Table 2.
Histological, virologic, serologic, and biochemical response at week 52.
| End points | Treatment group (n = 136) | Control group (n = 135) | P value |
|---|---|---|---|
| Necroinflammatory improvement* | 22 (53.7) | 13 (33.3) | 0.076 |
| Fibrosis improvement* | 17 (41.5) | 14 (35.9) | 0.652 |
| HBV DNA <1000 copies/mL by PCR assay | 93 (68.4) | 91 (67.4) | 0.897 |
| ≥2 lg copies/mL reduction in HBV DNA compared to baseline | 134 (98.5) | 125 (92.6) | 0.019 |
| Mean change in HBV DNA from baseline by PCR assay (lg copies/mL)† | 5.5 ± 1.6 | 5.4 ± 1.9 | 0.010 |
| HBeAg loss | 31 (22.8) | 17 (12.6) | 0.038 |
| Undetectable HBV DNA and HBeAg loss | 29 (21.3) | 12 (8.9) | 0.006 |
| HBeAg seroconversion | 19 (14.0) | 15 (11.1) | 0.583 |
| Undetectable HBV DNA and HBeAg seroconversion | 19 (14.0) | 11 (8.1) | 0.175 |
| HBsAg loss | 2 (1.5) | 1 (0.7) | 1.000 |
| ALT normalization | 106 (77.9) | 106 (78.5) | 1.000 |
*A total of 80 patients had adequate baseline and liver-biopsy specimens at week 52 (41 patients in treatment group and 39 in control group). Values in parentheses are percentages unless indicated otherwise; †value was presented as mean ± standard deviation.