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替沙格韦单抗和西加韦单抗(Evusheld)用于 1112 例严重免疫功能低下患者的 COVID-19 暴露前预防。

Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients.

机构信息

Service de Médecine Interne, Hôpital Cochin, Centre de référence maladies systémiques auto-immunes rares d'Ile-de-France, Assistance Publique, Hôpitaux de Paris (AP-HP), Centre, Université Paris Cité, Paris, France.

Service de Néphrologie, Hôpital Européen Georges Pompidou, France.

出版信息

Clin Microbiol Infect. 2022 Dec;28(12):1654.e1-1654.e4. doi: 10.1016/j.cmi.2022.07.015. Epub 2022 Aug 1.

Abstract

OBJECTIVE

Immunocompromised patients have an increased risk of a severe form of COVID-19. The clinical efficacy of the tixagevimab/cilgavimab monoclonal antibody combination as pre-exposure prophylaxis against BA.1 and BA.2 SARS-CoV-2 Omicron sublineages is unknown. We aimed to describe the incidence and outcomes of COVID-19 among immunocompromised patients receiving tixagevimab/cilgavimab as preexposure prophylaxis during the Omicron wave in France.

METHODS

This was an observational multicentre cohort study of immunocompromised patients receiving tixagevimab/cilgavimab as preexposure prophylaxis between December 28, 2021 and March 31, 2022. Patients received tixagevimab/cilgavimab 150/150 mg intramuscularly if they had impaired vaccine response and a high risk of severe form of COVID-19.

RESULTS

Tixagevimab/cilgavimab was administered to 1112 immunocompromised patients. After a median (range) follow-up of 63 (49-73) days, COVID-19 was confirmed in 49/1112 (4.4%) ≥5 days after treatment. During the study period, mean weekly incidence rate was 1669 in 100 000 inhabitants in Ile-de-France and 530 in 100 000 among patients who received tixagevimab/cilgavimab prophylaxis. Among infected patients, 43/49 (88%) had a mild-to-moderate form and 6/49 (12%) had a moderate-to-severe form of COVID-19. Patients with moderate-to-severe illnesses were less likely to have received early therapies than patients with mild forms (53.5% vs. 16.7% respectively) and 2/49 (4%) patients died from COVID-19.

DISCUSSION

Our study reported a low rate of infections and severe illnesses among immunocompromised patients treated with tixagevimab/cilgavimab. A global preventive strategy including vaccines, preexposure prophylaxis with monoclonal antibodies, and early therapies might be effective to prevent severe forms of COVID-19 among severely immunocompromised patients.

摘要

目的

免疫功能低下的患者罹患 COVID-19 严重型的风险增加。替沙格韦单抗/西加韦单抗单克隆抗体联合用药作为 BA.1 和 BA.2 奥密克戎亚谱系 SARS-CoV-2 的暴露前预防的临床疗效尚不清楚。本研究旨在描述在法国奥密克戎流行期间,接受替沙格韦单抗/西加韦单抗作为暴露前预防的免疫功能低下患者 COVID-19 的发病和结局。

方法

这是一项观察性多中心队列研究,纳入 2021 年 12 月 28 日至 2022 年 3 月 31 日期间接受替沙格韦单抗/西加韦单抗暴露前预防的免疫功能低下患者。如果患者疫苗反应受损且有罹患 COVID-19 严重型的高风险,则给予替沙格韦单抗/西加韦单抗 150/150 mg 肌内注射。

结果

替沙格韦单抗/西加韦单抗用于 1112 例免疫功能低下患者。中位(范围)随访 63(49-73)天,治疗后≥5 天有 49/1112(4.4%)例确诊 COVID-19。在研究期间,巴黎大区每 10 万人的每周平均发病率为 1669 例,接受替沙格韦单抗/西加韦单抗预防的患者为 530 例。在感染患者中,43/49(88%)为轻至中度,6/49(12%)为中至重度。患有中度至重度疾病的患者比患有轻度疾病的患者更不可能接受早期治疗(分别为 53.5%和 16.7%),49 例患者中有 2 例(4%)死于 COVID-19。

讨论

本研究报告了接受替沙格韦单抗/西加韦单抗治疗的免疫功能低下患者感染和重症疾病的发生率较低。包括疫苗、单克隆抗体暴露前预防和早期治疗在内的全球预防策略可能对预防严重免疫功能低下患者的 COVID-19 严重型有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0ed/9340091/9a30304f3011/gr1_lrg.jpg

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