Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.
Identifieur interne : 000E50 ( Main/Exploration ); précédent : 000E49; suivant : 000E51Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.
Auteurs : François Montastruc [France] ; Samuel Thuriot [France] ; Geneviève Durrieu [France]Source :
- Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [ 1542-7714 ] ; 2020.
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.
DOI: 10.1016/j.cgh.2020.07.050
PubMed: 32721580
PubMed Central: PMC7381904
Affiliations:
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Electronic address: francois.montastruc@univ-tlse3.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>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</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Thuriot, Samuel" sort="Thuriot, Samuel" uniqKey="Thuriot S" first="Samuel" last="Thuriot">Samuel Thuriot</name><affiliation wicri:level="3"><nlm:affiliation>Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Durrieu, Genevieve" sort="Durrieu, Genevieve" uniqKey="Durrieu G" first="Geneviève" last="Durrieu">Geneviève Durrieu</name><affiliation wicri:level="3"><nlm:affiliation>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.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>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</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author></analytic><series><title level="j">Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association</title><idno type="eISSN">1542-7714</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.<sup>1</sup><sup>,</sup><sup>2</sup> 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.<sup>3</sup> 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.<sup>4</sup><sup>,</sup><sup>5</sup> 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).<sup>6</sup> 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.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32721580</PMID><DateRevised><Year>2020</Year><Month>09</Month><Day>09</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1542-7714</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Jul</Month><Day>25</Day></PubDate></JournalIssue><Title>Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association</Title><ISOAbbreviation>Clin. Gastroenterol. Hepatol.</ISOAbbreviation></Journal><ArticleTitle>Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">S1542-3565(20)31060-0</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.cgh.2020.07.050</ELocationID><Abstract><AbstractText>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.<sup>1</sup><sup>,</sup><sup>2</sup> 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.<sup>3</sup> 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.<sup>4</sup><sup>,</sup><sup>5</sup> 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).<sup>6</sup> 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.</AbstractText><CopyrightInformation>Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Montastruc</LastName><ForeName>François</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thuriot</LastName><ForeName>Samuel</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Durrieu</LastName><ForeName>Geneviève</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>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.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Gastroenterol Hepatol</MedlineTA><NlmUniqueID>101160775</NlmUniqueID><ISSNLinking>1542-3565</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>07</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>07</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>07</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32721580</ArticleId><ArticleId IdType="pii">S1542-3565(20)31060-0</ArticleId><ArticleId IdType="doi">10.1016/j.cgh.2020.07.050</ArticleId><ArticleId IdType="pmc">PMC7381904</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Therapie. 2019 Apr;74(2):225-232</Citation><ArticleIdList><ArticleId IdType="pubmed">30773344</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 May 16;395(10236):1569-1578</Citation><ArticleIdList><ArticleId IdType="pubmed">32423584</ArticleId></ArticleIdList></Reference><Reference><Citation>Pharmacol Res. 2020 Aug;158:104899</Citation><ArticleIdList><ArticleId IdType="pubmed">32407959</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 May 27;:</Citation><ArticleIdList><ArticleId IdType="pubmed">32459919</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 Jun 11;382(24):2327-2336</Citation><ArticleIdList><ArticleId IdType="pubmed">32275812</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>France</li></country><region><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li></region><settlement><li>Toulouse</li></settlement></list><tree><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Montastruc, Francois" sort="Montastruc, Francois" uniqKey="Montastruc F" first="François" last="Montastruc">François Montastruc</name></region><name sortKey="Durrieu, Genevieve" sort="Durrieu, Genevieve" uniqKey="Durrieu G" first="Geneviève" last="Durrieu">Geneviève Durrieu</name><name sortKey="Thuriot, Samuel" sort="Thuriot, Samuel" uniqKey="Thuriot S" first="Samuel" last="Thuriot">Samuel Thuriot</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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