Table 2.
Characteristics of the Per Protocol Population
| Characteristic | ETV + BR (n = 358) | ETV + Placebo (n = 347) | P Value |
|---|---|---|---|
| Age, y, mean ± SD | 42.2 ± 9.8 | 42.4 ± 10.1 | .74 |
| Male sex, No. (%) | 243 (67.9) | 241 (69.5) | .65 |
| WBC count, × 109/L, mean ± SD | 5.4 ± 1.7 | 5.5 ± 1.8 | .59 |
| Hemoglobin, g/L, mean ± SD | 142.0 ± 16.9 | 143.5 ± 17.0 | .24 |
| Prothrombin time, sec, mean ± SD | 12.6 ± 1.7 | 12.5 ± 1.6 | .97 |
| ALT, U/L, median (P25, P75) | 53 (30, 87) | 53 (33, 117) | .16 |
| Bilirubin, μmol/L, median (P25, P75) | 13.4 (10.4, 18.0) | 14.2 (11.0, 19.0) | .15 |
| Albumin, g/L, median (P25, P75) | 42.0 (39.0, 44.8) | 42.0 (39.0, 45.0) | .34 |
| Platelet count × 109/L, mean ± SD | 161.7 ± 58.9 | 161.0 ± 58.3 | .87 |
| HBV DNA, 1og10 copies/mL, mean ± SD | 6.2 ± 1.6 | 6.1 ± 1.6 | .72 |
| HBeAg positive, No. (%) | 202 (56.4) | 200 (57.6) | .74 |
| Knodell necroinflammatory score | .64 | ||
| 3–6 | 158 (44.1) | 145 (41.8) | |
| 7–10 | 177 (49.5) | 174 (50.1) | |
| 11–14 | 23 (6.4) | 28 (8.1) | |
| Ishak fibrosis score | .59 | ||
| 3 | 86 (24.0) | 99 (28.5) | |
| 4 | 68 (19.0) | 64 (18.4) | |
| 5 | 77 (21.5) | 70 (20.2) | |
| 6 | 127 (35.5) | 114 (32.9) |
Abbreviations: ALT, alanine aminotransferase; BR, Biejia-Ruangan; ETV, entecavir; HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; P25, 25th percentile; P75, 75th percentile; SD, standard deviation; WBC, white blood cell.