TABLE 1.
Patient Demographics and Clinical Characteristics at the Baseline (the ITT Population)
| Prophylaxis Arm (n = 55) | Observation Arm: All Patients (n = 60) | |
|---|---|---|
| Male sex, n (%) | 45 (81.8) | 48 (80.0) |
| Race, n (%) | ||
| White | 46 (83.6) | 50 (83.3) |
| Black | 3 (5.5) | 5 (8.3) |
| Asian | 1 (1.8) | 2 (3.3) |
| Other | 5 (9.1) | 3 (5.0) |
| Recipient age (years), median (range)* | 51.0 (35-68) | 53.5 (38-66) |
| Weight (kg), median (range)† | 81.8 (44-115) | 79.1 (53-120) |
| Weight ≥ 75 kg, n (%) | 33 (63.5) | 37 (62.7) |
| Days from transplantation to the baseline, median (range)‡ | 111.5 (71-235) | 121.0 (14-248) |
| HCV genotype, n (%) | ||
| Type 1 | 43 (78.2) | 48 (81.4) |
| Not type 1 | 12 (21.8) | 11 (18.6) |
| Unknown | 0 | 1 |
| Pretransplant HCV RNA (log10 IU/mL), median (range)§ | 4.8 (0.4-6.4) | 5.3 (0.4-6.8) |
| Baseline HCV RNA (log10 IU/mL), median (range) | 6.8 (4.6-8.0) | 6.9 (4.0-8.0)∣ |
| Baseline HCV RNA > 800,000 IU/mL, n (%) | 43 (78.2) | 48 (81.4)∣ |
| Alanine aminotransferase (U/L), median (range) | 66.0 (18-754) | 76.0 (17-401) |
| Aspartate aminotransferase (U/L), median (range) | 46.0 (15-736) | 54.0 (15-447) |
| Cold ischemia time (hours), median (range) | 7.0 (0-17) | 6.9 (0-18) |
| Identical donor/recipient histocompatibility (ABO typing), n (%) | 52 (94.5) | 57 (95.0) |
*
The donor age was not collected.
†
Prophylaxis arm, n = 52; observation arm, n = 59.
‡
The baseline is defined as the first day of treatment for the prophylaxis arm and as the day of randomization for the observation arm (prophylaxis arm, n = 54).
§
Prophylaxis arm, n = 24; observation arm, n = 21.
∣
n = 59 (for 1 patient, baseline HCV RNA levels were missing, but the patient had positive HCV RNA titers in weeks 12 and 48).