Table 3.
Association of prevaccination demographic and clinical characteristics with antibody responses 6 months after the second dose of the Pfizer BTN162b2 vaccine.
| Univariate analysis |
Multivariate analysis |
|||||
|---|---|---|---|---|---|---|
| Anti-s-RBD IgG negative (n = 26) | Anti-s-RBD IgG positive (n = 97) | p value | OR | 95% CI | p value | |
| Age at LT (years) | 60.5 (57.7-65.8) | 57.4 (50.8-61.8) | 0.014 | |||
| Male sex | 16 (61.5) | 72 (74.21) | 0.203 | |||
| BMI (kg/m2) | 26.0 (23.5-228.7) | 25.5 (23.4-28.5) | 0.923 | |||
| Months between LT and vaccination | 54.1 (18.9-98.4) | 118 (59.1-189) | 0.006 | |||
| Etiology: HCV, HBV, AH, AI, other (%) | 6, 6, 8, 3, 3 (23.1, 23.1, 30.8, 11.5, 11.5) | 20, 15, 46, 8, 8 (20.6, 15.5, 47.4, 8.2, 8.2) | 0.636 | |||
| HCC | 9 (34.6) | 38 (39.2) | 0.671 | |||
| DM | 8 (30.8) | 34 (.5.1) | 0.683 | |||
| Dyslipidemia | 7 (26.9) | 20 (20.6) | 0.490 | |||
| Alcohol consumption >40 g/day | 3 (11.5) | 7 (7.2) | 0.474 | |||
| HTN | 11 (42.3) | 45 (46.4) | 0.710 | |||
| Presence of esophageal varices | 2 (7.7) | 4 (4.1) | 0.453 | |||
| Presence of ascites | 3 (11.5) | 1 (1.0) | 0.007 | 0.036 | 0.003-0.486 | 0.012 |
| IS treatment | ||||||
| Tacrolimus | 18 (69.2) | 63 (65.0) | 0.683 | |||
| Cyclosporine | 7 (26.9) | 21 (21.7) | 0.569 | |||
| MMF | 23 (88.5) | 29 (29.9) | <0.001 | |||
| Everolimus | 1 (3.9) | 11 (11.3) | 0.253 | |||
| Prednisone | 4 (15.4) | 8 (8.3) | 0.276 | |||
| Double-triple IS including MMF | 22 (84.6) | 24 (24.7) | <0.001 | |||
| MMF+T; +C; +E; +P; +C+P (%) | 16, 4, 0, 1, 1 (61.5, 15.4, 0, 3.8, 3.8) | 11, 10, 2, 0, 1 (11.3, 10.3, 2.1, 0, 1) | ||||
| Double-triple IS excluding MMF | 2 (7.7) | 11 (11.3) | 0.591 | |||
| T+E, T+A, T+P, C+P, T+E+P (%) | 0, 0, 1, 0, 1 (0, 0, 3.8, 0, 3.8) | 3, 1, 5, 1, 1 (3.1, 1, 5.2, 1, 1) | ||||
| Any double IS therapy | 22 (84.6) | 33 (34.0) | <0.001 | |||
| Any triple IS therapy | 2 (7.7) | 2 (2.1) | 0.151 | |||
| Serum IS drug levels or daily dose# | ||||||
| Tacrolimus (ng/ml) | 4.02 ±0.59 | 4.35 ±0.82 | 0.276 | |||
| Cyclosporine (ng/ml) | 5.30 ±2.34 | 11.8 ±2.72 | 0.561 | |||
| MMF (g/day) | 1.54 ±0.14 | 0.48 ±0.08 | <0.001 | 0.282 | 0.140-0.564 | <0.001 |
| Everolimus (ng/ml) | 0.18 ±0.18 | 0.57 ±0.18 | 0.277 | |||
| Prednisone (mg/day) | 0.0.67 ±0.36 | 0.46 ±0.17 | 0.303 | |||
| IS levels with respect to reference# | ||||||
| Below | 13 (50.0) | 46 (47.4) | 0.815 | |||
| Above | 0 (0.0) | 5 (5.2) | 0.237 | |||
| Hemoglobin (g/dl) | 12.7 (11.6-13.6) | 13.6 (12.8-15.0) | 0.007 | |||
| Leukocytes (n/μl) | 4,550 (3,700-5,630) | 5,980 (4,840-6,950) | 0.001 | 1.001 | 1.000-1.001 | 0.016 |
| Neutrophils (n/μl) | 2,850 (1,890-3,780) | 3,540 (2,910-4,310) | 0.016 | |||
| Albumin (g/dl) | 4.50 (4.07-4.61) | 4.24 (4.10-4.42) | 0.182 | |||
| Bilirubin (mg/dl) | 0.57 (0.37-0.73) | 0.63 (0.43-0.97) | 0.202 | |||
| eGFR (ml/min/1.73 m2) | 52.0 (45.3-70.6) | 63.1 (48.4-80.1) | 0.072 | |||
| AST (IU/L) | 15 (13-19) | 20 (16-25) | 0.001 | |||
| ALT (IU/L) | 11.5 (9-17) | 18 (12-27) | 0.001 | |||
| INR | 1.04 (0.96-1.14) | 1.04 (0.98-1.11) | 0.733 | |||
| 25-OH-Vitamin D (ng/ml) | 32.2 (28.6-35.0) | 31 (25.0-35.0) | 0.296 | |||
Logistic model estimation parameters: pseudo R2 = 0.393; area under the ROC curve = 0.905; correct classification = 88.6%.
Association between prevaccination demographic and clinical characteristics of COVID-19 naïve liver transplanted patients (n = 123) with regards to the development of a positive (≥0.8 U/ml) or negative (<0.8 U/ml) anti-SARS-CoV-2 s-RBD antibody response, as assessed 6 months (165±4 days) after the second dose of the Pfizer® BTN162b2 vaccine. Categorical parameters are presented as frequencies (%), and the Pearson chi-squared test was used for statistical comparisons. Continuous variables are presented as medians (IQR), for serum immunosuppressive drug levels, they are presented as the means (±SE), and the rank-sum test (Mann-Whitney) was used for statistical comparisons. Stepwise regression with a forward approach was used to discriminate independent predictive variables to achieve a positive antibody response after vaccination in a multivariate logistic model analysis.
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