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Molnupiravir for COVID-19
37 studies from 705 scientists
126,024 patients in 9 countries
Statistically significant lower risk for mortality, recovery, and viral clearance.
18 studies from 15 teams in 7 countries show statistically significant improvements.
Potential risks include the creation of dangerous variants, carcinogenicity, and genotoxicity.
COVID-19 Molnupiravir studies. Dec 2023. c19early.org
0 0.5 1 1.5+ All studies 15% With exclusions 18% Mortality 24% Hospitalization 2% Recovery 18% Cases 24% Viral clearance 27% RCTs 34% RCT mortality 45% Prophylaxis 24% Early 14% Late 12% Favorsmolnupiravir Favorscontrol
Potential risks include the creation of dangerous variants and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity Hadj Hassine, Huntsman, Marikawa, Swanstrom, Waters, Zhou, Zibat. Multiple analyses have identified variants potentially created by molnupiravir Fountain-Jones, Kosakovsky Pond, Sanderson, twitter.com. There is substantial publication bias. Multiple trials have not reported results and did not respond to requests Lawrence. Recent:
Strizki
Xu
Winyupakorn
Gbinigie
Kosakovsky Pond
Fung
Wan.
Molnupiravir has been officially adopted in 17 countries. Submit updates/corrections.
Nov 23
Strizki et al., Infectious Diseases and Therapy, doi:10.1007/s40121-023-00891-1 Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial
Virological outcomes for the MOVe-OUT trial. Results are shown with the main paper [Jayk Bernal].
Nov 22
Park et al., Infection & Chemotherapy, doi:10.3947/ic.2023.0087 Effectiveness of Molnupiravir Treatment in Patients with COVID-19 in Korea: A Propensity Score Matched Study
25% lower mortality (p<0.0001) and 29% lower progression (p<0.0001). PSM retrospective 190,692 COVID-19 patients treated with molnupiravir and 762,768 matched controls, showing lower mortality and combined severe/critical illness and mortality with treatment.
Nov 20
Tare et al., BJGP Open, doi:10.3399/bjgpo.2023.0109 The DAWN antivirals trial: process evaluation of a COVID-19 trial in general practice
83% worse recovery (p=0.36). Very small early terminated RCT with 8 molnupiravir and 17 placebo patients showing worse recovery with molnupiravir, without statistical significance.
Nov 11
Xu et al., Nucleic Acids Research, doi:10.1093/nar/gkad1002 Uridine–cytidine kinase 2 potentiates the mutagenic influence of the antiviral β-d-N4-hydroxycytidine
In Vitro study showing that molnupiravir increased mutation rates in mouse blood cancer cell lines. The mutagenic effects were enhanced by overexpression of the enzyme uridine-cytidine kinase 2 (Uck2), and lessened in Uck2 knockout cells...
Oct 31
Winyupakorn et al., Research Square, doi:10.21203/rs.3.rs-3484296/v1 Liver injury in non-severe COVID-19 with various pandemic phases: a real-world study
Prospective study of 300 patients with mild to moderate COVID-19 in Thailand, showing the highest risk of liver injury with molnupiravir treatment, OR 3.4 (p = 0.06).
Oct 24
Kosakovsky Pond et al., Nature, doi:10.1038/d41586-023-03248-3 Anti-COVID drug accelerates viral evolution
Discussion of the creation of new COVID-19 variants via treatment with molnupiravir. Sanderson et al. [Sanderson] showed that thousands of viruses with many mutations - sometimes more than 100 - survived molnupiravir treatment, and that m..
Oct 23
Fung et al., JAMA Internal Medicine, doi:10.1001/jamainternmed.2023.5099 Nirmatrelvir and Molnupiravir and Post–COVID-19 Condition in Older Patients
4% lower PASC (p=0.001). Retrospective 8,089 molnupiravir patients in the USA showing a small reduction in long COVID with treatment. Confounding is likely significant as below, and may eliminate the benefit. Results specific to the COVID-19 code should be closer..
