Table 1.
Patient baseline demographic and disease characteristics for all treatment groups in PILLAR and ASPIRE
| PILLAR | ASPIRE | |||
|---|---|---|---|---|
| All simeprevir (N = 309) | PR (N = 77) | All simeprevir (N = 396) | PR (N = 66) | |
| Male, n (%) | 174 (56.3) | 39 (50.6) | 269 (67.9) | 42 (63.6) |
| Caucasian race, n (%) | 288 (93.2) | 74 (96.1) | 366 (92.4) | 62 (93.9) |
| Age (range), years† | 47.0 (18–69) | 45.0 (21–67) | 50.0 (20–69) | 50.5 (22–66) |
| Body mass index (range), kg/m2 † | 24.9 (16.8–39.6) | 25.6 (17.5–42.2) | 27.0 (18.2–48.7) | 28.0 (18.5–40.5) |
| HCV RNA (range) log10 IU/mL† | 6.6 (3.5–8.1) | 6.6 (4.3–7.5) | 6.6 (3.5–7.7) | 6.6 (5.2–7.6) |
| HCV RNA >800,000 IU/mL, n (%) | 268 (86.7) | 63 (81.8) | 344 (86.9) | 55 (83.3) |
| HCV genotype, N‡ | 307 | 76 | 389 | 66 |
| 1a, n (%) | 144 (46.9) | 29 (38.2) | 161 (41.4) | 27 (40.9) |
| 1b, n (%) | 161 (52.4) | 47 (61.8) | 223 (57.3) | 39 (59.1) |
| Metavir score, N | 309 | 77 | 391 | 64 |
| F3, n (%) | 46 (14.9) | 7 (9.1) | 73 (18.7) | 13 (20.3) |
| F4, n (%) | 1 (0.3) | 0 (0) | 73 (18.7) | 10 (15.6) |
| EQ-5D, N | 305 | 77 | 384 | 64 |
| Baseline valuation index, mean (SE) | 0.9 (0.01) | 0.9 (0.03) | 0.9 (0.01) | 0.9 (0.02) |
| Baseline VAS, mean (SE) | 82.2 (0.91) | 83.6 (1.42)§ | 80.3 (0.83) | 80.5 (2.22) |
| FSS, N | 195 | 50 | 385 | 64 |
| Baseline, mean (SE) | 3.3 (0.12) | 3.2 (0.21) | 3.4 (0.08) | 3.2 (0.22) |
†Median; ‡NS5B sequence-based assay; §n = 76.
PR placebo/peginterferon-α and ribavirin, HCV hepatitis C virus, EQ-5D European Quality of Life 5-Dimensions, SE standard error, FSS Fatigue Severity Scale, VAS visual analog scale.