Molnupiravir for oral treatment of Covid-19 in non-hospitalized patients

  • 1. WHO coronavirus (COVID-19) dashboard. Geneva: World Health Organization, 2021 (https://covid19.who.int).

  • 2. Stokes EK, Zambrano LD, Anderson K.N., et al. Coronavirus disease 2019 case surveillance – United States, from January 22 to May 30, 2020. MMWR Morb Mortal Wkly Rep 2020;69:759765.

  • 3. KoJY, Danielson ML, City M, et al. Risk factors for hospitalization associated with coronavirus disease 2019 (COVID-19): COVID-19 hospitalization surveillance network and behavioral risk factor surveillance system. Blink Infect Dis 2021;72(11):e695e703.

  • 4. Kompaniyets L, Goodman AB, Relay B, et al. Body mass index and risk of COVID-19 hospitalization, intensive care unit admission, invasive mechanical ventilation, and death – United States, March-December 2020. MMWR Morb Mortal Wkly Rep 2021;70:355361.

  • 5. Wagner EC, Saad Roy CM, Morris SE, et al. Vaccine nationalism and dynamics and control of SARS-CoV-2. Science 2021;373(6562):eabj7364eabj7364.

  • 6. Nguyen KH, Nguyen K, Corlin L., Allen J.D., Chung M. Changes in COVID-19 vaccination receipt and intention to vaccinate by socioeconomic characteristics and geography, United States, January 6 – March 29, 2021. Ann Med 2021;53:14191428.

  • seven. Arribas JR, Bhagani S, Lobo S, et al. Randomized trial of molnupiravir or placebo in patients hospitalized with Covid-19. NEJM testimonial. DOI: 10.1056/EVIDoa2100044.

  • 8. AC injured, Wheatley AK. Neutralizing antibody therapy for COVID-19. Virus 2021;13:628628.

  • 9. Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Early treatment of Covid-19 with sotrovimab, an antibody neutralizing SARS-CoV-2. N English J med 2021;385:19411950.

  • ten. Fischer W, Eron JJ Jr., Holman W, et al. Molnupiravir, an oral antiviral treatment for COVID-19. June 17, 2021 (https://www.medrxiv.org/content/10.1101/2021.06.17.21258639v1). preprint.

  • 11. MS Cohen, Wohl DA, Fischer WA, Smith DM, Eron JJ. Outpatient treatment of SARS-CoV-2 infection to prevent progression of COVID-19. Blink Infect Dis 2021;73:17171721.

  • 12. Yoon JJ, Toots M, Lee S, et al. Orally effective broad-spectrum ribonucleoside analog, inhibitor of influenza viruses and respiratory syncytial viruses. Chemother Antimicrobial Agents 2018;62(8):e00766-18.

  • 13. Cox RM, Wolf J.D., Plemper RK. The therapeutically administered ribonucleoside analog MK-4482/EIDD-2801 blocks transmission of SARS-CoV-2 in ferrets. Nat Microbiol 2021;6:1118.

  • 14. Sheahan TP, CA Sims, Zhou S, et al. An orally bioavailable broad-spectrum antiviral inhibits SARS-CoV-2 in human airway epithelial cell cultures and several coronaviruses in mice. Sci Transl Med 2020;12(541):eabb5883eabb5883.

  • 15. Wahl A, Gralinski LE, Johnson CE, et al. SARS-CoV-2 infection is effectively treated and prevented by EIDD-2801. Nature 2021;591:451457.

  • 16. Abdelnabi R., Foo CS, De Jonghe S, Maes P, Weynand B, Neyts J. Molnupiravir inhibits replication of emerging SARS-CoV-2 variants of concern (VoC) in a hamster infection model. J Infect Dis 2021;224:749753.

  • 17. Agostini ML, Pruijssers AJ, JD Chappell, et al. Beta-dN small molecule antiviral4-hydroxycytidine inhibits an intact coronavirus in proofreading with a high genetic barrier to resistance. J. Virol 2019;93(24):e0134819.

  • 18. Urakova N, Kuznetsova V, Crossman DK, et al. β-dN4-hydroxycytidine is a potent anti-alphavirus compound that induces a high level of mutations in the viral genome. J. Virol 2018;92(3):e01965e17.

  • 19. Grobler J, Strizki J, Murgolo N, et al. Molnupiravir maintains antiviral activity against SARS-CoV-2 variants in vitro and in early clinical studies. In: Proceedings and summaries of IDWeek 2021, From September 29 to October 3, 2021. Arlington, Virginia: American Society for Infectious Diseases, 2021.

