Safety of Remdesivir in Patients With Reduced Renal Function

The US Food and Drug Administration has approved remdesivir for the treatment of COVID-19. The clinical trials examining the efficacy and safety of remdesivir did not include patients with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or those on dialysis.

According to Deepak Chandramohan and colleagues, the solubilizing excipient used in intravenous formulations of remdesivir (sulfobutylether-ß-cyclodextrin) may accumulate in renal tubules, causing further renal dysfunction.

To define the safety profile of remdesivir, the researchers conducted a meta-analysis. Results were reported during a poster presentation at the American Society of Nephrology Kidney Week 2023 in a poster titled A Meta-Analysis to Evaluate the Safety of Remdesivir in Patients With Reduced Renal Function.

The systematic search of included PubMed, Google Scholar, EMBASE, Cochrane, Web of Science, and clinicaltrials.gov from inception to January 2023. Studies of interest were those with populations of patients more than 18 years of age with chronic kidney disease and end-stage kidney disease (ESKD) who received therapy with remdesivir.

The primary outcomes of interest were the pooled rates of liver failure, renal failure, and serious adverse events. Secondary outcomes were requirements for oxygen and mechanical ventilation, and mortality rate.

A total of 18 studies representing 764 patients met inclusion criteria. Of the 764 patients, 58.3% were male, 82.6% had ESKD and were receiving dialysis.

Analysis of the primary outcomes revealed that 1.6% of the patient population experienced liver failure, and 8.9% of  patients with eGFR <30 mL/min/1.73 m² had renal failure.

The pooled proportion of all serious adverse effects related to remdesivir was 2.9%, and 17.7% of the patients were required mechanical ventilation. The mortality rate in patients with CKD or ESKD treated with remdesivir was 26.8%.

“The use of remdesivir in CKD and ESKD is relatively safe from our meta-analysis,” the researchers said. “Randomized clinical trials are needed to further evaluate the safety and other adverse effects of remdesivir in this population.”

Source: Chandramohan Deepak, Chandramohan Divya, Deotare A, Pujari AS, Avula S. A meta-analysis to evaluate the safety of remdesivir in patients with reduced renal function. TH-PO1097. Abstract of a poster presented at the American Society of Nephrology Kidney Week 2023; November 2, 2023; Philadelphia, Pennsylvania.