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Efficacy and safety of increasing doses of the cyclophilin inhibitor Debio 025 in combination with pegylated interferon alpha-2a in treatment naive chronic HCV patients
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Reported by Jules Levin
43rd EASL Conference, April 23-27, Milan, Italy
R. Flisiak1, S.V. Feinman2, M. Jablkowski3, A. Horban4, W. Kryczka5, W. Halota6, J.E. Heathcote7, G. Mazzella8, C. Vandelli9, J.S. Liz10, R. Crabb10, P. Scalfaro10, H. Porchet10
1 Department of Infectious Diseases, Medical University, Bialystok, Poland;
2 Mount Sinai Hospital, Toronto, Canada;
3 Clinic for Infectious Diseases, Medical University, Lodz, Poland;
4 Hospital for Infectious Diseases, Warsaw, Poland;
5 Department of Infectious Diseases, Regional Hospital, Kielce, Poland;
6 Department of Infectious Diseases, Medical University, Bydgoszcz, Poland;
7 Department of Medicine, University of Toronto, Toronto, Canada;
8 Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy;
9 Department of Medicine, University of Modena and Reggio Emilia, Modena, Italy;
10 Debiopharm SA, Lausanne, Switzerland
AUTHOR CONCLUSIONS
Debio 025 at daily doses of 1000 or 60 mg demonstrates an additive anti-HCV effect in combination with Peg-IFNa-2 was well tolerated and the majority of reported adverse events were known side effects of alpha interferons.
Debio 025 in daily doses of 200 or 600 mg in combination with PegIFNa-2 was well tolerated and the majority of reported adverse events were known side effects of alpha interferons.
Isolated hyperbilirubinaemias, was the most important dose-limiting adverse event, which occurred only during treatment with 1000 mg of Debio 025.
Debio 025 in daily dose 600 mg in combination with 180 ug of Pegasys per week, shows the best balance between antiviral effect and safety.
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