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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.