Chronic Hepatitis C Clinical Trial
Official title:
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C Non 2 -3 Genotype naïve Patients Treated With a 12 Weeks Bitherapy of Peginterferon Alpha 2a-Ribavirin, and Followed by a Tritherapy of Peginterferon Alpha 2a-Ribavirin-Amantadine for 36 Weeks
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
The study is conducted in naive patients infected with genotype non 2 non 3 administered
peginterferon alpha 2-a (40KD) weekly, and ribavirin with dose adjusted on BW (< 75 kg 1000
mg/day, >75 kg 1200 mg/day) for the first three months with adjunction of amantadine 200 mg
daily for the following 9 months.
Plasma concentration profiles of ribavirin were studied after the first dose (D0) and at
W12. At each period, blood samples were collected pre-dose and 30 minutes, 1, 1.5, 2, 3, 4,
6, 8, and 10 hours post-dosing. Ribavirin concentrations were measured using liquid
chromatography-tandem mass spectrometry and ribavirin area under the concentration-timcurves
(AUC0-10h) were derived from plasma concentrations profiles using the linear trapezoidal
rule.
Virological follow-up was performed at W2, W4, W6, W8, W12, W24 and W72. Early virological
response was defined by undetectable viral load at W12.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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