Impact of age in renal safety of medium-term treatment with Entecavir and Tenofovir in real-life in a real-world cohort: Analysis of the Spanish national chronic hepatitis B register (CIBERHEP)
AASLD LiverLearning®. Tabernero D. Nov 14, 2016; 144801
Topic: Treatment and Clinical Trials
Dr. David Tabernero
Dr. David Tabernero
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TITLE: Impact of age in renal safety of medium-term treatment with Entecavir and Tenofovir in real-life in a real-world cohort: Analysis of the Spanish national chronic hepatitis B register (CIBERHEP)

The CIBERHEP register is funded by an unrestricted grant from Gilead and BMS.

Introduction: Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are first-line treatments for chronic hepatitis B (CHB). In patients with previous renal impairment, long-term therapy with these drugs has been associated with nephrotoxicity [Gish Clin Gastroenterol Hepatol. 2012;10(8):941-6]. The impact of age on this adverse event has not been evaluated. Our aim was to assess the incidence and severity of renal impairment during treatment with TDF or ETV in a real-world cohort of older (≥65 years) CHB patients.
Methods: Retrospective assessment of a cohort of CHB patients from the Spanish multicenter database CIBERHEP. Adult patients receiving TDF or ETV for at least 36 months were included. Liver transplantation and co-infection by human immunodeficiency and/or hepatitis C or D virus were exclusion criteria. Nephrotoxicity was evaluated at 36 months of treatment and defined by changes in either serum creatinine (SCr) levels (≥0.2 mg/dL from baseline or SCr ≥1.2 mg/dL in patients with previous normal baseline levels) or in the estimated glomerular filtrate (Modification of Diet in Renal Disease [MDRD] decrease >10% from baseline or MDRD <60 mL/min/1.73 m2 in patients with baseline MDRD >60).
Results: The study included 239 Caucasian CHB patients, 152 (64%) treated with TDF and 87 (34%) with ETV. Thirty (13%) patients were at least 65 years old at the beginning of therapy. At baseline, 8/29 (27.6%) patients aged ≥65 years and 18/191 (9.4%) <65 years had SCr ≥1.2 mg/dL (p= 0.005). In the group receiving TDF-containing regimens, 1/16 (6.2%) patients ≥65 years and 1/119 (0.8%) <65 years, who had shown normal SCr levels previously, had SCr ≥1.2 mg/dL 36 months after starting antiviral therapy (p=0.09). In the group receiving ETV-containing regimens 6/11 (54.5%) patients ≥65 years and 12/62 (19.4%) <65 years showed a >10% MDRD decrease (p=0.013). The differences in baseline SCr and MDRD and renal events of CHB patients according to age at the start of antiviral therapy are shown in the Table.
Conclusions: Medium-term antiviral treatment with TDF or ETV was associated with trends to renal impairment in patients 65 years or older at the beginning of therapy. Further studies are needed to evaluate renal events and renal monitoring in older CHB patients receiving antiviral therapy.

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