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1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies
BACKGROUND: Emergency use of tixagevimab-cilgavimab was based on data collected prior to the emergence of SARS-CoV-2 omicron variant and subvariants. Dosing recommendations changed twice based on neutralization data alone, leading to patients receiving different doses at varying intervals. We provid...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678513/ http://dx.doi.org/10.1093/ofid/ofad500.1176 |
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author | Dluzynski, Daniela Ssentongo, Paddy Shaheen, Shareef Maglakelidze, Natella Hale, Cory Henao, Maria Paula Chinchilli, Vernon M Paules, Catharine I |
author_facet | Dluzynski, Daniela Ssentongo, Paddy Shaheen, Shareef Maglakelidze, Natella Hale, Cory Henao, Maria Paula Chinchilli, Vernon M Paules, Catharine I |
author_sort | Dluzynski, Daniela |
collection | PubMed |
description | BACKGROUND: Emergency use of tixagevimab-cilgavimab was based on data collected prior to the emergence of SARS-CoV-2 omicron variant and subvariants. Dosing recommendations changed twice based on neutralization data alone, leading to patients receiving different doses at varying intervals. We provide real-world data on efficacy of tixagevimab-cilgavimab in immunocompromised patients throughout 2022, including the incidence and timing of infection based on dosing scheme. METHODS: Charts of 471 patients who received and 126 patients who declined administration of tixagevimab-cilgavimab were analyzed through December 14(th), 2022. We evaluated incidence of SARS-CoV2, severity, risk factors and vaccination status. For analysis, we grouped patients with similar dosing: Group A received one initial dose of 150mg/150mg of tixagevimab-cilgavimab, Group B received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1(st), and Group C patients were up to date with the FDA dosing guidelines. RESULTS: The tixagevimab-cilgavimab group had higher incidence of stem cell transplant or CAR T-cell therapy (115/471, 24% compared to 18/126, 14% p < 0.01) and had higher vaccination status (411/471, 89% compared to 37/126, 29%, p < 0.0001). Patients that received tixagevimab-cilgavimab had a trend towards higher incidence of SARS-CoV-2 infection (70/471, 15% compared to 11/126, 9%; p = 0.08). Incidence of SARS-CoV-2 was similar amongst all dosing groups (6/21, 29% in Group A; 37/251, 15% in Group B, and 27/199, 14% in Group C, p = 0.188). Group C experienced the most infections in November and early December 2022. [Figure: see text] Group A patients received one initial dose of 150 mg/150mg of tixagevimab-cilgavimab. Group B patients received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1st, 2022 . Group C patients were up to date with the FDA dosing guidelines. CONCLUSION: The tixagevimab-cilgavimab group demonstrated increased incidence of SARS-CoV-2. This may reflect increased healthcare system utilization, as most infections were self-reported in this study. Those with the FDA recommended dose were most likely to develop SARS-CoV-2 in November and December 2022 when circulating variants were not neutralized by tixagevimab-cilgavimab in vitro. This suggests in vitro neutralization data correlates with clinical efficacy. DISCLOSURES: All Authors: No reported disclosures |
format | Online Article Text |
id | pubmed-10678513 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-106785132023-11-27 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies Dluzynski, Daniela Ssentongo, Paddy Shaheen, Shareef Maglakelidze, Natella Hale, Cory Henao, Maria Paula Chinchilli, Vernon M Paules, Catharine I Open Forum Infect Dis Abstract BACKGROUND: Emergency use of tixagevimab-cilgavimab was based on data collected prior to the emergence of SARS-CoV-2 omicron variant and subvariants. Dosing recommendations changed twice based on neutralization data alone, leading to patients receiving different doses at varying intervals. We provide real-world data on efficacy of tixagevimab-cilgavimab in immunocompromised patients throughout 2022, including the incidence and timing of infection based on dosing scheme. METHODS: Charts of 471 patients who received and 126 patients who declined administration of tixagevimab-cilgavimab were analyzed through December 14(th), 2022. We evaluated incidence of SARS-CoV2, severity, risk factors and vaccination status. For analysis, we grouped patients with similar dosing: Group A received one initial dose of 150mg/150mg of tixagevimab-cilgavimab, Group B received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1(st), and Group C patients were up to date with the FDA dosing guidelines. RESULTS: The tixagevimab-cilgavimab group had higher incidence of stem cell transplant or CAR T-cell therapy (115/471, 24% compared to 18/126, 14% p < 0.01) and had higher vaccination status (411/471, 89% compared to 37/126, 29%, p < 0.0001). Patients that received tixagevimab-cilgavimab had a trend towards higher incidence of SARS-CoV-2 infection (70/471, 15% compared to 11/126, 9%; p = 0.08). Incidence of SARS-CoV-2 was similar amongst all dosing groups (6/21, 29% in Group A; 37/251, 15% in Group B, and 27/199, 14% in Group C, p = 0.188). Group C experienced the most infections in November and early December 2022. [Figure: see text] Group A patients received one initial dose of 150 mg/150mg of tixagevimab-cilgavimab. Group B patients received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1st, 2022 . Group C patients were up to date with the FDA dosing guidelines. CONCLUSION: The tixagevimab-cilgavimab group demonstrated increased incidence of SARS-CoV-2. This may reflect increased healthcare system utilization, as most infections were self-reported in this study. Those with the FDA recommended dose were most likely to develop SARS-CoV-2 in November and December 2022 when circulating variants were not neutralized by tixagevimab-cilgavimab in vitro. This suggests in vitro neutralization data correlates with clinical efficacy. DISCLOSURES: All Authors: No reported disclosures Oxford University Press 2023-11-27 /pmc/articles/PMC10678513/ http://dx.doi.org/10.1093/ofid/ofad500.1176 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Abstract Dluzynski, Daniela Ssentongo, Paddy Shaheen, Shareef Maglakelidze, Natella Hale, Cory Henao, Maria Paula Chinchilli, Vernon M Paules, Catharine I 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies |
title | 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies |
title_full | 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies |
title_fullStr | 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies |
title_full_unstemmed | 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies |
title_short | 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies |
title_sort | 1339. effects of tixagevimab-cilgavimab in clinical practice is consistent with preliminary neutralization studies |
topic | Abstract |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678513/ http://dx.doi.org/10.1093/ofid/ofad500.1176 |
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