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Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection and Mild-To-Moderate Fibrosis Displaying Early On-Treatment Virologic Response

Author

Listed:
  • Tarik Asselah
  • Christophe Moreno
  • Christoph Sarrazin
  • Michael Gschwantler
  • Graham R Foster
  • Antonio Craxí
  • Peter Buggisch
  • Faisal Sanai
  • Ceyhun Bicer
  • Oliver Lenz
  • Gino Van Dooren
  • Catherine Nalpas
  • Isabelle Lonjon-Domanec
  • Michael Schlag
  • Maria Buti

Abstract

Background: HCV GT4 accounts for up to 20% of HCV infections worldwide. Simeprevir, given for 12 weeks as part of a 24- or 48-week combination regimen with PR is approved for the treatment of chronic HCV GT4 infection. Primary study objectives were assessment of efficacy and safety of simeprevir plus PR in treatment-naïve patients with HCV GT4 treated for 12 weeks. Primary efficacy outcome was sustained virologic response 12 weeks post-treatment (SVR12). Additional objectives included investigation of potential associations of rapid virologic response and baseline factors with SVR12. Methods: This multicentre, open-label, single-arm study (NCT01846832) evaluated efficacy and safety of simeprevir plus PR in 67 patients with HCV GT4 infection. Patients were treatment-naïve, aged 18–70 years with METAVIR F0–F2 fibrosis. Patients with early virologic response (HCV RNA

Suggested Citation

  • Tarik Asselah & Christophe Moreno & Christoph Sarrazin & Michael Gschwantler & Graham R Foster & Antonio Craxí & Peter Buggisch & Faisal Sanai & Ceyhun Bicer & Oliver Lenz & Gino Van Dooren & Catherin, 2017. "Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection and Mild-To-Moderate Fibrosis Displaying ," PLOS ONE, Public Library of Science, vol. 12(1), pages 1-16, January.
    • Handle: RePEc:plo:pone00:0168713
    DOI: 10.1371/journal.pone.0168713
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