Prophylactic role of tixagevimab/cilgavimab for COVID-19 in newly transplanted kidney recipients: Single-center experience and review of literature

Table 1 Summary of studies on the use of tixagevimab-cilgavimab in solid organ transplant recipients

Ref.	Country	Study design	Intervention	Number of patients	Types of SOTRs	Duration of SOTRs	Age (year)	Female (%)	Outcomes	Conclusions
Al Jurdi et al[11]	United States	Retrospective multicenter	150-150 mg: 90; 300-300 mg: 131	444	Kidney, lung, liver, multi-organ	3.8 years	65 (55-72)	39	Breakthrough: 5%; hospitalization: 1; death: 0	Lower breakthrough infection in higher dose group; well tolerated in kidney and lung recipients
Sanayei et al[17]	United States	Prospective single center	Dose not specified	323	Liver, kidney, pancreas	7 years	61.5 (10.5)	35.5	Breakthrough: 10.5%; hospitalization: 2; death: NA	Pre-exposure prophylaxis reduced infection; no significant mortality difference
Bravo González-Blas et al[18]	Spain	Prospective cohort	150-150 mg	55	Kidney only	9 years	67.8 (10)	51	Breakthrough: 12.7%; hospitalization: 1; death: 1	Safe and efficacious in immunocompromised kidney recipients
Ordaya et al[19]	United States	Retrospective multicenter	300-300 mg (92.6%), 150-150 mg (7.4%)	163	Heart, heart/lung, heart + abdomen	2.5 years	61 (48-69)	34.4	Breakthrough: 14.7%; hospitalization: 1; death: 0	Well tolerated; tacrolimus users more prone to infection
Angelico et al[20]	Italy	Single-center observational	All received Tix-cil	306	Kidney: 197; liver: 109	5.2 years	Kidney: 57.5	Kidney: 41.1	Breakthrough: 22.9%; hospitalization: 8; death: 0	Safe and effective in kidney recipients; comparable to protective antibody titres
Morado et al[21]	United States	Retrospective single-center	300-300 mg (93.3%), 150-150 mg (6.7%)	90	Kidney, lung, liver, heart	94 days	50.2 (14.5)	48.9	Breakthrough: 6.7%; hospitalization: 0; death: 0	Lower infection rate in Tix-cil group; well tolerated during Omicron
Alejo et al[22]	United States	Prospective observational study	150-150 mg (48%), 300-300 mg (52%)	392	Kidney, liver, lung, heart and multi-organ	150-150 mg: 4.7 years, 300-300 mg: 6.75 years	64	58.2	Breakthrough: 9.2%; hospitalization: 0.5%	Well-tolerated and improvement in patient reported outcomes
Sindu et al[14]	United States	Retrospective single center	300-300 mg (37.1%)	546	Lung	2.1 years	67.5 (59.6-73.9)	39	Breakthrough: 16.3%; hospitalization: 6.04%; death: 2.2%	Moderate effectiveness in lung transplant recipients
Jordan et al[23]	United States	Prospective single center	Tix-cil (41.8%)	911	Kidney, heart, lung, lover, multi-organ	Not reported	60.53 (13.5)	41.9	Breakthrough: 35.6%; hospitalization: 2.9%; death: 0	Reduction in breakthrough infections
Benotmane et al[10]	France, Europe	Retrospective single center	124 (100%)	124	Kidney	5.5 years	55	34.7	Breakthrough: 91.1%; hospitalization: 12.9%; death: 2.42%	Early administration of prophylaxis in high-risk kidney transplant patients associated with favorable outcomes
Kaminski et al[8]	France, Europe	Retrospective single center	77.42%	430	Kidney	8.2 years	59.2	37.9	Breakthrough: 19.3%; hospitalization: 3.5%; death: 0.7%	Significant reduction in infections and hospitalizations with a dose dependent benefit
Abraham et al[24]	United States	Retrospective single center	100%	481	Kidney, liver, heart, lung, multi-organ	19 months	58.8	35.1	Hospitalization: 5.4%; death: 1.6%	Reduced hospitalizations and severity of infections
Al Jurdi et al[25]	United States	Retrospective multicenter	50%	1266	Kidney, lung, heart, liver, multi-organ	4.6 years	63.5	38.3	Breakthrough: 11.2%; hospitalization: 1.2%; death: 0	Tix-cil not associated with significant reduction of outcomes in BA.5 period
Sindu et al[26]	United States	Retrospective single center	12.3%	195	Lung	3.3 years	66.6	41.5	Hospitalization: 57.9%; death: 24.1%	Less virulent omicron strain associated with poorer outcomes in elderly; No significant reduction of adverse outcomes with Tix-cil

Tix-cil: Tixagevimab-cilgavimab; SOTRs: Solid organ transplant recipients.

