Table 1.
Baseline Demographics and Patient Characteristics
| Substudy 1 Patients Without Cirrhosis | Substudy 2 Patients With Cirrhosis | ||
|---|---|---|---|
| Group A DB OBV/PTV/r (n = 215) | Group B DB Placebo (n = 106) | Group C OL OBV/PTV/r (n = 42) | |
| Sex, female, n (%) | 135 (62.8) | 59 (55.7) | 22 (52.4) |
| Age, years | |||
| Mean (SD) | 61.1 (9.6) | 61.5 (9.3) | 61.8 (8.3) |
| ≥ 65, n (%) | 86 (40.0) | 47 (44.3) | 21 (50.0) |
| BMI, kg/m2 | |||
| Mean (SD) | 22.4 (3.1) | 22.3 (2.7) | 23.6 (3.6) |
| ≥25, n (%) | 45 (20.9)a | 14 (13.2) | 13 (31.0) |
| IL28B CC genotype, n (%) | 120 (55.8) | 54 (50.9) | 27 (64.3) |
| HCV RNA level | |||
| Log10 IU/mL, mean (SD) | 6.74 (0.58) | 6.68 (0.61) | 6.64 (0.71) |
| ≥100,000 IU/mL, n (%) | 211 (98.1) | 103 (97.2) | 41 (97.6) |
| Prior therapy (IFN status) | |||
| Treatment‐naive, n (%) | 139 (64.7) | 68 (64.2) | 9 (21.4) |
| IFN‐eligible, n/N (%) | 116/139 (83.5) | 58/68 (85.3) | NA |
| IFN‐ineligible, n/N (%) | 23/139 (16.5) | 10/68 (14.7) | NA |
| Treatment‐experienced,b n (%) | 76 (35.3) | 38 (35.8) | 33 (78.6) |
| Relapser, n/N (%) | 22/76 (28.9) | 11/38 (28.9) | 8/33 (24.2) |
| Nonresponder, n/N (%) | 28/76 (36.8) | 14/38 (36.8) | 19/33 (57.6) |
| IFN‐intolerant, n/N (%) | 26/76 (34.2) | 13/38 (34.2) | 5/33 (15.2) |
| Baseline fibrosis stage | |||
| F0‐F1, n/N (%) | 49/82 (59.8) | 23/31 (74.2) | 0 |
| F2, n/N (%) | 17/82 (20.7) | 1/31 (3.2) | 0 |
| F3, n/N (%) | 16/82 (19.5) | 7/31 (22.6) | 1 (2.4)c |
| F4, n/N (%) | 0 | 0 | 41 (97.6) |
| Missing datad, n | 133 | 75 | 0 |
a
Statistically significant difference between group A and group B (placebo) using chi‐squared test at P = 0.05 level.
b
One treatment‐experienced patient with cirrhosis had a missing response type.
c
Discriminant score at screening indicated presence of cirrhosis, but FibroTest at baseline indicated stage F3.
d
Values were missing for a total of 208 patients whose cirrhosis status (yes/no) was determined by serum discriminant score, which does not differentiate between Metavir scores F0 to F3.
Abbreviations: BMI, body mass index; DB, double‐blind; NA, not available; OL, open‐label; SD, standard deviation.