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

Stefan Zeuzem; Jean Pawlotsky; Esther Lukasiewicz; Michael Wagner; Loannis Goulis; Yoav Lurie; Elia Gianfranco; Jan Vrolijk; Juan Esteban; Christophe Hezode; Martin Legging; Francesco Negro; Alexandre Soulier; Elke Hart; Bettine Hansen; Ronen Tal; Carlo Ferrari; Solko Schalm; Avidan Neumann

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

Author(s):

Stefan Zeuzem^1,*,

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

Hepatitis Monthly:Vol. 5, issue 3; 57-64

Article type:Research Article

How to Cite:Stefan ZeuzemJean Michel PawlotskyEsther LukasiewiczMichael Von WagnerLoannis GoulisYoav LurieElia GianfrancoJan Maarten VrolijkJuan I EstebanChristophe HezodeMartin LeggingFrancesco NegroAlexandre SoulierElke Verheij HartBettine HansenRonen TalCarlo FerrariSolko W SchalmAvidan U Neumannet 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.

Keywords

HCV RNA quantification

Viral kinetics

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