Pharmacokinetics of telbivudine in subjects with various degrees of hepatic impairment.

Antimicrobial Agents and Chemotherapy
Xiao-Jian ZhouNathaniel A Brown

Abstract

This study evaluated the effect of hepatic impairment on the pharmacokinetics of telbivudine, an investigational nucleoside antiviral for the treatment of chronic hepatitis B virus infection. Twenty-four subjects were assigned to four hepatic function groups (normal function and mild, moderate, and severe impairment, with six subjects in each group) on the basis of Child-Pugh scores. The subjects were administered a single oral dose of 600 mg telbivudine, and blood samples were collected over a 48-h interval for pharmacokinetic analyses. Telbivudine was well tolerated by all subjects. Telbivudine plasma concentration-time profiles were similar across the four hepatic function groups. The principal pharmacokinetic parameters of drug exposure, i.e., the maximum plasma concentration and area under the drug concentration-time curve, were comparable between subjects with various degrees of hepatic impairment and those with normal hepatic function. Results from this single-dose pharmacokinetic assessment therefore provide a pharmacologic rationale for further evaluation of the safety and efficacy of telbivudine in hepatitis B virus-infected patients with decompensated liver diseases.

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Citations

Feb 20, 2009·Advances in Therapy·Kathryn Nash
Sep 19, 2007·Antimicrobial Agents and Chemotherapy·Xiao-Jian ZhouNathaniel A Brown
Oct 24, 2009·Therapeutics and Clinical Risk Management·Melissa K Osborn
Aug 29, 2007·Drugs·Susan J Keam
Sep 15, 2010·Drugs·Kate McKeage, Susan J Keam
Apr 7, 2009·Expert Review of Anti-infective Therapy·Yanni Y N Lui, Henry L Y Chan
Nov 1, 2006·Expert Review of Clinical Immunology·Rosa ZampinoGiuseppe Ruggiero
Dec 24, 2015·Expert Review of Clinical Pharmacology·M A PenaP Zapater
Dec 17, 2008·Expert Review of Gastroenterology & Hepatology·Stephanos J Hadziyannis, Dimitrios Vassilopoulos
Mar 1, 2008·Expert Review of Clinical Pharmacology·Seng Gee Lim
Sep 19, 2008·Expert Opinion on Drug Metabolism & Toxicology·Yanni Y N Lui, Henry L Y Chan
Jul 29, 2010·Expert Opinion on Drug Safety·David Yiu-Kuen ButChing-Lung Lai
Nov 15, 2015·European Journal of Clinical Pharmacology·Li ChenBin Wang
Apr 28, 2009·Journal of Clinical Pharmacology·Xiao-Jian ZhouHelen S Pentikis
Jan 11, 2013·Liver International : Official Journal of the International Association for the Study of the Liver·Geoffrey Dusheiko

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