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remdesivir (Veklury)

Indications: - has been tested against Ebola virus - clinical trials of remdesivir for treatment of SARS CoV-2 promising [2,4] - clinical benefit in patients with severe COVID-19 - may confer modest clinical benefit in hospitalized patients with moderate COVID-19 - remdesivir with no clinical or antiviral benefit in hospitalized Covid-19 patients [16] - FDA-approved for all hospitalized patients with COVID-19 [8,10] - adding remdesivir to standard care improves outcomes (including pulmonary function & mortality) among hospitalized adult patients with COVID-19 [20] - FDA issues emergency use authorization for baricitinib-remdesivir combination to treat hospitalized COVID-19 patients >= 2 years who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation [11] (guideline withdrawn) [12] - remdesivir of no benefit for mechanically ventilated COVID-19 patients [22] - in other hospitalised patients, remdesivir has a small benefit for mortality death or need for mechanical ventilation (or both). [22] - outpatient treatment of Covid-19 (prevention of hospitalization) - 87% reduction in risk for COVID-19-related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) in high-risk patients [18] - requires 3 IV infusions on consecutive days - may be useful in skilled nursing home setting Contraindications: - initiation of remdesivir not recommended in patients who require mechanical ventilation [12,13, 21] or extracorporeal membrane oxygenation [13] - remdesivir treatment of Covid-19 is not associated with improved survival but is associated with longer hospital stays [15] Benefit/risk: - superior to placebo in COVID-19 adult patients hospitalized with evidence of lower respiratory tract infection - shortening time to recovery - including non-white hospitalized patients [14] - diminishing mortality 7.1% vs 11.9% for placebo [4] - no mortality benefit [9,14] Dosage: - 200 mg IV loading dose on day 1, then 100 mg IV QD for total of 5 days [21] - consider increasing duration of therapy to 10 days if mechanical ventilation or ECMO becomes necessary* [4,21] * patients with severe COVID-19 not requiring mechanical ventilation, 5 days of remdesivir may be as beneficial as 10 days [6] Mechanism of action: - nucleotide analog - broad spectrum antiviral [4] Clinical trials: - superior to placebo in COVID-19 adult patients hospitalized with evidence of lower respiratory tract infection - shortening time to recovery, median of 10 vs 15 days [4] - diminishing mortality 11% vs 15% for placebo [4] - clinical improvement in 68% of patients hospitalized for severe Covid-19 treated with remdesivir [4] - controlled trial of remdesivir is currently underway in China [2] - mistakenly released data from China show no clinical benefit from remdesivir in patients with severe COVID-19 [2] - World Health Organization - remdesivir does not reduce mortality in hospitalized patients with COVID-19 nor does it shorten recovery time [9] Notes: - cost: $520/100-mg vial, totaling $3,120 for a 5-day treatment [17]

