Table 2.
Comparison of efficacy endpoints between the treatment and control groups.
| Endpoint | Treatment group (n = 271) | Control group (n = 272) | P |
|---|---|---|---|
| HBsAg loss | 15 (5.5) | 5 (1.8) | 0.031 |
| Decrease in HBsAg to ≥1 lg·IU/mL | 30 (11.1) | 16 (5.9) | 0.043 |
| HBV DNA suppression | 261 (97.8) | 267 (98.2) | 0.770 |
| Mean decrease in cccDNA (lg IU/mL)†‡ | 3.66 ± 1.75 | 3.06 ± 1.32 | 0.636 |
| Necroinflammatory improvement‡ | 9 (29.0) | 10 (29.4) | 0.766 |
| Fibrosis improvement‡ | 11 (35.5) | 4 (11.8) | 0.031 |
| ALT normalization§ | 201 (91.8) | 199 (91.3) | 0.868 |
Values in parentheses are percentages; †value is the mean ± standard deviation. ‡A total of 65 patients had liver biopsy specimens assessed both at baseline and at 96 weeks (31 in the treatment group and 34 in the control group). §A total of 437 patients had abnormal ALT levels at baseline (219 patients in the treatment group and 218 patients in the control group).