Z Gastroenterol 2008; 46 - P5_05
DOI: 10.1055/s-2008-1037654

A prospective multicenter pilot study to investigate the efficacy of pegylated Interferon-α2b and ribavirin in HBsAg+/HCV-RNA+ patients: The HEP-NET B/C coinfection trial

A Potthoff 1, H Wedemeyer 1, WO Boecher 2, T Berg 3, S Zeuzem 4, J Arnold 5, U Spengler 6, K Deterding 1, MP Manns 7, C Trautwein 8
  • 1Abt. Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover
  • 2I. Medizinische Klinik, Universität Mainz, Mainz
  • 3Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie; Charité - Campus Virchow Klinikum, Berlin
  • 4Medizinische Klinik I, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main
  • 5I. Medizinische Klinik , Diakoniekrankenhaus Rotenburg/Wümme, Rotenburg/Wümme
  • 6Medizinische Klinik I, Universität Bonn, Bonn
  • 7Medizinische Hochschule Hannover, Hannover
  • 8Medizinische Klinik III Universitätsklinikum Aachen, Aachen

Background and Patients: HBV/HCV coinfection has been associated with more severe liver disease and a higher risk of hepatocellular carcinoma. Interferon alpha alone or in combination with ribavirin (RBV) can achieve sustained HCV clearance and long-term HBV-DNA suppression. The aim of this prospective multicenter pilot trial was to assess the efficacy of PEG-IFN-α2b and RBV in HBV/HCV coinfected patients.

Nineteen patients with chronic HBV/HCV coinfection were treated with weight adjusted dosing of PEG-IFN-α2b (1.5µg/kg) and RBV (800–1200mg/day) for 48 weeks. All patients were positive for HBsAg, anti-HCV and HCV-RNA (10 genotype 1, 4 genotype 2, 5 genotype 3). Portal fibrosis (Metavir stage 1) was found in 9 patients (47%), 7 individuals showed incomplete porto-portal fibrosis (grade 2) and stage 3 and 4 (cirrhosis) was found in one patient each.

Results: 63% of patients (12/19) had normal ALT levels at week 24, end-of-treatment and end-of-follow up (FU24). Baseline HBV-DNA was negative in 13/19 patients (group I) and positive in 6 patients (Group II; HBV-DNA 25.000–1.2×107 IU/ml; 4 genotype D, 1 genotype A, 1 genotype E). Overall end-of-treatment and sustained HCV-RNA responses were 74% in the intent-to-treat analysis (14/19; 85% in group I and 50% in group II). Since 4 patients did not complete treatment (1 SAE and 3 lost-to-follow-up), the per-protocol HCV-RNA SVR was 93%. Two out of five HBV viremic patients with follow-up data available were HBV-DNA negative at FU24. In contrast, HBV-DNA became positive in 4 initially HBV-DNA negative patients after clearance of HBV-DNA (29%). Antiviral treatment was well tolerated and side effects were comparable to treatment of HCV monoinfection. Serious adverse events (SAE) led to treatment interruption in one patient and treatment discontinuation for 3–6 weeks in two patients.

Conclusion: Combination therapy with PEG-IFN-a2b and RBV is as at least as effective in inducing a sustained HCV-RNA response in patients with HBV/HCV coinfection as compared with HCV monoinfection. However, HBV re-occurrence may occur after clearance of HCV and thus close monitoring for both viruses is recommended even for patients with initially undetectable HBV-DNA. Larger trials are necessary to confirm our findings.

HBV re-occurence - HBV/HCV co-infection - Peginterferon-a2b - hepatitis C clearance - ribavirin