Table 2.
Summary of results of efficacy assessments at week 240
| ITT population (N = 509) | PPW population (N = 444) | |||
|---|---|---|---|---|
| TDF–TDF | ADV–TDF | TDF–TDF | ADV–TDF | |
| HBeAg-positive, N | 103 | 99 | 89 | 87 |
| Virological, n (%) | ||||
| HBV DNA < 69 IU/mL | 87 (84.5) | 87 (87.9) | 85 (95.5) | 85 (97.7) |
| Log10 copies/mL reduction in HBV DNAa, mean (SD) | − 6.6 (1.01) | − 6.5 (0.79) | − 6.5 (1.01) | − 6.6 (0.77) |
| Virological breakthrough | 4 (3.9) | 11 (11.1) | 3 (3.4) | 7 (8.0) |
| ALT normalization, n (%) | 82/102 (80.4) | 80/97 (82.5) | 81/88 (92.0) | 78/85 (91.8) |
| Serologic, n (%) | ||||
| HBeAg loss | 43 (41.7) | 36 (36.4) | 41 (46.1) | 34 (39.1) |
| HBsAg loss | 1 (1.0) | 0 | 1 (1.1) | 0 |
| HBeAg seroconversionb | 33 (32.0) | 28 (28.3) | 31 (34.8) | 27 (31.0) |
| HBsAg seroconversion | 0 | 0 | 0 | 0 |
| Log10 IU/mL reduction in quantitative HBsAga, mean (SD) | − 0.9 (0.97) | − 0.7 (0.91) | − 0.9 (0.98) | − 0.8 (0.92) |
| HBeAg-negative, N | 154 | 153 | 135 | 133 |
| Virological, n (%) | ||||
| HBV DNA < 69 IU/mL | 138 (89.6) | 137 (89.5) | 135 (100.0) | 132 (99.2) |
| Log10 copies/mL reduction in HBV DNAa, mean (SD) | − 4.9 (1.16) | − 4.9 (1.07) | − 4.9 (1.16) | − 4.9 (1.07) |
| Virological breakthrough | 3 (1.9) | 8 (5.2) | 1 (0.7) | 4 (3.0) |
| ALT normalization, n (%) | 119/136 (87.5) | 111/132 (84.1) | 116/119 (97.5) | 107/116 (92.2) |
| Serologic, n (%) | ||||
| HBsAg loss | 0 | 0 | 0 | 0 |
| HBsAg seroconversion | 0 | 0 | 0 | 0 |
| Log10 IU/mL reduction in quantitative HBsAga, mean (SD)c | − 0.4 (0.62) | − 0.4 (0.51) | − 0.3 (0.62) | − 0.4 (0.51) |
Data are presented as n (%) unless otherwise stated. ADV adefovir dipivoxil; ALT alanine aminotransferase; HBV hepatitis B virus; HBsAg hepatitis B surface antigen; ITT intention-to-treat; PPW population, per-protocol population in whole 5 years’ period; SD standard deviation, TDF tenofovir disoproxil fumarate
aIn the ITT population, HBeAg-positive patients: TDF–TDF (n = 91) and ADV–TDF (n = 90); HBeAg-negative patients: TDF–TDF (n = 138) and ADV–TDF (n = 138)
bGenotype B patients: 32.98%; Genotype C patients: 28.71%
cMean change (SD) in HBsAg level: Genotype B: − 0.8 log10 IU/mL (0.87); Genotype C: − 0.3 log10 IU/mL (0.57)