Clinical Trials Study
Copyright ©The Author(s) 2017.
World J Gastroenterol. Apr 28, 2017; 23(16): 2978-2986
Published online Apr 28, 2017. doi: 10.3748/wjg.v23.i16.2978
Table 1 Baseline clinical data of patients before treatment
DNA expression level at 24-wk (IU/mL)
P value
< 1010-103> 103
Number of cases547147
Gender (male/female)39/1659/1226/210.108
Age (yr)37.79 ± 8.6839.33 ± 6.9235.82 ± 10.080.181
ALT (U/L) median (range)333 (80-897)367 (84-813)319 (82-965)0.212
AST (U/L)206.73 ± 133.09183 ± 147.19177 ± 109.850.323
PLT (109/L)203.02 ± 70.16263.33 ± 96.15176.86 ± 62.030.109
Total bilirubin (μmol/L)12.19 ± 4.0711.26 ± 6.339.08 ± 100.750.791
Albumin (g/L)43.12 ± 8.2445.39 ± 7.1542.29 ± 7.290.838
HBV DNA (log10 IU/mL)7.37 ± 0.497.59 ± 0.637.26 ± 0.370.785
HBsAg (log10 IU/mL) median (range)3.78 (2.98-5.46)3.66 (3.03-5.71)3.49 (3.04-5.66)0.801
HBeAg (s/co) median (range)303.78 (1.32-5663.42)179.79 (1.92-6558.76)230.32 (1.65-6288.83)0.206
Table 2 Rates of alanine aminotransaminase normalization according to 24-wk DNA load
DNA expression level at 24-wk (IU/mL)
< 1010-103> 103
24 wk94.40%85.9%40.4%
96 wk100%93.0%51.1%
Table 3 DNA expression at 24 wk and DNA response at 96 wk
24-wk DNA (IU/mL)DNA response at 96 wk (IU/mL)
< 1010-103DNA complete response rateNo response (> 103)
< 1090.74% (50/54)9.26% (5/54)100.00%0
10-10364.79% (46/71)21.13% (15/71)85.92%14.08% (10/71)
> 1034.26% (2/47)27.66% (13/47)31.92%68.08% (32/47)
Table 4 DNA expression at 24 wk and HBeAg response at 96 wk
HBeAg response at 96 wkDNA expression level at 24 wk (IU/mL)
P value
< 1010-103> 103
Rate of conversion to HBeAg negative status53.70% (29/54)35.21% (25/71)6.38% (3/47)0.012
HBeAg conversion rate51.85% (28/54)32.39% (23/71)6.38% (3/47)0.017
Table 5 Treatment efficacies of various antiviral therapies
Virological parameter at 96 wkLAM + ADVTelbivudineEntecavir tabletsEntecavir dispersible tabletsP value
HBV DNA below detection (< 1000 IU/mL as a reference)68.75%66.67%79.66%78.13%0.089
ALT normalization rate81.25%75.76%86.44%85.94%0.096
Rate of conversion to HBeAg negative status31.25%36.36%35.59%34.38%0.615
HBeAg seroconversion rate25.00%33.33%32.20%31.25%0.203
Table 6 Predictive value of DNA load for treatment response at 96 wk in the three different groups (according to DNA load at 24 wk)
GroupAUC95%CISensitivitySpecificityPPVNPV
< 10 IU/mL0.8690.778-0.96084.76%87.30%74.09%93.04%
< 1000 IU/mL0.7970.684-0.88372.00%82.78%64.18%87.34%
> 1000 IU/mL0.5050.344-0.65666.67%45.45%34.37%76.09%
Table 7 Drug-resistant mutations in 26 cases of chronic hepatitis B virus infection
Number of casesResistance mutation
1rtM204I/V + rtN236T + rtS202G
1rtL180M + rtS202G + rtM204I/V + rtN236T
1rtM204I/V + rtN236T
1rtAl81V + rtM204I/V + rtN236T
1rtM204I/V
1rtAl81V + rtN236T + rtS202G
1rtAl81V + rtM204I/V
1rtL180M + rtAl81V + rtM204I/V + rtN236T
1rtAl81V + rtM204I/V + rtS202G
1rtAl81V + rtM204I/V + rtN236T
1rtL180M + rtM204V
2rtM204I + rtN236T
2rtL180M + rtAl81V + rtM204I/V + rtN236T + rtS202G
3rtM204I + rtN236T
4rtN236T
4rtAl81V + rtM204I/V + rtN236T + rtS202G