Merck announced results from the C-EDGE Head-to-Head trial that evaluated the safety and efficacy of Zepatier (elbasvir/grazoprevir) vs. a regimen of sofosbuvir plus peginterferon and ribavirin (pegIFN/RBV) in treatment-naive and pegIFN/RBV treatment-experienced patients with chronic hepatitis C (HCV) genotype (GT) 1 or GT4 infection. 

The Phase 3, randomized, open-label, parallel-group trial, showed that Zepatier  50mg/100mg was superior on efficacy and safety endpoints vs. sofosbuvir 400mg plus pegIFN/RBV based on pre-specified analyses. 

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The efficacy endpoint of sustained virologic response 12 weeks after completion of therapy (SVR12) was achieved in 99% of patients (n=128/129) of patients receiving Zepatier vs. 90% (n=114/126) of patients receiving the sofosbuvir regimen. The safety endpoint was frequency of pre-specified adverse events regarding tolerability, hematologic side effects, and liver-related laboratory abnormalities. Study authors reported that virologic failure occurred in 11 patients in the sofosbuvir arm vs. 0 patients in the Zepatier arm. 

In January 2016, Zepatier was approved by the Food and Drug Administration (FDA) for the treatment of chronic HCV GT1 or GT4 infection in adults with or without RBV. It is a fixed-dose combination drug containing elbasvir, a HCV NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor. It is available as 50mg/100mg strength tablets in 2 x 14 dose packs.

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