Sep 25
Sanderson et al., Nature, doi:10.1038/s41586-023-06649-6 A molnupiravir-associated mutational signature in global SARS-CoV-2 genomes
Identification of SARS-CoV-2 variants created by molnupiravir treatment, including cases of onwards transmission. Authors find a class of long phylogenetic branches almost exclusively matching the time period, location, and age groups of ..
Sep 23
Marikawa et al., Reproductive Toxicology, doi:10.1016/j.reprotox.2023.108475 An active metabolite of the anti-COVID-19 drug molnupiravir impairs mouse preimplantation embryos at clinically relevant concentrations
Analysis of molnupiravir active metabolite N4-hydroxycytidine's effects on mouse preimplantation embryos in vitro, showing embryotoxicity at clinically relevant concentrations. The researchers found that N4-hydroxycytidine impaired blasto..
Sep 8
Alpizar et al., Journal of Infection, doi:10.1016/j.jinf.2023.08.016 Molnupiravir for Intra-Household Prevention of COVID-19: the MOVe-AHEAD Randomized, Placebo-Controlled Trial
24% fewer symptomatic cases (p=0.06). PEP RCT 1,527 patients showing lower COVID-19 cases with molnupiravir, without statistical significance.
Aug 31
Zibat et al., iScience, doi:10.1016/j.isci.2023.107786 N4-hydroxycytidine, the active compound of Molnupiravir, promotes SARS-CoV-2 mutagenesis and escape from a neutralizing nanobody
In Vitro study showing that NHC, the active compound molnupiravir, can promote rapid selection of immune escape mutants. NHC treatment enabled selection of nanobody-resistant mutants much faster than without NHC. While an in vitro model w..
Aug 7
Gbinigie et al., BMJ Open, doi:10.1136/bmjopen-2022-069176 Platform adaptive trial of novel antivirals for early treatment of COVID-19 In the community (PANORAMIC): protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease
PANORAMIC protocol paper, published over 9 months after publication of the molnupiravir arm [Butler].
Aug 7
Shiau et al., Virology, doi:10.1016/j.virol.2023.109865 Molnupiravir, a ribonucleoside antiviral prodrug against SARS-CoV-2, alters the voltage-gated sodium current and causes adverse events
In vitro study showing that molnupiravir inhibited sodium channel currents by altering channel gating kinetics, which may explain some of the neurological and gastrointestinal side effects.
Jul 19
Guan et al., Clinical Infectious Diseases, doi:10.1093/cid/ciad409 Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial
Symptom recovery details for the MOVe-OUT trial. Results are shown with the main paper [Jayk Bernal].
Jun 1
Butt et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiad195 Molnupiravir Use and 30-Day Hospitalizations or Death in Previously Uninfected Non-hospitalized High-risk Population with COVID-19
9% higher combined mortality/hospitalization (p=0.75). Retrospective 65,010 veterans in the USA, showing no significant difference in hospitalization/death with molnupiravir treatment. 1,729 patients received molnupiravir. Authors emulate a target trial closely matching the MOVe-OUT RCT and u..
May 16
Tazare et al., medRxiv, doi:10.1101/2023.05.12.23289914 Effectiveness of Sotrovimab and Molnupiravir in community settings in England across the Omicron BA.1 and BA.2 sublineages: emulated target trials using the OpenSAFELY platform
9% higher combined mortality/hospitalization (p=0.28). OpenSAFELY retrospective 75,048 outpatients in the UK, using the clone-censor-weight approach to address immortal time bias, showing no significant difference in combined mortality/hospitalization with molnupiravir treatment.
