2022 Oct 12;13:973768. doi: 10.3389/fphar.2022.973768. National Library of Medicine The Liverpool Drug Interaction Group, wellknown for providing detailed drug interactions for cancer therapeutics as well as drugs for the treatment of hepatitis B, hepatitis C, and HIV, recently launched a comprehensive website detailing drug interactions with experimental COVID19 therapies. In terms of CYP-related interactions with remdesivir, there are ample opportunities of modulating remdesivir metabolism due to the CYP inducers and inhibitors administered in COVID-19 patients [37]. Images sourced from PubChem Database, National Center for Biotechnology Information. 13 12 Cutrell, J.B. Pharmacologic treatments for coronavirus disease 2019 (COVID19): a review. [(accessed on 15 March 2021)]; Amiodarone Package Insert. Federal government websites often end in .gov or .mil. CYP3A4. Epub 2020 Oct 12. Safety, tolerability, and pharmacokinetics of remdesivir, an antiviral for treatment of COVID-19, in healthy subjects. The FDA has outlined that remdesivir should not be given to patients with eGFR less than 30 mL/min [15,18]. Humeniuk R, Mathias A, Cao H, Osinusi A, Shen G, Chng E, Ling J, Vu A, German P. Clin Transl Sci. For example, dexamethasone, which has been one of the mainstays of COVID-19 regimens, is an inducer of CES1 [61]. COVID-19 drug regimens and their classification as CYP inhibitors and inducers. Review of the basic and clinical pharmacology of sulfobutylethercydodextrin (SBECD). Laizure S.C., Herring V., Hu Z., Witbrodt K., Parker R.B. Remdesivir is also a weak inhibitor of CYP3A4, OATP1B1, OATP1B3, bile acid export pump, multidrug resistanceassociated protein 4, and sodiumtaurocholate cotransporter protein. Clinical laboratory evaluations were performed only on Day 5. The Full FDA EUA Prescribing Information released on May 1, 2020, notes that drugdrug interaction trials of remdesivir and other concomitant medication have not been conducted in humans and the clinical relevance of the in vitro studies have not been established, further underscoring the need for additional clinical studies. Would you like email updates of new search results? CES1 is one of the most abundant drug metabolizing enzymes and its levels are >5 fold higher than the most abundant CYP enzymes [60]. This. Rijpma S.R., van den Heuvel J.J.M.W., van der Velden M., Sauerwein R.W., Russel F.G., Koenderink J.B. Atovaquone and quinine anti-malarials inhibit ATP binding cassette transporter activity. Jorgensen S.C.J., Kebriaei R., Dresser L.D. Qian Y., Markowitz J.S. FOIA SBECD has been shown to accumulate in moderate to severe renal dysfunction and, in preclinical studies, has resulted in renal vacuolation. The clinical . and A.A.R. Authorization for emergency use of remdesivir for the treatment of COVID19 (letter). doi: 10.1021/acscentsci.0c00489. The majority of pharmacokinetic studies of remdesivir stem from in vitro, in vivo, and limited clinical studies for the treatment of Ebola. According to the Centers for Disease Control and Prevention (CDC) the most serious risk factors to severe COVID-19 infections are adults 65 years old, health care workers such as nurses in long-term care facilities, patients who are immunocompromised, and patients with pulmonary, cardiovascular, and endocrine diseases [9]. Intervirology. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: A systematic review and meta-analysis. Disclaimer. HHS Vulnerability Disclosure, Help 14 and transmitted securely. However, the study was terminated early due to failure to achieve its target enrollment and was, therefore, underpowered to show clinical benefit. This is an open access article under the terms of the, Compassionate use of remdesivir for patients with severe Covid19, Remdesivir in adults with severe COVID19: a randomised, doubleblind, placebocontrolled, multicentre trial. Dhama K., Sharun K., Tiwari R., Dadar M., Malik Y.S., Singh K.P., Chaicumpa W. COVID-19, an emerging coronavirus infection: Advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. See Pregnancy, Lactation, and COVID-19 Therapeutics for the Panels guidance regarding the use of remdesivir during pregnancy and lactation. Epub 2023 Feb 9. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. It binds to the viral RNA-dependent RNA polymerase and inhibits viral replication by terminating RNA transcription prematurely. National Library of Medicine 16 49% of the recovered dose is in the form of the metabolite GS-441524, and 10% is recovered as the unmetabolized parent compound. 1. On April 21, 2020, the National Institutes of Health (NIH) released their own COVID19 treatment guidelines. This is even more critical because of the ability of remdesivir to act as victim or perpetrator in drug interaction scenarios. Zhu W., Song L., Zhang H., Matoney L., LeCluyse E., Yan B. Dexamethasone differentially regulates expression of carboxylesterase genes in humans and rats. The case report outlined by Leegwater et al. The .gov means its official. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Wang Y., Wang Y., Chen Y., Qin Q. In addition, several commonly used diet and natural health supplements taken by the COVID-19 patients can influence its outcome. Efficacy of antiviral agents against the SARS-CoV-2 Omicron subvariant BA.2. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. 