尼塞韦单抗和双价母体疫苗对意大利婴儿呼吸道合胞病毒感染中的临床和经济影响。
完整摘要 · 中文译文
目的：本研究旨在评估尼塞韦单抗和母体疫苗在预防意大利全体进入首个呼吸道合胞病毒（RSV）流行季的新生儿队列中就医（MA）RSV相关下呼吸道感染（LRTIs）方面的潜在临床和经济影响，并与无预防策略的情况进行比较。 方法：采用先前发表的静态决策树模型进行成本-后果分析，以估计在单个RSV流行季中每种免疫策略所避免的RSV-MA-LRTIs及相关中长期并发症。尼塞韦单抗的效力来源于3期MELODY和2b期临床试验的汇总分析，并考虑6个月保护期且效力恒定。对于母体免疫（MI），足月婴儿的效力来源于MATISSE临床试验，并考虑至6月龄。两种预防策略均假定从第7个月起效力为零。分析的时间范围对应于一个RSV流行季。基础病例采用国家卫生服务体系（NHS）视角。 结果：从NHS视角来看，在首个RSV流行季，与无预防策略相比，MI免疫策略可导致减少68，358例RSV-MA-LRTIs和6，417例相关中长期并发症。这些RSV相关健康事件的减少可转化为约2450万欧元的经济节省。与无预防策略相比，尼塞韦单抗免疫策略 可减少118,123例呼吸道合胞病毒（RSV）所致下呼吸道感染（RSV-MA-LRTI），以及8,480例相关的中长期并发症。与这些RSV相关健康事件减少相关的经济节约估计为3,420万欧元。 结论：两种预防策略均为预防婴儿RSV感染的有效措施。除确保对孕妇和婴儿父母进行适当咨询以避免错过这些针对RSV的免疫接种机会外，还应评估这两种策略的组织影响。这些发现可为公共卫生决策提供支持，并为未来政策策略提供参考。
完整摘要 · 英文原文
OBJECTIVE: This study aimed to estimate the potential clinical and economic impact of nirsevimab and of a maternal vaccine in the prevention of medically attended (MA) RSV-associated lower respiratory tract infections (LRTIs) in the entire cohort of newborns entering their first RSV season in Italy compared with the absence of prevention strategies. METHODS: A cost-consequence analysis using a static decision tree model previously published was conducted to estimate the RSV-MA-LRTIs and associated mid-long-term complications avoided with each immunization strategy during a single RSV epidemic season. Nirsevimab efficacy was derived from the pooled analysis of Phase 3 MELODY and Phase 2b clinical trials and a protection of 6 months with constant efficacy was considered. For maternal immunization (MI), the efficacy for term infants was derived from MATISSE clinical trial and it was considered until 6 months of age. Zero efficacy was assumed starting from the seventh month for both preventive strategies. The time horizon of the analysis corresponding to one RSV epidemic season. National Health Service (NHS) perspective was considered in the base-case. RESULTS: From the NHS perspective, over the first RSV season, the immunization strategy with MI compared with no preventive strategies could lead to a reduction of 68,358 RSV-MA-LRTIs and 6,417 associated mid-long-term complications. These reductions in terms of RSV‑related health events can be translated into economic savings of about € 24.5 million. The immunization strategy with nirsevimab compared with no preventive strategies could lead to a reduction of 118,123 RSV-MA-LRTIs, 8,480 associated mid-long-term complications. The economic saving associated with these reductions in terms of RSV-related health events was estimated equal to € 34.2 million. CONCLUSION: Both preventive strategies represent effective measures for the prevention of RSV infections in infants. The organizational impact of these two strategies should also be assessed, in addition to ensuring appropriate counselling for pregnant women and the parents of infants, to avoid missing these immunization opportunities against RSV. These findings may support public health decision-making and inform future policy strategies.