Vertex and Janssen expect to initiate a phase II proof-of-concept study of VX-135 and simeprevir in early 2013, following the completion of a drug-drug interaction (DDI) study. Costs associated with the studies will be shared equally between the two companies. The goals of the study will be to evaluate safety, tolerability and viral cure rates of multiple 12-week combination regimens (SVR12*) of VX-135 and simeprevir, with and without ribavirin. The study will include patients who have chronic non-cirrhotic genotype 1 hepatitis C and have not previously been treated (treatment-naïve). Additional information on the phase II study will be provided upon initiation of the study.* SVR12 = undetectable hepatitis C virus 12 weeks after the end of treatment.
- Simeprevir is evaluated in combination with Gilead Science, sofosbuvir (GS7977) in null responder hepatitis C genotype 1 infected patients.
- Simeprevir is evaluated in combination wtih BMS, daclatasvir in treatment-naïve or previous null responder hepatitis C genotype 1 infected patients.
- Simeprevir is evaluated in combination with TMC647055 (Janssen R&D) and ritonavir in low doses in treatment-naïve, relapser or null responder hepatitis C genotype 1 infected patients.