Merck announced that the FDA has granted Breakthrough Therapy designation to grazoprevir/elbasvir (Zepatier; Merck) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.

Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir, a NS3/4A protease inhibitor and elbasvir, a NS5A replication complex inhibitor. As part of Merck’s clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, cirrhosis, and those on opiate substitution therapy.

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Previously in October 2013, the FDA granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of patients with chronic HCV genotype 1 (GT1). Merck plans to present results from its clinical trial program at The International Liver Congress 2015.

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