10, Published guidance regarding remdesivir metabolism and drugdrug interactions. The site is secure. Sklov L., Szotkov B., Machala M., Nea J., Souek P., Havlasov J., Wsl V., Kdov L., Kvasnikov E., Lamka J. & eCollection 2022. San Francisco Centers for Disease Control and Prevention (CDC) People Who Are at Higher Risk for Severe Illness. World Health Organization (WHO) Coronavirus Disease (COVID-19) Pandemic. As such, there are 57 isoforms of human CYP enzymes that are responsible for the biotransformation of endobiotic and xenobiotic substances including COVID-19 medications [36]. Varis T., Kivisto K.T., Backman J.T., Neuvonen P.J. Based upon these data, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of remdesivir for the treatment of hospitalized patients with COVID19 on May 1, 2020. Remdesivir, baricinitib, and anakinra can be used concomitantly with antipsychotics without risk of drug-drug interaction (except for hematological risk with clozapine and baricinitib). Profiles Drug Subst Excip Relat Methodol. World Health Organization (WHO) WHO Coronavirus Disease (COVID-19) Dashboard. However, metabolism of remdesivir is believed to be mediated predominantly via hydrolases and not CYP enzymes, as noted above. 2021;1(1):15. doi: 10.1186/s44149-021-00017-5. Although there are no published drugdrug interaction studies with remdesivir, there are published guidance on the management of potential drug interactions (Table The clearance and volume of distribution ranged from 755 mL/min to 719 mL/min and 45.1 L to 66.5 L, respectively. 1 Clipboard, Search History, and several other advanced features are temporarily unavailable. Curr Res Pharmacol Drug Discov. World Health Organization (WHO) WHO Coronavirus Disease (COVID-19) Dashboard. Cytochrome P450 3A-mediated microsomal biotransformation of 1alpha,25-dihydroxyvitamin D3 in mouse and human liver: Drug-related induction and inhibition of catabolism. European Medicines Agency Committee for Human Medicinal Products. sharing sensitive information, make sure youre on a federal In Vitro and In Vivo Drug-Drug Interaction Study of the Effects of Ivermectin and Oxantel Pamoate on Tribendimidine. 2023 Mar;116(3):317-320. doi: 10.14423/SMJ.0000000000001519. 1 Jodlowski, T.Z. Schlamm, H.T. Inside the cell, remdesivir undergoes metabolic activation to form the intracellular active triphosphate metabolite, GS-443902 (detected in peripheral blood mononuclear cells), and ultimately, the renally eliminated plasma metabolite GS-441524. As a library, NLM provides access to scientific literature. Remdesivir is used to treat coronavirus disease, also known as COVID-19, for certain patients who are in the hospital. https://creativecommons.org/licenses/by/4.0/, https://www.who.int/emergencies/diseases/novel-coronavirus-2019, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html, https://www.who.int/teams/blueprint/covid-19, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment#:~:text=The%20emergency%20use%20authorization%20allows,children%20hospitalized%20with%20severe%20disease, https://www.ema.europa.eu/en/documents/other/summary-compassionate-use-remdesivir-gilead_en.pdf, https://www.fda.gov/media/137566/download, https://www.covid19treatmentguidelines.nih.gov/, https://www.rxabbvie.com/pdf/kaletratabpi.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf, https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers, https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf, CES, CYP3A4, CYP2C8, CYP2D6, P-gp, OATP1B1. Received 2020 Apr 24; Revised 2020 Apr 17; Accepted 2020 May 11. For the treatment of COVID19, remdesivir is given as a 200mg i.v. An official website of the United States government. ACS Cent. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Unauthorized use of these marks is strictly prohibited. The brand name is Veklury. PMC The U.S. Food and Drug Administration (FDA) is advising health care workers of a potential interaction when remdesivir is co-administered with chloroquine phosphate or hydroxychloroquine sulfate. https://www.who.int/emergencies/diseases/novel-coronavirus-2019. 2021;24:277-291. doi: 10.18433/jpps32011. Takahashi T., Luzum J.A., Nicol M.R., Jacobson P.A. Unauthorized use of these marks is strictly prohibited. Coronavirus disease 2019 (COVID19) treatment guidelines. Gottlieb RL, Vaca CE, Paredes R, et al. This is in contrast to a recent review of COVID19 pharmacologic therapeutics published in JAMA, which states that while not a significant inducer/inhibitor of CYP enzymes, monitor with strong inducers/inhibitors. Route of elimination. The results are consistent with a systematic review of observational studies13 and other retrospective studies that have reported that the use of remdesivir was not associated with an increased incidence of adverse effects in patients with COVID-19 who had baseline eGFRs of <30 mL/min.14 These data suggest that remdesivir can be used in patients with an eGFR of <30 mL/min if the potential benefits outweigh the risks. There were also no statistically significant differences between the arms in the need for new dialysis, the need for new mechanical ventilation, or mortality. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. https://www.who.int/news-room/detail/29-06-2020-covidtimeline, Humeniuk R, Mathias A, Cao H, Osinusi A, Shen G, Chng E, et al. By understanding these properties, clinicians can prevent subtherapeutic and supratherapeutic levels of remdesivir and thus avoid further complications in COVID-19 patients. Making Sense of Mutation: What D614G Means for the COVID-19 Pandemic Remains Unclear. 11 Coronavirus disease 2019 (COVID-19): a literature review. All authors have read and agreed to the published version of the manuscript. Likewise, the knowledge of induction and inhibition profile of the drug in question is important to predict and characterize its effects on the metabolism of other co-administered agents (perpetrator). Chemical structures of remdesivir (GS5734) and the nucleoside metabolite, GS441524. The intravenous administration of remdesivir affords patients to achieve therapeutically meaningful plasma concentrations. Interestingly, the parent remdesivir prodrug PK characteristics for 150 mg/day either for 7 days or 14 days were comparable. Results: The main interactions between COVID-19 drugs and antipsychotics are the risk of QT-prolongation and TdP, and cytochromes P450 interactions. In a comprehensive dose escalation study with healthy volunteers, single or multiple dose regimens of remdesivir were studied for up to 14 days. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Would you like email updates of new search results? Likewise, drugs used to manage COVID-19 comorbidities such as cardiovascular diseases (e.g., telmisartan, carvedilol, diltiazem, nitrendipine, procainamide, quinidine) and hyperlipidemia (e.g., simvastatin, fenofibrate) can inhibit CES1 [62,63] and block the conversion of remdesivir to its intermediate and active metabolites. As of April 30, 2020, the global pandemic of SARSCoV2 infections has resulted in >3.4 million cases of coronavirus disease 2019 (COVID19) and almost 240,000 deaths worldwide. The clinical relevance of lower RDV levels is unknown. The interaction between antiviral agents and hepatic transporters may result in hepatotoxicity and adverse drug . injection on day 1, followed by 100mg i.v. However, the focus of the clinical analyses should be on drugs used to treat COVID . Transporters, CYP enzymes, and CES1 are involved in remdesivir disposition. Special populations with hepatic and renal dysfunction have demonstrated indications of differential pharmacokinetics and have the potential for toxicity from remdesivir. To understand the potential drug-drug interactions of remdesivir, we must identify drugs that may be given before, with, and immediately after remdesivir administration. HHS Vulnerability Disclosure, Help We comply with the HONcode standard for trustworthy health information. Gotte, M. The antiviral compound remdesivir potently inhibits RNAdependent RNA polymerase from Middle East respiratory syndrome coronavirus, Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019nCoV) in vitro, Discovery and synthesis of a phosphoramidate prodrug of a Pyrrolo[2,1f][triazin4amino] adenine CNucleoside (GS5734) for the treatment of Ebola and emerging viruses. The potential drug-drug interactions could complicate the treatment outcomes of COVID-19. J Infect Public Health. Remdesivir has demonstrated in vitro and in vivo activity against SARS-CoV-2.1 Remdesivir retains in vitro neutralization activity against the Omicron variant and its subvariants.2-5. The .gov means its official. Remdesivir is an investigational drug, now in clinical trials in the US. Remdesivir (GS5734), developed by Gilead Sciences, has recently emerged as a promising new antiviral agent against SARSCoV2. Experience at a large tertiary urban medical center. COVID-19 Treatment Guidelines Panel, National Institutes of Health (NIH) Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Additional research is needed on remdesivirs ADME interactions with COVID-19 drug regimens and drugs used to treat preexisting conditions for better treatment outcomes. As a library, NLM provides access to scientific literature. correctly noted that the initial ACTT protocol erroneously stated that remdesivir is a prodrug that is metabolized to its active form as a substrate of CYP3A4 when, in fact, remdesivir is activated to the active metabolite GG441524 via plasma carboxylesterases and metabolized by hydrolases. Coronaviridae. Conceptualization, S.D. This has led to an urgency to develop new pharmacologic treatment options. Remdesivir (RDV, Veklury) is a once-daily, nucleoside ribonucleic acid polymerase inhibitor of severe acute respiratory syndrome coronavirus 2 replication. Using physiologically based pharmacokinetic modeling, RDV is not predicted to be a clinically significant inhibitor of drug-metabolizing enzymes or transporters in patients infected with COVID-19 at therapeutic RDV doses. Enzyme-mediated bioactivation or inactivation of drugs can occur in most of the organs in mammals. 2014. 1983;20:181189. Remdesivir has wide distribution to most tissues, including the kidneys, liver, prostate gland, and salivary gland, but does not cross the bloodbrain barrier. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. It is also used to treat mild to moderate COVID-19 in non-hospitalized patients who are at high risk for progression to severe COVID-19 (eg, hospitalization, death). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (, remdesivir, ADME, pharmacokinetics, COVID-19, cytochrome P450, drug interaction, transporter. 1, followed by 100mg i.v during Pregnancy and Lactation is unknown with healthy volunteers, or. Induction and inhibition of catabolism et al taken by the COVID-19 Pandemic Remains Unclear ( remdesivir drug interactions levitra professional ) doi! 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