TABLE 1.
Patient characteristics of included patients and comparison between patients with and without a severe flare (≥ 10×ULN).
| Total number of patients (N = 78) | No severe flare (≥ 10×ULN) (N = 56) | Severe flare (≥ 10×ULN) (N = 22) | p b | |
|---|---|---|---|---|
| Patient characteristics | ||||
| Sex, male (n, %) | 50 (64) | 33 (59) | 17 (77) | 0.129 |
| Age, years (mean ± SD) | 49 (±9.7) | 50 (±10.1) | 47 (±8.5) | 0.257 |
| Ethnicity, Asian/Caucasian/Other (n, %) | 54 (69)/16 (21)/8 (10) | 36 (64)/13 (23)/7 (13) | 18 (82)/3 (14)/1 (5) | 0.304 |
| Type of therapy, ETV/TDF/TAF (n, %) | 24 (31)/51 (65)/3 (4) | 20 (36)/34 (61)/2 (4) | 4 (18)/17 (77)/1 (5) | 0.320 |
| Duration of NA therapy, years (mean ± SD) | 8.4 (4.1) | 8.1 (3.9) | 9.3 (4.5) | 0.260 |
| HBeAg positive at SOT (n, %) | 21 (27) | 11 (20) | 10 (46) | 0.021 |
| Liver stiffness, kPa (mean ± SD) | 4.8 (±1.1) | 4.8 (±1.1) | 4.8 (±1.1) | 0.738 |
| Serology at NA cessation a | ||||
| HBsAg, log 10 IU/mL (mean ± SD) | 2.88 (±0.75) | 2.83 (±0.81) | 3.01 (±0.57) | 0.273 |
| HBsAg categorised (n, %) | 0.529 | |||
| > 1000 | 38 (49) | 26 (46) | 12 (57) | |
| 100–1000 | 30 (39) | 23 (41) | 7 (33) | |
| < 100 | 9 (12) | 7 (13) | 2 (10) | |
| HBcrAg, log 10 IU/mL (mean ± SD) | 3.36 (±0.83) | 3.23 (±0.80) | 3.68 (±0.83) | 0.040 |
| HBcrAg, < 3 log 10 IU/mL (n, %) | 32 (41) | 26 (47) | 6 (29) | 0.140 |
| Anti‐HBc, log 10 IU/mL (mean ± SD) | 2.38 (±0.50) | 2.46 (±0.47) | 2.16 (±0.54) | 0.034 |
| HBcrAg/antiHBc‐ratio (mean ± SD) | 1.51 (±0.62) | 1.39 (±0.58) | 1.84 (±0.63) | 0.010 |
| ALT × ULN (mean ± SD) | 0.62 (±0.24) | 0.59 (±0.24) | 0.70 (±0.22) | 0.061 |
Abbreviations: Anti‐HBc, hepatitis B core antibody; ETV, entecavir; HBcrAg, hepatitis B core‐related antigen; HBsAg, hepatitis B surface antigen; IQR, interquartile range; NA, nucleos(t)ide analogue; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; ULN, upper limit of normal.
Due to lack of sample residue, HBcrAg and anti‐HBc could not be determined at end of therapy in 2 and 4 patients, respectively. HBsAg at EOT was not available from 1 patient.
Compared using the independent t‐test (normal distribution, presented as mean (SD)), Wilcoxon rank sum test (if not normally distributed, presented as median [IQR]) and Chi‐square test (categorical).