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Official Journal of Research Center for Gastroenterology and Liver Diseases
e-ISSN 1735-3408
p-ISSN 1735-143X
International, Multicenter, Randomized, Controlled Study Comparing Dynamically Individualized Versus Standard Treatment in Patients with Chronic Hepatitis C* , **
Authors
Stefan Zeuzem1,*, Jean Michel Pawlotsky2, Esther Lukasiewicz3, Michael Von Wagner4, Loannis Goulis5, Yoav Lurie6, Elia Gianfranco7, Jan Maarten Vrolijk8, Juan I Esteban9, Christophe Hezode9, Martin Legging10, Francesco Negro10, Alexandre Soulier10, Elke Verheij Hart8, Bettine Hansen8, Ronen Tal3, Carlo Ferrari7, Solko W Schalm8, Avidan U Neumann3
1Saarland University Hospital, Zeuzem@uniklinik-saarland.de, Germany
2Hspital Henri Mondor, Universit Paris XII, France
3Bar-Ilan University, Israel
4Saarland University Hospital, Germany
5Aristotle University of Thessaloniki, Greece
6Tel Aviv Sourasky Medical Center, Israel
7Azienda Ospedaliera di Parma, Italy
8University Hospital Rotterdam Dijkzigt, Netherlands
9Hospital General Vall d'Hebron, Spain
10Hspital Henri Mondor, Universit Paris XII, France
*Corresponding Author: Saarland University Hospital, Zeuzem@uniklinik-saarland.de, Germany. Tel: +49 6841 16 23201. Fax: +49 6841 16 23267. Email: Zeuzem@uniklinik-saarland.de
How to Cite:Zeuzem S, Pawlotsky J, Lukasiewicz E, Wagner M, Goulis L, et al. International, Multicenter, Randomized, Controlled Study Comparing Dynamically Individualized Versus Standard Treatment in Patients with Chronic Hepatitis C* , **. Hepat Mon. 2005;5(3):. doi:
Abstract
Background and Aims: The aim of this study was to increase virologic response rates by individualized treatment according to the early virologic response.
Methods: Serum HCV-RNA was frequently quantified in patients with chronic hepatitis C (n=270) treated with peginterferon alfa-2a (180 µg/week) and ribavirin (1000-1200 mg/day). After 6 weeks patients were classified as rapid (RVR), slow (SPR), flat (FPR), or null responders (NUR) and randomized within each viral kinetic class to continue therapy either with an individualized or standard regimen. Individualized therapy comprised peginterferon monotherapy (48 weeks) or shorter combination therapy (24 weeks) for RVR, triple therapy with histamine (1 mg/day) (48 weeks) or prolonged combination therapy (72 weeks) for SPR, triple therapy for FPR, and high-dose peginterferon (360 µg/week) plus ribavirin for NUR patients.
Results: Patients were categorized as RVR (n=171), SPR (n=65), FPR (n=10), or NUR (n=22). Overall end-of-treatment and sustained virologic response rates were 77 and 60% in the individualized and 77 and 66% in the standard treatment arm, respectively. Histamine in addition to peginterferon and ribavirin and highdose peginterferon plus ribavirin did not improve virologic response rates in patients with FPR and NUR, respectively.
Conclusions: An improvement in virologic efficacy was not achieved with the available individualized treatment options.
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Copyright
© 2005, Author(s). This open-access article is available under the Creative Commons Attribution 4.0 (CC BY 4.0) International License (https://creativecommons.org/licenses/by/4.0/), which allows for unrestricted use, distribution, and reproduction in any medium, provided that the original work is properly cited.
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