1. Pharmacokinetics and safety of a single dose of stavudine (d4T) in patients with severe hepatic impairment.
- Author
-
Schaad HJ, Petty BG, Grasela DM, Christofalo B, Raymond R, and Stewart M
- Subjects
- Administration, Oral, Adult, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Anti-HIV Agents adverse effects, Anti-HIV Agents pharmacokinetics, Liver Cirrhosis metabolism, Stavudine adverse effects, Stavudine pharmacokinetics
- Abstract
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.
- Published
- 1997
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