Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy

Summary

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

Timeline

Start

2013-01

Primary completion

2014-10

Completion

2014-10

Outcome

Met primary endpoint

paper The proportion of patients achieving SVR12 was 88.8% in the Lambda/RBV/DCV arm and 70.5% in the Alfa/RBV/TVR arm PMID 27327078 ↗

paper difference between arms: 18.3%; 95% confidence interval: 9.9-25.7; P < 0.0001 PMID 27327078 ↗

Publications

• Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S. Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b. J Interferon Cytokine Res. 2016 Nov;36(11):635-643. doi: 10.1089/jir.2015.0173. Epub 2016 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daclatasvir	Small molecule	60 mg	Oral
Subject	Peginterferon Lambda-1a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ribavirin	Small molecule	1000 mg	Oral
Subject	Ribavirin	Small molecule	1200 mg	Oral
Subject	Telaprevir	Small molecule	750 mg	Oral

Indications