  • 20. Kabinger F, Stiller C, Schmitzova J, et al. Mechanism of molnupiravir-induced SARS-CoV-2 mutagenesis. Nat Struct Mol Biol 2021;28:740746.

  • 21. Gordon CJ, Tchesnokov EP, Schinazi RF, Gotte M. Molnupiravir promotes mutagenesis of SARS-CoV-2 via template RNA. J Biol Chem 2021;297:100770100770.

  • 22. Malone B, E. A. Campbell. Molnupiravir: disaster coding. Nat Struct Mol Biol 2021;28:706708.

  • 23. WP Painter, Holman W, Bush JA, et al. Human safety, tolerability, and pharmacokinetics of molnupiravir, a novel broad-spectrum oral antiviral agent with activity against SARS-CoV-2. Chemother Antimicrobial Agents 2021;65(5):e02428-20e02428-20.

  • 24. Khoo SH, Fitzgerald R., FletcherT, et al. Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a phase I randomized, open-label, dose-escalation controlled study. J Antimicrob Chemother 2021;76:32863295.

  • 25. Chawla A, Cao Y, Peter J, et al. Model-based dose selection for the phase 3 evaluation of molnupiravir (MOV) for the treatment of COVID-19 in adults. In: Proceedings and abstracts of the 31st annual meeting of the European Congress of Clinical Microbiology and Infectious Diseases, From July 9 to 12, 2021. Basel, Switzerland: European Society for Clinical Microbiology and Infectious Diseases, 2021.

  • 26. COVID-19: developing drugs and biologics for treatment or prevention: guidance for industry. Silver Spring, MD: Food and drug administration, Can 2020 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention).

  • 27. WHO COVID-19 case definitions. Geneva: World Health Organization, December 16, 2020 (https://apps.who.int/iris/rest/bitstreams/1322790/retrieve).

  • 28. Miettinen O, Nurminen M. Comparative analysis of two rates. StatMed 1985;4:213226.

  • 29. Hwang IK, Shih WJ, By Cani JS. Group sequential designs using a family of Type I error probability expense functions. Stat Med 1990;9:14391445.

  • 30. Rosenberg ES, Holtgrave DR, Dorabawila V, et al. New COVID-19 cases and hospitalizations among adults, by vaccination status – New York, May 3 to July 25, 2021. MMWR Morb Mortal Wkly Rep 2021;70:13061311.

  • 31. Camisole Y, Crofoot G, Moncada PA, et al. Phase 2/3 trial of molnupiravir for the treatment of Covid-19 in non-hospitalized adults. NEJM testimonial. DOI: 10.1056/EVIDoa2100043.

  • 32. Tenford MW, Kim SS, Lindsell CJ, et al. Duration of symptoms and risk factors for delayed return to usual health in outpatients with COVID-19 in a multistate health care system network – United States, March-June 2020. MMWR Morb Mortal Wkly Rep 2020;69:993998.

  • 33. Tenford MW, Auto WH, Naioti EA, et al. Sustained efficacy of Pfizer-BioNTech and Moderna vaccines against COVID-19-associated hospitalizations in adults – United States, March-July 2021. MMWR Morb Mortal Wkly Rep 2021;70:11561162.

  • 34. Bajema KL, Dahl RM, Prill MM, et al. Effectiveness of COVID-19 mRNA vaccines against COVID-19 associated hospitalization – five veterans medical centers, USA, February 1 to August 6, 2021. MMWR Morb Mortal Wkly Rep 2021;70:12941299.

  • 35. Gottlieb RL, Nirula A, Chen P, et al. Effect of bamlanivimab monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA 2021;325:632644.

  • 36. Horby P.W., Mafham M, Peto L, et al. Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomized, controlled, open-label, platform-based trial. June 16, 2021 (https://www.medrxiv.org/content/10.1101/2021.06.15.21258542v1). preprint.

  • 37. Pogue J.M., Laura AS, Gandhi TN, et al. Monoclonal antibodies for the early treatment of COVID-19 in a world of evolving SARS-CoV-2 mutations and variants. Infect Dis Open Forum 2021;8(7):ofab268ofab268.

  • 38. Cowman K, Guo Y, Pirofski LA, et al. Coronavirus 2 post-severe acute respiratory syndrome monoclonal antibody treatment hospitalizations as sentinel for emergence of viral variants in New York City. Infect Dis Open Forum 2021;8(8):ofab313ofab313.

  • Comments are closed.