Conditions: Hepatitis C Virus
Keywords: ribavirin pharmacokinetics Hepatitis C virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease will be randomized to receive concentration-guided or standard weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided through the study.

Detailed description:

Arms:
arm 1: 1000 mg daily in patients weighing \<75 kg and 1200 mg daily in patients weighing ≥ 75 kg arm 2: Dose adjusted based on first dose AUC0-12

Interventions: intervention 1: ribavirin
Intervention descriptions: intervention 1: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12

Protocol document: