TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

Phase 3 Completed 771 enrolled Janssen R&D Ireland

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

Timeline

Start: 2012-02
Primary completion: 2014-04
Completion: 2014-04

Outcome

Met primary endpoint

paper Simeprevir and peginterferon alfa-2a and ribavirin was non-inferior to telaprevir and peginterferon alfa-2a and ribavirin for SVR12 PMID 25482330 ↗

paper difference -1·1%, 95% CI -7·8 to 5·5; p=0·0007 PMID 25482330 ↗

Publications

Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, Villamil FG, Andreone P, George J, Dammers E, Fu M, Kurland D, Lenz O, Ouwerkerk-Mahadevan S, Verbinnen T, Scott J, Jessner W. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2015 Jan;15(1):27-35. doi: 10.1016/S1473-3099(14)71002-3. Epub 2014 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simeprevir	Small molecule	150 mg	Oral
Comparator	Telaprevir	Small molecule	375 mg	Oral