Howard Nick, Pudim Edward
Market Access & Healthcare Consulting, Cencora, Conshohocken, PA, USA.
ForHealth Consulting, UMass Chan Medical School, Shrewsbury, MA, USA.
Ann Pharmacother. 2025 Jan 2:10600280241302085. doi: 10.1177/10600280241302085.
The objective was to describe the pharmacology, efficacy, safety, and recommendations for the use of newly approved preventive agents and vaccines for respiratory syncytial virus (RSV) and discuss their uptake during the 2023 to 2024 RSV season.
A literature search of PubMed was performed (January 2020 to February 2024) with the search terms RSV vaccine, preventive antibody, and RSV prevention. Utilization data were collected from TriNetX using the US Collaborative Network (May 2024) using the terms palivizumab, nirsevimab, and RSV prefusion F protein.
Relevant English-language studies assessing the use of Food and Drug Administration (FDA)-approved preventive agents and vaccines for RSV in humans were considered. Population-level utilization data were extracted from TriNetX.
Nirsevimab was observed to have noninferior efficacy and safety compared with palivizumab with less frequent administration. Nirsevimab is recommended to replace palivizumab for RSV prophylaxis in all eligible infants. Arexvy and Abrysvo are effective at reducing the risk of RSV infection in adults aged ≥60 years, and Arexvy is indicated in adults aged ≥50 years. These vaccines are equally recommended for use in the elderly adult population, but only Abrysvo is indicated and recommended for maternal administration. Most infants only require prophylaxis through either maternal RSV vaccination or nirsevimab administration.
This review compares the indications for use, guideline recommendations, and clinical trial efficacy and safety data for palivizumab, nirsevimab, Abrysvo, and Arexvy to guide clinical decision-making.
Novel RSV preventive agents, including Abrysvo, Arexvy, and nirsevimab, offer less burdensome dosing and administration compared with palivizumab, show promising efficacy and safety data, and expand the populations eligible for RSV prevention. Updated clinical guidance supports immediate adoption of these agents in practice, and population-level data suggest these agents were used during the 2023 to 2024 RSV season.
描述新批准的呼吸道合胞病毒（RSV）预防药物和疫苗的药理学、疗效、安全性及使用建议，并讨论其在2023至2024年RSV流行季的使用情况。
于2020年1月至2024年2月在PubMed上进行文献检索，检索词为RSV疫苗、预防性抗体和RSV预防。利用数据于2024年5月从TriNetX使用美国协作网络收集，检索词为帕利珠单抗、尼塞韦单抗和RSV预融合F蛋白。
纳入评估美国食品药品监督管理局（FDA）批准的用于人类RSV预防药物和疫苗使用情况的相关英文研究。从TriNetX提取人群水平的利用数据。
观察到尼塞韦单抗与帕利珠单抗相比具有非劣效的疗效和安全性，且给药频率更低。建议在所有符合条件的婴儿中用尼塞韦单抗替代帕利珠单抗进行RSV预防。Arexvy和Abrysvo可有效降低≥60岁成年人感染RSV的风险，Arexvy适用于≥50岁的成年人。同样建议在老年人群中使用这些疫苗，但仅Abrysvo被批准并推荐用于孕妇接种。大多数婴儿仅需通过孕妇接种RSV疫苗或使用尼塞韦单抗进行预防。
本综述比较了帕利珠单抗、尼塞韦单抗、Abrysvo和Arexvy的使用指征、指南推荐以及临床试验的疗效和安全性数据，以指导临床决策。
新型RSV预防药物，包括Abrysvo、Arexvy和尼塞韦单抗，与帕利珠单抗相比，给药负担和管理负担更小，显示出有前景的疗效和安全性数据，并扩大了符合RSV预防条件的人群范围。更新后的临床指南支持在实践中立即采用这些药物，人群水平的数据表明这些药物在2023至2024年RSV流行季期间得到了使用。
