Myotoxicity of telbivudine in pre-existing muscle damage

Abstract

ObjectivesIt is unknown if telbivudine causes muscle damage only in patients with pre-existing muscle pathology.Case reportA 27 yo male of African origin received telbivudine for hepatitis B during 3 months. Three weeks after initiation of the drug he developed myalgia, and tiredness. Creatine-kinase increased from 278 U/l (n, <170 U/l) at baseline to 3243 U/l. Shortly after discontinuation of telbivudine muscle symptoms and hyper-CK-emia disappeared. The findings suggest that pre-existing muscle damage favored the myotoxic effect of telbivudine.ConclusionsTelbivudine appears to cause accelerated muscle toxicity if given to patients who already have muscle damage. Patients under telbivudine should be closely monitored for muscular side effects and those with pre-existing muscle damage should not receive the drug.

Two cases of telbivudine-induced myopathy in siblings with chronic hepatitis B

“…Myopathy, characterized by muscle pain, weakness, and elevated CK levels, was reported in two patients, which resolved after telbivudine was discontinued 12,17. Preliminary data in the GLOBE trial11 found that 9 (1.4%) patients had new onset of grade 3 or 4 CK elevations and 9 (1.4%) had myalgia or myositis between 104 and 156 weeks 11,15,19. The safety profile of telbivudine over three years was similar to that reported at two years in the GLOBE trial; most adverse effects were mild and transient in nature and no new safety signals were observed 20.…”

“…Xue-song Zhang et al retrospectively reviewed five patients,18 and reported adverse reactions of telbivudine. Myalgia accompanied by general weakness, was the most common adverse reaction and the limb skeletal muscles were affected most frequently 17,19. There were four cases with peripheral nervous system involvement, represented by numbness and neuralgia, and one case with cardiac arrhythmia 12,18.…”

“…Some investigators have reported that these adverse reactions are related to mitochondrial toxicity because most NAs including telbivudine as well as clevudine commonly induce mitochondrial damage by inhibiting mitochondrial DNA polymerase 18,26. Another study has suggested that the mechanism is associated with cell energy metabolism 14,18,19. Mitochondria are involved in the production of energy 18.…”

Telbivudine-Related Myopathy: A Case Report

“…In the literature, there are a few case reports of telbivudineinduced myopathy (3,6). To our knowledge, this is the first report in Turkey regarding telbivudine-related myopathy confirmed by EMG.…”

“…Nucleos(t)ide analogues have an important role in the treatment of CHB. Telbivudine is a new nucleoside analogue (2,3). Transient creatine kinase (CK) elevation and rarely myopathy have been reported in a few number of patients who were treated with telbivudine (3).…”