Table 2 ∣.
Week 48 |
Week 192 |
|||||
---|---|---|---|---|---|---|
Lam & Adv (n = 22) |
Adv (n = 19) |
P-value | Lam & Adv (n = 22) |
Adv (n = 19) |
P-value* | |
Normal ALT | 86% | 53% | 0.037 | 95% | 63% | 0.016 |
HBV DNA Mean ± s.d. change (log10 copies/mL) | −6.8 ± 2.1 | −4.5 ± 2.7 | 0.0048‡ | −5.6 ± 1.6 | −3.0 ± 2.8 | 0.0006† |
HBV DNA <105 copies/mL | 91% | 53% | 0.007 | 91% | 53% | 0.007 |
HBV DNA <500 copies/mL | 68% | 53% | 0.35 | 77% | 32% | 0.005 |
HBeAg loss | 41% | 21% | 0.28 | 76% | 36% | 0.03 |
HBsAg loss | 0% | 5% | 0.46 | 0% | 5% | 0.46 |
Histological response‡ | 67% (14/21) | 53% (10/19) | 0.52 | 83% (15/18) | 56% (5/9) | 0.18 |
Genotypic resistance | 0% | 0% | 0% | 32% | 0.03 | |
Treatment failure | 9% | 37% | 0.06 | 18% | 68% | 0.002 |
Combined response§ | 59% | 26% | 0.058 | 68% | 31% | 0.03 |
Fisher exact test.
Student’s t-test.
Liver histology was not available on all enroled patients at 48 and 192 weeks; actual numbers given in parentheses. The last result before censoring was used for the week 192 results for subjects who were censored (two in the combination group and nine in the monotherapy group).
Primary endpoint.