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Table 3 Key safety endpoints (SP)

From: Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study

Adverse events (week 96) TDF (N = 75)
n (%)
On-therapy AE 58 (77)
On-therapy serious AE 2 (3)
On-therapy AE leading to study withdrawal 1 (1)
Drug-related AE 18 (24)
 Drug-related urine beta-2-microglobulin increase 15 (20)
 Renal tubular disorder 1 (1)
 Renal tubular dysfunction 1 (1)
 Prothrombin time prolonged 1 (1)
Other key safety endpoints n Median (min, max) Median change from baseline (min, max)
Serum creatinine (mg/dL)    
 Baseline 75 0.70 (0.38, 1.01)  
 Week 4 75 0.71 (0.44, 1.02) 0.01 (−0.14, 0.20)
 Week 24 74 0.74 (0.41, 1.05) 0.02 (−0.08, 0.15)
 Week 48 73 0.72 (0.42, 1.09) 0.04 (−0.11, 0.12)
 Week 96 72 0.76 (0.45, 1.02) 0.06 (−0.10, 0.17)
eGFR by JSN-CKDI (mL/min/1.73m2)    
 Baseline 75 86 (60, 135)  
 Week 4 75 84 (60, 138) −2.0 (−21, 20)
 Week 24 74 81 (57, 124) −3.0 (−21, 13)
 Week 48 73 82 (56, 124) −6.0 (−20, 12)
 Week 96 72 79.0 (52, 118) −9.5 (−24, 14)
Urine beta-2-microglobulin ratio (µg/g creatinine)
 Baseline 75 154.91 (40.71, 1636.09)  
 Week 4 75 198.91 (25.72, 4779.66) 45.02 (−317.50, 3143.57)
 Week 24 74 185.88 (8.93, 9006.76) 41.17 (−361.52, 7890.23)
 Week 48 73 192.50 (13.02, 10,546.26) 38.16 (−582.24, 9429.72)
 Week 96 72 154.96 (11.20, 9052.18) 15.19 (−166.80, 7935.65)
Serum phosphorus (mg/dL)    
 Baseline 75 3.3 (1.9, 4.4)  
 Week 4 75 3.2 (2.0, 4.4) −0.10 (−1.0, 0.9)
 Week 24 74 3.3 (1.4, 4.5) −0.10 (−1.1, 1.4)
 Week 48 73 3.3 (2.0, 4.7) 0.00 (−1.3, 0.9)
 Week 96 72 3.4 (2.2, 4.5) 0.10 (−1.1, 1.2)
%TRP
 Baseline 75 89.92 (77.91, 97.71)  
 Week 4 75 88.49 (77.04, 98.79) −0.69 (−13.26, 6.75)
 Week 24 74 90.20 (78.96, 96.26) −0.52 (−11.81, 9.75)
 Week 48 73 89.44 (81.51, 97.71) 0.17 (−8.71, 8.27)
 Week 96 72 89.83 (81.07, 96.90) −0.818 (−10.25, 15.47)
ALT (U/L)
 Baseline 75 19.0 (7, 147)  
 Week 4 75 22.0 (8, 141) 4.0 (−14, 60)
 Week 24 74 22.5 (10, 130) 4.0 (−32, 61)
 Week 48 73 23.0 (12, 83) 4.0 (−79, 23)
 Week 96 72 21.5 (11, 220) 2.5 (−20, 73)
BMD safety endpoints n Median (min, max) Median % change from baseline (min, max)
BMD, femur (g/cm2)
 Baseline 23 0.83 (0.64, 0.99)  
 Week 96 23 0.80 (0.66, 1.00) −2.09 (−12.67, 6.59)
BMD, lumbar vertebra (g/cm2)
 Baseline 75 1.00 (0.63, 1.43)  
 Week 96 72 0.96 (0.64, 1.52) −2.24 (−12.21, 6.73)
  1. AE adverse event, ALT alanine aminotransferase, BMD bone mineral density, eGFR by JSN-CKDI estimated glomerular filtration rate calculated by the Japanese Society of Nephrology-Chronic Kidney Disease Initiatives (JSN-CKDI) equation, SD standard deviation, SP safety population, TDF tenofovir disoproxil fumarate, TRP renal tubular reabsorption of phosphate