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USFDA approved Zepatier

The United States Food and Drug Administration (USFDA) has approved Zepatier (Elbasvir and Grazoprevir) for therapeutic management of chronic hepatitis C infection (HCV) genotypes 1 and 4 in adults. Zepatier can be administered with or without Ribavirin. Zepatier is to be commercialized by Merck & Co.

 

Clinical trials involving 1373 chronic HCV patients with genotype 1 or 4 infections with or without cirrhosis were conducted to demonstrate the safety and efficacy of Zepatier (without or with Ribavirin). The patients were assigned to receive the treatment once daily for 12-16 weeks. The endpoint of the study is disappearance of viral load or antigen in patient’s blood sample, 12 weeks after treatment.

 

The overall sustained virological response was 94-97% and 97-100% in genotype-1 and genotype-4 infected patients, respectively.

 

Zepatier is to be marketed with a Boxed Warning about the potential risk of elevations (up to 5 folds) of hepatic enzymes, possibly at or after 8 weeks of treatment. Zepatier is contraindicated in patients with severe liver impairment.

 

Some of the reported common adverse events of Zepatier without Ribavirin therapy were nausea, fatigue and headache. The combined therapy of Ribavirin with Zepatier can cause headache and anemia.

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