Date: 2012-09-20
Type of
information: Initiation of the trial
phase: 2a
Announcement: initiation
Company: Medivir (Sweden) Janssen (J&J - USA)
Product: simeprevir (TMC435) and TMC647055
Action
mechanism:
- direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS5B) inhibitor/RNA polymerase (NS3A) inhibitor. Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir.
TMC647055 is a potent NNI (non-nucleoside inhibitor) of the HCV NS5B polymerase and is being developed by Janssen R&D.
Disease: C hepatitis
Therapeutic
area: Infectious diseases
Country:
Trial
details:
- The study will be an open label study in patients who are chronically infected with HCV genotype-1a or 1b to assess the efficacy, safety and tolerability of the combination. The primary endpoint in the study will be SVR12 (sustained virologic response 12 weeks after end of treatment). Simeprevir, TMC647055 and low-dose ritonavir will be co-administered once daily, with and without ribavirin.
Approximately 40 patients will be enrolled in this study, which is divided in two parts. The first part will include patients chronically infected with HCV genotype-1, who are either treatment-naive or have relapsed after prior pegylated interferon (PegIFN)/ribavirin treatment. The treatment will consist of simeprevir, TMC647055 and low-dose ritonavir, with and without ribavirin for 12 weeks. The second part of the trial will investigate the same regimen in prior null responder patients chronically infected with HCV genotype 1a.
Latest
news:
- Medivir has announced that simeprevir (TMC435) and TMC647055, a non-nucleoside inhibitor (NNI) will enter a phase IIa interferon free combination trial.
Is
general: Yes
