1093 POPULATION PHARMACOKINETIC (PK) ANALYSIS OF RIBAVIRIN (COPEGUS) IN CHRONIC HEPATITIS C (CHC) PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD) LEADS TO CHANGES IN RECOMMENDED DOSING

Abstract

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. Clinical, hematological, biochemical and virological data were recorded in the pre-treatment, the treatment and the follow-up period. 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 18.4% (bezafibrate group) and 11.1% (placebo group). cEVR rate in the bezafibrate group was 55.3%, whereas in the placebo group, 41.7% of patients reached cEVR. Additionally, there was a significant negative correlation between screening GGT levels and treatment efficacy (r = −0.28, p = 0.023). Conclusions: Pre-treatment GGT values seem to have an impact on antiviral treatment efficacy and the application of bezafibrate prior to antiviral therapy led to a significant reduction in GGT levels and also some reduction in viral load.