What is the efficacy of elbasvir/grazoprevir (Zepatier) for the treatment of hepatitis C (Hep C) infection?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Answer

Elbasvir/grazoprevir (Zepatier)

The fixed-dose HCV NS5A and NS3/4A protease inhibitor, elbasvir/grazoprevir (Zepatier) was approved in January 2016 for use with or without ribavirin for adults with HCV genotypes 1 or 4 infection. Elbasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. Grazoprevir is an inhibitor of HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV-encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is also essential for viral replication.

Efficacy of elbasvir/grazoprevir was evaluated in clinical trials that included nearly 1400 patients. The overall SVR rates ranged from 94% to 97% for genotype 1 and 97% to 100% for genotype 4 across trials. [118, 119] The approved dosage regimens are specific to the characteristics of the patients and their virus genotype. Prior to initiating therapy, patients with HCV genotype 1a should be tested for NS5A resistance-associated substitutions (RASs) to determine the dosage regimen and duration. Those without RASs are treated for 12 weeks, but treatment is given for 16 weeks with weight-based ribavirin in those with RASs. For patients with subtype 1b infection, the regimen is given for 12 weeks without ribavirin. Duration of treatment is the same in patients with and without cirrhosis with SVR rates greater than 95%. [120]  However, this regimen is contraindicated in those with Child-Pugh classes B and C cirrhosis.


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