Baloxavir marboxil 2mg/ml oral suspension sugar free

Objective Comparing the clinical efficacy and safety of baloxavir marboxil and oseltamivir against influenza viruses in children, to provide theoretical references for clinical practice. Methods A systematic search of PubMed, Embase, Web of Science, Cochrane Library, Epistemonikos, CNKI, Wipu.com, Wan Fang Database, and China Biomedical Literature Database for articles published up to December 25th, 2024, was conducted. After literature screening, data extraction, and quality evaluation, descriptive analysis was performed. Results Eight papers were included, comprising three randomized controlled studies and Five cohort studies, involving 3141 patients (1745 in the baloxavir marboxil group and 1396 in the oseltamivir group). Meta-analysis revealed no significant differences in time to remission of influenza symptoms and duration of fever between the two groups. However, baloxavir marboxil demonstrated a significantly greater reduction in influenza virus titer and RNA load. Additionally, the incidence of adverse events was significantly lower with baloxavir marboxil (p = 0.03). Conclusions Baloxavir marboxil appears more effective than oseltamivir in reducing viral load and is associated with fewer adverse events in children with influenza, while both drugs yield comparable effects in relieving symptoms. Given the limited number of included studies and absence of subgroup analyses, further well-designed trials are needed to corroborate these findings. PROSPERO Registration Number: CRD42024565338

Abstract licence: CC BY 4.0

ObjectiveThis systematic review aimed to assess the clinical effectiveness and safety profile of baloxavir marboxil for managing influenza in pediatric populations.MethodsThis review has been registered on the INPLASY platform (INPLASY2025110063). Designed in accordance with the PRISMA 2020 guidelines, we searched four major biomedical databases (PubMed, Embase, Web of Science, Cochrane Library) covering publications from January 1, 2015, to January 30, 2025. Eligibility criteria encompassed both randomized controlled trials and observational cohort studies evaluating this antiviral agent in children with laboratory-confirmed influenza. Methodological rigor was appraised using the Cochrane Collaboration's risk of bias instrument for randomized controlled trials (RCTs) and the Newcastle-Ottawa Quality Assessment Scale for cohort studies. Statistical synthesis was conducted using RevMan 5.3 software (Version 5.3.5) with metafor package implementation.ResultsOur analysis incorporated 12 clinical investigations involving a total of 4,586 patients. A random-effects model meta-analysis demonstrated that, compared to neuraminidase inhibitors (oseltamivir, zanamivir, peramivir, laninamivir), baloxavir marboxil achieved accelerated resolution of febrile symptoms (MD = −13.16 h, 95% CI: −19.16 to −7.15, P < 0.0001). Subgroup analyses stratified by viral subtype demonstrated consistent therapeutic advantages in influenza A infections (random-effects model, MD = −9.40 h, 95% CI: −18.31 to −0.49, P = 0.04), particularly regarding time to symptom alleviation (fixed-effect model, MD = −8.50 hours, 95% CI: −13.14 to −3.86, P = 0.0003). Safety assessments indicated a 59% reduction in drug-related adverse events relative to oseltamivir (fixed-effect model, OR 0.41, 95% CI 0.31–0.56; P < 0.001), while total adverse event rates showed comparable incidence between treatment arms (fixed-effect model, OR = 0.85, 95% CI: 0.69–1.05, P = 0.14).ConclusionThese findings suggest baloxavir marboxil demonstrates faster fever resolution and a favorable safety profile in pediatric influenza management. However, continuous monitoring for baloxavir-resistant mutations (such as PA/I38T) in the pediatric population is warranted. Furthermore, confirmation through large-scale multicenter trials with extended follow-up periods remains warranted.

Abstract licence: CC BY 4.0