Baseline characteristics of the study patients according to disease severity*
| Characteristic | Bridging fibrosis (N=752)† | Cirrhosis (N=835) | Overall (N=1587) |
|---|---|---|---|
| Panel A | |||
| Age year—mean (range) | 52 (22–73) | 54 (19–75) | 53 (19–75) |
| Body mass index (BMI)‡ | 26±3.7 | 27±4.2 | 27±4.0 |
| BMI—range | 18–42 | 19–47 | 18–47 |
| Males sex—no. (%) | 463 (62) | 549 (66) | 1012 (64) |
| Race or ethnic group—no. (%)§ | |||
| White | 740 (98) | 817 (98) | 1557 (98) |
| Black, Asian or other | 12 (2) | 18 (2) | 30 (2) |
| HCV-1 subtype—no. (%) | |||
| 1a | 168 (22) | 189 (23) | 357 (22) |
| 1b | 562 (75) | 609 (73) | 1171 (74) |
| Missing or unknown | 22 (3) | 37 (4) | 59 (4) |
| HCV RNA log10—IU/mL, mean (SD)¶ | 6.2±0.66 | 6.1±0.74 | 6.1±0.71 |
| HCV RNA ≥ 800 000 IU/mL—no. (%) | 507 (67) | 548 (66) | 1055 (66) |
| Model for End Stage Liver Disease score | 7 (6–8) | 7 (7–8) | 7 (6–8) |
| α-Fetoprotein—µg/L | 5.6 (3.5–10.0) | 9.0 (5.3–16.9) | 7.1 (4.2–13.1) |
| Albumin—g/L | 44.0 (41.1–46.1) | 42.2 (40.0–45.0) | 43.0 (40.4–46.0) |
| Bilirubin—µmol/L | 11.8 (8.2–15.4) | 13.5 (10.0–17.5) | 12.3 (9.0–16.7) |
| Creatine—µmol/L | 69.8 (59.2–79.6) | 69.0 (60.0–79.0) | 69.0 (59.2–79.6) |
| Glucose—mmol/L | 5.2 (4.7–5.8) | 5.4 (4.8–6.3) | 5.3 (4.8–6.0) |
| Haemoglobin—g/L | 151 (141–160) | 149 (140–159) | 150 (140–159) |
| Neutrophils –×109/L | 3.2 (2.5–4.0) | 3.0 (2.3–3.8) | 3.0 (2.4–3.9) |
| Platelets –×109/L | 182 (149–226) | 144 (114–184) | 161 (126–205) |
| Prothrombin intl. normalised ratio | 1.0 (1.0–1.1) | 1.1 (1.0–1.1) | 1.04 (1.00–1.11) |
| Panel B** | |||
| IFNλ-3—no. (%) | |||
| Missing or unknown | 577 (77) | 620 (74) | 1197 (75) |
| CC | 23 (3) | 50 (6) | 73 (5) |
| CT | 117 (16) | 121 (14) | 238 (15) |
| TT | 35 (5) | 44 (5) | 79 (5) |
| Previous type of response—no. (%) | |||
| Prior null responder | 180 (24) | 256 (31) | 436 (27) |
| Prior partial responder | 91 (12) | 112 (13) | 203 (13) |
| Total non-responders†† | 291 (39) | 394 (47) | 685 (43) |
| Relapsers | 265 (35) | 266 (32) | 531 (33) |
| Treatment naive | 169 (22) | 152 (18) | 321 (20) |
| Viral breakthrough | 26 (3) | 23 (3) | 49 (3) |
| Unknown | 1 (0) | 0 (0) | 1 (0) |
*Values are medians and IQR unless otherwise indicated. Percentages may not total 100 because of rounding.
†Includes three F1 patients and three F2 patients.
‡BMI is the weight in kilograms divided by the square of the height in metres.
§Race or ethnic group was self-reported. Patients of any race could also identify themselves as Hispanic.
¶Log10 values for HCV RNA are means±SE.
**Values are means±SD unless otherwise indicated. Percentages may not total 100 because of rounding.
††Includes prior null responders, prior partial responders and non-responders-unspecified.