Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study
<i>Background and Objectives</i>: In addition to a suboptimal and rapidly diminishing response to the coronavirus disease 2019 (COVID-19) vaccine, hemodialysis (HD) patients are at risk for developing a severe COVID-19 infection. In 2022, the combination of cilgavimab and tixagevimab (Ev...
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MDPI AG
2023-12-01
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| Series: | Medicina |
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| Online Access: | https://www.mdpi.com/1648-9144/59/12/2109 |
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| author | Mohammed Kamal Nassar Alaa Sabry Mohamed Elgamal Zeinab Zeid Dalia Abdellateif Abdelghany Samar Tharwat |
| author_facet | Mohammed Kamal Nassar Alaa Sabry Mohamed Elgamal Zeinab Zeid Dalia Abdellateif Abdelghany Samar Tharwat |
| author_sort | Mohammed Kamal Nassar |
| collection | DOAJ |
| description | <i>Background and Objectives</i>: In addition to a suboptimal and rapidly diminishing response to the coronavirus disease 2019 (COVID-19) vaccine, hemodialysis (HD) patients are at risk for developing a severe COVID-19 infection. In 2022, the combination of cilgavimab and tixagevimab (Evusheld, AstraZeneca) was approved for COVID-19 preexposure prophylaxis in high-risk groups. The purpose of this study was to evaluate the humoral response and short-term safety of this antibody combination in a group of HD patients. <i>Materials and Methods</i>: Seventy-three adult maintenance hemodialysis patients were recruited from a tertiary-care hospital for this double-blinded, non-randomized, placebo-controlled study. Patients were placed into two groups: the intervention group (n = 43) received a single 300 mg dosage of cilgavimab and tixagevimab, while the control group (n = 30) received a saline placebo. The titer of COVID-19-neutralizing antibodies was measured at baseline and after 1 and 6 months. The patients were evaluated for any drug-related adverse effects and monitored for six months for the emergence of any COVID-19-related events. <i>Results</i>: Patients in the intervention group were substantially older and had been on HD for longer (<i>p</i> = 0.002 and 0.006, respectively). The baseline antibody levels were higher in the Evusheld group. The antibody level in the intervention group increased significantly after 1 month and remained consistent for 6 months, whereas the antibody level in the control group fell significantly after 6 months during the study period (Wald χ<sup>2</sup> = 30.620, <i>p</i> < 0.001). The drug-related adverse effects were modest and well-tolerated, and only seven patients experienced them. Six months after study enrollment, 10 patients in the intervention group and 6 patients in the control group had been infected with COVID-19, respectively. In the control group, ICU admission and mortality were observed, but in the intervention group, the infection was milder with no aggressive consequences. <i>Conclusions</i>: This study demonstrated the short-term safety and efficacy of tixagevimab–cilgavimab for COVID-19 preexposure prophylaxis in HD patients. These findings require more studies with more HD patients and longer follow-up periods. |
| first_indexed | 2024-03-08T20:33:13Z |
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| publishDate | 2023-12-01 |
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| spelling | doaj.art-e93cebd672664860986decd9a59c15de2023-12-22T14:23:49ZengMDPI AGMedicina1010-660X1648-91442023-12-015912210910.3390/medicina59122109Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center StudyMohammed Kamal Nassar0Alaa Sabry1Mohamed Elgamal2Zeinab Zeid3Dalia Abdellateif Abdelghany4Samar Tharwat5Mansoura Nephrology & Dialysis Unit (MNDU), Department of Internal Medicine, Faculty of Medicine, Mansoura University, Mansoura 35516, EgyptMansoura Nephrology & Dialysis Unit (MNDU), Department of Internal Medicine, Faculty of Medicine, Mansoura University, Mansoura 35516, EgyptChest Department, Faculty of Medicine, Mansoura University, Mansoura 35516, EgyptAl-Khezam Dialysis Center, Al-Adan Hospital, Hadiya 47000, KuwaitChest Department, Faculty of Medicine, Mansoura University, Mansoura 35516, EgyptDepartment of Internal Medicine, Faculty of Medicine, Horus University, New Damietta 34517, Egypt<i>Background and Objectives</i>: In addition to a suboptimal and rapidly diminishing response to the coronavirus disease 2019 (COVID-19) vaccine, hemodialysis (HD) patients are at risk for developing a severe COVID-19 infection. In 2022, the combination of cilgavimab and tixagevimab (Evusheld, AstraZeneca) was approved for COVID-19 preexposure prophylaxis in high-risk groups. The purpose of this study was to evaluate the humoral response and short-term safety of this antibody combination in a group of HD patients. <i>Materials and Methods</i>: Seventy-three adult maintenance hemodialysis patients were recruited from a tertiary-care hospital for this double-blinded, non-randomized, placebo-controlled study. Patients were placed into two groups: the intervention group (n = 43) received a single 300 mg dosage of cilgavimab and tixagevimab, while the control group (n = 30) received a saline placebo. The titer of COVID-19-neutralizing antibodies was measured at baseline and after 1 and 6 months. The patients were evaluated for any drug-related adverse effects and monitored for six months for the emergence of any COVID-19-related events. <i>Results</i>: Patients in the intervention group were substantially older and had been on HD for longer (<i>p</i> = 0.002 and 0.006, respectively). The baseline antibody levels were higher in the Evusheld group. The antibody level in the intervention group increased significantly after 1 month and remained consistent for 6 months, whereas the antibody level in the control group fell significantly after 6 months during the study period (Wald χ<sup>2</sup> = 30.620, <i>p</i> < 0.001). The drug-related adverse effects were modest and well-tolerated, and only seven patients experienced them. Six months after study enrollment, 10 patients in the intervention group and 6 patients in the control group had been infected with COVID-19, respectively. In the control group, ICU admission and mortality were observed, but in the intervention group, the infection was milder with no aggressive consequences. <i>Conclusions</i>: This study demonstrated the short-term safety and efficacy of tixagevimab–cilgavimab for COVID-19 preexposure prophylaxis in HD patients. These findings require more studies with more HD patients and longer follow-up periods.https://www.mdpi.com/1648-9144/59/12/2109tixagevimabcilgavimabEvusheldhemodialysis |
| spellingShingle | Mohammed Kamal Nassar Alaa Sabry Mohamed Elgamal Zeinab Zeid Dalia Abdellateif Abdelghany Samar Tharwat Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study Medicina tixagevimab cilgavimab Evusheld hemodialysis |
| title | Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study |
| title_full | Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study |
| title_fullStr | Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study |
| title_full_unstemmed | Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study |
| title_short | Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study |
| title_sort | tixagevimab and cilgavimab evusheld boosts antibody levels to sars cov 2 in end stage renal disease patients on chronic hemodialysis a single center study |
| topic | tixagevimab cilgavimab Evusheld hemodialysis |
| url | https://www.mdpi.com/1648-9144/59/12/2109 |
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