Cumulative incidence and risk factors of creatine kinase elevation associated with telbivudine

Chen, Li; Cai, Cheng; Chen, Bicui; Zhao, Yue; Zhang, Jiming; Wang, Bin

doi:10.1007/s00228-015-1978-9

Cited by 7 publications

(4 citation statements)

References 34 publications

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“…We found that the accumulative incidence of drug resistance might increase with treatment duration, so more long-term data are needed in the future. Another concern biomarker is CK elevation during LdT therapy, which have been reported in many previous studies [16,17]. Chen, et al studied 527 CHB patients and reported that 60.91% of them had CK elevation [18], which was similar with our result (55%).…”

Section: Safety Evaluationsupporting

confidence: 91%

Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections

Wei

Zhang

et al. 2020

BMC Infect Dis

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Background Evaluate the safety and efficacy of 104-week regimen of Telbivudine(LdT)-based optimization strategy for Chinese patients who have chronic hepatits B(CHB) with HBeAg-negative. Methods This multi-center, open-label, prospective study enrolled 108 HBeAg-negative CHB patients who received LdT (600 mg/day) for 24 weeks, Adefovir (ADV) was added if HBV DNA remained detectable at week 24, otherwise LdT was maintained to use until 104 weeks. HBV DNA, alanine amino transferase (ALT), hepatitis B surface antigen(HBsAg), creatinine kinase(CK), and estimated glomerular filtration rate (eGFR) were measured, safety was assessed. Results Eighty-eight patients (81%) had HBV-DNA undetectable at 24 weeks and maintained to receive LdT monotherapy until 104 weeks, whereas the other 20 patients had HBV-DNA detectable and ADV was used in combination. For all patients, 72% of patients reached ALT normalization at 24 weeks, which increased to 80% at 52 weeks and 104 weeks, respectively.. 81% of total patients had undetectable HBV-DNA at 24 weeks, 92% at 52 weeks, and 94% at 104 weeks. The HBsAg titre declined steadily from baseline to 104 weeks (3.62 vs. 2.98 log10 IU/mL, p < 0.05), and the eGFR increased steadily from baseline to 104 weeks (92.9 vs. 104.4 mL/min/1.73 m2, p < 0.05). Although 79 patients (73%) had at least one time of elevated CK, most of these patients had CK elevated in Grade 1/2. Conclusions LdT was well tolerated and effective, and 94% of patients achieved virological suppression after 104 weeks. Trial registration This study was registered in clinicaltrials.gov on January 31, 2012 and the ID No. was NCT01521975.

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Section: Safety Evaluationsupporting

confidence: 91%

Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections

Wei

Zhang

et al. 2020

BMC Infect Dis

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“…A longitudinal study of muscle events associated with telbivudine found that lower baseline eGFR was a significant predictor of CK elevation in patients treated with telbivudine. 38 Based on the findings of the present study, the TIM risk tended to be higher (adjusted OR=4.82) ( Table 4 ) in patients with CKD grade 3 or higher (i.e., eGFR ≤60 mL/min/1.73 m 2 ). These data suggest that impaired baseline renal function increases the risk of telbivudine-induced myotoxicity.…”

Section: Discussionsupporting

confidence: 53%

Telbivudine-Induced Myopathy: Clinical Features, Histopathological Characteristics, and Risk Factors

Lan

Lin

et al. 2023

J Clin Neurol

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Background and Purpose Oral nucleos(t)ide analogs (NAs) are the mainstay treatment for chronic hepatitis B (CHB). Myotoxicity is an important extrahepatic effect related to NA treatment. Telbivudine is the NA for CHB that is frequently associated with muscle-related side effects. The risk factors for telbivudine-induced myopathy (TIM) are not yet clear. Methods This study characterized the clinical, magnetic resonance images (MRI), and pathological features of 12 TIM cases. A group of telbivudine-tolerant (TT) patients with CHB who received regular telbivudine treatment during the same period without the occurrence of myopathy was collected. Demographic and clinical factors were compared between the patients with TIM and the TT controls. Factors independently associated with TIM were identified using logistic regression analysis. Results The patients with TIM (males/females: 7/5, mean age: 57 years) developed myopathy after using telbivudine for a median period of 19.5 months. Muscle histopathology revealed abnormal proliferation, subsarcolemmal or sarcoplasmic accumulations, and ultrastructural defects of mitochondria. When compared with TT cases, patients with TIM had a lower estimated glomerular filtration rate and were more frequently positive for hepatitis B e antigen (HBeAg). Conclusions Mitochondrial abnormalities are characteristic histopathological features, and impaired renal function and HBeAg positivity are risk factors for TIM. Telbivudine-induced mitochondrial dysfunction and immune activation related to mitochondrial damage and HBeAg serostatus changes may underlie TIM. Constant clinical surveillance of myopathy during telbivudine treatment is needed due to the significant latency of its development. Dose adjustment for impaired renal function does not eliminate the risk of TIM occurrence.

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“…Recently, Chen et al . found that male sex and lower baseline estimated glomerular filtration rate were significant risk factors for elevation of CK levels during telbivudine treatment [ 13 ]. In our patient, the CK level was markedly elevated (peak at 8050 U/L).…”

Section: Discussionmentioning

confidence: 99%

Rhabdomyolysis, lactic acidosis, and multiple organ failure during telbivudine treatment for hepatitis B: a case report and review of the literature

et al. 2017

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BackgroundTelbivudine can cause severe side effects, including myositis, neuritis, rhabdomyolysis, and lactic acidosis. However, reported cases of telbivudine leading to multiple organ failure are rare. Here, we report a case of telbivudine-induced severe polymyositis, lactic acidosis, and multiple organ failure.Case presentationA 30-year-old Chinese man with hepatitis B virus infection received antiviral treatment with 600 mg of telbivudine daily for more than 11 months. He developed progressive weakness and myalgia, and subsequently experienced palpitations, chest tightness, lethargy, hypotension, and hypoxemia. Blood tests showed markedly elevated levels of alanine aminotransferase (955 U/L), aspartate aminotransferase (1375 U/L), blood urea nitrogen (14.9 mmol/L), creatine kinase (peak at 8050 U/L), and blood lactate (>20.0 mmol/L). His symptoms improved after continuous renal replacement therapy and short-term methylprednisolone treatment. Hyperbaric oxygen therapy, physical therapy, and rehabilitation for more than 2 months led to recovery of muscle strength to the normal range.ConclusionsWe conclude that continuous renal replacement and steroid therapies play key roles in stabilizing telbivudine-induced severe rhabdomyolysis, lactic acidosis, and multiple organ failure. Hyperbaric oxygen, physical therapy, and rehabilitation may aid in functional recovery after the acute phase of lactic acidosis and organ failure.

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Cumulative incidence and risk factors of creatine kinase elevation associated with telbivudine

Cited by 7 publications

References 34 publications

Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections

Efficacy of 104-week Telbivudine-based optimization strategy in patients with HBeAg-negative chronic hepatitis B virus infections

Telbivudine-Induced Myopathy: Clinical Features, Histopathological Characteristics, and Risk Factors

Rhabdomyolysis, lactic acidosis, and multiple organ failure during telbivudine treatment for hepatitis B: a case report and review of the literature

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