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www.fdanews.com/articles/175158-merck-nabs-fda-approval-for-zepatier-to-treat-hcv-genotypes-1-and-4
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Merck Nabs FDA Approval for Zepatier to Treat HCV Genotypes 1 and 4

February 3, 2016

The FDA has blessed Merck’s Zepatier, a combination of elbasvir and grazoprevir, with or without ribavirin, for the treatment of chronic hepatitis C virus genotypes 1 and 4.

An oral treatment, Zepatier was evaluated in 1,373 patients with chronic HCV genotype 1 or 4 infections with and without cirrhosis for 12 or 16 weeks.

Zepatier was granted breakthrough therapy designation for the HCV genotype 1 infection in patients with end-stage renal disease and for chronic HCV genotype 4 infection.