Pharmacokinetics and safety of a single dose of stavudine (d4T) in patients with severe hepatic impairment.
This open-label study enrolled five subjects with biopsy-proven cirrhosis and moderate to severe hepatic impairment (Child-Pugh classification grade B or C) and five age- and gender-matched controls. All subjects received a single 40-mg oral dose of stavudine (d4T). Stavudine pharmacokinetics in subjects with hepatic impairment were similar to those in age- and gender-matched control subjects and were not substantially different from those previously observed in human immunodeficiency virus-infected patients. Based on these findings, stavudine use does not require modification of the dose or dosing interval for patients with liver disease.
Schaad
H J
HJ
Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-5554, USA.
Petty
B G
BG
Grasela
D M
DM
Christofalo
B
B
Raymond
R
R
Stewart
M
M
D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000493:pharmacokinetics*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D018119:Stavudine / Q000009:adverse effects* / Q000493:pharmacokinetics*
D019380:Anti-HIV Agents; D018119:Stavudine