Abstract
Objective: This study was designed to evaluate the effect of hepatic impairment on the pharmacokinetics of lamivudine. Methods: Sixteen patients not infected with hepatitis B virus or human immunodeficiency virus who had hepatic impairment due to liver cirrhosis were assigned to moderately or severely impaired groups by clinical signs/symptoms, C-14-aminopyrine metabolic activity and caffeine clearance and compared with eight healthy controls.
Following a 300-mg dose of lamivudine, blood and urine samples were taken for drug assay. Results: Lamivudine was well tolerated in patients with hepatic impairment.
There were no statistical differences in overall lamivudine exposure (in terms of AUC or C-max) or other major pharmacokinetic parameters i.e. CLR, t(max) and t(1/2), between healthy control subjects and patients with moderate or severe hepatic impairment.
Conclusions: Hepatic impairment does not warrant dose modification of lamivudine based on this single-dose pharmacokinetic study.