CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News UpdateSWEDEN: A Phase IIa Interferon Free Combination Hepatitis C Trial of Simeprevir (TMC435) and TMC 647055 Will Commence Shortly
September 21, 2012
Sacramento Bee (09.20.12)
The Swedish pharmaceutical company Medivir AB announced a phase IIa combination trial of simeprevir (TMC435), a protease inhibitor, and TMC647055, a non-nucleoside inhibitor for treatment of chronic hepatitis C. At present, Simeprevir is in phase II clinical development and is being developed jointly by Medivir and Janssen Research & Development (R&D), Ireland. The non-nucleoside inhibitor TMC647055 is also developed by Janssen R&D. The trial will be an open label study of chronically- infected hepatitis C patients with HCV genotype-1a or 1b to determine the efficacy, safety, and tolerability of the combined drugs. The endpoint of the study is the patients’ sustained virologic response 12 weeks after end of treatment (SVR12), that is the number of patients who will be virus free 12 weeks after the end of the combination drug treatment. Simeprevir, TMC647055, and low-dose ritonavir will be co-administered once daily with and without ribavirin for 12 weeks. The second part of the trial will test the same regimen in prior null responder patients chronically infected with HCV genotype 1a. For information about the study see http://www.clinicaltrials.gov.