Z Gastroenterol 2009; 47 - P086
DOI: 10.1055/s-0029-1241337

Präsidentenposter: Early versus delayed treatment of acute hepatitis C: The German HEP-NET acute HCV-III study – a randomized controlled trial

K Deterding 1, 2, N Grüner 3, J Wiegand 2, 4, P Buggisch 5, P Galle 6, U Spengler 7, H Hinrichsen 8, T Berg 9, M Cornberg 1, 2, A Potthoff 1, H Diepolder 3, S Feyerabend 2, MC Jung 3, MP Manns 1, 2 H Wedemeyer 1, 2, Acute HCV-III Study group
  • 1Hannover Medical School, Hannover, Germany
  • 2Hep-Net: German Network of Competence on Viral Hepatitis, Hannover, Germany
  • 3Ludwig-Maximillians-University, Munich, Germany
  • 4University of Leipzig, Leipzig, Germany
  • 5University Hamburg-Eppendorf, Hamburg, Germany
  • 6Johannes-Gutenberg University, Mainz, Germany
  • 7University of Bonn, Bonn, Germany
  • 8University of Schleswig-Holstein, Campus Kiel, Kiel, Germany
  • 9Charite-Berlin, Campus Virchow, Berlin, Germany

Early treatment of acute hepatitis C virus (HCV) infection with interferon alpha monotherapy is highly effective with SVR rates of >85%. However, 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 study 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). We here report a planed analysis of all patients who were randomized until December 31st 2007. 108 patients were recruited by 72 Hep-Net-centers. The efficacy analysis was based on 89 patients as 19 patients dropped-out after randomisation for various reasons.

Results: Patients were predominantly male (60%), had a mean age of 40±13 years, were mainly genotype 1-infected (67%) and 62% were icteric. Intent-to-treat virological response rates were 78% in the early treatment arm-A (n=36) and 54% in the delayed treatment arm-B (n=37; p=0.034). Adherent patients in arm-A (80% of study drug; n=31) showed an SVR of 87%. Spontaneous sustained HCV clearance was observed in 8 arm-B patients (22%). 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. Patients with asymptomatic acute hepatitis C (n=16, arm-C) showed an ITT-SVR of 69%, all 11 adherent patients cleared HCV.

Conclusion: This so far largest prospective and the first randomized European trial on acute hepatitis C confirmed that early immediate treatment with PEG-IFNa-2b is highly effective in both symptomatic and asymptomatic patients. Delayed 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.