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Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance

Flisiak et al., Pharmacological Reports, doi:10.1007/s43440-022-00408-6 (date from preprint)

Jul 2022

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Retrospective 590 patients in Poland, 203 treated with mulnupiravir, showing lower mortality with treatment.

Potential risks of molnupiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-10. Multiple analyses have identified variants potentially created by molnupiravir11-15.

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risk of death, 39.5% lower, RR 0.61, p = 0.03, treatment 20 of 203 (9.9%), control 63 of 387 (16.3%), NNT 16.

risk of mechanical ventilation, 4.7% lower, RR 0.95, p = 1.00, treatment 7 of 203 (3.4%), control 14 of 387 (3.6%), NNT 591.

hospitalization time, 0.9% higher, relative time 1.01, p = 0.96, treatment mean 11.6 (±7.9) n=203, control mean 11.5 (±9.3) n=387.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

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5. Zibat et al., N4-hydroxycytidine, the active compound of Molnupiravir, promotes SARS-CoV-2 mutagenesis and escape from a neutralizing nanobody, iScience, doi:10.1016/j.isci.2023.107786.sciencedirect.com, doi.org.

6. Shiraki et al., Convenient screening of the reproductive toxicity of favipiravir and antiviral drugs in Caenorhabditis elegans, Heliyon, doi:10.1016/j.heliyon.2024.e35331.sciencedirect.com, doi.org.

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8. Marikawa et al., An active metabolite of the anti-COVID-19 drug molnupiravir impairs mouse preimplantation embryos at clinically relevant concentrations, Reproductive Toxicology, doi:10.1016/j.reprotox.2023.108475.sciencedirect.com, doi.org.

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10. Chamod et al., Molnupiravir Metabolite--N4-hydroxycytidine Causes Cytotoxicity and DNA Damage in Mammalian Cells in vitro: N4-hydroxycytidine Induced Cytotoxicity DNA Damage, Asian Medical Journal and Alternative Medicine, 23:3, asianmedjam.com/index.php/amjam/article/view/1448.asianmedjam.com.

11. Focosi et al., The fitness of molnupiravir-signed SARS-CoV-2 variants: imputation analysis based on prescription counts and GISAID analyses by country, Intervirology, doi:10.1159/000540282.karger.com, doi.org.

12. Sanderson et al., A molnupiravir-associated mutational signature in global SARS-CoV-2 genomes, Nature, doi:10.1038/s41586-023-06649-6.nature.com, doi.org.

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Flisiak et al., 6 Jul 2022, retrospective, Poland, peer-reviewed, 13 authors, study period 1 January, 2022 - 30 April, 2022. Contact: robert.flisiak1@gmail.com.

This Paper Molnupiravir All

Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance

Robert Flisiak, Dorota Zarębska-Michaluk, Magdalena Rogalska, Justyna Anna Kryńska, Justyna Kowalska, Ewa Dutkiewicz, Krystyna Dobrowolska, Jerzy Jaroszewicz, Anna Moniuszko-Malinowska, Marta Rorat, Regina Podlasin, Olga Tronina, Piotr Rzymski

Pharmacological Reports, doi:10.1007/s43440-022-00408-6

Background The real-world effectiveness of molnupiravir (MOL) during the dominance of Omicron SARS-CoV-2 lineage is urgently needed since the available data relate to the period of circulation of other viral variants. Therefore, this study assessed the efficacy of MOL in patients hospitalized for COVID-19 in a real-world clinical practice during the wave of Omicron infections. Methods Among 11,822 patients hospitalized after 1 March 2020 and included in the SARSTer national database, 590 were treated between 1 January and 31 April 2022, a period of dominance of the Omicron SARS-CoV-2 variant. MOL was administered to 203 patients, whereas 387 did not receive any antiviral regimen. Both groups were similar in terms of sex, BMI and age allowing for direct comparisons. Results Patients who did not receive antiviral therapy significantly more often required the use of Dexamethasone and Baricitinib. Treatment with MOL resulted in a statistically significant reduction in mortality during the 28-day follow-up (9.9 vs. 16.3%), which was particularly evident in the population of patients over 80 years of age treated in the first 5 days of the disease (14.6 vs. 35.2%). MOL therapy did not affect the frequency of the need for mechanical ventilation, but patients treated with MOL required oxygen supplementation less frequently than those without antivirals (31.7 vs. 49.2%). The time of hospitalization did not differ between groups. Conclusions The use of molnupiravir in patients hospitalized for COVID-19 during the dominance of Omicron variant reduced mortality. This effect is particularly evident in patients over 80 years of age.

References

Arribas, Bhagani, Lobo, Khaertynova, Mateu et al., Randomized trial of molnupiravir or placebo in patients hospitalized with covid-19, NEJM Evid, doi:10.1056/evidoa2100044

Flisiak, Horban, Jaroszewicz, Kozielewicz, Mastalerz-Migas et al., Diagnosis and therapy of SARS-CoV-2 infection: recommendations of the Polish Association of Epidemiologists and Infectiologists as of November 12, 2021. Annex no. 1 to the Recommendations of April 26, 2021, Pol Arch Intern Med, doi:10.20452/pamw.16140

Flisiak, Horban, Jaroszewicz, Kozielewicz, Mastalerz-Migas et al., Management of SARS-CoV-2 infection: recommendations of the Polish Association of Epidemiologists and Infectiologists as of February 23, Pol Arch Intern Med, doi:10.20452/pamw.16230

Flisiak, Zarębska-Michaluk, Berkan-Kawińska, Tudrujek-Zdunek, Rogalska et al., Remdesivir-based therapy improved the recovery of patients with COVID-19 in the multicenter, real-world SARSTer study, Pol Arch Intern Med

Gordon, Tchesnokov, Schinazi, Götte, Molnupiravir promotes SARS-CoV-2 mutagenesis via the RNA template, J Biol Chem

Jayk, Da Silva, Musungaie, Kovalchuk, Gonzalez et al., Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients, N Engl J Med

Kumarasamy, Jindal, Saha, Singh, Rodduturi et al., Phase III trial of molnupiravir in adults with mild SARS-cov2 infection in India

Mader, Tydykov, Glück, Bertok, Weidlich et al., Omicron's binding to sotrovimab, casirivimab, imdevimab, CR3022, and sera from previously infected or vaccinated individuals, IScience

Painter, Natchus, Cohen, Holman, Painter, Developing a direct acting, orally available antiviral agent in a pandemic: the evolution of molnupiravir as a potential treatment for COVID-19, Curr Opin Virol

Rahmah, Abarikwu, Arero, Jibril, Fal et al., Oral antiviral treatments for COVID-19: opportunities and challenges, Rep: Pharmacol, doi:10.1007/s43440-022-00388-7

Vangeel, Chiu, Jonghe, Maes, Slechten et al., Remdesivir, molnupiravir and nirmatrelvir remain active against SARS-CoV-2 Omicron and other variants of concern, Antiviral Res

Wahl, Gralinski, Johnson, Yao, Kovarova et al., SARS-CoV-2 infection is effectively treated and prevented by EIDD-2801, Nature

Wong, Au, Lau, Lau, Cowling et al., Real-world effectiveness of molnupiravir and nirmatrelvir/ ritonavir among COVID-19 inpatients during Hong Kong's Omicron BA.2 wave: an observational study, doi:10.1101/2022.05.19.22275291

Zarębska-Michaluk, Jaroszewicz, Rogalska, Martonik, Pabjan et al., Effectiveness of tocilizumab with and without dexamethasone in patients with severe COVID-19: a retrospective study, J Inflamm Res

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