Remdesivir use in hospitalized children with COVID-19: hepatic and systemic safety

Abstract

Safety data regarding remdesivir in pediatric populations remain limited, particularly for those with complex comorbidities. This study evaluated the hepatic and systemic safety of remdesivir in hospitalized children with COVID-19 by comparing treated patients to a control group receiving no antiviral therapy. This single-center, retrospective case-control study included 76 hospitalized children: 42 children treated with remdesivir and 34 controls. Clinical and laboratory parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, creatinine, and C-reactive protein were asse- ssed at baseline and at peak during hospitalization. Clinical severity was evaluated using the World Health Organization clinical progression ordinal scale. To isolate treatment-emergent hepatotoxicity, patients presenting with baseline transaminase elevations > 2 × the upper limit of normal (ULN) were excluded from hepatic sub-analyses. The treated group was significantly older (median 12.3 vs. 2.3 years; p < 0.001) and required longer hospitalization (median 10 vs. 5 days; p < 0.001). Baseline disease severity was comparable (p = 0.173), though all patients requiring mechanical ventilation were in the treated cohort. Peak ALT and AST values were significantly higher in the remdesivir group (ALT: 51.0 vs. 22.5 U/l, p = 0.006; AST: 47.0 vs. 38.0 U/l, p = 0.033). Treatment-emergent ALT elevation > 2 × ULN occurred in 19.0% of treated patients vs. 5.9% of controls (p = 0.039). However, all elevations were transient and not associated with clinically significant hepatic dysfunction or treatment discontinuation. No significant differences were observed in bilirubin or creatinine levels between groups. Mortality (7.1%) occurred only among critically ill patients with severe comorbidities and was not attributed to remdesivir toxicity. Remdesivir is associated with transient, manageable elevations in liver enzymes but demonstrates a favorable safety profile in hospitalized children. These findings support its use in pediatric COVID-19 management, even among those with significant underlying comorbidities.