eGFR 30 mL/min/1.73m²未満患者におけるレムデシビル減量投与と標準量投与の臨床的検討：有効性および安全性

抄録

Remdesivir has been approved for use in patients with severe renal impairment following evidence from a phase 3, randomized, double-blind, placebo-controlled study (the REDPINE trial) demonstrating its safety in those with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m². However, subsequent meta-analyses have reported safety concerns. Therefore, reduced-dose regimens may offer potential benefits, including a lower likelihood of concentration-dependent adverse events and reduced drug-related costs. Despite these considerations, clinical evidence comparing the effectiveness and safety of reduced-dose vs standard-dose remdesivir in this population remains limited. This single-center retrospective observational study included patients with COVID-19 and eGFR < 30 mL/min/1.73m² who received remdesivir between January 2022 and December 2024. Patients were categorized into a reduced-dose group based on the regimen proposed by Sukeishi et al, or a standard-dose group according to the package insert. The primary outcome was 28-day mortality. The secondary outcomes included adverse events (hepatic enzyme elevation, potassium abnormalities, and acute kidney injury). This study included 36 patients in the effectiveness analysis and 24 patients in the safety analysis. The 28-day mortality rate was identical between the groups (16.7％ vs 16.7％). No clear differences were observed in the overall safety outcomes, although aspartate aminotransferase (AST) elevation and acute kidney injury tended to occur more frequently in the standard-dose group. Reduced-dose remdesivir was associated with no apparent difference in 28-day mortality and no clear overall safety disadvantage compared with standard dosing in patients with severe renal impairment.