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NS5B and NS3 Inhibitors in Patients with Resistance-Associated Variants of Hepatitis C Virus: A Review of the Clinical Effectiveness

Published on: August 8, 2016
Project Number: RC0799-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of hepatitis C pharmacotherapies containing NS5B inhibitors in direct-acting antiviralnaive patients infected with NS5B resistance-associated variants of hepatitis C virus at baseline?
  2. What is the clinical effectiveness of hepatitis C pharmacotherapies in direct-acting antiviralexperienced patients infected with treatment-emergent NS5B resistance-associated variants of hepatitis C virus?
  3. What is the clinical effectiveness of hepatitis C pharmacotherapies containing NS3 protease inhibitors in direct-acting antiviralnaive patients infected with NS3 protease inhibitor resistance-associated variants of hepatitis C virus at baseline?
  4. What is the clinical effectiveness of hepatitis C pharmacotherapies in direct-acting antiviralexperienced patients infected with treatment-emergent NS3 protease inhibitor resistance-associated variants of hepatitis C virus?

Key Message

Evidence suggests that in direct acting antiviral (DAA) treatment-naïve patients who were infected with hepatitis C virus (HCV), genotype (GT) 1, the sustained virological response (SVR) rates with sofobusvir (SOF) or with paritaprevir (PRV) ± dasabuvir (DSV) containing treatment regimens were comparable between patients with and without NS5B resistance associated variants (RAVs).Evidence suggests that in DAA treatment experienced patients who were infected with HCV GT1, the SVR rates with SOF containing treatment regimens were comparable between patients with and without NS5B RAVs. Evidence suggests that in DAA treatment-naïve patients who were infected with HCV GT1, the SVR rates with asunaprevir or grazoprevir containing treatment regimens were comparable between patients with and without NS3 RAVs; and the SVR rates with PRV or simeprevir containing regimens varied depending on the other drugs that were used in combination in these regimens. Evidence suggests that in DAA treatment experienced patients who were infected with HCV GT1 the majority of patients with NS3 RAVs achieved SVR with retreatment with GRZ containing regimens; the SVR rates for retreatment with simeprevir containing regimens varied depending on whether it was used in combination with daclatasvir or pegylated interferon and ribavirin. Some studies included only few patients and the numbers of patients with NS5B or NS3 RAVs were small compared with the numbers of patients without the RAVs, hence the finding need to be interpreted in the light of these limitations.

Tags

genetics, hepatitis c, infectious diseases, RAV, RAVs, non-structural protein 3, non-structural protein 5B, nonstructural protein 3, nonstructural protein 5B, resistance-associated variant, resistant-associated variant, resistant-associated variants