Table 2.
Efficacy Endpoints*
| End of Treatment (EOT) | End of Follow-up (EOF) | |||
|---|---|---|---|---|
| Endpoints | n=28 (%) | 95% Confidence Intervals (%) |
n=28 (%) | 95% Confidence Intervals (%) |
| HBsAg loss | 0 (0) | (0.0–12.3) | 0 (0) | (0.0–12.3) |
| HBsAg seroconversion | 0 (0) | (0.0–12.3) | 0 (0) | (0.0–12.3) |
| HBeAg loss** | 1 (4) | (0.1–18.3) | 1 (4) | (0.1–18.3) |
| HBeAg seroconversion | 1 (4) | (0.1–18.3) | 1 (4) | (0.1–18.3) |
| HBV DNA< 20 IU/mL | 5 (18) | (6.1–36.9) | 0 (0) | (0.0–12.3) |
| HBV DNA≤ 1000 IU/mL | 26 (93) | (76.5–99.1) | 0 (0) | (0.0–12.3) |
| ALT< 1x ULN | 11 (39) | (21.5–59.4) | 13 (46) | (27.5–66.1) |
| ALT< 1.5 x ULN | 16 (57) | (24.5–62.8) | 21 (75) | (55.1–89.3) |
| Primary Endpoint: | ||||
| HBeAg loss** & HBV DNA≤ 1000 IU/mL | 1 (4) | (0.1–18.3) | 0 (0) | (0.0–12.3) |
Analyses were performed using all enrolled participants.
The individual with discrepant qualitative (positive) and quantitative (negative) HBeAg results over time was not regarded as HBeAg loss.