General

antiviral agent

Database Correlations

PUBCHEM cid=121304016

References

  1. PubChem: 121304016
  2. Brink D Remdesivir Under Study as Treatment for Novel Coronavirus. Medscape - Feb 07, 2020. https://www.medscape.com/viewarticle/924964 - Walker M. Remdesivir Fails in Severe COVID-19 Trial in China. No clinical benefit between groups in randomized trial, mistakenly released data show. MedPage Today April 23, 2020
  3. Wang M, Cao R, Zhang L et al Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. PMID: 32020029 Free PMC Article
  4. Grein J, Ohmagari N, Shin D et al Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. April 10, 2020 PMID: 32275812 https://www.nejm.org/doi/full/10.1056/NEJMoa2007016 - National Institutes of Health NIH clinical trial of remdesivir to treat COVID-19 begins News Release. Feb 25, 2020 https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins - Beigel JH, Tomashek KM, Dodd LE et al Remdesivir for the Treatment of Covid-19 - Preliminary Report. N Engl J Med. May 22, 2020 PMID: 32445440 https://www.nejm.org/doi/full/10.1056/NEJMoa2007764 - Beigel JH, Tomashek KM, Dodd LE et al. Remdesivir for the treatment of Covid-19 - Final report. N Engl J Med 2020 Oct 8; [e-pub]. PMID: 32445440 Free PMC article. https://www.nejm.org/doi/10.1056/NEJMoa2007764
  5. Wikipedia: Remdesivir https://en.wikipedia.org/wiki/Remdesivir
  6. Goldman JD, Lye DCB, Hui DS et al. Remdesivir for 5 or 10 days in patients with severe Covid-19. N Engl J Med 2020 May 27; PMID: 32459919 https://www.nejm.org/doi/10.1056/NEJMoa2015301 - Dolin R, Hirsch MS Remdesivir - An Important First Step N Engl J Med. May 27, 2020. PMID: 32459913 https://www.nejm.org/doi/full/10.1056/NEJMe2018715
  7. Spinner CD, Gottlieb RL, Criner GJ et al Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19A Randomized Clinical Trial. JAMA. Published online August 21, 2020 PMID: 32821939 PMCID: PMC7442954 Free PMC article https://jamanetwork.com/journals/jama/fullarticle/2769871
  8. FDA News Release. Aug 28, 2020 COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19.
  9. Ellis R Remdesivir Does Not Reduce COVID-19 Mortality, Study Says. Medscape - Oct 16, 2020. https://www.medscape.com/viewarticle/939289
  10. Ingram I FDA OKs Remdesivir, First Drug for COVID-19 - - Approval comes a week after WHO trial showed no survival benefit. MedPage Today October 22, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/89281 - Kincaid E FDA Approves Remdesivir, First Treatment for COVID-19 - Medscape - Oct 22, 2020 - American Medical Association AMA Morning Rounds. October 23, 2020 - FDA News Release. Oct 22, 2020 FDA Approves First Treatment for COVID-19. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19
  11. FDA News Release. Vov 19, 2020 Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19
  12. NIH COVID-19 Treatment Guidelines. December 3, 2020 Therapeutic Management of Patients with COVID-19 https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/
  13. Qaseem A, Yost J Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 2) Ann Intern Med 2021. Feb 9 https://www.acpjournals.org/doi/10.7326/M20-8101
  14. Garibaldi BT et al Comparison of Time to Clinical Improvement With vs Without Remdesivir Treatment in Hospitalized Patients With COVID-19. JAMA Netw Open 2021 PMID: 33760094 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777863
  15. Ohl ME, Miller DR, Lund BC et al Association of Remdesivir Treatment With Survival and Length of Hospital Stay Among US Veterans Hospitalized With COVID-19. JAMA Netw Open. 2021;4(7):e2114741 PMID: 34264329 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2781959
  16. Barratt-Due A et al. Evaluation of the effects of remdesivir and hydroxychloroquine on viral clearance in COVID-19: A randomized trial. Ann Intern Med 2021 Jul 13; PMID: 34251903 PMCID: PMC8279143 Free PMC article https://www.acpjournals.org/doi/10.7326/M21-0653
  17. Bergman SJ COVID-19 Treatment: Investigational Drugs and Other Therapies. Mesdcape. August 18, 2021 https://emedicine.medscape.com/article/2500116-overview
  18. Frellick M Remdesivir Sharply Cuts COVID Hospitalization Risk, Gilead Says. Medscape. September 22, 2021 https://www.medscape.com/viewarticle/959284 - Ellis R Remdesivir May Keep Unvaccinated Out of the Hospital: Study. Medscape. December 23, 2021 https://www.medscape.com/viewarticle/965521 - Gottlieb RL, Vaca CE, Paredes R et al. Early remdesivir to prevent progression to severe Covid-19 in outpatients. N Engl J Med 2021 Dec 22; [e-pub]. PMID: 34937145 https://www.nejm.org/doi/10.1056/NEJMoa2116846
  19. Remdesivir (Rx) Medscape https://reference.medscape.com/drug/veklury-remdesivir-4000090
  20. Ali K, Azher T, Baqi M et al. Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: A randomized controlled trial. CMAJ 2022 Jan 19; [e-pub]. PMID: 35045989 Free article https://www.cmaj.ca/content/early/2022/01/19/cmaj.211698 - Marrone A, Nevola R, Sellitto A et al. Remdesivir plus dexamethasone versus dexamethasone alone for the treatment of COVID-19 patients requiring supplemental O2 therapy: A prospective controlled non-randomized study. Clin Infect Dis 2022 Jan 27; [e-pub]. PMID: 35084022 PMCID: PMC8807307 Free PMC article https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac014/6515763
  21. Reuters Staff No Change in ACP Advice on Remdesivir for Hospitalized COVID-19 Patients. Medscape. March 1, 2022 https://www.medscape.com/viewarticle/969367
  22. WHO Solidarity Trial Consortium. Remdesivir and three other drugs for hospitalised patients with COVID-19: Final results of the WHO Solidarity randomised trial and updated meta-analyses. Lancet May 2; [e-pub] PMID: 35512728 PMCID: PMC9060606 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00519-0/fulltext