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Recommendations for Dosing of Repurposed COVID-19 Medications in Patients with Renal and Hepatic Impairment
Fiona Marra1,2, Elise J Smolders3,4, Omar El-Sherif5
1Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK. fmarra@liverpool.ac.uk.
Introduction:
In December 2019, an outbreak of a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began, resulting in a number of antivirals and immune modulators being repurposed to treat the associated coronavirus disease 2019 (COVID-19). Many patients requiring treatment for COVID-19 may have either pre-existing renal or hepatic disease or experience acute renal/hepatic injury as a result of the acute infection. Altered renal or hepatic function can significantly affect drug concentrations of medications due to impaired drug metabolism and excretion, resulting in toxicity or reduced efficacy. The aim of this paper is to review the pharmacokinetics and available study data for the experimental COVID-19 therapies in patients with any degree of renal or hepatic impairment to make recommendations for dosing.
Methods:
COVID-19 agents included in these recommendations were listed as primaries on the University of Liverpool COVID-19 drug interaction website ( www.covid19-druginteractions.org ), initially identified from Clinicialtrials.gov and ChicCTR.org.cn. A literature search was performed using PubMed and EMBASE as well as product licences and pharmacokinetic databases.
Findings:
Remdesivir, dexamethasone, azithromycin, favipiravir, lopinavir/ritonavir, atazanavir, hydroxychloroquine, interferon beta, ribavirin, tocilizumab, anakinra and sarilumab were identified as experimental drugs being used in COVID-19 trials as of November 2020. Limited study data was found for these drugs in patients with renal or hepatic impairment for COVID-19 or other indications. Recommendations were made based on available data, consideration of pharmacokinetic properties (including variability), the dosing and anticipated treatment duration of each regimen in COVID-19 and known toxicities.
Conclusion:
Dosing of drugs used to treat COVID-19 in patients with renal or hepatic impairment is complex. These recommendations were produced to provide guidance to clinicians worldwide who are treating patients with COVID-19, many of whom will have some degree of acute or chronic renal or hepatic impairment.
Insights
Dosing experimental COVID-19 drugs in patients with kidney or liver impairment is complex. This review provides dosing recommendations for these vulnerable populations to optimize treatment efficacy and safety.
Area of Science:
- Pharmacology
- Infectious Diseases
- Nephrology
- Hepatology
Background:
- The COVID-19 pandemic necessitated the repurposing of antivirals and immune modulators.
- Patients with COVID-19 often have pre-existing or acute renal/hepatic impairment.
- Impaired organ function affects drug metabolism and excretion, risking toxicity or reduced efficacy.
Purpose of the Study:
- To review pharmacokinetics and available data for experimental COVID-19 therapies.
- To provide dosing recommendations for patients with renal or hepatic impairment.
- To address the complexity of drug dosing in this patient population.
Main Methods:
- Identified COVID-19 agents from the University of Liverpool drug interaction website.
- Conducted a literature search using PubMed, EMBASE, and pharmacokinetic databases.
- Included agents initially identified from ClinicalTrials.gov and ChicCTR.org.cn.
Main Results:
- Eleven experimental COVID-19 drugs were identified (e.g., remdesivir, dexamethasone, tocilizumab).
- Limited study data exists for these drugs in renally or hepatically impaired patients.
- Recommendations were based on available data, pharmacokinetics, dosing, and toxicity.
Conclusions:
- Dosing of COVID-19 treatments in patients with renal or hepatic impairment is challenging.
- These recommendations offer guidance for clinicians globally.
- The guidance addresses the needs of patients with varying degrees of organ impairment.
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