Clinical features of adverse reactions associated with telbivudine

Abstract

AIM:To analyze the clinical features and risk factors of adverse reactions associated with telbivudine. METHODS: C l i n i c a l d a t a w e r e c o l l e c t e d f r o m 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. CONCLUSION: 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.

Clevudine myopathy in patients with chronic hepatitis B

“…This study also showed that an adverse event, a grade 3 or 4 elevation in serum creatine kinase level, occurred in 9% of patients receiving telbivudine [17]. A Chinese study showed that five of 105 chronic hepatitis B patients who received telbivudine treatment developed clinical myopathy [18].…”

Clinical, biochemical, and pathological characteristics of clevudine-associated myopathy

“…It is of interest that the main clinical features were related to a decrease in motor function rather than myalgia, whereas the main adverse reactions of telbivudine therapy were myalgia and general weakness [30]. Although symptoms and nerve damage lasted for long a time after telbivudine was discontinued in telbivudine cases, nervous symptoms were not dominant in clevudine-associated myopathy patients with normal nerve conduction velocities as determined by electrophysiology studies.…”

Comparison of Clevudine and Entecavir for Treatment-naive Patients With Chronic Hepatitis B Virus Infection

“…35 Clinically, skeletal limb muscles, which are highly dependent on ATP are frequent targets of myopathy. 36 Previous studies of incidence of myopathy during clevudine treatment have reported various results of 2.9% to 14.6%. 24,26,32,37 In our study, 10 patients developed muscle-related symptoms at 69.7±16.6 weeks, which comprise 11.6%, only in those who were treated with clevudine.…”