Table 1. Baseline Demographic and Disease Characteristics for Patients Enrolled in the PILLAR Study.
| Characteristics | SMV 75 mg 12W + Peg-IFN/RBV, n = 78 | SMV 75 mg 24W + Peg-IFN/RBV, n = 75 | SMV 150 mg 12W + Peg-IFN/RBV, n = 77 | SMV 150 mg 24W + Peg-IFN/RBV, n = 79 | Placebo + Peg-IFN/RBV, n = 77 |
|---|---|---|---|---|---|
| Male/female, n (%) | 40/38 (51.3/48.7) | 47/28 (62.7/37.3) | 43/34 (55.8/44.2) | 44/35 (55.7/44.3) | 39/38 (50.6/49.4) |
| Age, years, median (range) | 47 (19-66) | 46 (18-67) | 47 (18-69) | 47 (19-69) | 45 (21-67) |
| BMI, kg/m2, median (range) | 25.9 (16.8-39.6) | 24.2 (17.4-37.8) | 24.7 (18.1-38.2) | 24.9 (17.6-37.3) | 25.6 (17.5-42.2) |
| Ethnicity, n (%) | |||||
| Caucasian | 70 (89.7) | 71 (94.7) | 74 (96.1) | 73 (92.4) | 74 (96.1) |
| Black/African American | 3 (3.8) | 2 (2.7) | 3 (3.9) | 3 (3.8) | 2 (2.6) |
| Asian | 5 (6.4) | 1 (1.3) | 0 | 2 (2.5) | 0 |
| Native Hawaiian/other Pacific Islander | 0 | 1 (1.3) | 0 | 1 (1.3) | 1 (1.3) |
| HCV subtype 1a (NS5B), n (%) | 36 (46.8) | 34 (45.3) | 37 (48.7) | 37 (46.8) | 29 (38.2) |
| Baseline HCV RNA log10 IU/mL, mean (SD) | 6.49 (0.68) | 6.51 (0.59) | 6.53 (0.54) | 6.55 (0.59) | 6.41 (0.63) |
| Baseline HCV RNA ≥800,000 IU/mL, n (%) | 64 (82.1) | 63 (84.0) | 69 (89.6) | 72 (91.1) | 63 (81.8) |
| Baseline HCV RNA <400,000 IU/mL, n (%) | 6 (7.7) | 8 (10.7) | 4 (5.2) | 5 (6.3) | 9 (11.7) |
| METAVIR score, n (%) | |||||
| F0 | 9 (11.5) | 7 (9.3) | 12 (15.6) | 8 (10.1) | 9 (11.7) |
| F1 | 33 (42.3) | 25 (33.3) | 32 (41.6) | 33 (41.8) | 35 (45.5) |
| F2 | 26 (33.3) | 26 (34.7) | 26 (33.8) | 25 (31.6) | 26 (33.8) |
| F3 | 10 (12.8) | 17 (22.7) | 7 (9.1) | 12 (15.2) | 7 (9.1) |
| F4 | 0 | 0 | 0 | 1 (1.3)* | 0 |
| IL28B genotype | |||||
| Patients with data, n† | 58 | 51 | 55 | 52 | 46 |
| CC, n (%) | 13 (22.4) | 18 (35.3) | 22 (40.0) | 13 (25.0) | 12 (26.1) |
| CT, n (%) | 36 (62.1) | 28 (54.9) | 27 (49.1) | 33 (63.5) | 28 (60.9) |
| TT, n (%) | 9 (15.5) | 5 (9.8) | 6 (10.9) | 6 (11.5) | 6 (13.0) |
*
One patient was inadvertently randomized despite a METAVIR score of F4 on biopsy. The patient was discontinued from treatment 13 days after starting therapy and discontinued the trial. These data are included in efficacy and safety analyses.
†
IL28B data only available for patients who signed the separate consent form.
Abbreviation: SD, standard deviation; W, week.