Z Gastroenterol 2012; 50 - K064
DOI: 10.1055/s-0032-1323999

Effects of pre-treatment with bezafibrate followed by standard of care in treatment-naive patients with chronic hepatitis C genotype 1 infection and elevated GGT levels

A Böhlig 1, V Knop 2, 3, M Biermer 2, R Somasundaram 4, H Hinrichsen 5, R Heyne 6, B Möller 6, B Ruf 7, U Spengler 8, R Link 9, A Herrmann 10, P Malfertheiner 11, AW Lohse 12, E Herrmann 13, S Zeuzem 3, R Schäfer 14, T Berg 1, 6
  • 1Universitätsklinikum Leipzig, Leipzig, Germany
  • 2Universitätsklinikum Charité, Campus Virchow-Klinikum, Berlin, Germany
  • 3Klinikum der Goethe-Universität Frankfurt, Medizinische Klinik 1, Frankfurt, Germany
  • 4Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany
  • 5Gastroenterologisch-hepatologisches Zentrum, Kiel, Germany
  • 6Leber- und Studienzentrum am Checkpoint, Berlin, Germany
  • 7Klinikum St. Georg gGmbH, Zentrum für Reise- und Tropenmedizin, Leipzig, Germany
  • 8Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Bonn, Germany
  • 9St. Josefsklinik, Offenburg, Germany
  • 10Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II, Jena, Germany
  • 11Universitätsklinikum Magdeburg, Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie, Magdeburg, Germany
  • 12Universitätsklinikum Eppendorf, Hamburg, Germany
  • 13Goethe-Universität Frankfurt, Institut für Biostatistik und mathematische Modellierung, Frankfurt, Germany
  • 14Roche Pharma AG, Grenzach-Wyhlen, Germany

Background/Aims: Only 50% of patients with chronic hepatitis C genotype 1 infection (HCV1) respond to peginterferon-alpha2a and ribavirin (PR). Previous studies showed that the levels of GGT correlate with nonresponsiveness to treatment.

The aim of this randomized, controlled, double-blind trial was to examine if a pre-treatment reduction of GGT levels is capable of increasing response to treatment of patients with HCV type 1 infection measured by early viral kinetics including rapid and early virologic response patterns (RVR and cEVR) as compared to pre-treatment with placebo. Additionally, the effect of GGT levels on viral kinetics should be investigated.

Methods: A total number of 74 treatment-naive patients with HCV1 was included and randomly assigned to either the bezafibrate group (A, N=38) or a placebo group (B, N=36). Group A was pre-treated with 400mg bezafibrate daily for 16 weeks followed by 48 weeks of PR and 400mg bezafibrate per day. Group B was given 400mg of placebo daily for 16 weeks and was then treated with PR and 400mg placebo for 48 weeks. Follow-up was done until 24 weeks after end of treatment.

Results: Viral load in the pre-treatment phase did not differ significantly between both groups. Viral kinetic modeling showed that there were no significant differences in interferon treatment efficacy between both groups (p>0.2). Although the fitted curves of viral kinetics were highly similar, the bezafibrate group had lower HCV-RNA at begin of antiviral treatment. RVR rates were 13.5% (bezafibrate group) and 6.9% (placebo group). cEVR rate in the bezafibrate group was 45.9%, whereas in the placebo group, 41.4% of patients reached cEVR.

In the pre-treatment period of group A, mean GGT levels decreased significantly from 2,24 (SD 1,6) to 1,15µkat/l (SD 0,78) (p<0.001), whereas in group B this difference was not significant (p=0.08). Additionally, there was a significant negative correlation between screening GGT levels and treatment efficacy (r=-0.28, p=0.023).

Conclusions: Application of bezafibrate prior to antiviral therapy has lowering effects on GGT levels and can also lead to some reduction in viral load. Pre-treatment GGT values seem to have an impact on antiviral treatment efficacy. SVR results will be presented at the meeting.