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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.