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Table 1 Patient baseline demographic and disease characteristics for all treatment groups in PILLAR and ASPIRE

From: Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection

  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)
  1. Median; NS5B sequence-based assay; §n = 76.
  2. 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.