Chicago Department of Public Health, Chicago, Illinois, USA.
Rush University Medical Center, Chicago, Illinois, USA.
Transpl Infect Dis. 2024 Feb;26(1):e14194. doi: 10.1111/tid.14194. Epub 2023 Nov 21.
There are limited real-world data on the effectiveness of tixagevimab-cilgavimab as pre-exposure prophylaxis of COVID-19. We describe lessons learned when coordinating data collection and identifying breakthrough SARS-CoV-2 infections among patients across indications and institutions in a major US city. The Chicago Department of Public Health requested patient-level tixagevimab-cilgavimab administration data from all prescribing providers in Chicago, for treatments December 8, 2021 through June 30, 2022. Records were matched to COVID-19 vaccinations and laboratory-confirmed SARS-CoV-2 infections through December 31, 2022. Due to difficulty collecting data from all providers, targeted follow-up was conducted to improve completeness on key variables (demographics, vaccination status, clinical indication for prophylaxis). Over half of reported tixagevimab-cilgavimab administrations were to patients residing outside Chicago. Five hundred forty-four Chicago residents who received at least one dose of tixagevimab-cilgavimab were included in this analysis. Most were age 50 years or older (72%), Black non-Latinx (33%) or White non-Latinx (29%), and fully vaccinated (80%). Seventy-five patients (14%) had laboratory-confirmed COVID-19. Patients with and without breakthrough infections were demographically similar. Clinical indication was missing for >95% of cases, improved to 64% after follow-up; the most frequently specified was hematologic malignancy (10%). Severe outcomes were uncommon: 16% had documented COVID-19-related hospitalizations, one death was identified. Tixagevimab-cilgavimab recipients in Chicago had a lower rate of severe SARS-CoV-2 infection than reported among other untreated high-risk patients, including during predominance of non-neutralizing variants. Improving stakeholder collaboration is essential for generation of real-world effectiveness data, informing pandemic preparedness and optimizing use of medical countermeasures.
关于替沙格韦单抗-西加韦单抗作为 COVID-19 暴露前预防的实际效果，目前相关数据有限。我们介绍了在美国主要城市的多个机构，针对不同适应证的患者，在协调数据收集并确定突破性 SARS-CoV-2 感染时所获得的经验教训。芝加哥公共卫生部向芝加哥所有开具处方的医疗机构请求了替沙格韦单抗-西加韦单抗的患者用药数据，涵盖 2021 年 12 月 8 日至 2022 年 6 月 30 日的治疗数据。通过与截至 2022 年 12 月 31 日的 COVID-19 疫苗接种和实验室确诊的 SARS-CoV-2 感染记录进行匹配，确定了患者的用药信息。由于从所有提供者那里收集数据存在困难，因此进行了针对性的随访，以提高关键变量（人口统计学、疫苗接种状态、预防用药的临床适应证）的完整性。报告的替沙格韦单抗-西加韦单抗给药中，有一半以上是给居住在芝加哥以外的患者。本分析共纳入 544 名至少接受一剂替沙格韦单抗-西加韦单抗的芝加哥居民。大多数患者年龄在 50 岁或以上（72%）、非拉丁裔黑人（33%）或非拉丁裔白人（29%），并且已完全接种疫苗（80%）。75 名患者（14%）实验室确诊 COVID-19。有和无突破性感染的患者在人口统计学上相似。临床适应证缺失率>95%，随访后提高至 64%；最常指定的适应证是血液恶性肿瘤（10%）。严重结局少见：16%的患者有记录的 COVID-19 相关住院治疗，发现 1 例死亡。与其他未经治疗的高危患者（包括非中和变异株流行期间）相比，芝加哥的替沙格韦单抗-西加韦单抗接受者 SARS-CoV-2 感染的严重程度较低。加强利益相关者合作对于生成真实世界的效果数据至关重要，这将为大流行的准备和优化使用医疗对策提供信息。
