A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection

Fabien Zoulim, Christophe Moreno, Samuel S. Lee, Peter Buggisch, Andrzej Horban, Eric Lawitz, Chris Corbett, Oliver Lenz, Bart Fevery, Thierry Verbinnen, Umesh Shukla, Wolfgang Jessner

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Background: Simeprevir is approved with pegylated interferon and ribavirin (PR) for chronic hepatitis C virus (HCV) genotype (GT) 1 and GT4 infection in the USA and the European Union. Methods: This 3-year follow-up study assessed the durability of sustained virologic response (SVR) (undetectable HCV RNA 12 or 24 weeks after treatment end), and evaluated the persistence of treatment-emergent NS3/4A protease inhibitor resistance in patients not achieving SVR following treatment with simeprevir plus PR in the parent study. The maintenance of SVR after the last post-therapy follow-up visit of the parent study (LPVPS) was assessed using HCV RNA measurements. The persistence of treatment-emergent NS3 amino acid substitutions in patients with no SVR at LPVPS was assessed using population sequencing. No study medications were administered. Results: Overall, 249 patients were enrolled (200 with SVR at LPVPS; 49 with no SVR at LPVPS); 40 patients discontinued prematurely (18 with SVR; 22 with no SVR). All 200 enrolled patients who achieved SVR in the parent study maintained SVR until the last available visit in this study (median follow-up time: 35.8 months). The treatment-emergent NS3 amino acid substitutions detected at time of failure in the parent study in 43/49 enrolled patients were no longer detected in 37/43 (86.0%) at the end of this study (median follow-up time: 179.9 weeks [41.3 months]). Conclusion: This 3-year follow-up study provides evidence for the long-term durability of SVR (100%) after successful treatment with simeprevir plus PR. Treatment-emergent NS3 amino acid substitutions became undetectable in the majority of patients. Trial registration: NCT01349465; ClinicalTrials.gov.

Original languageEnglish (US)
Article number26
JournalVirology Journal
Volume15
Issue number1
DOIs
StatePublished - Jan 30 2018

Keywords

  • Direct-acting antivirals
  • Hepatitis C virus
  • NS3 amino acid substitutions
  • Pegylated interferon
  • Simeprevir
  • Sustained virologic response

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Fingerprint Dive into the research topics of 'A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection'. Together they form a unique fingerprint.

  • Cite this

    Zoulim, F., Moreno, C., Lee, S. S., Buggisch, P., Horban, A., Lawitz, E., Corbett, C., Lenz, O., Fevery, B., Verbinnen, T., Shukla, U., & Jessner, W. (2018). A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection. Virology Journal, 15(1), [26]. https://doi.org/10.1186/s12985-018-0936-4