Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients
<i>Background and Objectives</i>: Underpowered immune response to vaccines against SARS-CoV-2 was observed in solid organ transplant (SOT) recipients. A novel combination of monoclonal antibodies tixagevimab-cilgavimab (TGM/CGM) received authorization as pre-exposure prophylaxis (PrEP) i...
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| Format: | Article |
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MDPI AG
2023-11-01
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| Series: | Medicina |
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| Online Access: | https://www.mdpi.com/1648-9144/59/12/2101 |
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| author | Roberta Angelico Francesca Romano Luigi Coppola Marco Materazzo Domiziana Pedini Maria Sara Santicchia Roberto Cacciola Luca Toti Loredana Sarmati Giuseppe Tisone |
| author_facet | Roberta Angelico Francesca Romano Luigi Coppola Marco Materazzo Domiziana Pedini Maria Sara Santicchia Roberto Cacciola Luca Toti Loredana Sarmati Giuseppe Tisone |
| author_sort | Roberta Angelico |
| collection | DOAJ |
| description | <i>Background and Objectives</i>: Underpowered immune response to vaccines against SARS-CoV-2 was observed in solid organ transplant (SOT) recipients. A novel combination of monoclonal antibodies tixagevimab-cilgavimab (TGM/CGM) received authorization as pre-exposure prophylaxis (PrEP) in those with reduced response to vaccine. We aimed to evaluate the response rate to COVID-19 vaccination in kidney transplant (KT), compared to liver transplant (LT) recipients, and the efficacy and safety of PrEP with TGM/CGM. <i>Material and Methods</i>: Between March and November 2022, adult KT and LT recipients who had completed the vaccination schedule (3 doses) were tested for anti-SARS-CoV-2 antibodies titer. SOT recipients with anti-SARS-CoV-2 titer ≥ 100 IU/mL were considered protected against infection, while those with titer < 100 UI/mL were defined non-protected. Patients with inadequate response were invited to PrEP. <i>Results</i>: In total, 306 patients were enrolled [KT:197 (64.4%), LT:109 (35.6%)]. After the complete scheme of vaccination, 246 (80.3%) patients developed a protective titer, while 60 (19.6%) did not have a protective titer. KT recipients had a lower rate of protective anti-COVID-19 titer compared to LT patients [149 (75.6%) vs. 97 (89.0%), <i>p</i> = 0.004]. Recipients with non-protective anti-COVID-19 titer received mainly tacrolimus-based regimen associated with mycophenolate mofetil (MMF) (70%) e steroids (46.7%) as maintenance immunosuppression, while those treated with everolimus were associated with higher protective titer. Of 35 (58.3%) patients who received PrEP, within 12 months, 6 (17.1%) (all KT) developed pauci-symptomatic COVID-19 disease, while 15/25 (60%) of non-responders, who did not receive the prophylaxis, developed COVID-19 disease. After PrEP, hospitalization rate was lower (2.8% vs. 16%), and no adverse events, neither graft loss nor rejection, were observed. <i>Conclusions</i>: Despite complete COVID-19 vaccination, SOT recipients might be not protected from the SARS-CoV-2 infection, especially after KT. In non-protected SOT patients, the subsequent pre-exposure prophylaxis with combination of monoclonal antibodies (TGM/CGM) might be an efficacy and safe strategy to prevent COVID-19 severe disease and hospitalization. |
| first_indexed | 2024-03-08T20:32:42Z |
| format | Article |
| id | doaj.art-4cabe28e00d34374be43538836ee8cee |
| institution | Directory Open Access Journal |
| issn | 1010-660X 1648-9144 |
| language | English |
| last_indexed | 2024-03-08T20:32:42Z |
| publishDate | 2023-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Medicina |
