Randomized, controlled trial with IFN-alpha combined with ribavirin with and without amantadine sulphate in non-responders with chronic hepatitis C.

Teuber, G; Pascu, M; Berg, T; Lafrenz, M; Pausch, J; Kullmann, F; Ramadori, G; Arnold, R; Weidenbach, H; Musch, E; Junge, U; Wiedmann, KH; Herrmann, E; Zankel, M; Zeuzem, S

2003

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Title:: Randomized, controlled trial with IFN-alpha combined with ribavirin with and without amantadine sulphate in non-responders with chronic hepatitis C.
Document type:: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
Author(s):: Teuber, G; Pascu, M; Berg, T; Lafrenz, M; Pausch, J; Kullmann, F; Ramadori, G; Arnold, R; Weidenbach, H; Musch, E; Junge, U; Wiedmann, KH; Herrmann, E; Zankel, M; Zeuzem, S
Abstract:: BACKGROUND/AIMS: Efficacy and safety of interferon-alpha (IFN-alpha)/ribavirin retreatment with or without amantadine sulphate were evaluated in non-responders with chronic hepatitis C. METHODS: Two hundred twenty five consecutive non-responders to previous antiviral treatment(s) with IFN-alpha alone or in combination with ribavirin or amantadine were treated with IFN-alpha 2b 5 MU daily for 4 weeks, 5 MU tiw for 20 weeks, followed by 3 MU tiw for additional 24 weeks combined with ribavirin 1000-1200 mg/d. One hundred fifteen of 225 patients were randomized to receive amantadine sulphate 100 mg bid for 48 weeks. Treatment was discontinued in patients with detectable serum hepatitis C virus (HCV)-RNA at treatment week 24. RESULTS: An overall sustained virologic response with undectable serum HCV-RNA levels was observed in 49/225 patients (22%). Patients infected with HCV-genotype non-1 (P<0.001), low viremia (P=0.011) and only one previous antiviral treatment (P=0.032) were more likely to respond to antiviral retreatment. There was a trend towards higher sustained virologic response rates in patients receiving triple retreatment compared with those treated with IFN-alpha/ribavirin alone (25 versus 18%, P=0.172). CONCLUSIONS: The addition of amantadine was well tolerated and led to an improvement of sustained virologic responses compared with retreatment with IFN-alpha/ribavirin alone, in particular in patients with low baseline viremia.
Journal title abbreviation:: J Hepatol
Year:: 2003
Journal volume:: 39
Journal issue:: 4
Pages contribution:: 606-13
Language:: eng
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/12971972
Print-ISSN:: 0168-8278
TUM Institution:: II. Medizinische Klinik und Poliklinik (Gastroenterologie)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin II, Gastroenterologie (Prof. Schmid)2003