Chronic kidney disease progression in patients with chronic hepatitis B on tenofovir, entecavir, or no treatment

Background: In clinical trials involving patients with preserved renal function, tenofovir disoproxil fumarate (TDF) use was associated with mild renal impairment in 1% of patients. Aim: To compare serial renal function of entecavir (ETV)-treated, TDF-treated, and untreated patients with chronic hepatitis B. Methods: We studied the risk of chronic kidney disease (CKD) progression in a territory-wide cohort of patients with chronic hepatitis B without treatment and of those on ETV or TDF treatment. Estimated glomerular filtration rate (eGFR) was determined by the CKD Epidemiology Collaboration equationand was classified into five CKD stages. CKD progression, defined as an increase of at least one CKD stage, was compared among treated and untreated patients. Results: After propensity score matching, 2254 ETV-treated, 2254 TDF-treated, and 2254 untreated patients were included in the analysis. Their mean baseline eGFR was 90.319.6, 91.3 +/- 20.6, and 92.2 +/- 20.0 mL/min/1.73 m(2), respectively. During a mean follow-up of 2.4 +/- 1.5 years, 639 ETV-treated, 706 TDF-treated, and 564 untreated patients exhibited CKD progression 1 stage. The 5-year cumulative incidence (95% confidence interval) of CKD progression was 43% (40%-46%) in ETV-treated, 48% (45%-51%) in TDF-treated, and 43% (39%-47%) in untreated patients (reference group), respectively (P = 0.267 and <0.001, respectively). The number of patients who exhibited CKD progression >= 2 stages was 92 (4.1%) in the untreated cohort, 95 (4.2%) in the ETV-treated cohort, and 51 (2.3%) in the TDF-treated cohort. Conclusions: The use of TDF was associated with mild renal impairment in a minority of patients; those treated with ETV had a similar risk compared to untreated patients.