Telbivudin May Cause Increased Polineuropathy/Myopathy in Liver Transplant Recipients

Abstract

Purpose: Liver transplantation (LT) is often complicated by chronic renal disease with multifactorial causes. Some recent studies have suggested that telbivudine treatment can contribute to provide an improvement on renal functions, compared with lamivudine in patients with hepatitis B virus (HBV)-related cirrhosis. This study was initiated to examine the effects of switching to telbivudine treatment on renal functions in LT recipients receiving lamivudine treatment for prophylaxis of HBV recurrence. Because of the high percentage of polyneuropathy and myopathy that we observed in the study group, we did an interim analysis, and report our preliminary 6-month results. Methods: Forty patients (35 men) with an average age of 57 years (SD ± 9.38), who had been transplanted for HBV-related cirrhosis were enrolled. All patients had a serum creatinine concentration more than the upper limit of the normal range. Creatinine clearance (CrCl) and modification of diet in renal disease (MDRD) formulation were used to estimate glomerular filtration rate. Serum creatinine kinase (CK) and myoglobin levels were monitored. Electrophysiological tests were performed if the patient had elevated CK and muscle pain and/or weakness. All patients continued their regular immunosuppressive medications. Results: Six-month data were available in 25 of 40 patients. Mean (± SD) of CrCl at baseline (CrCl0), 3-month (CrCl3), and 6-month (CrCl6) were: 53.42±21.19, 51.52±23.08, and 57.81±19.53, respectively. Mean (± SD) of MDRD at baseline (MDRD0), 3-month (MDRD3), and 6-month (MDRD6) were: 47.18±10.59, 48.06±12.89, and 51.67±12.99, respectively. No statistical difference was found between CrCl0 vs. CrCl3, CrCl0 vs. CrCl6, and MDRD0 vs. MDRD3, but the difference was significant between MDRD0 vs. MDRD6 (p=0.017). Of 10 patients who had elevated CK levels underwent electrophysiological tests, seven patients (18%) diagnosed polyneuropathy (n=5) or myopathy (n=2), with a median duration of 6 (range, 2-9) months after switching to telbivudine. Conclusion: Although telbivudine may provide a promising beneficial effect on renal functions in LT recipients, high polyneuropathy/myopathy rates observed in our study group indicate that it is necessary to be very careful with its use in LT settings.