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Antimicrobial Agents and Chemotherapy, May 2006, p. 1721-1726, Vol. 50, No. 5
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.5.1721-1726.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Pharmacokinetics of Telbivudine in Subjects with Various Degrees of Hepatic Impairment

Xiao-Jian Zhou,1* Thomas C. Marbury,2 Harry W. Alcorn,3 William B. Smith,4 Gloria Dubuc Patrick,1 George C. Chao,1 and Nathaniel A. Brown1

Idenix Pharmaceuticals Inc., 60 Hampshire Street, Cambridge, Massachusetts,1 Orlando Clinical Research Center, Orlando, Florida,2 DaVita Clinical Research, Minneapolis, Minnesota,3 New Orleans Center for Clinical Research, New Orleans, Louisiana4

Received 7 October 2005/ Returned for modification 3 December 2005/ Accepted 27 February 2006

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.

* Corresponding author. Mailing address: Idenix Pharmaceuticals Inc., 60 Hampshire Street, Cambridge, MA 02139. Phone: (617) 995-9805. Fax: (617) 995-9817. E-mail: zhou.xiao-jian{at}idenix.com.

Antimicrobial Agents and Chemotherapy, May 2006, p. 1721-1726, Vol. 50, No. 5
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.5.1721-1726.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Zhou, X.-J., Ke, J., Sallas, W. M., Farrell, C., Mayers, D. L., Pentikis, H. S. (2009). Population Pharmacokinetics of Telbivudine and Determination of Dose Adjustment for Patients With Renal Impairment. J Clin Pharmacol 49: 725-734 [Abstract] [Full Text]  
  • Dusheiko, G, Antonakopoulos, N (2008). Current treatment of hepatitis B. Gut 57: 105-124 [Full Text]  
  • Zhou, X.-J., Swan, S., Smith, W. B., Marbury, T. C., Dubuc-Patrick, G., Chao, G. C., Brown, N. A. (2007). Pharmacokinetics of Telbivudine in Subjects with Various Degrees of Renal Impairment. Antimicrob. Agents Chemother. 51: 4231-4235 [Abstract] [Full Text]  
  • Tenney, D. J., Rose, R. E., Baldick, C. J., Levine, S. M., Pokornowski, K. A., Walsh, A. W., Fang, J., Yu, C.-F., Zhang, S., Mazzucco, C. E., Eggers, B., Hsu, M., Plym, M. J., Poundstone, P., Yang, J., Colonno, R. J. (2007). Two-Year Assessment of Entecavir Resistance in Lamivudine-Refractory Hepatitis B Virus Patients Reveals Different Clinical Outcomes Depending on the Resistance Substitutions Present. Antimicrob. Agents Chemother. 51: 902-911 [Abstract] [Full Text]  


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