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HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment

Author

Listed:
  • Christoph Sarrazin
  • Michael Manns
  • Jose Luis Calleja
  • Javier Garcia-Samaniego
  • Xavier Forns
  • Renee Kaste
  • Xiaofei Bai
  • Jing Wu
  • Jerry O Stern

Abstract

This study evaluated the interferon-free, oral combination of deleobuvir (non-nucleoside HCV NS5-RNA-polymerase inhibitor) and faldaprevir (HCV NS3/4A-protease inhibitor) with ribavirin in patients with HCV genotype-1b and moderate (Child-Pugh B [CPB], n = 17) or mild hepatic impairment (Child-Pugh A [CPA], n = 18). Patients received faldaprevir 120 mg and deleobuvir (600 mg [CPA], 400 mg [CPB]) twice-daily with weight-based ribavirin for 24 weeks. Baseline characteristics were similar between groups. Among CPA patients, 13/18 completed treatment; discontinuations were for adverse events (AEs, n = 1), lack of efficacy (n = 3) and withdrawal (n = 1). Among CPB patients, 8/17 completed treatment; discontinuations were for AEs (n = 6), withdrawal (n = 1) and ‘other’ (n = 2). Sustained virologic response at post-treatment Week 12 (SVR12) was achieved by 11 (61%) CPA patients (95% confidence interval: 38.6%–83.6%) and 9 (53%) CPB patients (95% confidence interval: 29.2%–76.7%), including most CPA (11/16) patients with Week 4 HCV RNA

Suggested Citation

  • Christoph Sarrazin & Michael Manns & Jose Luis Calleja & Javier Garcia-Samaniego & Xavier Forns & Renee Kaste & Xiaofei Bai & Jing Wu & Jerry O Stern, 2016. "HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment," PLOS ONE, Public Library of Science, vol. 11(12), pages 1-10, December.
    • Handle: RePEc:plo:pone00:0168544
    DOI: 10.1371/journal.pone.0168544
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