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Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.
Clin Gastroenterol Hepatol. 2020 11; 18(12):2835-2836.CG

Abstract

Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection.1,2 In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19.3 In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported.4,5 In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n = 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0).6 Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients.

Authors+Show Affiliations

Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France. Electronic address: francois.montastruc@univ-tlse3.fr.Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France.

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

32721580

Citation

Montastruc, François, et al. "Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 18, no. 12, 2020, pp. 2835-2836.
Montastruc F, Thuriot S, Durrieu G. Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019. Clin Gastroenterol Hepatol. 2020;18(12):2835-2836.
Montastruc, F., Thuriot, S., & Durrieu, G. (2020). Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 18(12), 2835-2836. https://doi.org/10.1016/j.cgh.2020.07.050
Montastruc F, Thuriot S, Durrieu G. Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019. Clin Gastroenterol Hepatol. 2020;18(12):2835-2836. PubMed PMID: 32721580.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019. AU - Montastruc,François, AU - Thuriot,Samuel, AU - Durrieu,Geneviève, Y1 - 2020/07/25/ PY - 2020/07/15/received PY - 2020/07/22/revised PY - 2020/07/24/accepted PY - 2020/7/30/pubmed PY - 2020/11/6/medline PY - 2020/7/30/entrez SP - 2835 EP - 2836 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin Gastroenterol Hepatol VL - 18 IS - 12 N2 - Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection.1,2 In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19.3 In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported.4,5 In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n = 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0).6 Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients. SN - 1542-7714 UR - https://www.unboundmedicine.com/medline/citation/32721580/Hepatic_Disorders_With_the_Use_of_Remdesivir_for_Coronavirus_2019_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(20)31060-0 DB - PRIME DP - Unbound Medicine ER -