Fu XY, Tan DM, Liu CM, Gu B, Hu LH, Peng ZT, Chen B, Xie YL, Gong HY, Hu XX, Yao LH, Xu XP, Fu ZY, He LQ, Li SH, Long YZ, Li DH, Gu JL, Peng SF. Early hepatitis B viral DNA clearance predicts treatment response at week 96. World J Gastroenterol 2017; 23(16): 2978-2986 [PMID: 28522916 DOI: 10.3748/wjg.v23.i16.2978]
Corresponding Author of This Article
Shi-Fang Peng, PhD, Key Laboratory of Viral Hepatitis, Department of Infectious Diseases, Xiangya Hospital, Central South University, 87 Xiangya Road, Changsha 410008, Hunan Province, China. 917940984@qq.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Clinical Trials Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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
< 10
10-103
> 103
Number of cases
54
71
47
Gender (male/female)
39/16
59/12
26/21
0.108
Age (yr)
37.79 ± 8.68
39.33 ± 6.92
35.82 ± 10.08
0.181
ALT (U/L) median (range)
333 (80-897)
367 (84-813)
319 (82-965)
0.212
AST (U/L)
206.73 ± 133.09
183 ± 147.19
177 ± 109.85
0.323
PLT (109/L)
203.02 ± 70.16
263.33 ± 96.15
176.86 ± 62.03
0.109
Total bilirubin (μmol/L)
12.19 ± 4.07
11.26 ± 6.33
9.08 ± 100.75
0.791
Albumin (g/L)
43.12 ± 8.24
45.39 ± 7.15
42.29 ± 7.29
0.838
HBV DNA (log10 IU/mL)
7.37 ± 0.49
7.59 ± 0.63
7.26 ± 0.37
0.785
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)
< 10
10-103
> 103
24 wk
94.40%
85.9%
40.4%
96 wk
100%
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)
< 10
10-103
DNA complete response rate
No response (> 103)
< 10
90.74% (50/54)
9.26% (5/54)
100.00%
0
10-103
64.79% (46/71)
21.13% (15/71)
85.92%
14.08% (10/71)
> 103
4.26% (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 wk
DNA expression level at 24 wk (IU/mL)
P value
< 10
10-103
> 103
Rate of conversion to HBeAg negative status
53.70% (29/54)
35.21% (25/71)
6.38% (3/47)
0.012
HBeAg conversion rate
51.85% (28/54)
32.39% (23/71)
6.38% (3/47)
0.017
Table 5 Treatment efficacies of various antiviral therapies
Virological parameter at 96 wk
LAM + ADV
Telbivudine
Entecavir tablets
Entecavir dispersible tablets
P value
HBV DNA below detection (< 1000 IU/mL as a reference)
68.75%
66.67%
79.66%
78.13%
0.089
ALT normalization rate
81.25%
75.76%
86.44%
85.94%
0.096
Rate of conversion to HBeAg negative status
31.25%
36.36%
35.59%
34.38%
0.615
HBeAg seroconversion rate
25.00%
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)
Group
AUC
95%CI
Sensitivity
Specificity
PPV
NPV
< 10 IU/mL
0.869
0.778-0.960
84.76%
87.30%
74.09%
93.04%
< 1000 IU/mL
0.797
0.684-0.883
72.00%
82.78%
64.18%
87.34%
> 1000 IU/mL
0.505
0.344-0.656
66.67%
45.45%
34.37%
76.09%
Table 7 Drug-resistant mutations in 26 cases of chronic hepatitis B virus infection
Number of cases
Resistance mutation
1
rtM204I/V + rtN236T + rtS202G
1
rtL180M + rtS202G + rtM204I/V + rtN236T
1
rtM204I/V + rtN236T
1
rtAl81V + rtM204I/V + rtN236T
1
rtM204I/V
1
rtAl81V + rtN236T + rtS202G
1
rtAl81V + rtM204I/V
1
rtL180M + rtAl81V + rtM204I/V + rtN236T
1
rtAl81V + rtM204I/V + rtS202G
1
rtAl81V + rtM204I/V + rtN236T
1
rtL180M + rtM204V
2
rtM204I + rtN236T
2
rtL180M + rtAl81V + rtM204I/V + rtN236T + rtS202G
3
rtM204I + rtN236T
4
rtN236T
4
rtAl81V + rtM204I/V + rtN236T + rtS202G
Citation: Fu XY, Tan DM, Liu CM, Gu B, Hu LH, Peng ZT, Chen B, Xie YL, Gong HY, Hu XX, Yao LH, Xu XP, Fu ZY, He LQ, Li SH, Long YZ, Li DH, Gu JL, Peng SF. Early hepatitis B viral DNA clearance predicts treatment response at week 96. World J Gastroenterol 2017; 23(16): 2978-2986