May 10
Torti et al., Elsevier BV, doi:10.2139/ssrn.4444431 Real-Life Comparison of Mortality in Non-Hospitalised Patients with SARS-CoV-2 Infection at Risk for Clinical Progression Treated with Molnupiravir or Nirmatrevir Plus Ritonavir During the Omicron Era in Italy: A Nationwide, Observational Study
47% higher mortality (p=0.0001). Prospective study of 17,977 outpatients treated with molnupiravir and 11,576 treated with paxlovid, showing significant mortality with both treatments, and lower mortality with paxlovid.
Apr 30
Wan et al., Annals of Internal Medicine, doi:10.7326/M22-3057 Effectiveness of Molnupiravir and Nirmatrelvir–Ritonavir in Hospitalized Patients With COVID-19
13% lower mortality (p<0.0001), 7% higher ventilation (p=0.49), and 2% higher ICU admission (p=0.9). Target trial emulation retrospective with 16,495 patients in Hong Kong, showing lower mortality with molnupiravir, but no significant difference for ventilation and ICU admission. See also [acpjournals.org], [acpjournals.org].
Mar 15
Goodwin et al., PLOS ONE, doi:10.1371/journal.pone.0281915 Evaluation of outpatient treatment for non-hospitalised patients with COVID-19: The experience of a regional centre in the UK
110% higher mortality (p=0.47) and 58% lower hospitalization (p=0.7). Retrospective 604 outpatients in the UK, showing lower risk of hospitalization with molnupiravir treatment, without statistical significance due to the small number of hospitalizations.
Feb 24
European Medicines Agency Refusal of the marketing authorisation for Lagevrio (molnupiravir)
The European Medicines Agency has recommended the refusal of the marketing authorisation of molnupiravir.
Feb 22
Wan et al., Journal of Infection, doi:10.1016/j.jinf.2023.02.029 Molnupiravir and nirmatrelvir-ritonavir reduce mortality risk during post-acute COVID-19 phase
11% lower mortality (p=0.02), 1% lower hospitalization (p=0.76), and 4% higher progression (p=0.18). Retrospective 30,040 hospitalized patients in Hong Kong, showing lower mortality with molnupiravir treatment.
Feb 21
Merck, Press Release Merck Provides Update on Phase 3 MOVe-AHEAD Trial Evaluating LAGEVRIO™ (molnupiravir) for Post-exposure Prophylaxis for Prevention of COVID-19
MOVe-AHEAD PEP RCT reporting no significant difference in cases. Limited information is available. There were 23.6% fewer cases with treatment, but the number of cases and confidence interval are not provided.
Feb 1
Service, R., Science, doi:10.1126/science.adg9677 Could a popular COVID-19 antiviral supercharge the pandemic?
Coverage of [Fountain-Jones, Sanderson] which show evidence for molnupiravir creating new variants. The quote "Right now, it’s much ado about nothing" is from Emory University, where Molnupiravir was invented..
Jan 25
Evans et al., Journal of Infection, doi:10.1016/j.jinf.2023.02.012 Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study
51% lower combined mortality/hospitalization (p=0.008). Retrospective high risk outpatients in the UK, showing lower hospitalization/death with molnupiravir treatment. Residual confounding is likely with adjustments having no detail on specific comorbidities.
Jan 22
Zheng et al., medRxiv, doi:10.1101/2023.01.20.23284849 Comparative effectiveness of Paxlovid versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised patients: observational cohort study using the OpenSAFELY platform
285% higher combined mortality/hospitalization (p=0.004). OpenSAFELY retrospective 5,638 outpatients in the UK, showing significantly higher hospitalization/death for molnupiravir compared with paxlovid.
Jan 15
Inaba et al., Research Square, doi:10.21203/rs.3.rs-2451986/v1 Real-world data concerning the efficacy of molnupiravir in patients vaccinated against COVID-19 during the Omicron surge in Japan
127% higher combined mortality/hospitalization (p=0.22) and 127% higher hospitalization (p=0.22). Retrospective 294 consecutive patients in Japan, showing higher risk of hospitalization/death with molnupiravir, without statistical significance.
