Table 4.
Responses in Group B patients
| Liver transplant prior to entry (n = 13) | Non-liver transplant prior to entry (n = 25) | Overall (n = 38) | |
|---|---|---|---|
| HBV DNA > 105 at baseline, N (%) | 13/13 (100) | 25/25 (100) | 38/38 (100) |
| HBV DNA response, N (%) | |||
| Week 52 | 12/13 (92) | 22/25 (88) | 34/38 (89) |
| Week 104 | 12/13 (92) | 21/25 (84) | 33/38 (87) |
| Median HBV DNA (log10 copies/mL), (range) | |||
| Baseline | 9.0 (7.2, 10.1) | 8.14 (5.4, 9.4) | 8.50 (5.4, 10.1) |
| Week 52 | 3.13 (2.3, 6.4) | 2.42 (2.3, 5.9) | 2.57 (2.3, 6.4) |
| Week 104 | 2.72 (2.3, 5.7) | 2.30 (2.3, 4.8) | 2.30 (2.3, 5.7) |
| HBeAg loss, N (%) | |||
| Week 52 | 2/8 (25) | 7/18 (39) | 9/26 (35) |
| Week 104 | 3/8 (38) | 7/18 (39) | 10/26 (38) |
| HBeAg seroconversion, N (%) | |||
| Week 52 | 0/8 | 1/18 (6) | 1/26 (4) |
| Week 104 | 2/8 (25) | 2/18 (11) | 4/26 (15) |
| Median ALT × ULN change from baseline (range) | |||
| Week 52 | −0.84 (−9.9, 1.0) | −1.35 (−15.9, 1.1) | −1.02 (−15.9, 1.1) |
| Week 104 | −1.01 (−5.3, 0.9) | −1.51 (−16.1, 0.6) | −1.16 (−16.1, 0.9) |
| Median baseline bilirubin (mg/dL), (range) | 0.64 (0.2, 14.2) | 1.35 (0.4, 4.8) | 1.05 (0.2, 14.2) |
| Median bilirubin change from baseline (mg/dL), (range) | |||
| Week 52 | 0 (−13.3, 0.3) | −0.29 (−4.3, 1.8) | −0.15 (−13.3, 1.8) |
| Week 104 | −0.06 (−0.6, 0.4) | −0.47 (−4.0, 0.6) | −0.32 (−4.0, 0.6) |
| Median baseline albumin (g/L), (range) | 38 (28, 43) | 30 (21, 43) | 32 (21, 43) |
| Median albumin change from baseline (g/L), (range) | |||
| Week 52 | 5 (−3, 17) | 7 (0, 24) | 6 (−3, 24) |
| Week 104 | 5 (−1, 10) | 10 (1, 22) | 7 (−1, 22) |
| Median baseline CPT score (range) | 5.0 (5, 6) | 7 (5, 9)a | 6.0 (5, 9)a |
| Median CPT change from baseline (range) | |||
| Week 52 | 0 (−1, 1) | −1 (−3, 2)a | −1 (−3, 2)a |
| Week 104 | 0 (−1, 0) | −1 (−4, 0)a | −0.5 (−4, 0)a |
All patients were treated with lamivudine and adefovir
aTwo patients transplanted during study have been excluded for this evaluation