Table 1.
Characteristics of the Study Cohort
| Characteristics | Flare |
No Flare (n = 164) | P Value | ||
|---|---|---|---|---|---|
| Host (n = 19) | Virus (n = 17) | Indeterminate (n = 14) | |||
| Demography | |||||
| Mean age, (SD), y | 42 (12.8) | 27 (9.8) | 34 (11.4) | 33.5 (12.4) | .005 |
| Male | 15 (79%) | 14 (82%) | 12 (86%) | 126 (77%) | .85 |
| PEG-IFN monotherapy | 7 (37%) | 3 (18%) | 14 (100%) | 80 (49%) | <.001 |
| Race | .22 | ||||
| Caucasian | 15 (79%) | 14 (82%) | 8 (57%) | 120 (73%) | |
| Asian | 1 (5%) | 1 (6%) | 4 (29%) | 34 (21%) | |
| Other | 3 (16%) | 2 (12%) | 2 (14%) | 10 (6%) | |
| Laboratory results | |||||
| Mean (SD) ALTa | 3.1 (1.3) | 3.2 (1.7) | 2.6 (1.0) | 4.7 (3.3) | .005 |
| Mean (SD) HBV DNA, log c/mL | 9.3 (0.5) | 9.2 (1.1) | 9.3 (0.6) | 9.1 (0.9) | .51 |
| Mean (SD) HBsAg, log IU/mL | 4.6 (0.4) | 4.4 (0.7) | 4.4 (0.5) | 4.4 (0.6) | .38 |
| Mean (SD) HBeAg, log IU/mL | 2.5 (0.9) | 2.2 (0.8) | 2.6 (0.6) | 2.5 (0.7) | .55 |
| HBV genotype | .04 | ||||
| A | 12 (63%) | 2 (12%) | 5 (36%) | 55 (34%) | |
| B | 2 (11%) | 2 (12%) | 0 (0%) | 15 (9%) | |
| C | 0 (0%) | 1 (6%) | 4 (29%) | 24 (15%) | |
| D | 4 (21%) | 12 (71%) | 4 (29%) | 65 (40%) | |
| Other/mixed | 1 (5%) | 0 (0%) | 1 (7%) | 5 (3%) | |
| Previous IFN therapy | 3 (16%) | 5 (29%) | 2 (14%) | 28 (17%) | .62 |
| INNO-LiPA PreCore result | .007 | ||||
| Wild type | 11 (58%) | 1 (6%) | 7 (50%) | 57 (35%) | |
| Non-wild type | 8 (42%) | 16 (94%) | 7 (50%) | 107 (65%) | |
| Response | |||||
| HBeAg loss | 11 (58%) | 2 (12%) | 1 (7%) | 63 (38%) | .003 |
| Combined responseb | 8 (42%) | 0 (0%) | 0 (0%) | 33 (20%) | .003 |
| HBsAg loss | 8 (42%) | 0 (0%) | 0 (0%) | 9 (6%) | <.001 |
Abbreviations: ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; IFN, interferon; PEG-IFN, peginterferon; SD, standard deviation.
a Multiples of upper limit of the normal range.
b HBeAg loss and HBV DNA <10 000 copies/mL at week 78.