Table 2.
Patient characteristics at baseline
| |
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) |
EQ-5D VAS European Quality of Life 5 dimension questionnaire visual analog scale, FSS Fatigue Severity Scale, HCV hepatitis C virus, ITT intent to treat, PRO patient-reported outcome, SD standard deviation.