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

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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.

Keywords

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

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