Abstract：
Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections (LRTIs) and hospital admissions in early childhood. Recent advancements in novel preventive therapies, including extended half-life monoclonal antibodies and antenatal vaccination, have afforded new opportunities to significantly reduce the burden of this infection. Nirsevimab is a novel monoclonal antibody that provides sustained protection against RSV for at least 5 months among newborns and young children. It has received regulatory approval in numerous countries and is being implemented across various settings. Two pivotal Phase 3 trials (MELODY, HARMONIE) demonstrated significant reductions in RSV-associated LRTI hospitalisations following nirsevimab administration, with treatment efficacy of 62.1% and 83.2%. Emerging real-world data from early adopters of nirsevimab corroborates these findings. Studies from Spain, Luxembourg, France and the USA report effectiveness rates between 82% and 90% in preventing RSV-associated hospitalisations among infants entering their first RSV season. Current implementation strategies for nirsevimab have primarily focused on seasonal administration for all infants, aligned to local RSV seasons, and often include catch-up doses for those born before the season begins. Available cost-effectiveness analyses indicate that while nirsevimab offers significant potential public health benefits, its adoption must carefully consider economic factors such as treatment costs, implementation strategies tailored to local viral epidemiology, and logistics for vaccine delivery. Overall, nirsevimab presents a promising opportunity to alleviate the burden of severe RSV infections in young children. However, ongoing surveillance and refinements in implementation strategies are crucial to optimise its impact and ensure sustainability across diverse health-care settings.
摘要：
呼吸道合胞病毒（RSV）是儿童早期急性下呼吸道感染（LRTIs）和住院的主要原因。新型预防性疗法的最新进展，包括延长半衰期的单克隆抗体和产前疫苗接种，提供了新的机会来显著减轻这种感染的负担。Nirsevimab是一种新型单克隆抗体，可在新生儿和幼儿中提供至少5个月的持续RSV保护。它已在许多国家/地区获得监管部门的批准，并正在各种环境中实施。两个关键的第三阶段试验(MELODY，HARMONIE）在服用nirsevimab后，RSV相关的LRTI住院治疗显着减少，治疗有效率分别为62.1%和83.2%。来自nirsevimab早期采用者的新兴现实世界数据证实了这些发现。来自西班牙的研究，卢森堡,法国和美国报告，在进入第一个RSV季节的婴儿中，预防RSV相关住院的有效率在82％至90％之间。目前nirsevimab的实施策略主要侧重于所有婴儿的季节性管理，与当地RSV季节一致，通常包括在季节开始之前出生的人的补足剂量。现有的成本效益分析表明，虽然nirsevimab具有显著的潜在公共卫生效益，它的采用必须仔细考虑经济因素，如治疗成本，针对当地病毒流行病学的实施策略，和疫苗交付的物流。总的来说,nirsevimab为减轻幼儿严重RSV感染的负担提供了一个有希望的机会。然而,持续的监督和实施策略的改进对于优化其影响和确保各种医疗保健环境的可持续性至关重要。
