The study is designed to assess the safety and efficacy of TMC435 and daclatasvir in combination, with or without Ribavirin, in chronic genotype-1 hepatitis C infected patients who are treatment-naïve or null responders to previous peginterferon alfa / ribavirin therapy.
TMC435 is a once-daily, potent NS3 / 4A protease inhibitor in Phase 3 clinical development for the treatment of chronic genotype-1 hepatitis C virus (HCV) infection, while daclatasvir is Bristol-Myers Squibb´s investigational NS5A replication complex inhibitor.
The study will evaluate the potential to achieve sustained viral response (SVR), 12 (SVR12) and 24 (SVR24) weeks post treatment in treatment-naïve and null responder patients infected with HCV genotype 1a and 1b.
Patients with genotype 1b, where TMC435 and daclatasvir will be dosed with or without ribavirin for 12 weeks with 36 weeks follow-up or for 24 weeks with a 24 weeks follow-up, will be included in cohort one and two.
Patients with genotype 1a, where TMC435, daclatasvir and ribavirin will be dosed for 12 or 24 weeks with a 24 weeks post-treatment follow-up, will be included in cohort three and four.
The interferon-free study is a part of the agreement between Janssen R&D Ireland and Bristol-Myers Squibb announced on 2 December 2011 and on 18 April 2012.