Table 1 Clinical characteristics of 4D-DIA-MS discovery and PRM-MS validation cohorts
| Ā | 4D-DIA-MS: Short-term | PRM-MS: Short-term (nā=ā54) | p | 4D-DIA-MS: Long-term | PRM-MS: Long-term (nā=ā54) | p | ||
|---|---|---|---|---|---|---|---|---|
| Ā | Train (nā=ā57) | Test (nā=ā37) | Train (nā=ā22) | Test (nā=ā14) | ||||
Demographics | ||||||||
āAge, years | 32 (27, 41) | 40 (29, 46) | 37 (28, 42) | Hā=ā3.816 pā=ā0.148 | 44 (37, 51) | 41 (37, 49) | 37 (28, 42) | Hā=ā12.548 pā=ā0.002 |
āMale, n (%) | 45 (78.9) | 25 (67.6) | 42 (77.8) | ϲ = 1.783 pā=ā0.410 | 16 (72.7) | 12 (85.7) | 42 (77.8) | ϲ = 0.835 pā=ā0.659 |
Laboratory tests | ||||||||
ALT, U/L | ||||||||
āBaseline | 89.5 (42.0, 140.6) | 84.0 (35.0, 145.0) | 72.7 (49.5, 110.0) | Hā=ā0.282 pā=ā0.869 | 51.5 (36.0, 63.0) | 52.7 (34.0, 79.7) | 72.7 (49.5, 110.0) | Hā=ā5.926 pā=ā0.052 |
āWeek 78/260 | 21.7 (15.0, 31.0) | 25.0 (16.8, 32.6) | 26.5 (20.0, 38.7) | Hā=ā2.988 pā=ā0.225 | 24.0 (18.0, 32.0) | 26.5 (21.9, 40.0) | 21.7 (16.5, 28.0) | Hā=ā90.000 pā=ā0.132 |
AST, U/L | ||||||||
āBaseline | 53.3 (33.4, 80.0) | 51.0 (37.2, 98.4) | 53.5 (41.2, 82.0) | Hā=ā0.211 pā=ā0.900 | 42.2 (35.0, 53.0) | 43.4 (30.0, 83.0) | 53.5 (41.2, 82.0) | Hā=ā3.390 pā=ā0.184 |
āWeek 78/260 | 21.7 (19.0, 27.2) | 25.5 (20.0, 30.6) | 26.7 (21.0, 31.0) | Hā=ā4.346 pā=ā0.114 | 23.1 (19.0, 26.9) | 26.0 (22.5, 28.0) | 20.2 (18.0, 25.0) | Hā=ā6.614 pā=ā0.037 |
Total bilirubin, umol/L | ||||||||
āBaseline | 13.8 (10.8, 20.0) | 14.4 (12.1, 19.5) | 16.2 (11.9, 19.1) | Hā=ā0.517 pā=ā0.772 | 17.2 (12.9, 20.5) | 13.9 (10.9, 21.0) | 16.2 (11.9, 19.1) | Hā=ā4.044 pā=ā0.132 |
āWeek 78/260 | 14.3 (11.2, 16.7) | 12.6 (9.0, 17.7) | 12.4 (9.7, 15.2) | Hā=ā3.017 pā=ā0.221 | 18.0 (13.2, 21.7) | 14.8 (11.6, 19.4) | 14.0 (9.9, 17.5) | Hā=ā3.877 pā=ā0.144 |
Albumin, g/L | ||||||||
āBaseline | 43.0 (40.0, 46.0) | 42.6 (39.0, 47.4) | 42.6 (40.0, 45.3) | Hā=ā0.422 pā=ā0.810 | 43.6 (40.5, 46.5) | 42.5 (39.2, 45.5) | 42.6 (40.0, 45.3) | Hā=ā0.685 pā=ā0.710 |
āWeek 78/260 | 45.4 (43.0, 47.5) | 45.5 (43.6, 46.9) | 45.4 (43.0, 48.0) | Hā=ā0.023 pā=ā0.988 | 47.3 (43.5, 48.6) | 44.2 (43.9, 50.0) | 46.3 (43.7, 48.3) | Hā=ā0.580 pā=ā0.748 |
Platelet, 10^9/L | ||||||||
āBaseline | 162 (132, 223) | 137 (111, 192) | 167 (121, 189) | Hā=ā1.963 pā=ā0.375 | 128.5 (94, 147) | 127 (111, 151.5) | 166.5 (121, 189) | Hā=ā9.643 pā=ā0.008 |
āWeek 78/260 | 161 (121, 202) | 142.5 (115, 175.5) | 148 (119, 199) | Hā=ā1.854 pā=ā0.396 | 146 (126, 193) | 164 (103, 255) | 195 (171, 223) | Hā=ā11.844 pā=ā0.003 |
International normalized ratio | ||||||||
āBaseline | 1.06 (1.00, 1.14) | 1.09 (1.00, 1.14) | 1.05 (1.00, 1.13) | Hā=ā1.562 pā=ā0.458 | 1.12 (1.05, 1.20) | 1.16 (1.03, 1.21) | 1.05 (1.00, 1.13) | Hā=ā6.853 pā=ā0.033 |
