Table 2.
Virological, biochemical and serologic endpoints at week 48a
| Endpoint | Entecavir 0.5 mg | Lamivudine 100 mg | |||||
|---|---|---|---|---|---|---|---|
| HBeAg(+) population (n = 225) | HBeAg(−) population (n = 33) | Total population (n = 258) | HBeAg(+) population (n = 221) | HBeAg(−) population (n = 40) | Total population (n = 261) | P valueb | |
| Composite endpoint (HBV DNA <0.7 MEq/ml by bDNA assay and ALT <1.25 × ULN) | 119 (88%) | 32 (97%) | 231 (90%) | 143 (65%) | 31 (78%) | 174 (67%) | <0.0001 |
| HBV DNA by PCR assay | |||||||
| Mean (SE) change from baseline at week 48, log10 copies/ml | −6.00 (0.072) | −5.22 (0.230) | −5.90 (0.071) | −4.30 (0.134) | −4.50 (0.282) | −4.33 (0.122) | <0.0001 |
| HBV DNA <300 copies/ml at week 48 | 116 (74%) | 31 (94%) | 197 (76%) | 83 (38%) | 29 (73%) | 112 (43%) | <0.0001 |
| ALT normalization (ALT ≤1 × ULN) | 200 (89%) | 31 (94%) | 231 (90%) | 172 (78%) | 31 (78%) | 203 (78%) | 0.0003 |
| HBeAg loss and seroconversion (acquisition of antibodies to HBeAg) | |||||||
| HBeAg loss, No./No. HBeAg(+) at baseline | 41 (18%) | NA | 41/225 (18%) | 44 (20%) | NA | 44/221 (20%) | NS |
| HBeAg seroconversion, No./No. HBeAg(+) at baseline | 33 (15%) | NA | 33/225 (15%) | 39 (18%) | NA | 39/221 (18%) | NS |
aFor all analyses with the exception of mean reduction in HBV DNA by PCR assay, patients with a missing value for an endpoint were considered nonresponders for that endpoint
bP value refers to the significance of the differences between the total populations except for serology, which is between HBeAg(+) populations in each treatment arm
Abbreviations: ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; PCR, polymerase chain reaction; SE, standard error; NS, not significant; ULN, upper limit of normal