Patient-reported outcomes after Tixagevimab and Cilgavimab pre-exposure prophylaxis among solid organ transplant recipients : Safety, effectiveness, and perceptions of risk
© 2023 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd..
BACKGROUND: Tixagevimab and Cilgavimab (T + C) is authorized for pre-exposure prophylaxis (PrEP) against Coronavirus Disease 2019 (COVID-19) in solid organ transplant recipients (SOTRs), yet patient-reported outcomes after injection are not well described. Furthermore, changes in risk tolerance after T + C PrEP have not been reported, of interest given uncertain activity against emerging Omicron sublineages.
METHODS: Within a national prospective observational study, SOTRs who reported receiving T + C were surveyed for 3 months to ascertain: (1) local and systemic reactogenicity, (2) severe adverse events with focus on cardiovascular and alloimmune complications, and (3) breakthrough COVID-19, contextualized through (4) changes in attitudes regarding COVID-19 risk and behaviors.
RESULTS: At 7 days postinjection, the most common reactions were mild fatigue (29%), headache (20%), and pain at injection sites (18%). Severe adverse events were uncommon; over 3 months of follow-up, 4/392 (1%) reported acute rejection and one (.3%) reported a myocardial infarction. Breakthrough COVID-19 occurred in 9%, 16-129 days after receiving full dose (300/300 mg) T + C, including two non-ICU hospitalizations. Most surveyed SOTRs (65%) felt T + C PrEP was likely to reduce their COVID-19 risk, and 70% reported increased willingness to engage in social activities such as visiting friends. However, few felt safe to return to in-person work (20%) or cease public mask-wearing (15%).
CONCLUSIONS: In this prospective study of patient-reported outcomes, T + C was well tolerated with few serious events. Several COVID-19 breakthroughs were reported, notable as most SOTRs reported changes in risk tolerance after T + C. These results aid counseling of SOTRs regarding real-world safety and effectiveness of T + C.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:37 |
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| Enthalten in: |
Clinical transplantation - 37(2023), 4 vom: 01. Apr., Seite e14913 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Alejo, Jennifer L [VerfasserIn] |
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| Links: |
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| Themen: |
1KUR4BN70F |
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| Anmerkungen: |
Date Completed 12.04.2023 Date Revised 02.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/ctr.14913 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Alejo, Jennifer L |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Patient-reported outcomes after Tixagevimab and Cilgavimab pre-exposure prophylaxis among solid organ transplant recipients |b Safety, effectiveness, and perceptions of risk |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 12.04.2023 | ||
| 500 | |a Date Revised 02.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Tixagevimab and Cilgavimab (T + C) is authorized for pre-exposure prophylaxis (PrEP) against Coronavirus Disease 2019 (COVID-19) in solid organ transplant recipients (SOTRs), yet patient-reported outcomes after injection are not well described. Furthermore, changes in risk tolerance after T + C PrEP have not been reported, of interest given uncertain activity against emerging Omicron sublineages | ||
| 520 | |a METHODS: Within a national prospective observational study, SOTRs who reported receiving T + C were surveyed for 3 months to ascertain: (1) local and systemic reactogenicity, (2) severe adverse events with focus on cardiovascular and alloimmune complications, and (3) breakthrough COVID-19, contextualized through (4) changes in attitudes regarding COVID-19 risk and behaviors | ||
| 520 | |a RESULTS: At 7 days postinjection, the most common reactions were mild fatigue (29%), headache (20%), and pain at injection sites (18%). Severe adverse events were uncommon; over 3 months of follow-up, 4/392 (1%) reported acute rejection and one (.3%) reported a myocardial infarction. Breakthrough COVID-19 occurred in 9%, 16-129 days after receiving full dose (300/300 mg) T + C, including two non-ICU hospitalizations. Most surveyed SOTRs (65%) felt T + C PrEP was likely to reduce their COVID-19 risk, and 70% reported increased willingness to engage in social activities such as visiting friends. However, few felt safe to return to in-person work (20%) or cease public mask-wearing (15%) | ||
| 520 | |a CONCLUSIONS: In this prospective study of patient-reported outcomes, T + C was well tolerated with few serious events. Several COVID-19 breakthroughs were reported, notable as most SOTRs reported changes in risk tolerance after T + C. These results aid counseling of SOTRs regarding real-world safety and effectiveness of T + C | ||
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a safety | |
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| 650 | 7 | |a tixagevimab |2 NLM | |
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| 700 | 1 | |a Chiang, Teresa P Y |e verfasserin |4 aut | |
| 700 | 1 | |a Avery, Robin K |e verfasserin |4 aut | |
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| 700 | 1 | |a Segev, Dorry L |e verfasserin |4 aut | |
| 700 | 1 | |a Werbel, William A |e verfasserin |4 aut | |
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