Skip to main navigation Skip to search Skip to main content

Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b

  • Robert Flisiak
  • , Seiji Kawazoe
  • , Olga Znoyko
  • , Nimer Assy
  • , Adrian Gadano
  • , Jia Horng Kao
  • , Kwan Sik Lee
  • , Ricardo Zwirtes
  • , Simon Portsmouth
  • , Yuping Dong
  • , Dong Xu
  • , Hiromitsu Kumada
  • , Subasree Srinivasan
  • Medical University of Białystok
  • Saga Prefectural Hospital Koseikan
  • A.I. Yevdokimov Moscow State University of Medicine and Dentistry
  • Rebecca Sieff Government Hospital
  • Hospital Italiano de Buenos Aires
  • National Taiwan University
  • Yonsei University
  • Bristol-Myers Squibb
  • Toranomon Hospital

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

The study objective was to compare the efficacy and safety of peginterferon lambda-1a combined with ribavirin/ daclatasvir (Lambda/RBV/DCV), versus peginterferon alfa-2a combined with ribavirin/telaprevir (Alfa/RBV/TVR), in patients chronically infectedwith hepatitis C virus (HCV), genotype 1b. This was a prospective, randomized, openlabel, phase 3 study (NCT01718158) in adults (aged ‡18 years) who were treatment naïve or prior relapsers to peginterferon alfa/ribavirin therapy. The primary endpoint was sustained virologic response at post-Treatment followupweek 12 (SVR12). Patients were randomized in a 2:1 ratio to receive 24weeks of Lambda/RBV/DCV or responseguided 24 or 48weeks ofAlfa/RBV/TVR.Overall, 440 patientswere treated (294with Lambda/RBV/DCV; 146 with Alfa/RBV/TVR). The proportion of patients achieving SVR12 was 88.8%in the Lambda/RBV/DCV arm and 70.5% in theAlfa/RBV/TVRarm(difference between arms: 18.3%; 95%confidence interval: 9.9-25.7;P< 0.0001). Patients in the Lambda/RBV/DCV group had fewer rash-related adverse events (AEs), cytopenic abnormalities, flu-like symptoms, serious AEs, and discontinuations due toAEs, but more liver abnormalities than those in theAlfa/RBV/TVR group. In conclusion, treatment with Lambda/RBV/DCV led to higher SVR12 rates and amore favorable safety profile than Alfa/RBV/TVR in patients with chronic HCV, genotype 1b infection.

Original languageEnglish
Pages (from-to)635-643
Number of pages9
JournalJournal of Interferon and Cytokine Research
Volume36
Issue number11
DOIs
StatePublished - Nov 2016
Externally publishedYes

Bibliographical note

Publisher Copyright:
© Mary Ann Liebert, Inc.

Funding

We would like to acknowledge Eric Vandeloise for his significant contributions to the execution of the study. We would also like to thank the many investigators who contributed time and effort to this study, as well as Ryan Woodrow and Dena McWain of Infusion Communications for medical writing support and editorial assistance. This analysis and writing and editorial support was fully funded by Bristol-Myers Squibb.

Funders
Bristol-Myers Squibb

    UN SDGs

    This output contributes to the following UN Sustainable Development Goals (SDGs)

    1. SDG 3 - Good Health and Well-being
      SDG 3 Good Health and Well-being

    Keywords

    • Clinical trial
    • Daclatasvir
    • Hepatitis c
    • Interferon lambda-1a
    • Ribavirin

    Fingerprint

    Dive into the research topics of 'Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b'. Together they form a unique fingerprint.

    Cite this