Medivir AB (STO:MVIRB)(OMX: MVIR), announced today the initiation of cohort 2 in the interferon-free phase II trial combining simeprevir with sofosbuvir (GS7977) based on a safety and efficacy planned interim analysis of cohort 1 including prior null responder HCV genotype 1 infected patients without advanced hepatic fibrosis. Data from the cohort 1 study will be presented at a scientific conference during H1-2013.
Study design Simeprevir, a NS3/4A protease inhibitor is being studied with sofosbuvir, a nucleotide NS5B polymerase inhibitor, in a phase IIa, randomized, open-label study to investigate the efficacy and safety of 12 or 24 weeks of simeprevir (150 mg QD) and sofosbuvir (400 mg QD) with or without ribavirin (RBV) in HCV genotype 1 (GT1) patients.
Cohort 1 included a total of 80 HCV GT1 prior null responders to PegIFN/RBV therapy with METAVIR score F0-F2.
Cohort 2 (90 patients) will include both HCV GT1 treatment naïve and prior null responders to PegIFN/RBV patients with advanced hepatic fibrosis (METAVIR score F3 or F4). Patient screening for cohort 2 was recently initiated.
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 of simeprevir, include:
· Simeprevir in combination with Gilead Sciences' sofosbuvir (GS7977) in hepatitis C genotype 1 treatment-naïve or prior null responder patients.
· Simeprevir in combination with BMS's, daclatasvir in hepatitis C genotype 1 treatment-naïve or prior null responder patients
· Simeprevir in combination with Janssen's TMC647055 and low dose ritonavir in hepatitis C genotype 1 treatment-naïve, prior relapser or null responder patients
· Simeprevir in combination with Vertex's VX-135 in hepatitis C genotype 1 treatment-naïve patients.