Dec 22
2022
Fountain-Jones et al., medRxiv, doi:10.1101/2022.12.21.22283811 Antiviral treatments lead to the rapid accrual of hundreds of SARS-CoV-2 mutations in immunocompromised patients
Analysis of immunocompromised patients showing rapid creation of new variants with molnupiravir. All patients treated with molnupiravir accrued new mutations in the spike protein of the virus, including non-synonymous mutations that alter..
Dec 21
2022
Santi Laurini et al., Journal of Clinical Medicine, doi:10.3390/jcm12010034 Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data
Safety analysis of molnupiravir reporting an unexpectedly high rate of serious adverse reactions.
Dec 6
2022
Bajema et al., medRxiv, doi:10.1101/2022.12.05.22283134 Effectiveness of COVID-19 treatment with nirmatrelvir-ritonavir or molnupiravir among U.S. Veterans: target trial emulation studies with one-month and six-month outcomes
18% lower mortality (p=0.4), 1% lower ICU admission (p=1), and 30% higher hospitalization (p=0.04). Retrospective 112,380 high-risk patients in the USA, showing significantly higher acute or long-term care admission at 180 days with molnupiravir treatment, and no significant difference for other outcomes. The title and headers of Table ..
Nov 16
2022
Zheng et al., BMJ, doi:10.1136/bmj-2022-071932 Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform
100% higher combined mortality/hospitalization (p=0.005). Retrospective 3,331 sotrovimab and 2,689 molnupiravir patients in the UK, showing higher risk of combined hospitalization/death with molnupiravir.
Nov 14
2022
Sinha et al., Cureus, doi:10.7759/cureus.31508 Efficacy and Safety of Molnupiravir in Mild COVID-19 Patients in India
65% lower hospitalization (p=0.005), 53% greater improvement (p=0.01), and 48% improved viral clearance (p<0.0001). RCT 1,218 outpatients in India, showing lower hospitalization, better clinical improvement, and improved viral clearance with molnupiravir.
Oct 30
2022
Liu et al., Infectious Diseases and Therapy, doi:10.1007/s40121-022-00716-7 Disease Progression of Hospitalized Elderly Patients with Omicron BA.2 Treated with Molnupiravir
18% shorter hospitalization (p=0.14) and 21% faster viral clearance (p=0.1). Retrospective 42 elderly patients in China showing faster viral clearance with molnupiravir.
Oct 8
2022
Wong et al., The Lancet, doi:10.1016/S0140-6736(22)01586-0 Real-world effectiveness of molnupiravir and nirmatrelvir plus ritonavir against mortality, hospitalisation, and in-hospital outcomes among community-dwelling, ambulatory patients with confirmed SARS-CoV-2 infection during the omicron wave in Hong Kong: an observational study
24% lower mortality (p=0.01), 60% lower ventilation (p=0.02), 26% lower ICU admission (p=0.24), and 2% lower hospitalization (p=0.58). PSM retrospective 1,074,856 outpatients in Hong Kong, showing lower mortality with molnupiravir.
Oct 6
2022
Butler et al., The Lancet, doi:10.1016/S0140-6736(22)02597-1 (date from preprint) 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
6% higher combined mortality/hospitalization (p=0.69), 7% higher hospitalization (p=0.67), 2% lower transmission (p=0.88), and 22% improved recovery (p<0.0001). 26,411 patient RCT in the UK, showing faster recovery but no significant difference in hospitalization/death or transmission. Improved recovery may be in part due to the open label design with self-reported symptomatic data. Viral load in..
Oct 6
2022
Alteri et al., Research Square, doi:10.21203/rs.3.rs-2105569/v1 Genomic Evolution of Sars-Cov-2 in Molnupiravir-Treated Patients Compared to Paxlovid-Treated and Drug-Naïve Patients: A Proof-of-Concept Study
Mutation analysis showing over 5x greater within-host genetic diversity with molnupiravir compared to paxlovid or no treatment.
