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

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

“…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. Grading of the severity of symptoms was on the basis of "the division of AIDS table for grading the severity of adult and pediatric adverse events."…”

“…27,28 However, several clinical studies of clevudine, in which the drug was administered for longer than 6 months, reported a number of cases with development of myopathy. [29][30][31][32] Although the mechanism of clevudine associated myopathy is not clear, several possible explanations have been recently proposed. Myopathy may result from mitochondrial DNA mutation and mitochondrial oxidative stresses.…”

A comparison of 48-week treatment efficacy between clevudine and entecavir in treatment-naïve patients with chronic hepatitis B

“…In this study, two patients (3.4%) complained about proximal muscular weakness with corresponding elevation of muscle enzyme at 48th week, which disappeared after cessation of clevudine. The incidence of clevudine-associated myopathy was reported variable as 2.9-14.6% and almost always resolved after discontinuation [10,13,15,[24][25][26]. Although development of myopathy has been reported in other nucleos(t)ides analogs as well, such as lamivudine, adefovir, and tenofovir, the causal relationship was not elucidated [27].…”

Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

“…However, the Korean FDA approved continued marketing based on the idea that the risk of infrequent and reversible adverse events was not greater than the advantage of continuing clevudine. Currently, the incidence of clevudine-associated myopathy is reported to vary from 2.9 to 14.6% [23][24][25].…”