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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
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.