Table 1. Baseline Characteristics of the Study Population According to Study Group.
| Variable | No. (%) | |
|---|---|---|
| Preemptive therapy (n = 100)a | Antiviral prophylaxis (n = 105)a | |
| Demographics | ||
| Age, y | ||
| Median (IQR) | 57 (50-63) | 58 (51-63) |
| >65 | 19 (19) | 16 (15) |
| Sex | ||
| Male | 65 (65) | 78 (74) |
| Female | 35 (35) | 27 (26) |
| Medical history and comorbid conditions | ||
| Underlying liver disease(s)b | ||
| Hepatocellular carcinoma (any) | 37 (37) | 37 (35) |
| Alcoholic liver disease | 32 (32) | 38 (36) |
| Hepatitis C virus | 30 (30) | 37 (35) |
| Nonalcoholic steatohepatitis | 19 (19) | 26 (25) |
| Primary sclerosing cholangitis | 9 (9) | 5 (5) |
| Cryptogenic/autoimmune | 7 (7) | 9 (9) |
| Primary biliary cirrhosis | 6 (6) | 3 (3) |
| Other liver disease | 20 (20) | 22 (21) |
| Diabetes | 23 (23) | 31 (30) |
| Insulin dependent | 16 (16) | 16 (15) |
| Cardiovascular disease | 43 (43) | 46 (44) |
| Kidney replacement therapy at enrollment | 19 (19) | 24 (23) |
| MELD score, median (IQR)c | 30 (25-35) | 30 (25-35) |
| Source of donor graft | ||
| Deceased donation | 94 (94) | 102 (97) |
| Living donation | 6 (6) | 3 (3) |
| Valganciclovir use (before randomization) | 31 (31) | 28 (27) |
| Duration, median (IQR), d | 3 (1-5) | 2 (1-4) |
| Lymphocyte-depleting antibody inductiond | 15 (15) | 18 (17) |
| Primary immunosuppressive agente | ||
| Tacrolimus | 99 (99) | 105 (100) |
| Cyclosporine | 1 (1) | 0 |
Abbreviations: IQR, interquartile range; MELD, Model for End Stage Liver Disease.
a
The groups were well balanced at baseline for all baseline characteristics.
b
Some patients had more than 1 underlying liver disease.
c
The MELD score ranges from 6 to 40, with high scores indicating more severe disease. A waitlist MELD score of 30 has a 3-month mortality probability of about 50% without a liver transplant.
d
Lymphocyte-depleting antibody consisted of thymoglobulin in all cases.
e
Tacrolimus was the initial immunosuppressive agent for 204 of 205 patients, 5 patients (5%) in the preemptive therapy group and 7 patients (6.7%) in the prophylaxis group were later switched to cyclosporine.