| spelling | doaj.art-4cabe28e00d34374be43538836ee8cee2023-12-22T14:23:48ZengMDPI AGMedicina1010-660X1648-91442023-11-015912210110.3390/medicina59122101Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant RecipientsRoberta Angelico0Francesca Romano1Luigi Coppola2Marco Materazzo3Domiziana Pedini4Maria Sara Santicchia5Roberto Cacciola6Luca Toti7Loredana Sarmati8Giuseppe Tisone9HPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyDepartment of System Medicine, Tor Vergata University, 00133 Rome, ItalyHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyDepartment of System Medicine, Tor Vergata University, 00133 Rome, ItalyHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, Italy<i>Background and Objectives</i>: Underpowered immune response to vaccines against SARS-CoV-2 was observed in solid organ transplant (SOT) recipients. A novel combination of monoclonal antibodies tixagevimab-cilgavimab (TGM/CGM) received authorization as pre-exposure prophylaxis (PrEP) in those with reduced response to vaccine. We aimed to evaluate the response rate to COVID-19 vaccination in kidney transplant (KT), compared to liver transplant (LT) recipients, and the efficacy and safety of PrEP with TGM/CGM. <i>Material and Methods</i>: Between March and November 2022, adult KT and LT recipients who had completed the vaccination schedule (3 doses) were tested for anti-SARS-CoV-2 antibodies titer. SOT recipients with anti-SARS-CoV-2 titer ≥ 100 IU/mL were considered protected against infection, while those with titer < 100 UI/mL were defined non-protected. Patients with inadequate response were invited to PrEP. <i>Results</i>: In total, 306 patients were enrolled [KT:197 (64.4%), LT:109 (35.6%)]. After the complete scheme of vaccination, 246 (80.3%) patients developed a protective titer, while 60 (19.6%) did not have a protective titer. KT recipients had a lower rate of protective anti-COVID-19 titer compared to LT patients [149 (75.6%) vs. 97 (89.0%), <i>p</i> = 0.004]. Recipients with non-protective anti-COVID-19 titer received mainly tacrolimus-based regimen associated with mycophenolate mofetil (MMF) (70%) e steroids (46.7%) as maintenance immunosuppression, while those treated with everolimus were associated with higher protective titer. Of 35 (58.3%) patients who received PrEP, within 12 months, 6 (17.1%) (all KT) developed pauci-symptomatic COVID-19 disease, while 15/25 (60%) of non-responders, who did not receive the prophylaxis, developed COVID-19 disease. After PrEP, hospitalization rate was lower (2.8% vs. 16%), and no adverse events, neither graft loss nor rejection, were observed. <i>Conclusions</i>: Despite complete COVID-19 vaccination, SOT recipients might be not protected from the SARS-CoV-2 infection, especially after KT. In non-protected SOT patients, the subsequent pre-exposure prophylaxis with combination of monoclonal antibodies (TGM/CGM) might be an efficacy and safe strategy to prevent COVID-19 severe disease and hospitalization.https://www.mdpi.com/1648-9144/59/12/2101SARS-CoV-2anti-SARS-CoV-2 antibodies’ titerCOVID-19 diseasepre-exposure prophylaxislong-active antibodytixagevimab |
| spellingShingle | Roberta Angelico Francesca Romano Luigi Coppola Marco Materazzo Domiziana Pedini Maria Sara Santicchia Roberto Cacciola Luca Toti Loredana Sarmati Giuseppe Tisone Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients Medicina SARS-CoV-2 anti-SARS-CoV-2 antibodies’ titer COVID-19 disease pre-exposure prophylaxis long-active antibody tixagevimab |
| title | Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients |
| title_full | Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients |
| title_fullStr | Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients |
| title_full_unstemmed | Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients |
| title_short | Effects of Anti-COVID-19 Vaccination and Pre-Exposure Prophylaxis with Tixagevimab-Cilgavimab in Kidney and Liver Transplant Recipients |
| title_sort | effects of anti covid 19 vaccination and pre exposure prophylaxis with tixagevimab cilgavimab in kidney and liver transplant recipients |
| topic | SARS-CoV-2 anti-SARS-CoV-2 antibodies’ titer COVID-19 disease pre-exposure prophylaxis long-active antibody tixagevimab |
| url | https://www.mdpi.com/1648-9144/59/12/2101 |
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