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BACKGROUND

Respiratory syncytial virus (RSV) is a major cause of hospitalisations and deaths among infants worldwide. France was one of the first countries to implement a national programme (beginning on Sept 15, 2023) for administration of nirsevimab, a single-dose long-acting monoclonal antibody treatment, to infants born on or after Feb 6, 2023, to prevent lower respiratory tract infection caused by RSV. We aimed to estimate the effectiveness of nirsevimab and the number of hospitalisations averted in children younger than 24 months in real-world settings.

METHODS

In this modelling study, we developed an age-structured deterministic model characterising RSV transmission as well as plausible scenarios for the administration of nirsevimab doses based on maternity ward and community pharmacy supply data. We retrospectively estimated nirsevimab effectiveness in infants younger than 24 months during the 2023-24 RSV season in France (excluding overseas territories) and the number of averted hospitalisations for RSV bronchiolitis occurring after emergency department visits, by calibrating the model to hospital and virological surveillance data from Aug 21, 2017, to Feb 4, 2024, alongside serological data from a previous cross-sectional study. To assess the robustness of our estimates, we conducted sensitivity analyses in which we modified our assumptions about the number of doses administered, the reconstruction of the number of RSV-associated hospitalisations for bronchiolitis, the duration of maternal and post-infection immunity to RSV, and the number of contacts in children aged 0-2 months.

FINDINGS

We estimated that nirsevimab administration prevented 5800 (95% credible interval 3700-7800) RSV-associated hospitalisations for bronchiolitis after emergency department visits among children younger than 24 months, including 4200 (2900-5600) hospitalisations among those aged 0-2 months, between Sept 15, 2023 (the date nirsevimab was introduced), and Feb 4, 2024-a 23% (16-30) reduction in the total number of hospitalisations and a 35% (25-44) reduction in the 0-2 months age group, compared with the scenario without administration. In our baseline scenario, in which we estimated that 215 000 doses of nirsevimab were administered by Jan 31, 2024, the estimated effectiveness against RSV-associated hospitalisations for bronchiolitis was 73% (61-84), corresponding to one hospitalisation averted for every 39 (26-54) doses administered. In sensitivity analyses, nirsevimab remained effective against RSV-associated hospitalisations for bronchiolitis after emergency department attendance.

INTERPRETATION

Our findings show that nirsevimab administration campaigns could effectively reduce the RSV-related hospital burden of bronchiolitis in children younger than 24 months.

FUNDING

European Commission, Laboratoire d'Excellence Integrative Biology of Emerging Infectious Diseases programme, and INCEPTION project.

背景

呼吸道合胞病毒（RSV）是全球导致婴儿住院和死亡的主要原因之一。法国是最早实施国家计划（从 2023 年 9 月 15 日开始）的国家之一，为 2023 年 2 月 6 日或之后出生的婴儿接种 nirsevimab，这是一种单剂量长效单克隆抗体治疗药物，以预防 RSV 引起的下呼吸道感染。我们旨在估计 nirsevimab 的有效性以及在现实环境中 24 个月以下儿童的住院人数。

方法

在这项建模研究中，我们开发了一个年龄结构的确定性模型，该模型描述了 RSV 的传播情况，以及根据产房和社区药房供应数据进行 nirsevimab 剂量管理的可能情况。我们根据医院和病毒学监测数据以及之前的横断面研究中的血清学数据，对 2023-24 年 RSV 季节期间法国（不包括海外领地）24 个月以下婴儿的 nirsevimab 有效性和因急诊就诊后发生的 RSV 细支气管炎而避免的住院人数进行了回顾性估计。为了评估我们估计的稳健性，我们进行了敏感性分析，其中我们修改了我们对管理的剂量数、RSV 相关细支气管炎住院人数的重建、母婴和感染后对 RSV 免疫力的持续时间以及 0-2 个月儿童的接触人数的假设。

发现

我们估计，nirsevimab 的管理可预防 24 个月以下儿童因急诊就诊后发生的 RSV 相关细支气管炎住院 5800 例（95%可信区间为 3700-7800 例），其中 0-2 个月组有 4200 例（2900-5600 例），在 2023 年 9 月 15 日（nirsevimab 推出之日）至 2024 年 2 月 4 日期间，与不进行管理的情况相比，总住院人数减少 23%（16-30%），0-2 个月组减少 35%（25-44%）。在我们的基线情景中，我们估计到 2024 年 1 月 31 日，将管理 215000 剂 nirsevimab，对 RSV 相关细支气管炎住院的估计有效性为 73%（61-84），这意味着每管理 39 剂（26-54 剂）就可预防 1 例住院。在敏感性分析中，nirsevimab 对急诊就诊后 RSV 相关细支气管炎住院仍有效。

解释

我们的研究结果表明，nirsevimab 管理活动可有效降低 24 个月以下儿童 RSV 相关细支气管炎的住院负担。

资金

欧洲委员会、卓越综合传染病生物学实验室计划和 INCEPTION 项目。

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