Abstract: TH-PO1097
A Meta-Analysis to Evaluate the Safety of Remdesivir in Patients with Reduced Renal Function
Session Information
- COVID-19 - I
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Coronavirus (COVID-19)
- 000 Coronavirus (COVID-19)
Authors
- Chandramohan, Deepak, The University of Alabama at Birmingham, Birmingham, Alabama, United States
- Chandramohan, Divya, The University of Texas at San Antonio, San Antonio, Texas, United States
- Deotare, Apoorv, The University of Alabama at Birmingham, Birmingham, Alabama, United States
- Pujari, Ashwini S., The University of Alabama at Birmingham, Birmingham, Alabama, United States
- Avula, Sreekant, University of Minnesota Twin Cities School of Medicine, Minneapolis, Minnesota, United States
Background
Remdesivir is approved by the U.S. FDA for treating coronavirus disease-2019 (COVID-19). However, the clinical trials assessing remdesivir’s efficacy did not include patients on dialysis and those with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2. Sulfobutylether-β-cyclodextrin (SCEBD), the solubilizing excipient used in intravenous formulations could accumulate in renal tubules causing further renal dysfunction. We performed a meta-analysis to find the safety profile of this therapeutic agent.
Methods
We systematically searched PubMed, Google Scholar, EMBASE, Cochrane, Web of Science and Clinical trials.gov from inception to January 2023 to identify studies with CKD and ESRD patients over 18 years of age with COVID-19 who received Remdesivir therapy. Using a random effects model, proportional effect sizes were calculated. The heterogeneity between study-specific estimates was assessed by the I2 statistics. The primary outcome were the pooled rates of liver failure, renal failure and serious adverse effects. Secondary outcomes assessed were requirements of oxygen, mechanical ventilation, and mortality rate.
Results
Eighteen studies (764 patients) met the inclusion criteria. 58.3% (95% CI: 49.5-66.6; I2= 76.9%) were males. 82.6% (95% CI: 65.3-92.3; I2= 87.7%) were ESRD on dialysis. Severe liver failure occurred in 1.6% (95% CI:0.6-3.9; I2= 0%). The rate of renal failure in eGFR of <30 mL/min/1.73 m2 was 8.9% (95% CI:4.6-16.5; I2= 0%). The pooled proportion of all serious adverse effects due to remdesivir was 2.9% (95% CI:1.3-6.4; I2= 7.8%). 17.7% (95% CI: 13.0-23.7; I2= 62.5%) were on mechanical ventilation. The mortality rate in CKD and ESRD patients treated with remdesivir was 26.8% (95% CI: 21.1- 33.5; I2= 65.4%).
Conclusion
The use of remdesivir in CKD and ESRD is relatively safe from our meta-analysis. Randomized clinical trials are needed to further evaluate the safety and other adverse effects of remdesivir in this population.