Table 2 Patient characteristics at baseline
From: Validation of the Fatigue Severity Scale in chronic hepatitis C
Treatment-naïve (PILLAR) | Treatment-experienced (ASPIRE) | |||
|---|---|---|---|---|
All patients (ITT) | Patients with baseline FSS and ≥1 follow-up | All patients (ITT) | Patients with baseline FSS and ≥1 follow-up | |
N = 386 | N = 241 | N = 462 | N = 446 | |
Sex, n (%) | N = 386 | N = 241 | N = 462 | N = 446 |
Male | 213 (55.2) | 136 (56.4) | 311 (67.3) | 301 (67.5) |
Female | 173 (44.8) | 105 (43.6) | 151 (32.7) | 145 (32.5) |
Age, mean, SD (years) | 44.0 (11.81) | 45.9 (10.37) | 48.9 (10.36) | 48.9 (10.37) |
Race, n (%) | N = 386 | N = 241 | N = 462 | N = 446 |
Caucasian | 362 (93.8) | 225 (93.4) | 428 (92.6) | 414 (92.8) |
Non-Caucasian | 24 (6.2) | 16 (6.6) | 34 (7.4) | 32 (7.2) |
Region, n (%) | N = 386 | N = 241 | N = 462 | N = 446 |
North America | 82 (21.2) | 52 (21.6) | 120 (26.0) | 113 (25.3) |
Latin America | 0 | 0 | 0 | 0 |
Europe/Israel | 262 (67.9) | 147 (61.0) | 313 (67.7) | 306 (68.6) |
Asia | 42 (10.9) | 42 (17.4) | 29 (6.3) | 27 (6.1) |
HCV RNA, mean (log10 IU/mL) | 6.5 (0.61) | 6.5 (0.64) | 6.5 (0.57) | 6.5 (0.56) |
Genotype, n (%) | N = 383 | N = 239 | N = 455 | N = 439 |
1a | 173 (45.2) | 122 (51.0) | 188 (41.3) | 178 (40.5) |
1b | 208 (54.3) | 115 (48.1) | 262 (57.6) | 257 (58.5) |
Other | 2 (0.5) | 2 (0.8) | 5 (1.1) | 4 (0.9) |
METAVIR score, n (%) | N = 386 | N = 241 | N = 455 | N = 439 |
F0–F2 | 332 (86.0) | 203 (84.2) | 286 (62.9) | 278 (63.3) |
F3 | 53 (13.7) | 38 (15.8) | 86 (18.9) | 83 (18.9) |
F4 | 1 (0.3) | 0 | 83 (18.2) | 78 (17.8) |
Baseline PRO (mean) | ||||
FSS total score | 3.3 (1.58) | 3.3 (1.57) | 3.3 (1.65) | 3.3 (1.65) |
EQ-5D VAS | 82.4 (15.28) | 81.8 (15.75) | 80.4 (16.47) | 80.4 (16.42) |