Table 4.
Baseline characteristics of patients with vs. without the presence of liver fibrosis and/or cirrhosis in the overall cohorts, combining derivation and validation cohorts according to the VL trajectory classes..
| Parameter | Overall | No presence of liver fibrosis and cirrhosis | Presence of liver fibrosis or cirrhosis | p value |
|---|---|---|---|---|
| Number of patients | 1,412 | 1,080 | 332 | |
| VL trajectory pattern | <0.001 | |||
| Class 1 | 797 (56.4) | 611 (56.6) | 186 (56.0) | |
| Class 2 | 268 (19.0) | 204 (18.9) | 64 (19.3) | |
| Class 3 | 167 (11.8) | 143 (13.2) | 24 (7.2) | |
| Class 4 | 58 (4.1) | 46 (4.3) | 12 (3.6) | |
| Class 5 | 122 (8.6) | 76 (7.0) | 46 (13.9) | |
| Sex, male | 868 (61.5) | 631 (58.4) | 237 (71.4) | <0.001 |
| Age, years | 41 [33–52] | 40 [32–50] | 46 [36–57] | <0.001 |
| Age group, years | <0.001 | |||
| 18-24 | 63 (4.5) | 48 (4.4) | 15 (4.5) | |
| 25-34 | 359 (25.4) | 300 (27.8) | 59 (17.8) | |
| 35-44 | 396 (28.0) | 321 (29.7) | 75 (22.6) | |
| 45-54 | 307 (21.7) | 232 (21.5) | 75 (22.6) | |
| 55-64 | 193 (13.7) | 126 (11.7) | 67 (20.2) | |
| 65-74 | 71 (5.0) | 41 (3.8) | 30 (9.0) | |
| ≥75 | 23 (1.6) | 12 (1.1) | 11 (3.3) | |
| Ethnic group | 0.15 | |||
| Asian | 511 (43.1) | 403 (44.8) | 108 (37.8) | |
| Black | 216 (18.2) | 154 (17.1) | 62 (21.7) | |
| White | 266 (22.4) | 199 (22.1) | 67 (23.4) | |
| Mixed/other ethnicity | 193 (16.3) | 144 (16.0) | 49 (17.1) | |
| Not reported | 226 (16.0) | 180 (16.7) | 46 (13.9) | |
| IMD | 0.78 | |||
| 20% most deprived | 340 (26.9) | 259 (27.3) | 81 (25.7) | |
| 20% to 40% | 291 (23.0) | 220 (23.2) | 71 (22.5) | |
| 40% to 60% | 268 (21.2) | 205 (21.6) | 63 (20.0) | |
| 60% to 80% | 206 (16.3) | 151 (15.9) | 55 (17.5) | |
| 20% least deprived | 160 (12.6) | 115 (12.1) | 45 (14.3) | |
| Not reported | 147 (10.4) | 130 (12.0) | 17 (5.1) | |
| Coinfection (Yes) | 57 (4.0) | 37 (3.4) | 20 (6.0) | 0.05 |
| HBeAg status | 0.38 | |||
| Negative | 675 (68.6) | 521 (67.8) | 154 (71.3) | |
| Positive | 309 (31.4) | 247 (32.2) | 62 (28.7) | |
| Not available | 428 (30.3) | 312 (28.9) | 116 (34.9) | |
| Anti-HBe status | 0.43 | |||
| Negative | 340 (34.3) | 269 (35.0) | 71 (31.8) | |
| Positive | 652 (65.7) | 500 (65.0) | 152 (68.2) | |
| Not available | 420 (29.7) | 311 (28.8) | 109 (32.8) | |
| HBV VL categories, IU/ml | 0.18 | |||
| <20 | 97 (6.9) | 76 (7.0) | 21 (6.3) | |
| 20 - <2,000 | 637 (45.1) | 477 (44.2) | 160 (48.2) | |
| 2,000 - <20,000 | 193 (13.7) | 159 (14.7) | 34 (10.2) | |
| ≥20,000 | 485 (34.3) | 368 (34.1) | 117 (35.2) | |
| ALT, log IU/L | 3.5 [3.1, 3.9] | 3.5 [3.0, 3.9] | 3.6 [3.2, 4.1] | <0.001 |
| ALP, IU/L | 75 [60, 95] | 72 [59, 91] | 83 [64, 114] | <0.001 |
| Albumin, g/L | 41 [38, 44] | 41 [39, 44] | 40 [36, 43] | <0.001 |
| AST, IU/L | 30 [24, 40] | 29 [24, 37] | 35 [28, 49] | <0.001 |
| Platelets, 109/L | 209 [171, 250] | 216 [182, 257] | 186 [138, 228] | <0.001 |
| Bilirubin, μmol/L | 9 [7, 13] | 9 [6, 12] | 11 [8, 15] | <0.001 |
| eGFR categories, ml/min/1.73 m2 | <0.001 | |||
| ≥90 | 506 (48.4) | 392 (50.4) | 114 (42.5) | |
| ≥60 and ≤89 | 448 (42.8) | 340 (43.7) | 108 (40.3) | |
| ≤59 | 92 (8.8) | 46 (5.9) | 46 (17.2) | |
| Not available | 366 (25.9) | 302 (28.0) | 64 (19.3) | |
| Urea, mmol/L | 4.9 [4.0, 6.0] | 4.8 [3.9, 5.9] | 4.9 [4.1, 6.3] | 0.02 |
| Treatment regimens | <0.001 | |||
| TDF | 836 (59.2) | 671 (62.1) | 165 (49.7) | |
| ETV | 282 (20.0) | 215 (19.9) | 67 (20.2) | |
| ETV + TDF | 111 (7.9) | 70 (6.5) | 41 (12.3) | |
| LAM/ADV + TDF | 46 (3.3) | 30 (2.8) | 16 (4.8) | |
| LAM/ADV + ETV | 29 (2.1) | 18 (1.7) | 11 (3.3) | |
| Other regimens | 108 (7.6) | 76 (7.0) | 32 (9.6) |
A total of 1,412 patients with data available for determining liver fibrosis and cirrhosis were included for the comparison. Data are the number (%) or median [IQR]. Comparison was conducted across non-missing categories for a categorical variable. For categorical variables, Χ2 or Fisher’s exact tests were used for comparison. For continuous variables, t or Wilcoxon tests were used for two groups comparison, whilst ANOVA or the Kruskal–Wallis test was used for more than two groups comparison. All significance tests performed were two-sided.
Bold indicates p value lower than 0.05.
ADV, adefovir; ALP, alkaline phosphatase; ALT, alanine aminotransferase; Anti-HBe, Anti-Hepatitis B e-antigen; AST, aspartate aminotransferase; eGFR, estimated glomerular filtration rate; ETV, entecavir; HBV, hepatitis B virus; HBeAg, Hepatitis B e-Antigen; IMD, Index of Multiple Deprivation; IQR, interquartile range; LAM, lamivudine; TDF, tenofovir disoproxil fumarate; VL, viral load.