The single dose pharmacokinetics of ribavirin in subjects with chronic liver disease

Aims The primary objective of this study was to describe the single dose ph armacokinetics of ribavirin in subjects with normal liver function and thos e with various degrees of stable chronic liver disease. Additionally this s tudy assessed the safety and tolerability of ribavirin in this population. Methods Single oral 600 mg doses of ribavirin were administered to healthy male and female volunteers (n=6) and patients with stable chronic Liver dis ease (n=17), in a parallel group study. Pharmacokinetic sampling and tolera bility assessments were performed up to 168 h post dose. Results Single oral doses of 600 mg ribavirin were well tolerated by health y volunteers and patients with varying degrees of hepatic dysfunction. Alth ough mean C-max increased with the severity of hepatic dysfunction, there w as no change in extent of absorption or renal clearance of ribavirin. Conclusions There are no pharmacokinetic reasons for initial dose adjustmen t of ribavirin in patients with hepatic dysfunction.