Efficacy and safety of COVID-19 vaccination in patients with cirrhosis

Table 1 Main characteristics of enrolled patients by group

	Vaccinated (n = 89)	Unvaccinated (n = 148)	P value
Age, yr	59 [48-68]	57 [47-64]	0.161
Male/Female	50/39	66/82	0.055
Child-Turcotte-Pugh class A	52 (58.4%)	72 (48.6%)	0.092
Child-Turcotte-Pugh classes B and C	37 (41.6%)	76 (51.4%)
Etiology of cirrhosis
Hepatitis B virus	3 (3.4%)	9 (6.1%)	0.275
Hepatitis C virus	16 (18.0%)	29 (15.6%)	0.449
Alcohol	41 (46.0%)	56 (37.8%)	0.094
Metabolic associated liver disease	5 (5.6%)	7 (4.7%)	0.492
Autoimmune hepatitis	1 (1.1%)	9 (6.1%)	0.059
Primary biliary cholangitis	9 (10.1%)	8 (5.4%)	0.136
Primary sclerosing cholangitis	1 (1.1%)	2 (1.4%)	0.684
Wilson disease	1 (1.1%)	1 (0.7%)	0.611
Other	0	6 (4.1%)	0.057
Mixed	12 (13.5%)	21 (14.2%)	0.521
Comorbidity
Diabetes mellitus	18 (20.2%)	21 (14.2%)	0.151
Ischemic heart disease	7 (7.9%)	6 (4.1%)	0.170
Cancer	9 (10.1%)	12 (8.1%)	0.381
Hepatocellular carcinoma	1 (1.1%)	4 (2.7%)	0.379
Asthma	3 (3.4%)	2 (1.4%)	0.274
Chronic obstructive pulmonary disease	5 (5.6%)	2 (1.4%)	0.071

Table 2 Outcomes by group (n [per patient-yr])

	Vaccinated (n = 33.8 patient-yr)	Unvaccinated (n = 82.1 patient-yr)	P value
COVID-19 cases
Total	4 (11.8%)/3 (8.9%)1	24 (29.2%)	0.035/0.0131
Mild	1 (3.0%)	7 (8.5%)	0.260
Moderate	3 (8.9%)/2 (5.9%)1	5 (6.1%)	0.431/0.6661
Severe	0	12 (14.6%)	0.012
Death
Overall	1 (3.0%)	14 (17.1%)	0.001
Associated with COVID-19	0	10 (12.2%)	0.012
Liver-related	1 (3.0%)	4 (4.9%)	0.135
Non-COVID-19 complications (cases)
Liver decompensation	4 (11.9%)	21 (25.6%)	0.077
Bleeding esophageal varices	2 (5.9%)	8 (9.7%)	0.394
Myocardial infarction	0	1 (1.2%)	0.707
Pulmonary embolism	0	1 (1.2%)	0.707
Stroke	0	0	-
Transient ischemic attack	1 (3.0%)	0	0.293
Abdominal thrombosis	0	0	-

¹All vaccinated/fully vaccinated. COVID-19: Coronavirus disease 2019.

Table 3 Analysis of predictors of overall mortality among included patients with cirrhosis

Predictor	P value	Hazard ratio
Age	0.001	1.08 (95%CI: 1.04-1.15)
Vaccination	0.027	0.09 (95%CI: 0.01-0.76)
Child-Turcotte-Pugh class	0.001	4.13 (95%CI: 1.82-9.35)
Diabetes mellitus	0.363
Ischemic heart disease	0.595
Cancer	0.751
Asthma	0.342
Chronic obstructive pulmonary disease	0.851