Table 3.
With baseline FSS | Without baseline FSS | |||
---|---|---|---|---|
All simeprevir (N = 195) | PR (N = 50) | All simeprevir (N = 114) | PR (N = 27) | |
Male, n (%) | 115 (59.0) | 23 (46.0) | 59 (51.8) | 16 (59.3) |
Caucasian race, n (%) | 180 (92.3) | 49 (98.0) | 108 (94.7) | 25 (92.6) |
Age (range), years† | 48.0 (18–69) | 47.5 (21–61) | 42.5 (18–66) | 42.0 (21–67) |
Body mass index (range), kg/m2† | 25.1 (17.1–38.2) | 25.7 (17.6–36.0) | 24.7 (16.8–39.6) | 25.6 (17.5–42.2) |
HCV RNA (range) log10 IU/mL† | 6.6 (3.5–8.1) | 6.6 (4.3–7.5) | 6.5 (5.1–7.5) | 6.2 (5.4–7.1) |
HCV RNA >800,000 IU/mL, n (%) | 170 (87.2) | 43 (86.0) | 98 (86.0) | 20 (74.1) |
HCV genotype, N‡ | ||||
1a, n (%) | 105 (53.8) | 21 (42.0) | 40 (35.1) | 9 (33.3) |
1b, n (%) | 88 (45.1) | 29 (58.0) | 73 (64.0) | 18 (66.7) |
Metavir score, N | ||||
F3, n (%) | 33 (16.9) | 5 (10.0) | 13 (11.4) | 2 (7.4) |
F4, n (%) | 0 (0.0) | 0 (0.0) | 1 (0.9) | 0 (0.0) |
†Median; ‡NS5B sequence-based assay.
PR placebo/peginterferon-α and ribavirin, HCV hepatitis C virus, FSS Fatigue Severity Scale.