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Faldaprevir (BI 201335), BI 207127 and ribavirin oral therapy for treatment-naive HCV genotype 1 : SOUND-C1 final results

Zeuzem, S. and Asselah, T. and Angus, P. and Zarski, J. P. and Larrey, D. and Mullhaupt, B. and Gane, E. and Schuchmann, M. and Lohse, A. W. and Pol, S. and Bronowicki, J. P. and Roberts, S. and Arasteh, K. and Zoulim, F. and Heim, M. and Stern, J. O. and Nehmiz, G. and Kukolj, G. and Bocher, W. O. and Mensa, F. J.. (2013) Faldaprevir (BI 201335), BI 207127 and ribavirin oral therapy for treatment-naive HCV genotype 1 : SOUND-C1 final results. Antiviral therapy, Vol. 18, H. 8. pp. 1015-1019.

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Official URL: http://edoc.unibas.ch/dok/A6338558

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Abstract

BACKGROUND: Faldaprevir (BI 201335) and BI 207127 are direct-acting antiviral agents under development for the treatment of chronic hepatitis C virus infection. This article describes the final results of the phase 1b SOUND-C1 study which evaluated the interferon-free oral combination of faldaprevir, BI 207127, and ribavirin in 32 treatment-naive patients infected with hepatitis C virus genotype 1. METHODS: Patients were randomized to receive BI 207127 400 mg (n=15) or 600 mg (n=17) three times daily plus faldaprevir 120 mg once daily and weight-based ribavirin for 4 weeks. Interferon-free therapy was followed by response-guided faldaprevir plus pegylated interferon alfa-2a/ribavirin to week 24 or 48. RESULTS: At week 4, 73% (11/15) and 100% (17/17) of patients in the BI 207127 400 mg and 600 mg groups achieved hepatitis C virus (HCV) RNA >25 IU/mL, respectively. During interferon-free treatment, virological breakthrough was reported in one patient and re-increase of HCV RNA in one patient. Both patients were successfully treated with interferon-containing therapy. The rate of sustained virological response 24 weeks after completion of treatment was 73% (11/15) in the BI 207127 400 mg group and 94% (16/17) in the 600 mg group. During faldaprevir plus pegylated interferon alfa-2a/ribavirin treatment, the most common adverse events were pruritus (38% of patients), rash (31%), and asthenia (31%); these were severe in approximately 3% of patients. CONCLUSIONS: Potent antiviral activity and favourable safety of the treatment regimen were demonstrated. Furthermore, the results suggest that patients with breakthrough at week 4 may be rescued with an interferon-containing regimen.
Faculties and Departments:03 Faculty of Medicine > Departement Biomedizin > Department of Biomedicine, University Hospital Basel > Hepatology Laboratory (Heim)
UniBasel Contributors:Heim, Markus H.
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:International Medical Press
ISSN:1359-6535
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:10 Apr 2015 09:14
Deposited On:10 Apr 2015 09:14

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