Table 1.
Baseline characteristics of patients receiving study drug into the seven treatment groups (A-G) in the current study.
| Balapiravir dose (twice daily) | A | B | C | D | E | F | G |
|---|---|---|---|---|---|---|---|
| 1,000 mg | 500 mg | 500 mg | 1,500 mg | 1,000 mg | 500 mg | Placebo | |
|
| |||||||
| Peginterferon alfa-2a dose | ← 180 μg once weekly → | ←90 μg once weekly → | 180 μg once weekly | ||||
|
| |||||||
| Ribavirin dose | ← 1,000 or 1,200 mg/day → | 1,000 or 1,200 mg/day | |||||
|
| |||||||
| Duration of treatment | 48 weeks | 48 weeks | 24 or 48 weeks | 48 weeks | 48 weeks | 48 weeks | 48 weeks |
| Patients, n | 74 | 70 | 72 | 71 | 70 | 75 | 72 |
| Male sex, n (%) | 44 (59) | 42 (60) | 42 (58) | 43 (61) | 47 (67) | 45 (60) | 48 (67) |
| Mean age ± SD, years | 48.0 ± 9.4 | 45.1 ± 10.7 | 47.5 ± 9.0 | 45.7 ± 10.0 | 46.1 ± 9.5 | 48.3 ± 8.2 | 46.1 ± 10.6 |
| Race, n (%) | |||||||
| White | 69 (93) | 65 (93) | 69 (96) | 61 (86) | 63 (90) | 65 (87) | 63 (88) |
| African racial descent | 3 (4) | 1 (1) | 1 (1) | 6 (8) | 2 (3) | 7 (9) | 5 (7) |
| Other | 2 (3) | 4 (6) | 2 (3) | 4 (6) | 5 (7) | 3 (4) | 4 (6) |
| Mean weight ± SD, kg | 79.0 ± 16.0 | 77.2 ± 15.8 | 78.9 ± 17.1 | 78.2 ± 18.2 | 78.8 ± 15.0 | 78.0 ± 13.2 | 78.2 ± 15.8 |
| Mean BMI ± SD, kg/m2 | 26.9 ± 4.8 | 26.3 ± 4.2 | 26.8 ± 5.0 | 26.2 ± 4.8 | 26.6 ± 4.2 | 26.6 ± 3.9 | 25.9 ± 4.0 |
| BMI ≥ 30 kg/m2, n (%) | 18 (24) | 13 (19) | 17 (24) | 18 (25) | 10 (14) | 18 (24) | 10 (14) |
| Mean ALT ± SD, U/L | 65.5 ± 52.1 | 68.5 ± 51.1 | 60.5 ± 44.7 | 56.2 ± 46.3 | 60.4 ± 39.7 | 69.0 ± 43.5 | 65.8 ± 58.6 |
| ALT quotient ≤ 3.0, n (%) | 56 (75) | 52 (74) | 60 (83) | 63 (89) | 58 (83) | 58 (77) | 57 (79) |
| HCV subtype,* n (%) | |||||||
| 1a | 55 (74) | 45 (64) | 48 (67) | 47 (66) | 42 (61) | 45 (60) | 43 (60) |
| lb | 18 (24) | 25 (36) | 21 (29) | 24 (34) | 26 (38) | 28 (37) | 29 (40) |
| Mean log10 HCV RNA ± SD, IU/mL | 6.3 ± 0.6 | 6.2 ± 0.6 | 6.3 ± 0.7 | 6.4 ± 0.6 | 6.4 ± 0.5 | 6.3 ± 0.7 | 6.3 ± 0.6 |
| HCV RNA ≥ 400,000 IU/mL, n (%) | 66 (89) | 62 (89) | 59 (82) | 61 (86) | 64 (91) | 65 (87) | 65 (90) |
| Fibrosis score,* n (%) | |||||||
| F0-2 | 55 (75) | 58 (84) | 51 (72) | 57 (81) | 56 (80) | 62 (86) | 59 (86) |
| F3-4 | 18 (25) | 11 (16) | 20 (28) | 13 (19) | 14 (20) | 10 (14) | 10 (14) |
BMI: body-mass index. SD: standard deviation.
*
Patients with missing values were not included in calculations of percentages.