International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C

Stefan Zeuzem, Jean Michel Pawlotsky, Esther Lukasiewicz, Michael Von Wagner, Ioannis Goulis, Yoav Lurie, Elia Gianfranco, Jan Maarten Vrolijk, Juan I. Esteban, Christophe Hezode, Martin Lagging, Francesco Negro, Alexandre Soulier, Elke Verheij-Hart, Bettina Hansen, Ronen Tal, Carlo Ferrari, Solko W. Schalm, Avidan U. Neumann

Research output: Contribution to journalArticlepeer-review

148 Scopus citations

Abstract

Background/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 high-dose 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.

Original languageEnglish
Pages (from-to)250-257
Number of pages8
JournalJournal of Hepatology
Volume43
Issue number2
DOIs
StatePublished - Aug 2005

Bibliographical note

Funding Information:
This study was supported by the European Community (QLK2-2000-00836), Hoffmann La–Roche and Maxim Pharmaceuticals.

Funding

This study was supported by the European Community (QLK2-2000-00836), Hoffmann La–Roche and Maxim Pharmaceuticals.

FundersFunder number
Hoffmann La-Roche
Maxim Pharmaceuticals
European CommissionQLK2-2000-00836

    Keywords

    • HCV-RNA quantification
    • Hepatitis C virus
    • Histamine
    • Pegylated interferon
    • Ribavirin
    • Viral kinetics

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