Background
Methods
Patients
Serum assay
Statistical analysis
Results
Study population
Characteristics | rtA181 group (n = 31) | rtA181 + rtN236 group (n = 25) |
P value |
---|---|---|---|
Age (years) | |||
Mean ± SD | 42.4 ± 9.5 | 41.7 ± 7.6 | 0.763 |
Sex (No.) | |||
Male/Female | 27/4 | 24/1 | 0.245 |
Total bilirubin level (μmol/L) | |||
Mean ± SD | 17.2 ± 8.0 | 16.2 ± 8.2 | 0.671 |
ALT (U/L) | |||
Mean ± SD | 81.4 ± 88.4 | 162.2 ± 316.4 | 0.226 |
AST (U/L) | |||
Mean ± SD | 47.0 ± 31.4 | 79.8 ± 124.7 | 0.210 |
HBV DNA (log10 IU/mL) | |||
Mean ± SD | 4.15 ± 1.87 | 4.35 ± 1.71 | 0.678 |
HBsAg (log10 IU/ml) | |||
Mean ± SD | 3.57 ± 0.37 | 3.63 ± 0.39 | 0.561 |
HBeAg (No.) | |||
Positive/Negative | 24/7 | 18/7 | 0.642 |
Virological responses
Response | rtA181 group (n = 31) | rtA181 + rtN236 group (n = 25) |
P value |
---|---|---|---|
Virological | |||
HBV DNA Reduction (log10 IU/mL) | |||
6th Month (Mean ± SD) | 3.18 ± 1.92 | 3.52 ± 2.04 | 0.520 |
12th Month (Mean ± SD) | 3.59 ± 1.85 | 3.76 ± 2.15 | 0.756 |
undectectable | |||
6th Month (No. %) | 24/31 (77.4%) | 19/25 (76.0%) | 0.900 |
12th Month (No. %) | 27/31 (87.1%) | 22/25 (88.0%) | 0.919 |
HBeAg loss | |||
6th Month (No. %) | 3/24 (1.3%) | 1/18 (5.6%) | 0.448 |
12th Month (No. %) | 5/24 (20.8%) | 2/18 (11.1%) | 0.403 |
Biochemical | |||
Total bilirubin level (μmol/L) | |||
6th Month (Mean ± SD) | 16.0 ± 10.0 | 14.3 ± 4.7 | 0.440 |
12th Month (Mean ± SD) | 16.3 ± 8.9 | 14.4 ± 3.7 | 0.329 |
Normalization of serum Tbil | |||
6th Month (No. %) | 26/31 (%) | 22/25 (72.0%) | 0.661 |
12th Month (No. %) | 24/31 (89.6%) | 22/25 (88.0%) | 0.304 |
ALT (U/L) | |||
6th Month (Mean ± SD) | 38.3 ± 20.6 | 37.7 ± 15.0 | 0.903 |
12th Month (Mean ± SD) | 37.2 ± 18.4 | 34.3 ± 12.2 | 0.500 |
Normalization of serum ALT | |||
6th Month (No. %) | 23/31 (74.2%) | 21/25 (84.0%) | 0.374 |
12th Month (No. %) | 28/31 (90.3%) | 20/25 (80.0%) | 0.272 |
Serologic responses
Biochemical responses
Responses between different rtA181T/sW172 mutations
Characteristics | rtA181T/sW172* mutation group (n = 22) | other missense mutations group (n = 4) |
P value |
---|---|---|---|
Before Rescue | |||
HBV DNA (log10 IU/mL) | |||
Mean ± SD | 4.16 ± 2.35 | 3.61 ± 0.21 | 0.298 |
HBsAg (lg IU/ml) | |||
Mean ± SD | 3.52 ± 0.48 | 3.46 ± 0.40 | 0.795 |
ALT (U/L) | |||
Mean ± SD | 142.5 ± 253.8 | 59.0 ± 40.9 | 0.524 |
After Rescue | |||
HBV DNA Reduction (log10 IU/mL) | |||
6th Month (Mean ± SD) | 3.31 ± 2.25 | 3.61 ± 0.21 | 0.797 |
12th Month (Mean ± SD) | 3.66 ± 2.18 | 3.61 ± 0.21 | 0.918 |
HBsAg (log10 IU/ml) | |||
6th Month (Mean ± SD) | 3.50 ± 0.45 | 3.47 ± 0.42 | 0.908 |
12th Month (Mean ± SD) | 3.31 ± 0.50 | 3.14 ± 0.50 | 0.529 |
ALT (U/L) | |||
6th Month (Mean ± SD) | 39.6 ± 19.3 | 20.5 ± 11.7 | 0.069 |
12th Month (Mean ± SD) | 39.0 ± 20.0 | 23.5 ± 3.1 | 0.142 |
Varibles | Regression Coefficient | Standard Error |
P Value | OR (95% CI) |
---|---|---|---|---|
Mutation group | 0.487 | 1.515 | 0.748 | 1.627 (0.084–31.666) |
HBV DNA level | 1.906 | 0.832 | 0.022 | 6.723 (1.315–24.371) |
HBsAg level | 4.749 | 3.319 | 0.152 | 115.522 (0.173–77176.906) |
eAg | −1.696 | 1.542 | 0.271 | 0.183 (0.009–3.765) |
Sex | 2.256 | 1.733 | 0.193 | 9.545 (0.320–285.099) |
Age. | 0.064 | 0.095 | 0.501 | 1.066 (0.885–1.284) |
Tbil | −0.294 | 0.183 | 0.108 | 0.745 (0.520–1.067) |
ALT | 0.001 | 0.016 | 0.927 | 1.001 (0.971–1.033) |
AST | 0.002 | 0.038 | 0.951 | 1.002 (0.931–1.080) |