Background
Methods
Patients
Laboratory measurement
Outcomes
Statistical analysis
Results
Patient characteristics and clinical response rate
Characteristics | Total | CR (+) | CR (−) |
p value |
---|---|---|---|---|
No. of patients | 171 | 33 (19.3) | 138 (80.7) | |
Age (years) | 28.5 (7.9) | 26.7 (7.6) | 28.9 (7.9) | 0.09 |
Gender (male) | 130/171 (76.0) | 24/33 (72.7) | 106/138 (76.8) | 0.62 |
BMI | 22.2 (3.2) | 22.0 (2.9) | 22.2 (3.3) | 0.71 |
Years of HBV Exposure | 11.2 (9.3) | 7.8 (5.5) | 12.0 (9.8) | 0.02 |
HBV Genotype | ||||
B | 77 | 14 (42.4) | 63 (45.7) | 0.74 |
C | 94 | 19 (57.6) | 75 (54.3) | |
ALT (*ULN) | 4.0 (1.9) | 4.6 (2.3) | 3.8 (1.8) | 0.05 |
ALT > 5*ULN | 35/171 (20.5) | 10/33 (30.3) | 25/138 (18.1) | 0.12 |
HBsAg (Log10 IU/mL) | 4.2 (0.6) | 4.0 (0.6) | 4.3 (0.6) | 0.01 |
HBeAg (Log10 IU/mL) | 2.6 (0.6) | 2.4 (0.6) | 2.6 (0.6) | 0.09 |
HBV DNA (Log10 IU/mL) | 7.8 (0.8) | 7.7 (0.7) | 7.8 (0.8) | 0.44 |
On-treatment Quantifications, week 12 | ||||
HBsAg decrease > 1.5Log | 12/171 (7.0) | 5/33 (15.2) | 7/138 (5.1) | 0.04 |
HBeAg decrease > 1.5Log | 46/171 (26.9) | 15/33 (45.5) | 31/138 (22.5) | 0.01 |
HBV DNA decrease > 2.0Log | 51/171 (29.8) | 18/33 (54.5) | 33/138 (23.9) | <0.01 |
On-treatment Quantifications, week 24 | ||||
HBsAg decrease > 1.5Log | 30/171 (17.5) | 10/33 (30.3) | 20/138 (14.5) | 0.03 |
HBeAg decrease > 1.5Log | 69/171 (40.4) | 23/33 (69.7) | 46/138 (33.3) | <0.01 |
HBV DNA decrease > 2.0Log | 77/171 (45.0) | 24/33 (72.7) | 53/138 (38.4) | <0.01 |
Changes in on-treatment HBV DNA and HBV serological markers
Prediction of CR by HBV DNA and HBV serological biomarkers
CR (+) | CR (−) | PPV | NPV | ||
---|---|---|---|---|---|
HBsAg | Week 12 | ||||
Up to 1500 IU/mL | 13 | 25 | 34.2 | - | |
1500 - 20000 IU/mL | 17 | 68 | 20.0 | - | |
Over 20000 IU/mL | 3 | 45 | - | 93.8 | |
Week 12 Change | |||||
Up to −1.5 log IU/mL | 5 | 6 | 45.5 | - | |
− 1.5 ~ −0.5 log IU/mL | 14 | 37 | 27.5 | - | |
Over −0.5 log IU/mL | 14 | 95 | - | 87.2 | |
Week 24 | |||||
Up to 1500 IU/mL | 15 | 42 | 26.3 | - | |
1500 - 20000 IU/mL | 18 | 64 | 22.0 | - | |
Over 20000 IU/mL | 0 | 32 | - | 100.0 | |
Week 24 Change | |||||
Up to −1.5 log IU/mL | 10 | 20 | 33.3 | - | |
− 1.5 ~ −0.5 log IU/mL | 11 | 44 | 20.0 | - | |
Over −0.5 log IU/mL | 12 | 74 | - | 86.0 | |
HBeAg | Week 12 | ||||
Up to 10 IU/mL | 19 | 37 | 33.9 | - | |
10 - 100 IU/mL | 5 | 31 | 13.9 | - | |
Over 100 IU/mL | 9 | 70 | - | 88.6 | |
Week 12 Change | |||||
Up to −1.5 log IU/mL | 15 | 31 | 32.6 | - | |
− 1.5 ~ −0.5 log IU/mL | 11 | 34 | 24.4 | - | |
Over −0.5 log IU/mL | 7 | 73 | - | 91.3 | |
Week 24 | |||||
Up to 10 IU/mL | 24 | 53 | 31.2 | - | |
10 - 100 IU/mL | 4 | 24 | 14.3 | - | |
Over 100 IU/mL | 5 | 61 | - | 92.4 | |
Week 24 Change | |||||
Up to −1.5 log IU/mL | 23 | 46 | 33.3 | - | |
− 1.5 ~ −0.5 log IU/mL | 8 | 29 | 21.6 | - | |
Over −0.5 log IU/mL | 2 | 63 | - | 96.9 | |
HBV DNA | Week 12 | ||||
Up to 20000 IU/mL | 12 | 16 | 42.9 | - | |
Over 20000 IU/mL | 21 | 122 | - | 85.3 | |
Week 12 Change | |||||
Up to −2.0 log IU/mL | 18 | 33 | 35.3 | - | |
Over −2.0 log IU/mL | 15 | 105 | - | 87.5 | |
Week 24 | |||||
Up to 20000 IU/mL | 19 | 32 | 37.3 | - | |
Over 20000 IU/mL | 14 | 106 | - | 88.3 | |
Week 24 Change | |||||
Up to −2.0 log IU/mL | 24 | 53 | 31.2 | - | |
Over −2.0 log IU/mL | 9 | 85 | - | 90.4 |
Associated factors for predicting combined response
Characteristics | CR (+) | |||
---|---|---|---|---|
Univariate | Multivariate | |||
OR (95 % CI) |
p value | OR (95 % CI) |
p value | |
Age | 0.96 (0.91, 1.01) | 0.14 | ||
Gender (Male) | 0.81 (0.34, 1.91) | 0.62 | ||
BMI | 0.98 (0.87, 1.10) | 0.72 | ||
HBV Genotype (B) | 0.88 (0.41, 1.89) | 0.74 | ||
ALT (*ULN) | 1.19 (1.00, 1.43) | 0.05 | ||
ALT > 5*ULN | 1.97 (0.83, 4.64) | 0.12 | ||
HBsAg (Log10 IU/mL) | 0.41 (0.22, 0.79) | 0.01 | 0.38 (0.19, 0.79) | 0.01 |
HBeAg (Log10 IU/mL) | 0.61 (0.34, 1.08) | 0.09 | ||
HBV DNA (Log10 IU/mL) | 0.83 (0.51, 1.33) | 0.43 | ||
On-treatment Quantifications, week 12 | ||||
HBsAg decrease > 1.5Log | 3.34 (0.99, 11.30) | 0.05 | 3.36 (0.90, 12.56) | 0.07 |
HBeAg decrease > 1.5Log | 2.88 (1.30, 6.36) | 0.01 | ||
HBV DNA decrease > 2.0Log | 3.82 (1.73, 8.40) | <0.01 | ||
On-treatment Quantifications, week 24 | ||||
HBsAg decrease > 1.5Log | 2.57 (1.06, 6.19) | 0.04 | ||
HBeAg decrease > 1.5Log | 4.60 (2.02 10.47) | <0.01 | 4.02 (1.72, 9.39) | <0.01 |
HBV DNA decrease > 2.0Log | 4.28 (1.85, 9.90) | <0.01 |