āWeek 78/260 | 1.00 (0.96, 1.06) | 1.00 (0.96, 1.03) | 1.00 (0.93, 1.04) | Hā=ā0.319 pā=ā0.852 | 1.01 (0.96, 1.11) | 0.98 (0.95, 1.02) | 1.01 (0.96, 1.04) | Hā=ā2.041 pā=ā0.360 |
HBsAg, 103IU/mL | ||||||||
āBaseline | 4.8 (1.6, 9.6) | 2.8 (0.8, 5.0) | 4.0 (1.9, 13.4) | Hā=ā4.312 pā=ā0.116 | 1.7 (0.8, 4.7) | 2.8 (2.0, 5.0) | 4.0 (1.9, 13.4) | Hā=ā7.955 pā=ā0.019 |
HBeAg, n (%) | ||||||||
āBaseline | 36 (67.9) | 26 (72.2) | 43 (82.7) | ϲ = 3.139 pā=ā0.208 | 10 (45.5) | 6 (50.0) | 43 (82.7) | ϲ = 12.194 pā=ā0.002 |
HBV DNA, Log IU/mL | ||||||||
āBaseline | 6.6 (4.8, 7.6) | 6.3 (4.7, 7.2) | 6.7 (5.4, 7.5) | Hā=ā0.834 pā=ā0.659 | 4.7 (3.2, 6.0) | 6.1 (4.3, 6.9) | 6.7 (5.4, 7.5) | Hā=ā16.447 pā=ā0.000 |
āWeek 78/260 | 0.0 (0.0, 1.4) | 0.0 (0.0, 0.0) | 0 (0, 1.4) | Hā=ā1.814 pā=ā0.404 | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | Hā=ā0.660 pā=ā0.719 |
LSM, kPa | ||||||||
āBaseline | 9.9 (7.2, 14.4) | 10.7 (8.5, 15.2) | 12.6 (8.6, 18.6) | Hā=ā4.373 pā=ā0.112 | 13.5 (10.7, 19.6) | 14.0 (8.7, 20.4) | 12.6 (8.6, 18.6) | Hā=ā0.279 pā=ā0.870 |
āWeek 78/260 | 6.1 (5.3, 9.1) | 6.8 (6.1, 8.2) | 6.9 (5.6, 9.1) | Hā=ā1.409 pā=ā0.494 | 8.5 (6.7, 10.2) | 7.4 (6.1, 11.2) | 6.0 (4.6, 8.3) | Hā=ā13.563 pā=ā0.001 |
APRI | ||||||||
āBaseline | 0.8 (0.5, 1.4) | 0.9 (0.6, 1.9) | 0.9 (0.6, 1.4) | Hā=ā1.198 pā=ā0.549 | 0.9 (0.7, 1.4) | 0.9 (0.5, 1.6) | 0.9 (0.6, 1.4) | Hā=ā0.061 pā=ā0.970 |
āWeek 78/260 | 0.3 (0.2, 0.5) | 0.4 (0.3, 0.6) | 0.5 (0.3, 0.6) | Hā=ā4.054 pā=ā0.132 | 0.4 (0.3, 0.6) | 0.4 (0.3, 0.5) | 0.3 (0.2, 0.3) | Hā=ā13.315 pā=ā0.001 |
FIB4 | ||||||||
āBaseline | 1.2 (0.9, 1.6) | 1.8 (1.0, 3.1) | 1.5 (1, 2.2) | Hā=ā4.428 pā=ā0.109 | 2.3 (1.6, 3.2) | 2.3 (1.7, 2.8) | 1.5 (1, 2.2) | Hā=ā9.089 pā=ā0.011 |
āWeek 78/260 | 1.0 (0.8, 1.6) | 1.4 (0.9, 2.4) | 1.1 (0.8, 1.6) | Hā=ā5.693 pā=ā0.058 | 1.3 (1.1, 2.3) | 1.3 (1.0, 1.7) | 0.9 (0.7, 1.3) | Hā=ā22.381 pā=ā0.000 |
Histological assessments | ||||||||
Ishak fibrosis score, n (%) | ||||||||
āBaseline | Ā | Ā | Ā | ϲ = 7.600 pā=ā0.107 | Ā | Ā | Ā | ϲ = 46.499 pā=ā0.000 |
ā0/1/2 | 17 (29.8) | 10 (27.0) | 7 (13.0) | Ā | 2 (9.1) | 3 (21.4) | 7 (13.0) | Ā |
ā3/4 | 34 (59.6) | 20 (54.1) | 33 (61.1) | Ā | 4 (18.2) | 2 (14.3) | 33 (61.1) | Ā |
ā5/6 | 6 (10.5) | 7 (18.9) | 14 (25.9) | Ā | 4 (18.2) | 0 (0.0) | 14 (25.9) | Ā |
āUnknown | 0 | 0 | 0 | Ā | 12 (54.5) | 9 (64.3) | 0 | Ā |
āWeek 78/260 | Ā | Ā | Ā | ϲ = 6.311 pā=ā0.177 | Ā | Ā | Ā | ϲ = 10.622 pā=ā0.031 |
ā0/1/2 | 25 (43.9) | 15 (40.5) | 15 (27.8) | Ā | 4 (18.2) | 3 (21.4) | 22 (40.7) | Ā |
ā3/4 | 26 (45.6) | 17 (45.9) | 25 (46.3) | Ā | 12 (54.5) | 6 (42.9) | 28 (51.9) | Ā |
ā5/6 | 6 (10.5) | 5 (13.5) | 14 (25.9) | Ā | 6 (27.3) | 5 (35.7) | 4 (0.07) | Ā |