Overall cohort | Cirrhotics | |||||
---|---|---|---|---|---|---|
Characteristic | SOF plus RBV for 12 weeks (n=283) | SOF plus RBV for 16 weeks (n=38) | Total (n=321) | SOF plus RBV for 12 weeks (n=62) | SOF plus RBV for 16 weeks (n=24) | Total (n=86) |
Median age (range), years | 59.0 (21–80) | 62.5 (30–78) | 59.0 (21–80) | 60 (40–78) | 62 (46–78) | 60.5 (40–78) |
18–39 | 22 (7.8%) | 2 (5.3%) | 24 (7.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
40–64 | 202 (71.4%) | 22 (57.9%) | 224 (69.8%) | 49 (79.0%) | 16 (66.7%) | 65 (75.6%) |
65+ | 59 (20.8%) | 14 (36.8%) | 73 (22.7%) | 13 (21%) | 8 (33.3%) | 21 (24.4%) |
Male sex, n (%) | 174 (61.5%) | 22 (57.9%) | 196 (61.1%) | 40 (64.5%) | 14 (58.3%) | 54 (62.8%) |
Race, n (%) | ||||||
White | 243 (85.9%) | 33 (86.8%) | 276 (86.0%) | 55 (88.7%) | 22 (91.7%) | 77 (89.5%) |
Black | 16 (5.7%) | 2 (5.3%) | 18 (5.6%) | 2 (3.2%) | 0 (0.0%) | 2 (2.3%) |
Other | 24 (8.5%) | 3 (7.9%) | 27 (8.4%) | 5 (8.1%) | 2 (8.3%) | 7 (8.1%) |
Hispanic ethnicity, n (%) | 22 (7.8%) | 5 (13.2%) | 27 (8.4%) | 7 (11.3%) | 3 (12.5%) | 10 (11.6%) |
Prior HCV treatment, n (%) | ||||||
Naive | 205 (72.4%) | 18 (47.4%) | 223 (69.5%) | 32 (51.6%) | 7 (29.2%) | 39 (45.3%) |
Experienced | 78 (27.6%) | 20 (52.6%) | 98 (30.5%) | 30 (48.4%) | 17 (70.8%) | 47 (54.7%) |
Cirrhosis, n (%) | 62 (21.9%) | 24 (63.2%) | 86 (26.8%) | 62/62 (100%) | 24/24 (100%) | 86/86 (100%) |
History of hepatic decompensation, n (%) | 28 (9.9%) | 12 (31.6%) | 40 (12.5%) | 25 (40.3%) | 11 (45.8%) | 36 (41.9%) |
MELD≥10 (among cirrhotics)* | 17/43 (39.5%) | 11/19 (57.9%) | 28/62 (45.2%) | 17/43 (39.5%) | 11/19 (57.9%) | 28/62 (45.2%) |
HCV GT2 subtype | ||||||
2a | 18 (6.4%) | 3 (7.9%) | 21 (6.5%) | 3 (4.8%) | 2 (8.3%) | 5 (5.8%) |
2b | 125 (44.2%) | 22 (57.9%) | 147 (45.8%) | 31 (50.0%) | 13 (54.2%) | 44 (51.2%) |
2c | 2 (0.7%) | 0 (0.0%) | 2 (0.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
2d | 1 (0.4%) | 0 (0.0%) | 1 (0.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Not reported | 137 (48.4%) | 13 (34.2%) | 150 (46.7%) | 28 (41.2%) | 9 (37.5%) | 37 (43%) |
EU patients | 11 (4.8%) | 1 (2.7%) | 12 (3.8%) | 4 (6.4%) | 1 (4.2%) | 5 (5.8%) |
HCV RNA (median), log10 IU/mL | 6.3 | 6.4 | 6.3 | 5.9 | 6.0 | 5.9 |
Total bilirubin, median (range), mg/dL | 0.6 (0.1–6.2) | 0.8 (0.3–5.5) | 0.6 (0.1–6.2) | 1.0 (0.2–6.2) | 1.2 (0.3–5.5) | 1.0 (0.2–6.2) |
Albumin, median (range), g/dL | 4.2 (2.2–5.4) | 3.8 (2.6–4.6) | 4.2 (2.2–5.4) | 3.7 (2.2–4.9) | 3.7 (2.6–4.5) | 3.7 (2.2–4.9) |
ALT, median (range), IU/L | 53.0 (9.0–554.0) | 62.5 (20.0–428.0) | 53.0 (9.0–554.0) | 49.0 (24.0–278.0) | 81.0 (20.0–428.0) | 64.0 (20.0–428.0) |
Platelet count, median (range) (×103)/µL | 189 (35.0–407.0) | 111 (34.0–302.0) | 185 (34.0–407.0) | 105.5 (35.0–307.0) | 77 (34.0–229.0) | 100 (34.0–307.0) |
*In patients with available score.
ALT, alanine-aminotransferase; EU, European Union; MELD, model for end-stage liver disease.