TABLE 2.
Comparison of virological parameters in all patients at baseline with those at TW48
| Group | No. of patients who were treated with:
|
Values for parameter at the indicated time point
|
No. of patients with indicated status at TW48
|
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HBV DNA (log10 copies/ml)a
|
ALT (IU/ml)a
|
|||||||||
| ADV, 30 mg/dayb | ADV, 10 mg/dayb | Placebo | Baseline | TW48 | Δc | Baselined | TW48e | HbeAg− | Anti-Hbe+ | |
| 1 (n = 7) | 4 | 3 | 0 | 8.2 ± 0.7 | 3.0 ± 0.8 | −5.3 ± 1.3 | 133 ± 67 | 35 ± 13 | 7 | 4 |
| 2 (n = 6) | 3 | 3 | 0 | 8.5 ± 0.6 | 5.2 ± 1.0 | −3.4 ± 0.6 | 123 ± 65 | 43 ± 16 | 0 | 0 |
| 3 (n = 6) | 0 | 0 | 6 | 8.7 ± 0.7 | 8.0 ± 1.8 | −0.7 ± 1.1 | 74 ± 16 | 72 ± 42 | 0 | 0 |
The data are shown as means ± standard deviations.
According to the phase III trial protocol, patients receiving ADV were randomized to receive either a 30-mg or a 10-mg dose and the two columns reflect the ADV treatment groups per study protocol. In the present T-cell study, there was no statistical difference between the subgroups of patients receiving 10 versus 30 mg of ADV/day.
Δ, mean log10 copies/ml decrease in HBV DNA levels from baseline to TW48.
There is no significant difference in ALT at baseline between groups. P values were 0.78 for group 1 versus group 2, 0.063 for group 1 versus group 3, and 0.128 for group 2 versus group 3.
There is a significant difference in ALT at TW48 between group 1 and group 3 (P = 0.032), but not group 1 and group 2 (P = 0.317) or group 2 and group 3 (P = 0.11).