Background
Methods
Patients and study design
Serum assay and methodology
Definitions
Statistical analyses
Results
Baseline patient characteristics
Variables | ETV (n = 105) | TDF (n = 105) |
P
|
---|---|---|---|
Age (years) | 47.0 ± 12.0 | 45.5 ± 11.9 | 0.396 |
Sex (male, %) | 64 (61.0) | 67 (63.8) | 0.776 |
HBeAg-positive (%) | 58 (55.2) | 63 (50.0) | 0.577 |
Disease status; CHB/LC (%) | 62/43 (59.0/41.0) | 64/41 (61.0/39.0) | 0.888 |
MELD (<7/7-13/>13, %) | 73/26/6 (69.5/24.8/5.7) | 71/33/1 (67.6/31.4/1.0) | 0.800 |
Serum ALT (IU/L) | 179.5 ± 253.0 | 232.3 ± 427.7 | 0.278 |
Serum total bilirubin (mg/dL) | 1.20 ± 1.74 | 1.06 ± 1.29 | 0.507 |
Serum albumin (g/dL) | 4.11 ± 0.56 | 4.10 ± 0.53 | 0.905 |
INR | 1.12 ± 0.19 | 1.11 ± 0.17 | 0.927 |
Serum HBV DNA level (log10 IU/mL) | 6.56 ± 1.33 | 6.66 ± 1.26 | 0.564 |
Duration of follow-up (months) | 27.0 ± 7.2 | 23.6 ± 5.2 |
Therapeutic responses
Baseline | Week 24 | Week 48 | Total |
P
| |
---|---|---|---|---|---|
Mean HBV DNA (log10 IU/mL) | 6.61 | 1.72 | 1.49 | 5.12↓ | 0.559 |
ETV (n = 105) | 6.56 | 1.80 | 1.55 | 5.01↓ | |
TDF (n = 105) | 6.66 | 1.64 | 1.44 | 5.22↓ | |
HBV DNA negativity by PCR | 161(76.7%) | 0.192 | |||
ETV (n = 105) | 58 (55.2%) | 76 (72.4%) | |||
TDF (n = 105) | 56 (53.3%) | 85 (81.0%) | |||
HBeAg loss/seroconversion | 18 (14.9%) | 0.452 | |||
ETV (n = 58) | 7 (12.1%) | ||||
TDF (n = 63) | 11 (17.5%) | ||||
Biochemical response | 150 (81.5%) | 0.647 | |||
ETV (n = 92) | 77 (83.7%) | ||||
TDF (n = 92) | 73 (79.3%) |
Predictive factors for virologic response
Variables | Patients with VR (n = 161) | Patients without VR (n = 49) |
P
|
---|---|---|---|
Age (years) | 46.8 ± 11.0 | 44.4 ± 14.7 | 0.285 |
Sex (male, %) | 99 (61.5) | 32 (65.3) | 0.737 |
HBeAg-positive (%) | 77 (47.8) | 44 (89.8) | <0.001 |
Disease status; CHB/LC (%) | 85/76 (52.8/47.2) | 41/8 (83.7/16.3) | <0.001 |
MELD (<7/7-13/>13, %) | 109/47/5 (67.7/29.2/3.1) | 35/12/2 (71.4/24.5/4.1) | 0.768 |
Serum ALT (IU/L) | 198.0 ± 305.7 | 231.8 ± 475.0 | 0.557 |
Serum total bilirubin (mg/dL) | 1.12 ± 1.46 | 1.19 ± 1.77 | 0.774 |
Serum albumin(g/dL) | 4.10 ± 0.53 | 4.11 ± 0.60 | 0.952 |
INR | 1.12 ± 0.17 | 1.09 ± 0.21 | 0.319 |
IVR-3 (−/+) | 12/149(7.5/92.5) | 25/24 (51.0/49.0) | <0.001 |
Serum HBV DNA level (log10 IU/mL) | 6.30 ± 1.23 | 7.61 ± 0.97 | <0.001 |
Treatment regimens | 0.192 | ||
ETV (n = 105, %) | 76 (72.4) | 29 (27.6) | |
TDF (n = 105, %) | 85 (81.0) | 20 (19.0) |
Factors | RR | 95% CI |
P
|
---|---|---|---|
Disease status (CHB/LC) | 0.559 | 0.205–1.521 | 0.255 |
IVR-3 (+/−) | 6.214 | 2.500–15.443 | <0.001 |
HBeAg (−/+) | 3.184 | 0.977–10.377 | 0.055 |
Serum HBV DNA level (log10 IU/mL) | 0.605 | 0.357–1.023 | 0.061 |
Factors | Univariate analysis | Multivariate analysis | ||||
---|---|---|---|---|---|---|
RR | 95% CI |
P
| RR | 95% CI |
P
| |
Age (years) | 1.007 | 0.995–1.018 | 0.262 | |||
Sex (female/male) | 1.009 | 0.747–1.363 | 0.952 | |||
HBeAg-positive (−/+) | 3.031 | 2.209–4.158 | <0.001 | 1.834 | 1.246–2.698 | 0.002 |
Disease status (LC/CHB) | 1.577 | 1.172–2.121 | 0.003 | 1.028 | 0.748–1.411 | 0.867 |
MELD (<7/≥7) | 0.923 | 0.676–1.260 | 0.613 | |||
INR | 1.020 | 0.469–2.218 | 0.961 | |||
Serum ALT (IU/L) | 1.000 | 1.000–1.000 | 0.890 | |||
Serum total bilirubin (mg/dL) | 1.005 | 0.918–1.101 | 0.908 | |||
Serum albumin (g/dL) | 1.077 | 0.824–1.406 | 0.588 | |||
IVR-3 (+/−) | 4.851 | 2.902–8.109 | <0.001 | 3.403 | 1.977–5.859 | <0.001 |
Serum HBV DNA level (log10 IU/mL) | 0.638 | 0.569–0.715 | <0.001 | 0.817 | 0.696–0.958 | 0.013 |
Therapy regimens (TDF/ETV) | 1.162 | 0.868–1.555 | 0.313 |