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☆
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.
1Department of Gastroenterology, Hepatology and Endocrinology, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30623 Hannover, Germany
2I. Medizinische Klinik und Poliklinik, Johannes Gutenberg Universität, Langenbeckstr. 1, 55131 Mainz, Germany
3Department of Gastroenterology and Hepatology, Universitätsklinik Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany
4Department of Gastroenterology, Hepatology, Nutritial Medicine and Pneumology, Klinikum der Johann-Wolfgang Goethe-Universität, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany
☆ 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.