Early virological assessment during telaprevir- or boceprevir-based triple therapy in hepatitis C cirrhotic patients who failed a previous interferon based regimen - The ANRS CO20-CUPIC study

Clin Res Hepatol Gastroenterol. 2015 Sep;39(4):443-50. doi: 10.1016/j.clinre.2014.12.007. Epub 2015 Jan 27.

Abstract

Background and objective: To assess within the ANRS CO20-CUPIC cohort whether the viral load (VL) at week 2/week 6 for telaprevir/boceprevir-based triple therapy, respectively, was predictive of sustained virological response (SVR) in patients with hepatitis C virus (HCV) infection and to study the relevance of this measurement to early diagnose drug resistance.

Methods: Observational study of HCV genotype 1 patients with compensated cirrhosis (Child-Pugh A), non-responders to a prior course of interferon (IFN)-based therapy and who started triple therapy. Patients received either 12 weeks of telaprevir in combination with PEG-IFN/ribavirin (RBV), then 36 weeks of PEG-IFN/RBV, or 4 weeks of PEG-IFN/RBV, then 44 weeks of PEG-IFN/RBV and boceprevir.

Results: A total of 262 patients were analyzed. For telaprevir-treated patients, 28% had undetectable VL at W2 of whom 81% achieved SVR12 whereas 67% had undetectable VL at W4 of whom 67% achieved SVR12. For boceprevir-treated patients 20% had undetectable VL at W6 and 86% of them achieved SVR12 whereas 36% had undetectable VL at W8 among whom 73% achieved SVR12. Five telaprevir-treated patients had a VL increase between W2 and W4 after a decrease between D0 and W2. Four of them did not achieve SVR12. Similarly, six boceprevir-treated patients had a VL increase between W6 and W8 after a decrease between D0 and W6. Five did not reach SVR12.

Conclusions: The assessment of HCV RNA level after two weeks of triple therapy in cirrhotic non-responder patients is a good predictor of SVR. This assessment was useful to do an early diagnosis of viral breakthrough.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiviral Agents / therapeutic use
  • Drug Therapy, Combination
  • Female
  • Hepacivirus / genetics
  • Hepacivirus / metabolism
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferon-alpha / therapeutic use
  • Liver Cirrhosis / drug therapy*
  • Liver Cirrhosis / virology
  • Male
  • Middle Aged
  • Oligopeptides / therapeutic use
  • Polyethylene Glycols / therapeutic use
  • Proline / analogs & derivatives
  • Proline / therapeutic use
  • Prospective Studies
  • Protease Inhibitors / therapeutic use
  • RNA / metabolism
  • Recombinant Proteins / therapeutic use
  • Ribavirin / therapeutic use
  • Viral Load*

Substances

  • Antiviral Agents
  • Interferon-alpha
  • Oligopeptides
  • Protease Inhibitors
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • RNA
  • telaprevir
  • N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
  • Proline
  • peginterferon alfa-2a