Table 1.
Baseline demographic and clinical characteristics of the studied population.
| COVID-19-naïve (n = 131) | COVID-19-recovered (n = 12) | p value | |
|---|---|---|---|
| Age at LT (years) | 57.9 (51.8-62.8) | 57.5 (52.5-59.8) | 0.453 |
| Male sex | 92 (70.2) | 10 (83.3) | 0.337 |
| BMI (kg/m2) | 26.0 (23.5-28.7) | 28.8 (27.2-30.8) | 0.010 |
| Months between LT and vaccination | 94 (49-189) | 157 (87-203) | 0.192 |
| Etiology: HCV, HBV, NASH, AH, AI, other (%) | 28, 21, 0, 58, 13, 11 (21.4, 16.0, 0.0, 44.3, 9.9, 8.4) | 2, 3, 1, 4, 1, 1 (16.7, 25.0, 8.3, 33.3, 8.3, 8.3) | 0.036 |
| HCC | 47 (35.9) | 2 (16.7) | 0.180 |
| DM | 46 (35.1) | 8 (66.7) | 0.031 |
| Dyslipidemia | 29 (22.1) | 4 (33.3) | 0.378 |
| Alcohol consumption >40 g/day | 9 (6.9) | 1 (8.3) | 0.849 |
| HTN | 58 (44.3) | 6 (50.0) | 0.703 |
| Presence of esophageal varices | 6 (4.6) | 3 (25.0) | 0.005 |
| Presence of ascites | 4 (3.1) | 1 (8.3) | 0.341 |
| IS treatment | |||
| Tacrolimus | 85 (64.9) | 8 (66.7) | 0.901 |
| Cyclosporine | 31 (23.3) | 4 (33.3) | 0.456 |
| MMF | 58 (44.3) | 6 (50.0) | 0.703 |
| Everolimus | 12 (9.2) | 0 (0.0) | 0.273 |
| Prednisone | 13 (9.9) | 1 (8.3) | 0.859 |
| Double-triple IS including MMF | 51 (38.9) | 6 (19.5) | 0.454 |
| MMF+T;+C;+E;+P;+T+P;+C+P (%) | 30, 16, 2, 1, 0, 2 (22.9, 12.2, 1.5, 0.8, 0.0, 1.5) | 4, 1, 0, 0, 1, 0 (33.3, 8.3, 0.0, 0.0, 8.3, 0.0) | |
| Double-triple IS excluding MMF | 14 (10.7) | 0 (0.0) | 0.233 |
| T+E, T+A, T+P, C+P, T+E+P (%) | 3, 1, 7, 1, 2 (2.3, 0.8, 5.3, 0.8, 1.5) | 0, 0, 0, 0, 0 | |
| Any double IS therapy | 61 (46.6) | 5 (41.7) | 0.745 |
| Any triple IS therapy | 4 (3.1) | 1 (8.3) | 0.341 |
| IS levels with respect to reference# | |||
| Below | 63 (48.1) | 7(58.3) | 0.497 |
| Above | 6 (4.6) | 0 (0.0) | 0.449 |
| Serum IS drug levels or daily dose# | |||
| Tacrolimus (ng/ml) | 3.05 ±0.82 | 4.12 ±0.62 | 0.581 |
| Cyclosporine (ng/ml) | 17.2 ±8.0 | 11.8 ±2.2 | 0.440 |
| MMF (g/day) | 0.73 ±0.08 | 0.88 ±0.27 | 0.602 |
| Everolimus (ng/ml) | 0.0 ±0.0 | 0.43 ±0.14 | 0.321 |
| Prednisone (mg/day) | 0.42 ±0.42 | 0.51 ±0.15 | 0.860 |
| Hemoglobin (g/dl) | 13.5 (12.1-14.8) | 12.5 (12.0-14.6) | 0.378 |
| Leukocytes (n/μl) | 5,640 (4,500-6,590) | 6,420 (4,825-7,610) | 0.214 |
| Neutrophils (n/μl) | 3,357 (2,725-4,175) | 3,687 (2,736-4,424) | 0.749 |
| Albumin (g/dl) | 4.23 (4.07-4.53) | 4.08 (3.75-4.29) | 0.067 |
| Total bilirubin (mg/dl) | 0.60 (0.42-0.90) | 0.67 (0.54-0.86) | 0.340 |
| eGFR (ml/min/1.73 m2) | 59.1 (45.9-75.6) | 55.2 (45.5-68.6) | 0.600 |
| AST (IU/ml) | 18 (15-24) | 24 (18-27) | 0.082 |
| ALT (IU/ml) | 16 (11-23) | 19 (15-28) | 0.206 |
| INR | 1.04 (0.98-1.13) | 1.02 (0.96-1.11) | 0.664 |
| 25-OH-Vitamin D (ng/ml) | 31 (26.0-35.0) | 33.3 (27.8-41.6) | 0.224 |
Patients were divided with regard to the presence (COVID-19-recovered) or absence (COVID-19-naïve) of prevaccination anti-SARS-CoV-2-N protein IgG/IgM antibodies. Categorical variables are presented as frequencies (%), and the Pearson chi-square test was used for statistical comparisons. Continuous variables are presented as medians (IQR), and immunosuppressive drug serum levels are presented as the means (±SE). The rank-sum test (Mann-Whitney) was used for statistical comparisons.
A, azathioprine; AH, alcoholic hepatitis; AI, autoimmune hepatitis; ALT, alanine aminotransferase; AST, aspartate aminotransferase; C, cyclosporine; DM, diabetes mellitus; E, everolimus; eGFR, estimated glomerular filtration rate; HCC, hepatocellular carcinoma; HTN, arterial hypertension; INR, international normalized ratio; IS, immunosuppressive; LT, liver transplantation; NASH, non-alcoholic steatohepatitis, MMF, mycophenolate mofetil; P, prednisone; T, tacrolimus.
reference blood levels evaluated within 1 month before vaccination for each IS drug were calculated in accordance with Cillo et al.35