molnupiravir (Lagevrio)
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Introduction
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]
- 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
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]
- molnupiravir can cause transmissible mutations in 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]
More general terms
References
- ↑ 1.0 1.1 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
- ↑ 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
- ↑ 3.0 3.1 Bergman SJ COVID-19 Treatment: Investigational Drugs and Other Therapies. Mesdcape. August 18, 2021 https://emedicine.medscape.com/article/2500116-overview
- ↑ 4.0 4.1 Beasley D Merck Says Research Shows Its COVID-19 Pill Works Against Variants. Medscape. September 30, 2021 https://www.medscape.com/viewarticle/959950
- ↑ 5.0 5.1 5.2 5.3 5.4 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
- ↑ 6.0 6.1 Doheny K Merck's New COVID Pill: 'Game-Changer' or Just One More Tool? Medscape. Oct 6, 2021 https://www.medscape.com/viewarticle/960404
- ↑ 7.0 7.1 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/
- ↑ 8.0 8.1 Crist C Merck Seeks FDA Authorization for Antiviral COVID-19 Pill. Medscape. Oct 11, 2021 https://www.medscape.com/viewarticle/960638
- ↑ 9.0 9.1 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?
- ↑ 10.0 10.1 McNamara D FDA Okays Emergency Use of Molnupiravir Pill for COVID-19. Medscape. December 23, 2021 https://www.medscape.com/viewarticle/965484
- ↑ 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
- ↑ 12.0 12.1 Arribas JR et al. Randomized trial of molnupiravir or placebo in patients hospitalized with Covid-19. NEJM Evidence 2022 Jan; 1:EVIDoa2100044. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38319178 https://evidence.nejm.org/doi/10.1056/EVIDoa2100044
- ↑ 13.0 13.1 13.2 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: https://www.ncbi.nlm.nih.gov/pubmed/36472873 Free article. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2799218
- ↑ 14.0 14.1 14.2 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: https://www.ncbi.nlm.nih.gov/pubmed/36566761 PMCID: PMC9779781 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02597-1/fulltext
- ↑ 15.0 15.1 Xie Y et al. Molnupiravir and risk of post-acute sequelae of covid-19: Cohort study. BMJ 2023 Apr 25; 381:e074572. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37161995 PMCID: PMC10126525 Free PMC article https://www.bmj.com/content/381/bmj-2022-074572
- ↑ 16.0 16.1 16.2 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: https://www.ncbi.nlm.nih.gov/pubmed/37748513 https://www.nature.com/articles/s41586-023-06649-6.epdf - ↑ FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR LAGEVRIO. HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA). LAGEVRIO (molnupiravir) capsules, for oral use