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Individualized treatment duration with peginterferon alfa-2b and ribavirin for 24, 30 or 36 weeks in HCV genotype 1-infected patients with undetectable HCV-RNA early during therapy (INDIV-2 study)
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44th EASL April 23-26 2009
Reported by Jules Levin
Christoph Sarrazin 1, Susanne Schwendy 2, Bernd Möller 3, Nektarios Dikopoulos 4, Peter Buggisch 5, Jens Encke 6, Gerlinde Teuber 7, Tobias Goeser 8, Robert Thimme 9, Hartwig Klinker 10, Wulf O. Boecher 11, Ewert Schulte-Frohlinde 2, Renate Prinzing 12, Thomas Berg 13, Stefan Zeuzem 1
1 J. W. Goethe University Hospital, Medizinische Klinik I, Frankfurt / Main; 2 Uniklinik TU Munchen; 3 Leberzentrum Checkpoint, Berlin; 4 Uniklinik Ulm; 5 Uniklinik Hamburg; 6 Uniklinik Freiburg; 7 Interdisziplinäres Facharztzentrum, Frankfurt / Main; 8 Uniklinik Köln; 9 Uniklinik Freiburg; 10 Uniklinik Wurzburg; 11 Uniklinik Mainz; 12 Essex Pharma, Munchen; 13 Uniklinik Charité, Berlin; all Germany.
Disclosures: Disclosure information are available at the bottom of this poster.
398 treatment-naïve HCV genotype-1 patients were enrolled in a multicenter, randomized trial for individualization of duration of treatment with peginterferon alfa-2b and ribavirin. (Figure 1)
Here we report an interim analysis of patients with shortened treatment to 24, 30 or 36 weeks according to low-viral load (LVL) or high-viral load (HVL) (cut-off 800.000 IU/ml by Versant HCV Quantitative bDNA 3.0 assay) and undetectable HCV-RNA at week 4 (RVR) or 6 by a highly sensitive assay (Versant HCV Qualitative TMA assay, cut-off 5 -10 IU/ml).
Sustained virologic response (SVR) rates were compared to a historical control group of 224 patients treated for 48 weeks (INDIV-1-study)1 based on identical HCV-RNA
assays (bDNA3.0 and TMA). (Figure 2 and 3)
1 Berg et al., Individualized treatment strategy according to early viral kinetics in hepatitis C virus type 1- infected patients. Hepatology 2009 in press.
Thirty-eight patients with RVR and LVL were treated for 24 weeks. One discontinued therapy and one was lost to follow-up. Six patients with RVR and a HVL were treated for 30 weeks. One discontinued treatment at week 13 followed by a relapse. Twenty patients with undetectable HCV-RNA at week 6 and LVL were treated for 30 weeks. One patient experienced a relapse. Eleven patients with undetectable HCV RNA at week 6 and a HVL received 36 weeks of therapy. One of these patients had a relapse. SVR rates for individualized treated patients in comparison with the control group are given in Table 1. The remaining patients are currently still under therapy.
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