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Table 2 Mean change from baseline in FSS total scores at EOT and EOF

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

FSS total score PILLAR, n (%) ASPIRE, n (%)
All simeprevir (n = 309) PR (n = 77) All simeprevir (n = 396) PR (n = 66)
Week 24, N 174 (EOT) 48 343 52
Mean change (±SE) 1.16 (0.120) 1.25 (0.237) 0.99 (0.080) 0.73 (0.217)
Week 36, N 172 45 346 53
Mean change (±SE) 0.06 (0.130) 1.08 (0.272) 0.91 (0.086) 0.43 (0.221)
Week 48, N 166 43 (EOT) 344 (EOT) 52 (EOT)
Mean change (±SE) −0.19 (0.132) 1.19 (0.267) 0.85 (0.085) 0.50 (0.220)
Week 60, N 164 43 342 54
Mean change (±SE) −0.49 (0.112) −0.15 (0.186) −0.05 (0.079) −0.03 (0.188)
Week 72, N 164 (EOF) 44 (EOF) 338 (EOF) 56 (EOF)
Mean change (±SE) −0.50 (0.108) −0.40 (0.219) −0.22 (0.079) −0.18 (0.202)
  1. For the majority of SMV-treated patients, EOT was 24 weeks; 55 patients in the SMV group continued PR therapy through to Week 48 as they did not meet the response-guided therapy criteria at Week 24. FSS Fatigue Severity Scale, EOT end of treatment, EOF end of follow-up, PR placebo/peginterferon-α and ribavirin, SE standard error.