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.
About Simeprevir (TMC435)
Simeprevir is a once-daily potent investigational hepatitis C protease inhibitor in late phase III clinical development being jointly developed by Medivir AB and Janssen R&D Ireland to treat chronic hepatitis C virus infections. Simeprevir is being investigated in combination with PegIFN/RBV in phase III trials and is also being evaluated with Direct-acting Antiviral (DAA) agents in three other phase II interferon-free combinations both with and without ribavirin (RBV).Global phase III studies of simeprevir include QUEST-1 and QUEST-2 in treatment naïve patients, PROMISE in patients who have relapsed after prior IFN-based treatment and ATTAIN in treatment experienced patients. In parallel to these trials, phase III studies for simeprevir are ongoing in both treatment naïve and treatment experienced HIV-HCV co-infected patients, HCV genotype 4 infected patients and in Japanese HCV genotype 1 patients. The phase II interferon-free combinations both with and without ribavirin with simeprevir are:
- 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.