Table 1.
Patient demographics and baseline characteristics (ITT population)
| Characteristic | HBeAg-positive | HBeAg-negative | ||
|---|---|---|---|---|
| TDF (N = 103) | ADV (N = 99) | TDF (N = 154) | ADV (N = 153) | |
| Age (years) | 30.5 (8.88) | 30.3 (7.99) | 39.9 (9.76) | 40.4 (9.90) |
| Gender, n (%) | ||||
| Men | 87 (84.5) | 81 (81.8) | 127 (82.5) | 129 (84.3) |
| Women | 16 (15.5) | 18 (18.2) | 27 (17.5) | 24 (15.7) |
| Ethnicity, n (%) | ||||
| Asian–East Asian | 103 (100.0) | 99 (100.0) | 154 (100.0) | 153 (100.0) |
| BMI (kg/m2) | 22.3 (3.22) | 22.5 (3.30) | 23.3 (2.98) | 23.0 (3.03) |
| HBV DNA (log10 copies/mL) | 8.7 (0.87) | 8.7 (0.79) | 6.9 (1.18) | 7.0 (1.13) |
| ALT (U/L) | 199.1 (132.81) | 189.0 (121.54) | 133.4 (120.95) | 112.6 (80.35) |
| PLT (109/L) | 169.5 (50.9) | 172.4 (47.2) | 167.8 (43.8) | 161.1 (47.1) |
| Knodell necroinflammatory scorea | 8.2 (3.48) | 8.5 (2.56) | 6.9 (2.72) | 7.2 (3.08) |
| Previous treatment with lamivudine, n (%) | ||||
| Yes | 4 (3.9) | 4 (4.0) | 7 (4.5) | 4 (2.6) |
| No | 98 (95.1) | 95 (96.0) | 146 (94.8) | 147 (96.1) |
| HBV genotype, n (%) | ||||
| B | 49 (47.6) | 45 (45.5) | 71 (46.1) | 74 (48.4) |
| B/C | 3 (2.9) | 4 (4.0) | 1 (0.6) | 0 |
| C | 51 (49.5) | 50 (50.5) | 81 (52.6) | 78 (51.0) |
| Duration of hepatitis B (months), median (range) | 97.4 (8–413) | 114.0 (7–338) | 129.6 (7–429) | 139.2 (7–466) |
Data are presented as mean (SD) unless otherwise stated. ADV adefovir dipivoxil; ALT alanine aminotransferase; BMI body mass index; HBV hepatitis B virus; ITT intention-to-treat; TDF tenofovir disoproxil fumarate
Baseline HBsAg level, mean (SD): Genotype B: 3.5 log10 IU/mL (0.87) Genotype C: 3.4 log10 IU/mL (0.59)
aFor HBeAg-positive patients, n = 40 for TDF and n = 49 for ADV; for HBeAg-negative patients, n = 46 for TDF and n = 51 for ADV