Background: Respiratory syncytial virus (RSV) accounts for a significant health burden worldwide. A systematic literature review was conducted to understand the burden of RSV and its clinical sequelae, and healthcare resource utilization for RSV among U.S. infants and children up to 5 years of age.

Results: The literature searches identified 5,454 de-duplicated articles that were reviewed for relevance at the level of title and abstract. Approximately 18% were eligible for full-text review. Of these, approximately 35% were eligible for data abstraction leading to ~397 publications included in the qualitative synthesis.  A significant RSV burden was observed in the literature among infants and children up to 5 years of age. A majority of the articles were limited to the inpatient setting and focused on infants and children with comorbidities. Most studies presented indicators on inpatient hospital encounters and emergency department visits from analyses of claims and payer databases; cohort data were few and data for the outpatient setting were limited. This review highlights the need for systematic primary data generation, particularly for the outpatient setting, given the limited information available in the existing literature.

Conclusion: While the results of this review may be generalizable only to the patient populations and geographic areas included in the studies, this comprehensive review compiled information on RSV burden in all clinical settings. The potential gaps, biases, and limitations in the literature are also summarized in a critical assessment.