TABLE 1.
Demographics and baseline characteristicsa
| Parameter | Part C |
Part D, 600 mg/day | Part E, 600 mg/day | |||
|---|---|---|---|---|---|---|
| Placebo | 150 mg/day | 300 mg/day | 600 mg/day | |||
| Median age, yr (range) | 42 (31–57) | 42 (31–64) | 38 (31–58) | 44 (29–62) | 39 (30–44) | 56 (39–63) |
| Median BMI, kg/m2 (range) | 27.1 (20.1–33.5) | 26.0 (20.0–34.6) | 24.7 (22.7–26.6) | 24.6 (21.3–31.8) | 24.7 (21.2–31.8) | 26.2 (24.8–34.7) |
| Female/male, n (%)/n (%) | 3 (50)/3 (50) | 1 (17)/5 (83) | 3 (50)/3 (50) | 4 (67)/2 (33) | 0/6 (100) | 4 (67)/2 (33) |
| Race—white, n (%) | 6 (100) | 6 (100) | 6 (100) | 6 (100) | 6 (100) | 6 (100) |
| Median HCV RNA, log10 IU/ml (range) | 6.2 (5.3–6.9) | 5.7 (5.2–6.5) | 6.2 (5.4–6.9) | 6.2 (5.5–6.5) | 6.4 (5.6–7.2) | 6.4 (5.7–7.3) |
| Median ALT, U/liter (range) | 48 (28–112) | 53 (18–177) | 30 (16–47) | 50 (10–79) | 74 (46–170) | 44 (24–63) |
| Cirrhosis, n (%) | 0 | 0 | 0 | 0 | 0 | 6 (100) |
| Median FibroScan value, kPa (range) | 7.2 (5.6–11.8) | 6.6 (3.8–11.1) | 6.1 (4.3–6.8) | 6.3 (3.3–9.6) | 6.8 (4.5–11.0) | 17.6 (13.8–31.6) |
| IL28B status, n (%) | ||||||
| CC | 1 (17) | 1 (17) | 0 | 2 (33) | 4 (67) | 1 (17) |
| CT | 2 (33) | 5 (83) | 4 (67) | 3 (50) | 1 (17) | 4 (67) |
| TT | 2 (33) | 0 | 2 (33) | 1 (17) | 1 (17) | 1 (17) |
| HCV genotype, n (%) | ||||||
| 1b | 6 (100) | 6 (100) | 6 (100) | 6 (100) | 0 | 3 (50) |
| 2 | 0 | 0 | 0 | 0 | 0 | 1 (17) |
| 3 | 0 | 0 | 0 | 0 | 6 (100) | 2 (33) |
a
All treatments except placebo were AT-527. For all treatment groups, n = 6.