remdesivir (Veklury)
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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who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation[11] (guideline withdrawn)[12]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
- 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]
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
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
- controlled trial of remdesivir is currently underway in China[2]
- World Health Organization
- remdesivir does not reduce mortality in hospitalized patients with COVID-19 nor does it shorten recovery time[9]
Notes
More general terms
References
- ↑ PubChem: 121304016
- ↑ 2.0 2.1 2.2 2.3 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 - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/32020029 Free PMC Article
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/32445440 Free PMC article. https://www.nejm.org/doi/10.1056/NEJMoa2007764 - ↑ Wikipedia: Remdesivir https://en.wikipedia.org/wiki/Remdesivir
- ↑ 6.0 6.1 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/32459913 https://www.nejm.org/doi/full/10.1056/NEJMe2018715 - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/32821939 PMCID: PMC7442954 Free PMC article https://jamanetwork.com/journals/jama/fullarticle/2769871
- ↑ 8.0 8.1 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.
- ↑ 9.0 9.1 9.2 Ellis R Remdesivir Does Not Reduce COVID-19 Mortality, Study Says. Medscape - Oct 16, 2020. https://www.medscape.com/viewarticle/939289
- ↑ 10.0 10.1 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 - ↑ 11.0 11.1 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
- ↑ 12.0 12.1 NIH COVID-19 Treatment Guidelines. December 3, 2020 Therapeutic Management of Patients with COVID-19 https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/
- ↑ 13.0 13.1 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
- ↑ 14.0 14.1 14.2 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: https://www.ncbi.nlm.nih.gov/pubmed/33760094 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777863
- ↑ 15.0 15.1 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: https://www.ncbi.nlm.nih.gov/pubmed/34264329 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2781959
- ↑ 16.0 16.1 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: https://www.ncbi.nlm.nih.gov/pubmed/34251903 PMCID: PMC8279143 Free PMC article https://www.acpjournals.org/doi/10.7326/M21-0653
- ↑ 17.0 17.1 Bergman SJ COVID-19 Treatment: Investigational Drugs and Other Therapies. Mesdcape. August 18, 2021 https://emedicine.medscape.com/article/2500116-overview
- ↑ 18.0 18.1 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: https://www.ncbi.nlm.nih.gov/pubmed/34937145 https://www.nejm.org/doi/10.1056/NEJMoa2116846 - ↑ Remdesivir (Rx) Medscape https://reference.medscape.com/drug/veklury-remdesivir-4000090
- ↑ 20.0 20.1 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/35084022 PMCID: PMC8807307 Free PMC article https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac014/6515763 - ↑ 21.0 21.1 21.2 Reuters Staff No Change in ACP Advice on Remdesivir for Hospitalized COVID-19 Patients. Medscape. March 1, 2022 https://www.medscape.com/viewarticle/969367
- ↑ 22.0 22.1 22.2 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: https://www.ncbi.nlm.nih.gov/pubmed/35512728 PMCID: PMC9060606 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00519-0/fulltext