Oct 6
2022
Brown et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac527 Demographics and outcomes of initial phase of COVID-19 Medicines Delivery Units across 4 UK centres during peak B1.1.529 omicron epidemic: a service evaluation
101% higher hospitalization (p=0.51). Retrospective 442 patients in the UK treated with molnupiravir, and 222 eligible but declining treatment, showing no significant difference in hospitalization. No group details are provided and the results are subject to confounding by in..
Oct 5
2022
Suzuki et al., Clinical and Experimental Medicine, doi:10.1007/s10238-022-00949-3 (date from preprint) Real-world clinical outcomes of treatment with molnupiravir for patients with mild-to-moderate coronavirus disease 2019 during the Omicron variant pandemic
53% lower progression (p=0.04). Retrospective 1,921 patients in Japan, showing lower progression with molnupiravir use.
Oct 1
2022
Miranda et al., Environmental and Molecular Mutagenesis, doi:10.1002/em.22510 Evaluation of the mutagenic effects of Molnupiravir and N4-hydroxycytidine in bacterial and mammalian cells by HiFi sequencing
In Vitro genotoxocity study of molnupiravir showing dose dependent increased genome-wide mutation frequencies with mouse lymphoma L5178Y and human lymphoblastoid TK6 cells.
Sep 29
2022
Arbel et al., New England Journal of Medicine, doi:10.1056/NEJMoa2204919 (date from preprint) Molnupiravir Use and Severe Covid-19 Outcomes During the Omicron Surge
74% lower mortality (p=0.008) and 45% lower hospitalization (p=0.01). Retrospective 19,868 patients eligible for molnupiravir treatment in Israel with 1,069 treated, showing lower mortality and hospitalization with treatment for the subgroup of patients ≥65, and higher mortality for patients 40-64. Authors ..
Sep 20
2022
Najjar-Debbiny et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac781 Effectiveness of Molnupiravir in High Risk Patients: a Propensity Score Matched Analysis
19% lower mortality (p=0.48), 17% lower progression (p=0.34), and 25% lower severe cases (p=0.15). PSM retrospective 2,661 molnupiravir patients in Israel, showing lower mortality and severe COVID-19, without statistical significance. Significant benefit was seen in some subgroups, and significant harm was seen in the <75 subgroup.
Sep 9
2022
Kneidinger et al., Infection, doi:10.1007/s15010-022-01914-8 Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study
15% higher severe cases (p=0.71). Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early molnupiravir use.
Aug 2
2022
Lawrence et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac440 (date from preprint) Evaluation of publication bias for 12 clinical trials of molnupiravir to treat SARS-CoV-2 infection in 13,694 patients with meta-analysis
Meta analysis of molnupiravir trials showing 12 registered RCTs in India with only one presented at a conference, and two issuing press releases suggesting failure. Authors find that ~90% of the global data on molnupiravir has not been pu..
Jul 29
2022
Lieber et al., Nature Communications, doi:10.1038/s41467-022-32045-1 SARS-CoV-2 VOC type and biological sex affect molnupiravir efficacy in severe COVID-19 dwarf hamster model
Roborovski dwarf hamster and in vitro study finding molnupiravir efficacy varied significantly by SARS-CoV-2 variant in the hamster model, in contrast to no significant difference seen in cultured cells and human organoids. Efficacy for o..
Jul 24
2022
Khoo et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(22)00644-2 (date from preprint) Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial
89% lower hospitalization (p=0.12), 12% worse recovery (p=0.74), and 23% improved viral clearance (p=0.07). RCT 90 molnupiravir and 90 placebo patients, showing faster viral clearance with treatment, not reaching the pre-defined threshold for superiority and recommendation as a candidate for large scale evaluation.
