International, Multicenter, Randomized, Controlled Study Comparing Dynamically Individualized Versus Standard Treatment in Patients with Chronic Hepatitis C* , **

authors:

avatar Stefan Zeuzem 1 , * , avatar Jean Michel Pawlotsky 2 , avatar Esther Lukasiewicz 3 , avatar Michael Von Wagner 4 , avatar Loannis Goulis 5 , avatar Yoav Lurie 6 , avatar Elia Gianfranco 7 , avatar Jan Maarten Vrolijk 8 , avatar Juan I Esteban 9 , avatar Christophe Hezode 9 , avatar Martin Legging 10 , avatar Francesco Negro 10 , avatar Alexandre Soulier 10 , avatar Elke Verheij Hart 8 , avatar Bettine Hansen 8 , avatar Ronen Tal 3 , avatar Carlo Ferrari 7 , avatar Solko W Schalm 8 , avatar Avidan U Neumann 3

Saarland University Hospital, [email protected], Germany
Hspital Henri Mondor, Universit Paris XII, France
Bar-Ilan University, Israel
Saarland University Hospital, Germany
Aristotle University of Thessaloniki, Greece
Tel Aviv Sourasky Medical Center, Israel
Azienda Ospedaliera di Parma, Italy
University Hospital Rotterdam Dijkzigt, Netherlands
Hospital General Vall d'Hebron, Spain
Hspital Henri Mondor, Universit Paris XII, France

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.5(3): 57-64.

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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