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

Author(s):

Zeuzem S. , Pawlotsky Jm , Lukasiewicz E. , Wagner Mv , Goulis I. , Lurie Y. , Gianfranco E. , Vrolijk Jm , Esteban Ji , Hezode C. , Lagging , Negro F. , Soulier A. , Hart Ev , Hansen B. , Tal R. , Ferrari C. , Schalm Sw , Neumann Au

Message:
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.
Language:
English
Published:
Hepatitis Monthly, Volume:5 Issue: 3, Autumn 2005
Page:
57
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