Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM
Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
Summary
Peg interferon and ribavirin currently represent the standard approved association for
treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is
expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50
% of the patients remain relapsers or virological non responders. The main predictive factors
of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological
properties, particularly those of ribavirin requires complementary studies. This drug has a
large distribution volume and its concentrations display large inter-individual variability.
Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on
BW and a single ribavirin time point serum concentration at steady state.
The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of
ribavirin in hepatitis C patient