ribavirin was approved by the FDA today (January 28, 2016).

A total of 1,373 people participated in clinical trials evaluating the safety and efficacy of Zepatier, with or without ribavirin. Study participants had chronic HCV genotype 1 or 4 infections, with or without cirrhosis. Treatment with Zepatier with or without ribavirin was given once daily for 12 or 16 weeks, and the primary endpoint of the study was sustained viral response (SVR) at 12 weeks.

In study participants with HCV genotype 1, SVR rates ranged from 94%-97%, and in those with HCV genotype 4, SVR rates were between 97% and 100% across trials.

In the product labeling for Zepatier, there are recommendations regarding length of treatment with or without ribavirin that are specifically tailored to patient characteristics and the virus. In order to determine the proper dosing and length of treatment, healthcare professionals should screen genotype 1a-infected patients for certain viral genetic variations prior to starting the patient on treatment.

In clinical trials, the most common side effects of Zepatier without ribavirin included fatigue, headache, and nausea. In those who received Zepatier with ribavirin, the most common side effects were anemia and headache. The labeling for Zepatier includes a warning that elevations of liver enzymes to greater than 5 times the upper limit of normal occurred in about 1% of clinical trials participants. This occurred at or after treatment at week 8. It’s important to conduct liver-related blood tests prior to initiating treatment and at designated times during treatment. Further, Zepatier shouldn’t be given to patients with moderate or severe liver impairment.

Zepatier is marketed by Merck & Co. Inc.

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