Table 2 Characteristics of study population

Characteristics	All patients (n = 104)	No COVID-19 infection (n = 91)	COVID-19 breakthrough infection (n = 13)	P value
Median age (IQR), year	50 (41-59)	50 (41-59)	50 (44-59)	0.48
Gender, n (%)				0.33
Female	45 (43.3)	41 (45.1)	4 (30.8)
Male	59 (56.7)	50 (54.9)	9 (69.2)
Race, n (%)				0.65
Black	51 (49.0)	44 (48.4)	7 (53.8)
White	49 (47.1)	44 (48.4)	5 (38.5)
Hispanic	3 (2.9)	2 (2.2)	1 (7.7)
Asian/Pacific Islander	1 (1.0)	1 (1.1)	0
Comorbidities, n (%)
Hypertension	100 (96.1)	87 (85.6)	13 (100)	0.44
Diabetes	49 (47.1)	39 (42.9)	10 (76.9)	0.21
COPD	4 (3.8)	3 (3.3)	1 (7.7)	0.44
Asthma	4 (3.8)	4 (4.4)	0	0.44
Current smoker	5 (4.8)	5 (5.5)	0	0.39
Coronary artery disease	10 (9.6)	10 (11.0)	0	0.21
Prior kidney transplant, n (%)	11 (10.6)	11 (12.1)	0	0.18
COVID-19 vaccine dose, n (%)				0.6
0	3 (2.9)	3 (3.3)	0
1	6 (5.8)	5 (5.5)	1 (7.7)
2	41 (39.4)	38 (41.8)	3 (23.1)
3	38 (36.5)	31 (34.1)	7 (53.8)
4	16 (15.4)	14 (15.4)	2 (15.4)
Donor type, n (%)				0.45
Deceased	83 (79.8)	71 (78.0)	12 (92.3)
Living	21 (20.2)	20 (22.0)	1 (7.7)
KDPI (%), n (%)				0.27
0-20	24 (29.3)	22 (31.4)	2 (16.7)
21-34	14 (17.1)	13 (18.6)	1 (8.3)
35-85	44 (53.7)	35 (50.0)	9 (75.0)
cPRA (%), n (%)				0.02
0	36 (34.6)	32 (35.2)	4 (30.8)
1-20	19 (18.3)	18 (19.8)	1 (7.7)
21-79	26 (25.0)	18 (19.8)	8 (61.5)
80-97	13 (12.5)	13 (14.3)	0
98-100	10 (9.6)	10 (11.0)	0
ABDR Ag mismatch, n (%)				0.15
0	7 (6.7)	4 (4.4)	3 (23.1)
1	3 (2.9)	3 (3.3)	0
2	6 (5.8)	6 (6.6)	0
3	17 (16.3)	16 (17.6)	1 (7.7)
4	28 (26.9)	25 (27.5)	3 (23.1)
5	27 (26.0)	22 (24.2)	5 (38.5)
6	16 (15.4)	15 (16.5)	1 (7.7)
Delayed graft function, n (%)	17 (16.3)	15 (16.5)	2 (15.4)	0.92
Induction immunosuppression, n (%)	102 (98.1)	89 (97.8)	13 (100)	0.59
Alemtuzumab	2 (1.9)	2 (2.2)	0
Basiliximab
Maintenance immunosuppression, n (%)				1
Tacrolimus	104 (100.0)	91 (100.0)	13 (100.0)
Mycophenolate	104 (100.0)	91 (100.0)	13 (100.0)
Prednisone	96 (92.3)	84 (92.3)	12 (92.31)

COVID-19: Coronavirus disease 2019; COPD: Chronic obstructive pulmonary disease; KDPI: Kidney donor profile index; cPRA: Calculated panel reactive antibody; Ag: Antigen; ABDR: Australian Breast Device Registry.