TABLE 1.
Baseline characteristics by fibrosis stageg
| Characteristic | Value by treatment group and fibrosis stagec,d: |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TID16Wa |
TID28Wa |
TID40W |
Pooled TID,b cirrhosis (n = 21) | BID28W |
TID28W-NR |
||||||||
| F0–F2 (n = 63) | F3–F4 (n = 17) | F0–F2 (n = 58) | F3–F4 (n = 21) | F0–F2 (n = 62) | F3–F4 (n = 15) | F0–F2 (n = 57) | F3–F4 (n = 21) | Cirrhosis (n = 9) | F0–F2 (n = 35) | F3–F4 (n = 11) | Cirrhosis (n = 3) | ||
| Male, n (%) | 34 (54) | 10 (59) | 29 (50) | 12 (57) | 28 (45) | 8 (53) | 12 (57) | 26 (46) | 15 (71) | 7 (78) | 20 (57) | 4 (36) | 2 (67) |
| Median age, yr (IQR) | 49 (39–55) | 56 (48–64) | 45 (38–53) | 52 (46–58) | 49 (43–56) | 45 (42–62) | 53 (45–57) | 47 (40–56) | 49 (48–54) | 49 (47–54) | 44 (34–56) | 51 (41–57) | 51 (41–57) |
| White, n (%) | 62 (98) | 16 (94) | 57 (98) | 21 (100) | 61 (98) | 15 (100) | 20 (95) | 56 (98) | 21 (100) | 9 (100) | 35 (100) | 11 (100) | 3 (100) |
| IL28B non-CC, n (%) | 44 (70) | 15 (88) | 43 (74) | 14 (67) | 44 (71) | 14 (93) | 17 (81) | 41 (72) | 18 (86) | 7 (78) | 24 (69) | 9 (82) | 2 (66) |
| HCV genotype 1a, n (%) | 27 (43) | 7 (41) | 25 (43) | 6 (29) | 29 (47) | 5 (33) | 7 (33) | 25 (44) | 5 (24) | 4 (44) | 16 (46) | 2 (18) | 0 (0) |
| Mean HCV RNA, log10 IU/ml (SD) | 6.5 (0.69) | 6.7 (0.49) | 6.4 (0.60) | 6.8 (0.69) | 6.7 (0.53) | 6.5 (0.50) | 6.6 (0.74) | 6.6 (0.67) | 6.6 (0.50) | 6.4 (0.66) | 6.5 (0.61) | 6.8 (0.29) | 6.8 (0.24) |
| HCV RNA level of ≥800,000 IU/ml, n (%) | 54 (86) | 15 (88) | 46 (79) | 19 (90) | 54 (87) | 13 (87) | 17 (81) | 47 (82) | 19 (90) | 7 (78) | 25 (71) | 11 (100) | 3 (100) |
| Mean elastography, kPa (SD)e | 6.2 (3.10) | 14.9 (6.87) | 5.8 (1.45) | 15.8 (12.35) | 6.4 (1.76) | 12.3 (2.64) | 20.1 (11.84) | 5.7 (1.52) | 14.1 (4.33) | 17.3 (3.89) | 6.3 (1.65) | 14.6 (6.02) | 20.2 (8.20) |
| Mean APRI score (SD)f | 0.6 (0.58) | 1.1 (0.82) | 0.6 (0.39) | 0.9 (0.42) | 0.6 (0.40) | 1.0 (0.80) | NA | 0.6 (0.53) | 1.4 (1.12) | NA | 0.6 (0.32) | 1.1 (0.74) | NA |
Information on the stage of fibrosis was classified as “missing” for two patients (one in TID16W and one in TID28W).
The TID16W, TID28W, and TID40W treatment arms were pooled because of the small number of patients with cirrhosis in these treatment arms.
Fibroscan results were used to determine stage of fibrosis for patients without a liver biopsy result (<F3 = <9.5 kPa, ≥F3 = ≥9.5 kPa).
Cirrhosis was determined by the investigator based on Fibroscan, biopsy, and/or other clinical parameters.
Among patients with baseline liver elasticity data (n = 258).
Among patients with a baseline APRI score (n = 360).
Abbreviations: APRI, aspartate aminotransferase/platelet ratio index; BID, twice daily; HCV, hepatitis C virus; IQR, interquartile range; NA, not available; NR, no ribavirin; SD, standard deviation; TID, three times daily.