Jul 6
2022
Flisiak et al., Pharmacological Reports, doi:10.1007/s43440-022-00408-6 (date from preprint) Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance
39% lower mortality (p=0.03), 5% lower ventilation (p=1), and 1% longer hospitalization (p=0.97). Retrospective 590 patients in Poland, 203 treated with mulnupiravir, showing lower mortality with treatment.
Jun 15
2022
Zou et al., Frontiers in Pharmacology, doi:10.3389/fphar.2022.939573 Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial
29% faster recovery (p=0.5) and 10% faster viral clearance (p=0.009). RCT 116 mild/moderate COVID-19 patients in China, showing improved viral clearance with treatment.
May 24
2022
Yip et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac687 (date from preprint) Impact of the use of oral antiviral agents on the risk of hospitalization in community COVID-19 patients
12% higher combined mortality/ICU admission (p=0.66) and 17% higher hospitalization (p=0.06). Propensity score weighted retrospective of 93,883 outpatients in Hong Kong, 5,808 treated with molnupiravir and 4,921 treated with paxlovid, showing higher hospitalization and higher combined mortality/mechanical ventilation/ICU admission..
May 20
2022
Wong et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(22)00507-2 (date from preprint) Real-world effectiveness of early molnupiravir or nirmatrelvir–ritonavir in hospitalised patients with COVID-19 without supplemental oxygen requirement on admission during Hong Kong's omicron BA.2 wave: a retrospective cohort study
52% lower mortality (p<0.0001), 58% lower ventilation (p=0.06), 40% lower progression (p<0.0001), and 6% shorter hospitalization (p=0.03). PSM retrospective 40,776 patients in Hong Kong, showing lower mortality and lower combined mortality, ventilation, ICU, and oxygen therapy with molnupiravir treatment.
May 17
2022
Rosenke et al., JCI Insight, doi:10.1172/jci.insight.160108 Molnupiravir inhibits SARS-CoV-2 variants including Omicron in the hamster model
Syrian hamster study showing efficacy of molnupiravir for multiple variants including omicron.
Apr 18
2022
Hadj Hassine et al., Viruses, doi:10.3390/v14040841 Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity
Review of lethal mutagenesis for RNA viruses, as used by molnupiravir, favipiravir, and ribavirin. Authors note the potential for permanently modifying the genomes of patients while causing teratogenicity or embryotoxicity, and the potent..
Apr 8
2022
Lee, T. PANORAMIC recruitment analysis
Analysis of the PANORAMIC trial recuitment suggesting that if the trial shows efficacy, the NNT will be >200.
Mar 11
2022
Thorlund et al., The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-1339 Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial
Discussion of concerns with the MOVe-OUT trial, including the reversal of the treatment effect post-interim analysis.
Feb 24
2022
Tippabhotla et al., SSRN Electronic Journal, doi:10.2139/ssrn.4042673 Efficacy and Safety of Molnupiravir for the Treatment of Non-Hospitalized Adults With Mild COVID-19: A Randomized, Open-Label, Parallel-Group Phase 3 Trial
46% lower hospitalization (p=0.26), 46% greater improvement (p<0.0001), and 59% improved viral clearance (p<0.0001). RCT 1,220 patients in India, showing lower risk of hospitalization and improved recovery with treatment. CTRI/2021/07/034588.
Feb 3
2022
Swanstrom et al., Science, doi:10.1126/science.abn0048 Lethal mutagenesis as an antiviral strategy
Review of the unknown long-term cancer, reproductive, and escape variant creation risks of molnupiravir. For more discussion see [twitter.com, twitter.com, twitter.com].
Jan 28
2022
Waters et al., Environmental and Molecular Mutagenesis, doi:10.1002/em.22471 Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: the special case of molnupiravir
Review of antiviral nucleoside analog drugs that induce lethal mutagenesis, including molnupiravir and favipiravir, and the potential mutagenic risks to human DNA and human mitochondrial DNA. Author recommends monitoring for mutagenicity,..
