The study will 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-naive or null responders to previous Peginterferon alfa/Ribavirin therapy.
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 will be evaluated in the study.
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 study is a part of the agreement between Janssen R&D Ireland and Bristol-Myers Squibb Company announced on 2 December 2011 and on 18 April 2012.