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Volume 49, Issue 5, Pages 688-694 (November 2008)


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The HEP-NET B/C co-infection trial: A prospective multicenter study to investigate the efficacy of pegylated interferon-α2b and ribavirin in patients with HBV/HCV co-infection

Andrej Potthoff1, Heiner Wedemeyer1, Wulf O. Boecher2, Thomas Berg3, Stefan Zeuzem4, Joachim Arnold5, Ulrich Spengler6, Kurt Gruengreiff7, Thomas Kaeser8, Marcus Schuchmann2, Alexandra Bergk3, Nicole Forestier4, Katja Deterding1, Michael P. Manns1Corresponding Author Informationemail address, Christian Trautwein19, for the Hep-Net B/C Co-infection Study Group

Received 20 January 2008; received in revised form 4 March 2008; accepted 25 March 2008. published online 29 April 2008.

Background/Aims

The efficacy of pegylated interferon alpha and ribavirin in HBV/HCV co-infected patients is unknown.

Methods

Nineteen patients with chronic HBV/HCV co-infection (HBsAg and HCV-RNA positive; 10 HCV-genotype 1; 9 HCV-genotype 2 or 3) were included in this prospective multicenter pilot study. Baseline HBV-DNA was negative in 13 individuals. All patients received weight-adjusted PEG-IFN-α2b and ribavirin for 48 weeks.

Results

In the intent-to-treat analysis, a biochemical and an HCV-RNA response were observed in 12 and 14 patients, respectively (63% and 74%). At the end of the treatment as well as at the end of the follow-up the HCV-RNA response was 93% (14/15) in patients adherent to therapy (86% in genotype 1 and 100% in genotypes 2 and 3 infection). Two of the five initially HBV-DNA positive patients with follow-up available were HBV-DNA negative at follow-up week 24. In contrast, HBV-DNA became detectable after the clearance of HCV in four initially HBV-DNA negative patients.

Conclusions

Combination therapy with PEG-IFN-a2b and ribavirin is highly effective in inducing a virological response concerning HCV in patients with HBV/HCV co-infection. However, HBV replication may increase after the clearance of HCV and thus close monitoring for both the viruses is recommended even in patients with initially undetectable HBV-DNA.

Associate Editor: J.G. McHutchison

1 Department of Gastroenterology, Hepatology and Endocrinology, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30623 Hannover, Germany

2 I. Medizinische Klinik und Poliklinik, Johannes Gutenberg Universität, Langenbeckstr. 1, 55131 Mainz, Germany

3 Department of Gastroenterology and Hepatology, Universitätsklinik Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany

4 Department of Gastroenterology, Hepatology, Nutritial Medicine and Pneumology, Klinikum der Johann-Wolfgang Goethe-Universität, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany

5 II Medizinische Klinik, Diakoniekrankenhaus Rotenburg (Wümme), Elise-Averdieck-Strasse 17, 27356 Rotenburg (Wümme), Germany

6 Medizinische Klinik und Poliklinik I, Universitätsklinikum Bonn, Sigmund-Freud-Straße 25, 53127 Bonn, Germany

7 Gastroenterologische Praxis, Heydeckstr. 9, 39104 Magdeburg, Germany

8 Gastroenterologische Praxis, Marktplatz 14, 72250 Freudenstadt, Germany

9 Medizinische Klinik III, Universitätsklinikum Aachen, Pauwelstrasse 30, 52074 Aachen, Germany

Corresponding Author InformationCorresponding author. Tel.: +49 511 532 3305; fax: +49 511 532 4896.

 A.P., H.W., W.B., T.B., S.Z., U.S., K.D., M.P.M., C.T. were investigators in several clinical trials using different interferons. They also have received research grants and lecturer fees by Schering-Plough. M.P.M. and S.Z. have served as advisory board members for Schering-Plough. W.B. is currently an employee of Boehringer Ingelheim, Germany.

 Both authors contributed equally.

PII: S0168-8278(08)00282-1

doi:10.1016/j.jhep.2008.03.028


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