title: Telbivudine in liver transplant recipients: Renal protection does not overcome the risk of polyneuropathy and myopathy.
abstract: The recently reported benefit of telbivudine for renal function has not been systematically studied in long-term liver transplantation (LT) recipients who are at high risk for renal impairment. We aimed to examine whether switching lamivudine therapy to telbivudine could improve renal function in LT recipients who have impaired renal function. This single-center, prospective cohort study enrolled LT recipients who were on lamivudine for hepatitis B virus (HBV) prophylaxis and who had renal impairment for at least 1 year. Lamivudine was switched to telbivudine. The primary outcome was to evaluate the change in renal function at weeks 12, 24, 36, and 48. The secondary outcomes were to assess the efficacy of telbivudine for HBV prophylaxis and the safety profile of telbivudine in the posttransplant setting. After 45 patients were enrolled, the study was terminated early because of increased rates of polyneuropathy/myopathy. During telbivudine treatment (median, 64 weeks), estimated glomerular filtration rate (eGFR) increased in 34 patients (76%). The improvement in renal function was prominent after 24 weeks of telbivudine treatment. Telbivudine was effective as prophylaxis against HBV recurrence. Twenty-six patients (58%) developed polyneuropathy and/or myopathy. The 1-year estimated incidence of polyneuropathy/myopathy was 28%. Diabetes was the strongest predictor of polyneuropathy/myopathy (hazard ratio, 4.13; 95% confidence interval, 1.49-11.50; P = 0.007). In conclusion, although it seems to have a favorable effect in the improvement of renal function and seems to be effective in the prevention of HBV recurrence, the high risk of polyneuropathy and myopathy hampers the use of telbivudine in LT recipients.
authors.affiliation: Section of Gastroenterology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Ilker
authors.initials: I
authors.lastname: Turan
authors.affiliation: Section of Gastroenterology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Suna
authors.initials: S
authors.lastname: Yapali
authors.affiliation: Department of Neurology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Fikret
authors.initials: F
authors.lastname: Bademkiran
authors.affiliation: Department of Biostatistics, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Timur
authors.initials: T
authors.lastname: Kose
authors.affiliation: Section of Nephrology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Soner
authors.initials: S
authors.lastname: Duman
authors.affiliation: Department of Organ Transplantation and Research Center, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Murat
authors.initials: M
authors.lastname: Sozbilen
authors.affiliation: Section of Gastroenterology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Fulya
authors.initials: F
authors.lastname: Gunsar
authors.affiliation: Section of Gastroenterology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Galip
authors.initials: G
authors.lastname: Ersoz
authors.affiliation: Section of Gastroenterology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Ulus Salih
authors.initials: US
authors.lastname: Akarca
authors.affiliation: Section of Gastroenterology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Omer
authors.initials: O
authors.lastname: Ozutemiz
authors.affiliation: Section of Gastroenterology, School of Medicine, Ege University, Izmir, Turkey.
authors.forename: Zeki
authors.initials: Z
authors.lastname: Karasu
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects*; D003920:Diabetes Mellitus / Q000453:epidemiology; D057915:Drug Substitution; D058625:End Stage Liver Disease / Q000175:diagnosis / Q000601:surgery* / Q000821:virology; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006509:Hepatitis B / Q000150:complications / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D019259:Lamivudine / Q000009:adverse effects; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology; D011115:Polyneuropathies / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D020127:Recovery of Function; D012008:Recurrence; D051436:Renal Insufficiency, Chronic / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology; D012307:Risk Factors; D000077712:Telbivudine; D013936:Thymidine / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey / Q000453:epidemiology
chemical_list: D000998:Antiviral Agents; D000077712:Telbivudine; D019259:Lamivudine; D013936:Thymidine