Clinical features of adverse reactions associated with telbivudine.
OBJECTIVE
To analyze the clinical features and risk factors of adverse reactions associated with telbivudine.


METHODS
Clinical data were collected from cases that presented with serious adverse reactions to telbivudine. We analyzed general information and medicine status, clinical features, results of examination, and misdiagnosis.


RESULTS
Out of 105 patients who were treated with telbivudine for hepatitis B in an outpatient department from January, 2007 to January, 2008, five presented with serious adverse drug reactions. Most of these five patients had used other nucleoside analogues in the past. Four were treated with a combination of telbivudine and interferon or another nucleoside analogue, while the other received an increased dose of telbivudine. The main adverse reactions were myalgia and general weakness. This was accompanied by cardiac arrhythmia in one patient, and nervous symptoms in three. Serum creatine kinase was elevated. The rate of misdiagnosis was high.


CONCLUSIONS
The adverse reactions were related to telbivudine, but the biological mechanism of the reactions is not yet clear. Combination therapy with interferon or another nucleoside analogue and a high dose may increase the risk of adverse reactions.
Department of GI and Hepatology, Beijing Youan Hospital Affiliated to Capital Medical University, Beijing 100069, China.
Xue-Song
XS
Zhang
Rui
R
Jin
Shi-Bin
SB
Zhang
Ming-Ling
ML
Tao
D000328:Adult; D001145:Arrhythmias, Cardiac / Q000139:chemically induced; D003402:Creatine Kinase / Q000097:blood; D004357:Drug Synergism; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D018908:Muscle Weakness / Q000139:chemically induced; D009437:Neuralgia / Q000139:chemically induced; D009705:Nucleosides / Q000009:adverse effects* / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000009:adverse effects* / Q000627:therapeutic use*; D012189:Retrospective Studies; D012307:Risk Factors; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives
D009705:Nucleosides; D011744:Pyrimidinones; D000077712:Telbivudine; D007372:Interferons; D003402:Creatine Kinase; D013936:Thymidine