| |
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.
