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Safety evaluation of telbivudine
David Yiu-Kuen But1, Man-Fung Yuen, James Fung
1University of Hong Kong, Queen Mary Hospital, Department of Medicine, Pokfulam Road, Hong Kong SAR, China.
Expert Opinion on Drug Safety
|July 29, 2010
Summary
Long-term telbivudine effectively suppresses chronic hepatitis B (CHB) viral load in select patients. While generally safe, monitor for potential myopathy and neuropathy, as creatine kinase elevation isn't a reliable predictor of these adverse effects.
Area of Science:
- Hepatology and Viral Gastroenterology
- Pharmacology and Therapeutics
Background:
- Chronic hepatitis B (CHB) treatment necessitates long-term oral nucleoside/nucleotide agents, posing risks of resistance, non-compliance, and adverse effects.
- Telbivudine demonstrates potent hepatitis B DNA reduction, comparable to entecavir, and is FDA pregnancy Category B.
Purpose of the Study:
- To review the efficacy and safety profile of telbivudine in CHB patients.
- To compare telbivudine with other agents, focusing on viral resistance and adverse effects.
Main Methods:
- Review of clinical data on telbivudine efficacy and safety in compensated and decompensated CHB.
- Analysis of viral resistance patterns and characteristic adverse effects associated with telbivudine.
- Highlighting infrequent but significant adverse effects of other nucleoside/nucleotide analogs.
Main Results:
- Provides an updated clinical profile of long-term telbivudine use.
- Demonstrates effective viral suppression in CHB patients with specific baseline characteristics and virologic response.
Conclusions:
- Long-term telbivudine treatment achieves effective viral suppression for CHB patients meeting certain criteria.
- Creatine kinase elevation is not a reliable indicator of muscle-related adverse effects; however, myopathy and neuropathy can occur in a small subset of patients.
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