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

AUTHORS

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

1 Saarland University Hospital, [email protected], Germany

2 Hspital Henri Mondor, Universit Paris XII, France

3 Bar-Ilan University, Israel

4 Saarland University Hospital, Germany

5 Aristotle University of Thessaloniki, Greece

6 Tel Aviv Sourasky Medical Center, Israel

7 Azienda Ospedaliera di Parma, Italy

8 University Hospital Rotterdam Dijkzigt, Netherlands

9 Hospital General Vall d'Hebron, Spain

10 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. Online ahead of Print ; 5(3):57-64.

ARTICLE INFORMATION

Hepatitis Monthly: 5 (3); 57-64
Article Type: Research Article

Crossmark

CHEKING

READ FULL TEXT
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

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

© 0, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.

Full Text

Full text is available in PDF

COMMENTS

LEAVE A COMMENT HERE: