Z Gastroenterol 2012; 50 - FV3_01
DOI: 10.1055/s-0031-1295839

Early versus delayed treatment of acute hepatitis C: Final results of the randomized controlled German HEP-NET acute HCV-III study

K Deterding 1, N Grüner 2, P Buggisch 3, J Wiegand 4, P Galle 5, U Spengler 6, H Hinrichsen 7, T Berg 8, A Potthoff 1, N Malek 9, H Diepolder 2, S Feyerabend 10, M Cornberg 1, MC Jung 2, MP Manns 1, H Wedemeyer 1
  • 1Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover
  • 2Ludwig-Maximilians-University, Munich, Munich
  • 3I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf, Hamburg
  • 4University of Leipzig, Leipzig
  • 5Johannes-Gutenberg University, Mainz, Mainz
  • 6University of Bonn, Bonn
  • 7University of Schleswig-Holstein, Campus Kiel, Kiel
  • 8Charite Berlin Campus Virchow-Klinikum Berlin, Berlin
  • 9Medizinische Universitätsklinik, Tübingen, Tübingen
  • 10HEP-NET: German Network of Competence on Viral Hepatitis, Hannover

Early treatment of acute hepatitis C virus (HCV) infection with interferon alpha monotherapy is highly effective with SVR rates of >85%. An alternative strategy might be to delay treatment for 3 months and only to treat those patients who are not able to clear HCV spontaneously. The Hep-Net-Acute-HCV-III study was designed in 2004 as a prospective, randomized trial in patients with symptomatic acute hepatitis C comparing the efficacy and safety of immediate PEG-IFNa–2b treatment for 6 months (arm-A) versus delayed treatment with PEG-IFNa–2b plus ribavirin for 6 months starting 12 weeks after randomisation in patients who were still HCV-RNA positive (arm-B). All asymptomatic patients were assigned to early treatment with PEG-IFNa–2b (arm-C). 132 patients (66% genotype 1, 63% icteric) were recruited by 72 centers. The Intent-to-treat analysis included all patients and the completer analysis was based on all patients who completed 24 weeks of follow-up after treatment or 60 weeks of observation (arm B). Results: ITT virological response rates were 76% in the early treatment arm-A (n=49), 54% in the delayed treatment arm-B (n=52; p=0.023) and 75% in arm C. The completer analysis showed SVRs of 90% in arm-A (37/41), 90% in arm-B (28/31) and 95% in arm-C (18/19). In arm B, sustained spontaneous HCV clearance could be documented for 11 patients (21%). The lower overall SVR in arm-B was mainly due to drop-outs during the first 12 weeks observation period. However, delayed PEG-IFNa–2b and ribavirin treatment remained highly effective as all arm-B patients who completed treatment and follow-up achieved a SVR (n=14). Conclusion:. We confirm that early immediate treatment with PEG-IFNa–2b is highly effective in both symptomatic and asymptomatic patients. Delayed PEG-IFNa+ribavirin treatment resulted in lower overall response rates in this real-life treatment setting, however, if adherence can be assured this strategy seems to be of similar efficacy in symptomatic patients.

acute Hepatitis C - antiviral therapy