An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

Summary

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

Timeline

Start

2011-03

Primary completion

2013-02

Completion

2013-02

Outcome

Met primary endpoint

paper 209 (81%) of 257 patients in the simeprevir group and 67 (50%) of 134 in the placebo group had SVR12 PMID 24907224 ↗

registry p <0.001; Difference in proportions of SVR12 32.2 (95% CI 23.3 to 41.2) NCT01290679 ↗

Publications

• Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.
• Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014 Aug 2;384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9. Epub 2014 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simeprevir	Small molecule	150 mg	Oral
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Peginterferon alpha-2b	Protein / enzyme biologic	50 ug	Subcutaneous
Background	Peginterferon alpha-2b	Protein / enzyme biologic	80 ug	Subcutaneous
Background	Peginterferon alpha-2b	Protein / enzyme biologic	100 ug	Subcutaneous
Background	Peginterferon alpha-2b	Protein / enzyme biologic	120 ug	Subcutaneous
Background	Peginterferon alpha-2b	Protein / enzyme biologic	150 ug	Subcutaneous
Background	Ribavirin	Small molecule	200 mg	Oral

Indications