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NEW DRUG DEVELOPMENTS

Telbivudine: A Novel Nucleoside Analog for Chronic Hepatitis B

Assistant Professor of Clinical Pharmacy, School of Pharmacy, University of Southern California (USC); Department of Pharmacy, USC University Hospital, Los Angeles, CA

Susie H Park, PharmD

Assistant Professor of Clinical Pharmacy, School of Pharmacy, University of Southern California

Stan G Louie, PharmD

Associate Professor of Clinical Pharmacy and Pharmaceutical Sciences, Schools of Pharmacy and Keck School of Medicine, University of Southern California

Reprints: Dr. Kim, University of Southern California, School of Pharmacy, 1985 Zonal Ave., Los Angeles, CA 90089-9121, fax 323/442-8638, jiwonkim{at}usc.edu

OBJECTIVE: To review available literature on the pharmacology, pharmacokinetics, dosing and administration, efficacy, and safety of the antiviral nucleoside analog telbivudine.

DATA SOURCES: Information was obtained from searching MEDLINE (1966–December 2005), International Pharmaceutical Abstracts (1970–December 2005), and the Cochrane Database of Systematic Reviews (4th quarter 2005) using the search words telbivudine, L-dT, L-deoxythymidine, L-nucleosides, and nucleosides. Abstracts from the Annual Meeting of the American Association for the Study of Liver Diseases and European Association for the Study of the Liver were also searched, including bibliographies from the identified articles.

STUDY SELECTION AND DATA EXTRACTION: Data from double-blind, placebo-controlled clinical trials and unpublished information were extracted.

DATA SYNTHESIS: Telbivudine is a novel, orally administered nucleoside analog under development for use in the treatment of chronic hepatitis B. In contrast to other nucleoside analogs, telbivudine has not been associated with inhibition of mammalian DNA polymerase with mitochondrial toxicity. Telbivudine demonstrated potent activity against hepatitis B with significantly higher rate of response and superior viral suppression compared with lamivudine, the standard treatment. Telbivudine has been generally well tolerated, with low adverse effect profile, and at its effective dose, no dose-limiting toxicity has been observed.

CONCLUSIONS: Telbivudine is a novel oral nucleoside analog effective in the treatment of chronic hepatitis B infection.

Key Words: ß-L-thymidine, hepatitis B, nucleosides, telbivudine

Published Online, February 28, 2006. www.theannals.com, DOI 10.1345/aph.1G027

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				X.-J. Zhou, J. Ke, W. M. Sallas, C. Farrell, D. L. Mayers, and H. S. Pentikis Population Pharmacokinetics of Telbivudine and Determination of Dose Adjustment for Patients With Renal Impairment J. Clin. Pharmacol., June 1, 2009; 49(6): 725 - 734. [Abstract] [Full Text] [PDF]