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molnupiravir (Lagevrio)

Approved for use in U.K. Indications: - investigational treatment of COVID-19 - FDA emergency use authorization December 2021 [10] - eradication of SARS-CoV2 - reduces risk of hospitalization & death by 50% (Merck) [5] - no deaths in molnupiravir recipients? [5,8]; not so [6] - newer data finds molnupiravir reduces risk of hospitalization by 30% [9] * may be effective against Gamma, Mu & Delta variant (Merck) [4,5] * molnupiravir reduces risk of post-acute sequelae of SARS-CoV2 unvaccinated, vaccinated, & reinfected patients when administered within 5 days of symptom onset [15] Contraindications: - not recommended during pregnancy - not authorized for persons < 18 years of age - not effective in hospitalized patients with Covid-19 [12] Dosage: - 800 mg PO BID [3], 4 200 mg capsules for 5 days Capsules: 200 mg Dosage adjustment in renal failure: - none indicated Adverse effects: - possible toxicity to bone, cartilage, or both - viral rebound in molnupiravir uncommon (0.8% vs 0.6% in non-users) [13] - 1 of 6 molnupiravir users & 12 of 68 non-users with viral rebound died of Covid-19 [13] - molnupiravir can cause transmissible mutations in SARS-Cov2 [16] - no evidence that molnupiravir has caused more transmissible or severe variants of SARS-Cov2 [16] Drug interactions: - none known [14] Mechanism of action: - ribonucleoside analog that inhibits replication of several RNA viruses, including SARS-CoV2 Clinical trials: - 200, 400 & 800 mg PO BID for 5 days resulted in variable reductions in infectious virus in naspopharynx [1,7] - molnupiravir did not reduce hospitalization or death in Covid-19 vaccinated patients; hospitalization in 1% of participant regardless of molnupiravir therapy [14] Notes: - Merck plans to file for emergency use authorization [5]

General

antiviral agent

Database Correlations

PUBCHEM cid=145996610

References

  1. Boerner H Five-Day Course of Oral Antiviral Appears to Stop SARS-CoV-2 in Its Tracks. Medscape - Mar 08, 2021. https://www.medscape.com/viewarticle/947061
  2. Hackethal V How Molnupiravir Moved to the Head of the 'COVID Pill' Pack. Work on the broad-spectrum antiviral started over a decade ago at Emory. MedPage Today April 28, 2021 https://www.medpagetoday.com/special-reports/exclusives/92323
  3. Bergman SJ COVID-19 Treatment: Investigational Drugs and Other Therapies. Mesdcape. August 18, 2021 https://emedicine.medscape.com/article/2500116-overview
  4. Beasley D Merck Says Research Shows Its COVID-19 Pill Works Against Variants. Medscape. September 30, 2021 https://www.medscape.com/viewarticle/959950
  5. Walker M Oral COVID Drug Slashes Hospitalization and Death Risk, Merck Says. However, expert notes drug resistance, inducing viral mutations may be a problem. MedPage Today October 1, 2021 https://www.medpagetoday.com/infectiousdisease/covid19/94804
  6. Doheny K Merck's New COVID Pill: 'Game-Changer' or Just One More Tool? Medscape. Oct 6, 2021 https://www.medscape.com/viewarticle/960404
  7. Fischer W, Eron JJ, Holman W et al Molnupiravir, an Oral Antiviral Treatment for COVID-19. medRxiv. Preprint. 2021 Jun 17. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219109/
  8. Crist C Merck Seeks FDA Authorization for Antiviral COVID-19 Pill. Medscape. Oct 11, 2021 https://www.medscape.com/viewarticle/960638
  9. Kozlov M Merck's COVID pill loses its lustre: what that means for the pandemic. Nature News. December 13, 2021 https://www.nature.com/articles/d41586-021-03667-0?
  10. McNamara D FDA Okays Emergency Use of Molnupiravir Pill for COVID-19. Medscape. December 23, 2021 https://www.medscape.com/viewarticle/965484
  11. U.S. Food and Drug Administration. Fact sheet for healthcare providers: Emergency use authorization for molnupiravir FDA 2021 Dec 23. [ePub] https://www.fda.gov/media/155054/download
  12. Arribas JR et al. Randomized trial of molnupiravir or placebo in patients hospitalized with Covid-19. NEJM Evidence 2022 Jan; 1:EVIDoa2100044. PMID: 38319178 https://evidence.nejm.org/doi/10.1056/EVIDoa2100044
  13. Wong GL, Yip TC, Lai MS, Wong VW, Hui DS, Lui GC Incidence of Viral Rebound After Treatment With Nirmatrelvir-Ritonavir and Molnupiravir. JAMA Netw Open. 2022;5(12):e2245086. PMID: 36472873 Free article. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2799218
  14. Butler CC et al. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): An open-label, platform-adaptive randomised controlled trial. Lancet 2022 Dec 22; [e-pub] PMID: 36566761 PMCID: PMC9779781 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02597-1/fulltext
  15. Xie Y et al. Molnupiravir and risk of post-acute sequelae of covid-19: Cohort study. BMJ 2023 Apr 25; 381:e074572. PMID: 37161995 PMCID: PMC10126525 Free PMC article https://www.bmj.com/content/381/bmj-2022-074572
  16. Ellis R Study: Antiviral Med Linked to COVID Mutations That Can Spread. Medscape. Sept 26, 2023 https://www.medscape.com/s/viewarticle/996814 - Sanderson T, Hisner R, Donovan-Banfield I et al A molnupiravir-associated mutational signature in global SARS-CoV-2 genomes. Nature. 2023 Sept 25 PMID: 37748513 https://www.nature.com/articles/s41586-023-06649-6.epdf
  17. FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR LAGEVRIO. HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA). LAGEVRIO (molnupiravir) capsules, for oral use