Table 2.
Responses in Group A patients
| Lamivudine + Placebo (n = 40) | Lamivudine + Adefovir (n = 38) | |
|---|---|---|
| HBV DNA responsea | ||
| At weeks 48 and 52, N (%) | 3/38 (8) | 36/38 (95) |
| At weeks 100 and 104, N (%) | 5/38 (13)b | 29/38 (76)b |
| HBV DNA -ve | ||
| At week 52, N (%) | 0/40 | 10/38 (26) |
| At week 104, N (%) | 1/40 (3) | 13/38 (34) |
| HBV DNA change from baseline | ||
| At week 52 Median (range) | 0.11 (−3.8, 5.4) | −4.88 (−7.3, −0.9) |
| At week 104 Median (range) | −0.11 (−4.6, 2.2) | −6.18 (−7.3, 0.6) |
| HBeAg loss at week 104, N (%) | 4/34 (12) | 6/33 (18) |
| HBeAg seroconversion at week 104, N (%) | 3/34 (9) | 4/33 (12) |
| HBsAg loss at week 104, N (%) | 0/40 | 2/37 (5) |
| HBsAg seroconversion at week 104, N (%) | 0/40 | 2/37 (5) |
| ALT response (≤1.0 × ULN) | ||
| At weeks 48 and 52, N (%) | 2/40 (5) | 15/37 (41) |
| At weeks 100 and 104, N (%) | 4/40 (10)b | 18/37 (49)b |
| ALT × ULN change from baseline | ||
| At week 52 Median (range) | −0.48 (−38.2, 17.6) | −1.10 (−18.4, 1.0) |
| At week 104 Median (range) | −1.05 (−39.1, 0.5) | −1.29 (−18.4, −0.1) |
HBV DNA –ve No HBV DNA was detected using the Cobas Amplicor HBV Monitor PCR assay with a lower limit of detection of 200 copies/mL
aTwo patients, in the lamivudine and placebo group did not have HBV DNA > 105 at baseline and were excluded from the virological efficacy analysis
bp ≤ 0.001