BACKGROUND & AIMS: The safety and efficacy of the interferon-free combination of faldaprevir (NS3/A4 protease inhibitor), deleobuvir (BI 207127, non-nucleoside polymerase inhibitor), and ribavirin in treatment-naïve patients chronically infected with HCV genotype-1 was explored. METHODS: SOUND-C3 was a multicenter, open-label Phase 2b study. Treatment-naïve patients chronically infected with HCV genotype-1a (IL28B CC genotype only; n = 12) and genotype-1b (n = 20) were assigned to 16 weeks of treatment with faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and weight-based ribavirin. Patients with compensated liver disease, including cirrhosis, were eligible for inclusion in this study. The primary endpoint was sustained virological response 12 weeks after completion of therapy. RESULTS: Sustained virological response rates 12 weeks after completion of therapy were 17% and 95% in patients infected with HCV genotype-1a and genotype-1b respectively. All four patients with cirrhosis achieved sustained virological response 12 weeks after completion of therapy. The most frequently reported adverse events of at least moderate intensity were anaemia (16%), nausea, vomiting and fatigue (9% each). Three (9%) patients discontinued because of adverse events. CONCLUSIONS: The interferon-free regimen of faldaprevir, deleobuvir and ribavirin was efficacious in patients infected with genotype-1b and generally well tolerated.
BACKGROUND & AIMS: The safety and efficacy of the interferon-free combination of faldaprevir (NS3/A4 protease inhibitor), deleobuvir (BI 207127, non-nucleoside polymerase inhibitor), and ribavirin in treatment-naïve patients chronically infected with HCV genotype-1 was explored. METHODS: SOUND-C3 was a multicenter, open-label Phase 2b study. Treatment-naïve patients chronically infected with HCV genotype-1a (IL28B CC genotype only; n = 12) and genotype-1b (n = 20) were assigned to 16 weeks of treatment with faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and weight-based ribavirin. Patients with compensated liver disease, including cirrhosis, were eligible for inclusion in this study. The primary endpoint was sustained virological response 12 weeks after completion of therapy. RESULTS: Sustained virological response rates 12 weeks after completion of therapy were 17% and 95% in patients infected with HCV genotype-1a and genotype-1b respectively. All four patients with cirrhosis achieved sustained virological response 12 weeks after completion of therapy. The most frequently reported adverse events of at least moderate intensity were anaemia (16%), nausea, vomiting and fatigue (9% each). Three (9%) patients discontinued because of adverse events. CONCLUSIONS: The interferon-free regimen of faldaprevir, deleobuvir and ribavirin was efficacious in patients infected with genotype-1b and generally well tolerated.
Authors: Stefan Zeuzem; Vicente Soriano; Tarik Asselah; Edward J Gane; Jean-Pierre Bronowicki; Peter Angus; Ansgar W Lohse; Felix Stickel; Beat Müllhaupt; Stuart Roberts; Marcus Schuchmann; Michael Manns; Marc Bourlière; Maria Buti; Jerry O Stern; John-Paul Gallivan; Florian Voss; John P Sabo; Wulf Böcher; Federico J Mensa Journal: Antimicrob Agents Chemother Date: 2014-12-15 Impact factor: 5.191
Authors: Kristi L Berger; Christoph Sarrazin; David R Nelson; Joseph Scherer; Nanshi Sha; Martin Marquis; Alexandra Côté-Martin; Richard Vinisko; Jerry O Stern; Federico J Mensa; George Kukolj Journal: PLoS One Date: 2016-08-05 Impact factor: 3.240
Authors: Christoph Sarrazin; Michael Manns; Jose Luis Calleja; Javier Garcia-Samaniego; Xavier Forns; Renee Kaste; Xiaofei Bai; Jing Wu; Jerry O Stern Journal: PLoS One Date: 2016-12-28 Impact factor: 3.240
Authors: Christoph Sarrazin; Francesco Castelli; Pietro Andreone; Maria Buti; Massimo Colombo; Stanislas Pol; Filipe Calinas; Massimo Puoti; Antonio Olveira; Mitchell Shiffman; Jerry O Stern; George Kukolj; Michael Roehrle; Stella Aslanyan; Qiqi Deng; Richard Vinisko; Federico J Mensa; David R Nelson Journal: Clin Exp Gastroenterol Date: 2016-11-24