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Title: Antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2-6: TMC435-C202, a phase IIa, open-label study
Authors: Christophe Moreno
Thomas Berg
Tawesak Tanwandee
Satawat Thongsawat
Hans Van Vlierberghe
Stefan Zeuzem
Oliver Lenz
Monika Peeters
Vanitha Sekar
Goedele De Smedt
Hospital Erasme
Universitatsklinikum Leipzig und Medizinische Fakultat
Mahidol University
Chiang Mai University
University Hospital of Ghent
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitat Frankfurt am Main
Tibotec Inc.
Keywords: Medicine
Issue Date: 1-Jun-2012
Citation: Journal of Hepatology. Vol.56, No.6 (2012), 1247-1253
Abstract: Background & Aims: TMC435 is an investigational, once-daily, oral NS3/4A protease inhibitor currently in phase III development for the treatment of hepatitis C virus (HCV) infection. Phase I and II studies in patients infected with HCV genotype 1 have demonstrated that TMC435 is generally well tolerated, has a pharmacokinetic profile that supports once daily dosing, and demonstrates potent antiviral activity. This phase IIa study (TMC435-C202; NCT00812331) was conducted to investigate the antiviral activity, safety, tolerability, and pharmacokinetics of TMC435 in treatment-nave patients infected with HCV genotypes 2-6. Methods: The study consisted of 7 days of monotherapy with TMC435 (200 mg once daily). Patients could begin treatment with pegylated interferon/ribavirin from day 8 with a follow-up period up to days 37-42. Results: Thirty-seven patients were enrolled in Germany, Belgium and Thailand. For the primary end point at day 8, the mean (± standard error) change in plasma HCV ribonucleic acid (log 10 IU/ml) from baseline was the greatest for genotypes 6 (-4.35 ± 0.29) and 4 (-3.52 ± 0.43), followed by genotypes 2 (-2.73 ± 0.71) and 5 (-2.19 ± 0.39). No antiviral activity was evident for genotype 3. Viral breakthrough occurred in six patients during the monotherapy phase and in six additional patients during PegIFN/RBV-only period. All adver se events were mild or moderate and there were no discontinuations during the TMC435 monotherapy period. Conclusions: The results of this phase IIa proof-of-concept trial provide evidence that TMC435 has a spectrum of activity against multiple HCV genotypes, except for genotype 3. In this study, TMC435 was generally safe and well tolerated. © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
ISSN: 01688278
Appears in Collections:Scopus 2011-2015

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