Renal dysfunction during treatment of chronic hepatitis B with tenofovir disoproxyl fumarate and associated risk factors

Objectives To analyze the evolution of glomerular filtration rate (GFR) and the presence of renal tubular dysfunction during the treatment of chronic hepatitis B virus (HBV) infection with tenofovir disoproxil fumarate (TDF) and to determine the risk factors involved. Methods Retrospective cohort observational study of adults with chronic hepatitis B. Exclusion: hepatitis C virus-HBV coinfection, diabetes, baseline GFR less than 60 ml/min. Measurements of serum and urinary creatinine and phosphate; urinary albumin, retinol-binding protein (RBP) and neutrophil gelatinase-associated lipocalin (NGAL) were performed. Univariate and multivariate analyses tracked factors associated with worsening GFR. Results A total of 120 individuals were included: 35% NAiVE (G1); 49.2% HBV using TDF (G2); 15.8% HBV-HIV using TDF (G3); 63.3% men; 60.8% white; 30% hypertensive. Average age was 50.5 years (SD +/- 12.9 years). Reactive HBeAg predominated in G3 (P < 0.001) and cirrhosis in G2 (P < 0.036). NGAL was elevated in 5.3% of cases (G1 = 3.2%; G2 = 8.7%; G3 = 0%; P = 0.582), RBP in 6.7% (G1, G3 = 0%; G2 = 13.6%; P = 0.012), urinary phosphate/creatinine ratio in 16.2% (G1 = 15.2%; G2 = 14.5%; G3 = 23.5%; P = 0.842) and urinary albumin/creatinine ratio in 12.9% (G1 = 12.2%; G2 = 10.7%; G3 = 21.1%; P = 0.494). Worsening of renal function occurred in 22.5% of the population (G1 = 11.9%; G2 = 28.8%; G3 = 26.3%; P = 0.122), independently associated only with systemic arterial hypertension [adjusted odds ratio (AOR) = 4.14; P = 0.008], but not to TDF (AOR = 2.66; P = 0.110) or male sex (AOR = 2.39; P = 0.135). However, the concomitance of these variables generated a high estimated risk for this outcome (51%). Conclusions Renal tubular dysfunction was uncommon according to NGAL, RBP or urinary phosphate/creatinine ratio. TDF was not an independent factor for worsening renal function, significantly associated only with systemic arterial hypertension. However, in hypertensive men, the use of TDF should be monitored.