Table 5.
Baseline characteristics of subjects by study arm
| Characteristic | Placebo | Study drug | ||
|---|---|---|---|---|
| Treatment naïve n = 158 |
Treatment experienced n = 97 |
Treatment naïve n = 473 |
Treatment experienced n = 297 |
|
| Age (mean ± SD) | 51 ± 10 | 55 ± 8 | 49 ± 11 | 52 ± 10 |
| Male sexa | 73 (46) | 60 (62) | 271 (57) | 167 (52) |
| White race | 144 (91) | 86 (89) | 428 (91) | 86 (89) |
| BMI > 30 kg/m2 | 31 (20) | 19 (20) | 71 (15) | 59 (20) |
| Diabetes mellitus | 5 (3) | 4 (4) | 19 (4) | 14 (5) |
| HOMA IR 3 mU × mmol/L | 19 (17) | 16 (22) | 58 (16) | 56 (24) |
| Genotype 1a | 105 (66) | 57 (59) | 322 (68) | 173 (58) |
| HCV RNA > 800,000 IU/mL | 132 (82) | 88 (91) | 369 (78) | 255 (86) |
| F0–F1 fibrosis | 116 (73) | 66 (67) | 363 (77) | 202 (68) |
| Baseline ALT (IU/mL) (mean) | 64 | 65 | 68 | 64 |
Source: NDA demographic tabulation
ALT alanine aminotransferase, BMI body mass index, F0–F1 liver fibrosis stage 0–1, HCV RNA hepatitis C virus ribonucleic acid, HOMA IR homeostatic model assessment for insulin resistance, SD standard deviation
aUnless specified in the table, all values are number over column total (n) and percent (% = n/N)