Table 1.
Patient demographics and baseline characteristics (safety population)
| SMV12/PR24 50 mg (n = 27) | SMV24/PR24 50 mg (n = 13) | SMV12/PR24 100 mg (n = 26) | SMV24/PR24 100 mg (n = 13) | PR48 (control) (n = 13) | Total (n = 92) | |
|---|---|---|---|---|---|---|
| Male, n (%) | 12 (44) | 6 (46) | 10 (39) | 8 (62) | 7 (54) | 43 (47) |
| Age, years, median (range) | 53 (31–67) | 48 (34–67) | 56 (22–69) | 54 (28–68) | 54 (20–66) | 54 (20–69) |
| Age ≤ 65 years, n (%) | 25 (93) | 12 (92) | 24 (92) | 11 (85) | 12 (92) | 84 (91) |
| Weight, kg, median (range) | 56 (40–81) | 58 (44–80) | 56 (44–85) | 59 (46–83) | 59 (45–81) | 58 (40–85) |
| Baseline HCV RNA, log10 IU/mL, median (range) | 6.5 (4.5–6.9) | 6.2 (5.3–6.7) | 6.4 (5.2–6.9) | 6.5 (5.8–7.0) | 6.0 (5.1–6.9) | 6.3 (4.5–7.0) |
| Genotype 1b, n (%) | 27 (100) | 13 (100) | 26 (100) | 13 (100) | 13 (100) | 92 (100) |
| Metavir fibrosis stage, n (%) | ||||||
| 0: No fibrosis | 0 | 0 | 2 (8) | 2 (15) | 1 (8) | 5 (5) |
| 1: Periportal fibrosis expansion | 18 (67) | 8 (62) | 16 (62) | 6 (46) | 8 (62) | 56 (61) |
| 2: P-P septae (>1 septum) | 7 (26) | 3 (23) | 8 (31) | 4 (31) | 3 (23) | 25 (27) |
| 3: P-C septae | 2 (7) | 2 (15) | 0 | 1 (8) | 1 (8) | 6 (7) |
| 4: Cirrhosis | 0 | 0 | 0 | 0 | 0 | 0 |
All randomized patients who received any amount of study drug
P-P portal–portal, P-C portal-central