Dec 16
2021
Arribas et al., NEJM Evidence, doi:10.1056/EVIDoa2100044 Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19
282% higher mortality (p=0.31), 1% improved recovery (p=0.96), and 12% improved viral clearance (p=0.57). RCT 304 hospitalized patients, 218 treated with molnupiravir, showing no significant differences. MOVe-IN MK-4482-001. NCT04575584.
Dec 16
2021
Jayk Bernal et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116044 Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
89% lower mortality (p=0.01), 30% lower combined mortality/hospitalization (p=0.05), 15% faster recovery (p=0.02), and 4% improved viral clearance (p=0.2). MOVe-OUT RCT, showing significantly lower risk of hospitalization or death. In subgroup analysis efficacy was much lower with the delta variant. See also [Guan, Strizki]. Discussion of concerns with this trial can be found at [defyccc.com..
Dec 3
2021
Anonymous, Authorea, doi:10.22541/au.163854323.34557301/v1 Treating a Pandemic Respiratory Disease with a Mutagen is a Doomsday Scenario
Review of molnupiravir's mutagenic mechanism of action, and analysis of the increased probability of creating dangerous variants.
Nov 6
2021
Goldstein, L., TrialSite News Molnupiravir: mutagenic, carcinogenic, authorized in the UK
Discussion of concerns with molnupiravir and the MOVe-OUT trial. Author notes that results showing bone marrow toxicity in dogs were mentioned in this preprint [medrxiv.org], but removed from the journal version [journals.asm.org]. Some a..
Oct 9
2021
Reuters Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
no change in recovery (p=1). Trial CTRI/2021/08/035424 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].
Oct 9
2021
Reuters Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
no change in recovery (p=1). Trial CTRI/2021/05/033864 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].
Sep 13
2021
Malone et al., Nature Structural & Molecular Biology, doi:10.1038/s41594-021-00657-8 Molnupiravir: coding for catastrophe
Review of recent studies on molnupiravir's mechanism of lethal mutagenesis. Authors note that potential off-target effects require further investigation, because molnupiravir may be mutagenic to host DNA during host DNA replication.
Aug 27
2021
Khoo et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkab318 Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study
33% worse recovery (p=0.63). Dose and safety study of molnupiravir with 18 participants, finding no serious adverse events in short-term followup. There was no significant difference in clinical outcomes. NCT04746183.
Jul 21
2021
Optimus, Press Release Optimus announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
58% improved viral clearance (p<0.0001). Interim report on CTRI/2021/06/033992, showing faster viral clearance. Event counts are approximate, the press release only provides percentages.
Jul 9
2021
Hetero, Press Release Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
70% lower hospitalization (p=0.003) and 33% faster recovery (p=0.0001). Interim results for CTRI/2021/05/033739, showing lower mortality and faster recovery.
Jul 9
2021
Abdelnabi et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab361 Molnupiravir Inhibits Replication of the Emerging SARS-CoV-2 Variants of Concern in a Hamster Infection Model
Hamster study showing molnupiravir effective against the original, B.1.1.7, and B.1.351 variants.
Jun 18
2021
Fischer et al., medRxiv, doi:10.1101/2021.06.17.21258639 Molnupiravir, an Oral Antiviral Treatment for COVID-19
77% lower mortality (p=0.31) and 49% improved viral clearance (p=0.12). RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570.
May 7
2021
Zhou et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247 β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
In Vitro study showing that NHC (initial metabolite of molnupiravir) has high antiviral activity against SARS-CoV-2, but also shows host mutational activity in an animal cell culture assay. Authors note the concern that mutations in host ..
Apr 15
2021
Merck, News Release Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19
News release reporting that the trial of molnupiravir with hospitalized patients (NCT04575584) has been discontinued because data indicates it is unlikely to demonstrate a clinical benefit in hospitalized patients. Results are not availab..
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