A Valid Warning or Clinical Lore: An Evaluation of Safety Outcomes of Remdesivir in Patients with Impaired Renal Function from a Multicenter Matched Cohort.
Objective: Per prescribing guidance, remdesivir is not recommended for SARS-CoV-2 in patients with renal disease given the absence of safety data in this patient population. Methods: This study was a multi-center, retrospective chart review of hospitalized patients with SARS-CoV-2 who received remdesivir. Safety outcomes were compared between patients with an estimated creatinine clearance (eCrCl) < 30 mL/min and an eCrCl ≥ 30 mL/min. The primary endpoint was acute kidney injury (AKI) at the end of treatment (EOT). Results: Of 359 patients who received remdesivir, 347 met inclusion criteria. Patients with an eCrCl < 30 mL/min were older [median, 80 years (IQR, 63.8-89) versus 62 (IQR, 54-74); P<0.001], were more likely to be on vasopressors on the day of remdesivir administration (30% versus 12.7%; P=0.003), and were more likely to be mechanically ventilated during remdesivir therapy (27.5% versus 12.4%; P=0.01) compared to those with an eCrCl ≥ 30 mL/min. Despite these confounders, there was no significant difference in the frequency of EOT AKI (5% versus 2.3%; P=0.283) or early discontinuation due to abnormal LFTs (0% versus 3.9%; P=0.374). Of the 5% of patients who developed EOT AKI on remdesivir with an eCrCl <30mL/min, no cases were attributable to remdesivir administration per the treating physician. Comparable safety outcomes were observed when 1:1 nearest neighbor matching was applied to account for baseline confounders. Conclusion: Remdesivir administration was not significantly associated with increased EOT AKI in patients with an eCrCl < 30mL/min compared to patients with an eCrCl ≥ 30mL/min.