Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era
<h4>Background</h4> Pre-exposure prophylaxis for COVID-19 with tixagevimab/cilgavimab (T/C) received Emergency Use Authorization (EUA) based on results of a clinical trial conducted prior to the emergence of the Omicron variant. The clinical effectiveness of T/C has not been well describ...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2023-01-01
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| Series: | PLoS ONE |
| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10138227/?tool=EBI |
| _version_ | 1797836031327731712 |
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| author | Benjamin Chen Nina Haste Nancy Binkin Nancy Law Lucy E. Horton Nancy Yam Victor Chen Shira Abeles |
| author_facet | Benjamin Chen Nina Haste Nancy Binkin Nancy Law Lucy E. Horton Nancy Yam Victor Chen Shira Abeles |
| author_sort | Benjamin Chen |
| collection | DOAJ |
| description | <h4>Background</h4> Pre-exposure prophylaxis for COVID-19 with tixagevimab/cilgavimab (T/C) received Emergency Use Authorization (EUA) based on results of a clinical trial conducted prior to the emergence of the Omicron variant. The clinical effectiveness of T/C has not been well described in the Omicron era. We examined the incidence of symptomatic illness and hospitalizations among T/C recipients when Omicron accounted for virtually all local cases. <h4>Methods</h4> Through retrospective electronic medical record chart review, we identified patients who received T/C between January 1 –July 31, 2022 within our quaternary referral health system. We determined the incidence of symptomatic COVID-19 infections and hospitalizations due to or presumed to be caused by early Omicron variants before and after receiving T/C (pre-T/C and post-T/C). Chi square and Mann-Whitney Wilcoxon two-sample tests were used to examine differences between the characteristics of those who got COVID-19 before or after T/C prophylaxis, and rate ratios (RR) and 95% confidence intervals (CI) were calculated to assess differences in hospitalization rates for the two groups. <h4>Results</h4> Of 1295 T/C recipients, 105 (8.1%) developed symptomatic COVID-19 infection before receiving T/C, and 102 (7.9%) developed symptomatic disease after receiving it. Of the 105 patients who developed symptomatic infection pre-T/C, 26 (24.8%) were hospitalized, compared with six of the 102 patients (5.9%) who were diagnosed with COVID-19 post-T/C (RR = 0.24; 95% CI = 0.10–0.55; p = 0.0002). Seven of the 105 (6.7%) patients infected pre-T/C, but none of the 102 infected post-T/C required ICU care. No COVID-related deaths occurred in either group. The majority of COVID-19 cases among those infected pre-T/C treatment occurred during the Omicron BA.1 surge, while the majority of post-T/C cases occurred when Omicron BA.5 was predominant. In both groups, having at least one dose of vaccine strongly protected against hospitalization (pre-T/C group RR = 0.31, 95% CI = 0.17–0.57, p = 0.02; post-T/C group RR = 0.15; 95% CI = 0.03–0.94; p = 0.04). <h4>Conclusion</h4> We identified COVID-19 infections after T/C prophylaxis. Among patients who received T/C at our institution, COVID-19 Omicron cases occurring after T/C were one-fourth as likely to require hospitalization compared to those with Omicron prior to T/C. However, due to the presence of changing vaccine coverage, multiple therapies, and changing variants, the effectiveness of T/C in the Omicron era remains difficult to assess. |
| first_indexed | 2024-04-09T15:03:10Z |
| format | Article |
| id | doaj.art-9c1f54ff3c1f45169b427368c90cc445 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-09T15:03:10Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-9c1f54ff3c1f45169b427368c90cc4452023-05-01T05:31:31ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01184Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron eraBenjamin ChenNina HasteNancy BinkinNancy LawLucy E. HortonNancy YamVictor ChenShira Abeles<h4>Background</h4> Pre-exposure prophylaxis for COVID-19 with tixagevimab/cilgavimab (T/C) received Emergency Use Authorization (EUA) based on results of a clinical trial conducted prior to the emergence of the Omicron variant. The clinical effectiveness of T/C has not been well described in the Omicron era. We examined the incidence of symptomatic illness and hospitalizations among T/C recipients when Omicron accounted for virtually all local cases. <h4>Methods</h4> Through retrospective electronic medical record chart review, we identified patients who received T/C between January 1 –July 31, 2022 within our quaternary referral health system. We determined the incidence of symptomatic COVID-19 infections and hospitalizations due to or presumed to be caused by early Omicron variants before and after receiving T/C (pre-T/C and post-T/C). Chi square and Mann-Whitney Wilcoxon two-sample tests were used to examine differences between the characteristics of those who got COVID-19 before or after T/C prophylaxis, and rate ratios (RR) and 95% confidence intervals (CI) were calculated to assess differences in hospitalization rates for the two groups. <h4>Results</h4> Of 1295 T/C recipients, 105 (8.1%) developed symptomatic COVID-19 infection before receiving T/C, and 102 (7.9%) developed symptomatic disease after receiving it. Of the 105 patients who developed symptomatic infection pre-T/C, 26 (24.8%) were hospitalized, compared with six of the 102 patients (5.9%) who were diagnosed with COVID-19 post-T/C (RR = 0.24; 95% CI = 0.10–0.55; p = 0.0002). Seven of the 105 (6.7%) patients infected pre-T/C, but none of the 102 infected post-T/C required ICU care. No COVID-related deaths occurred in either group. The majority of COVID-19 cases among those infected pre-T/C treatment occurred during the Omicron BA.1 surge, while the majority of post-T/C cases occurred when Omicron BA.5 was predominant. In both groups, having at least one dose of vaccine strongly protected against hospitalization (pre-T/C group RR = 0.31, 95% CI = 0.17–0.57, p = 0.02; post-T/C group RR = 0.15; 95% CI = 0.03–0.94; p = 0.04). <h4>Conclusion</h4> We identified COVID-19 infections after T/C prophylaxis. Among patients who received T/C at our institution, COVID-19 Omicron cases occurring after T/C were one-fourth as likely to require hospitalization compared to those with Omicron prior to T/C. However, due to the presence of changing vaccine coverage, multiple therapies, and changing variants, the effectiveness of T/C in the Omicron era remains difficult to assess.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10138227/?tool=EBI |
| spellingShingle | Benjamin Chen Nina Haste Nancy Binkin Nancy Law Lucy E. Horton Nancy Yam Victor Chen Shira Abeles Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era PLoS ONE |
| title | Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era |
| title_full | Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era |
| title_fullStr | Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era |
| title_full_unstemmed | Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era |
| title_short | Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era |
| title_sort | real world effectiveness of tixagevimab cilgavimab evusheld in the omicron era |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10138227/?tool=EBI |
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