Table 2.
Variables |
Week 12 |
P value |
Week 24 |
P value |
Week 48 |
P value | |||
LdT + ADV | LAM + ADV | LdT + ADV | LAM + ADV | LdT + ADV | LAM + ADV | ||||
Serum HBV DNA, mean (SD) (log10 IU/mL) | 3.05 (1.51) | 3.84 (1.35) | 0.011 | 2.79 (1.52) | 3.65 (1.44) | 0.003 | 2.85 (1.73) | 3.29 (1.49) | 0.168 |
Reductions in HBV DNA1, mean (SD) (log10 IU/mL) | -0.68 (0.83) | 0.07 (0.60) | < 0.001 | -0.88 (1.06) | -0.11 (0.85) | < 0.001 | -0.81 (1.43) | -0.47 (1.04) | 0.167 |
HBV DNA undetectable2 | 8 (15.1) | 1 (1.9) | 0.030 | 12 (22.6) | 2 (3.8) | 0.004 | 16 (30.2) | 6 (11.5) | 0.019 |
Virologic nonresponders3 | - | - | - | 33 (62.3) | 48 (90.6) | 0.001 | - | - | - |
HBsAg loss | 0 (0) | 0 (0) | - | 0 (0) | 0 (0) | - | 0 (0) | 0 (0) | - |
HBeAg negativity, | 0 (0) | 0 (0) | - | 2 (3.8) | 0 (0) | - | 3 (5.7) | 2 (3.8) | 0.648 |
Normal range of ALT4 | 39 (73.6) | 38 (71.7) | 0.828 | 37 (69.8) | 40 (75.5) | 0.513 | 40 (75.5) | 38 (71.7) | 0.768 |
ALT normalization5 | 2/14 (14.3) | 6/14 (42.9) | 0.209 | 6/14 (42.9) | 5/14 (35.7) | 0.704 | 8/14 (57.1) | 3/14 (21.4) | 0.053 |
Reduction of hepatitis B virus (HBV) DNA from baseline;
Defined serum HBV DNA of < 12 IU/mL;
Defined as a < 1 log10 IU/mL reduction in serum HBV DNA level from baseline at 24 wk;
Upper normal limit of ALT, 40 IU/L;
Among patients who have elevated ALT levels at baseline. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; LAM: Lamivudine; ADV: Adefovir. HBsAg: Hepatitis B surface antigen; HBeAg: Hepatitis Be antigen.