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Abstract
Introduction: Respiratory Syncytial Virus (RSV) is one of the most common and severe causes of lower respiratory tract infections in infants, with the leading cause of paediatric hospitalization globally, especially in resource-constrained countries. Currently, there are not many preventive strategies available: one of the newest drugs is Nirsevimab with moderate effectiveness; however, it has a high price and limited availability. To assess its effectiveness, conducting a meta-analysis of available data is critical to make recommendations on clinical management of the RSV disease and public health policies to reduce the burden of the disease in the affected population.
Methods: A systematic search was conducted in PubMed, Cochrane Central, Scopus, and Google Scholar for studies published from 2022 onward. Eligible studies included randomized controlled trials (RCTs) and observational cohorts assessing the impact of Nirsevimab on RSV outcomes. Risk of bias was evaluated using the Newcastle-Ottawa Scale for observational studies and the Cochrane RoB 2.0 tool for RCTs. Meta-analyses were conducted to estimate pooled relative risks (RRs) with 95% confidence intervals (CI). Heterogeneity was assessed using the I² statistic, and meta-regression was examined through bubble plot analysis.
Results: Seven studies (four cohort and three RCTs), comprising 82,446 infants, met the inclusion criteria. Nirsevimab significantly reduced the risk of RSV-related hospitalization (RR: 0.14; 95% CI: 0.09–0.20; I² = 67%) and ICU admission (RR: 0.11; 95% CI: 0.06–0.18; I² = 23%). It also lowered the need for primary (RR: 0.40) and emergency care (RR: 0.28), and showed efficacy in preventing RSV A (RR: 0.25) and RSV B infections (RR: 0.24). No significant increase in adverse events was observed. Subgroup and sensitivity analyses confirmed robustness of findings, though heterogeneity was noted.
Conclusion: Nirsevimab provides a high efficacy in the prevention of RSV-associated hospitalizations and severe infection in infants with an acceptable safety profile. It has potential as a preventive intervention and could go a long way to reduce the burden caused by RSV on this group of patients. More research is necessary to assess long-term results and the effectiveness of Nirvesimab in the population.