Table 1. Baseline characteristics (all randomized patients).
BOC, boceprevir; MCB, mericitabine; P/R, peginterferon alfa-2a/ribavirin; TVR, telaprevir
| DYNAMO 1 | DYNAMO 2 | ||||||
|---|---|---|---|---|---|---|---|
| Arm A | Arm B | Arm C | Arm A | Arm B | Arm C | Arm D | |
| MCB + BOC + P/R × 24 weeks | MCB + BOC + P/R × 24 weeks, then BOC + P/R × 24 weeks | P/R lead-in × 4 weeks, then BOC + P/R × 44 weeks* | MCB + TVR + P/R × 12 weeks, then MCB + P/R × 12 weeks | MCB + TVR + P/R × 12 weeks, then MCB + P/R ×12 weeks, then P/R × 24 weeks | MCB + TVR + P/R × 12 weeks, then P/R × 36 weeks | TVR + P/R × 12 weeks, then P/R × 36 weeks* | |
| n = 25 | n = 20 | n = 13 | n = 21 | n = 24 | n = 24 | n = 11 | |
| Male, n (%) | 17 (68.0) | 13 (65.0) | 8 (61.5) | 15 (71.4) | 17 (70.8) | 17 (70.8) | 9 (81.8) |
| Mean (SD) age, years | 53.8 (8.0) | 53.3 (10.1) | 56.0 (8.1) | 51.9 (10.1) | 54.0 (7.6) | 53.5 (7.7) | 52.8 (6.7) |
| Race, n (%) | |||||||
| White | 23 (92.0) | 16 (80.0) | 13 (100) | 14 (66.7) | 20 (83.3) | 20 (83.3) | 11 (100) |
| Black | 2 (8.0) | 4 (20.0) | 0 | 5 (23.8) | 4 (16.7) | 2 (8.3) | 0 |
| Other | 0 | 0 | 0 | 2 (9.6) | 0 | 2 (8.3) | 0 |
| Mean (SD) BMI, kg/m2 | 26.3 (3.7) | 28.1 (2.6) | 27.7 (3.4) | 27.3 (4.5) | 26.6 (4.9) | 27.7 (3.9) | 25.8 (2.4) |
| HCV genotype, n (%) | |||||||
| 1a | 13 (52.0) | 12 (60.0) | 8 (61.5) | 14 (66.7) | 16 (66.7) | 15 (62.5) | 6 (54.5) |
| 1b | 12 (48.0) | 8 (40.0) | 5 (38.5) | 7 (33.3) | 8 (33.3) | 9 (37.5) | 5 (45.5) |
| Host IL28B genotype, n (%) | |||||||
| CC | 2 (8.0) | 1 (5.0) | 2 (15.4) | 0 | 3 (12.5) | 0 | 0 |
| Non-CC | 23 (92.0) | 19 (95.0) | 11 (84.6) | 21 (100) | 21 (87.5) | 24 (100) | 11 (100) |
| Bridging fibrosis/cirrhosis, n (%) | 11 (44.0) | 12 (60.0) | 8 (61.5) | 10 (47.6) | 14 (58.3) | 13 (54.2) | 7 (63.6) |
| Mean (SD) serum ALT, IU/L | 128.9 (90.8 | 129.4 (71.0) | 149.3 (151.4) | 118.4 (62.9) | 118.4 (60.9) | 128.2 (79.3) | 154.5 (254.0) |
| Mean (SD) serum AST, IU/L | 87.1 (57.3) | 93.2 (43.3) | 102.0 (84.7) | 77.5 (33.3) | 83.5 (48.9) | 98.1 (58.3) | 87.5 (104.4) |
| Mean (SD) serum albumin, g/L | 40.8 (3.5) | 40.7 (4.2) | 38.6 (3.4) | 40.7 (3.7) | 39.9 (4.0) | 40.4 (2.9) | 40.0 (2.7) |
| Mean (SD) total bilirubin, μmol/L | 9.7 (4.1) | 11.9 (5.4) | 11.0 (5.1) | 8.2 (2.1) | 8.7 (2.9) | 9.9 (3.4) | 10.0 (5.1) |
| Mean (SD) serum creatinine, μmol/L | 74.0 (10.7) | 77.3 (20.5) | 68.0 (11.3) | 75.6 (15.4) | 73.3 (15.4) | 76.1 (9.9) | 71.8 (9.6) |
| Mean (SD) blood glucose, mmol/L | 5.9 (2.6) | 6.1 (1.9) | 6.1 (1.1) | 6.3 (2.1) | 6.2 (1.8) | 5.9 (0.9) | 5.8 (1.3) |
| Mean (SD) alpha-fetoprotein, μg/L** | 24.8 (32.2) n = 9 | 37.4 (23.9) n = 12 | 18.2 (23.1) n = 4 | 10.9 (8.0) n = 11 | 8.7 (5.0) n = 11 | 23.3 (24.0) n = 15 | 27.3 (41.3) n = 5 |
| Mean (SD) erythrocytes, x 1012/L | 4.9 (0.4) | 4.8 (0.3) | 4.9 (0.3) | 5.0 (0.4) | 5.0 (0.4) | 5.0 (0.3) | 4.9 (0.4) |
| Mean (SD) leukocytes, x 109/L | 5.9 (2.3) | 5.2 (1.2) | 7.2 (4.4) | 6.0 (1.7) | 5.8 (2.2) | 6.4 (1.8) | 5.9 (2.1) |
| Mean (SD) platelets, x 109/L | 168.4 (64.7) | 174.3 (72.7) | 185.4 (72.8) | 199.7 (70.3) | 164.5 (41.6) | 190.9 (62.3) | 193.9 (55.6) |
| Mean (SD) neutrophils, x 109/L | 3.3 (1.6) | 2.8 (1.1) | 4.9 (4.4) | 3.4 (1.6) | 3.3 (1.9) | 3.6 (1.2) | 3.0 (1.0) |
| Mean (SD), lymphocytes, x 109/L | 2.0 (0.9) | 1.9 (0.5) | 1.8 (0.7) | 2.1 (0.6) | 1.9 (0.5) | 2.1 (0.7) | 2.2 (1.0) |
| Median HCV RNA, log10 IU/mL (range) | 6.6 (5.3, 7.3) | 6.7 (5.7, 7.1) | 6.7 (5.8, 7.3) | 6.9 (6.0, 7.4) | 6.9 (5.5, 7.6) | 6.8 (6.0, 7.3) | 6.5 (5.9, 6.9) |
| HCV RNA ≥800,000 IU/mL, n (%) | 23 (92.0) | 19 (95.0) | 12 (92.3) | 21 (100) | 21 (87.5) | 24 (100) | 11 (100) |
* MCB could be added to treatment at the investigator’s discretion
** Not collected in all patients.