Molnupiravir for Intra-Household Prevention of COVID-19: the MOVe-AHEAD Randomized, Placebo-Controlled Trial

Alpizar et al., Journal of Infection, doi:10.1016/j.jinf.2023.08.016, MOVe-AHEAD, NCT04939428

Sep 2023

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PEP RCT 1,527 patients showing lower COVID-19 cases with molnupiravir, without statistical significance.

Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer Hadj Hassine, Huntsman, Marikawa, Swanstrom, Waters, Zibat. Multiple analyses have identifed variants potentially created by molnupiravir Fountain-Jones, Sanderson, twitter.com.

1. Fountain-Jones et al., Antiviral treatments lead to the rapid accrual of hundreds of SARS-CoV-2 mutations in immunocompromised patients, medRxiv, doi:10.1101/2022.12.21.22283811.medrxiv.org, doi.org.

2. Hadj Hassine et al., Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity, Viruses, doi:10.3390/v14040841.mdpi.com, doi.org.

3. Huntsman, M., An assessment of the reproductive toxicity of the anti-COVID-19 drug molnupiravir using stem cell-based embryo models, Master's Thesis, scholarspace.manoa.hawaii.edu/items/cd11342c-b4dc-44c0-8b44-ce6e3369c40b.hawaii.edu.

4. 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.

5. 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.

6. Swanstrom et al., Lethal mutagenesis as an antiviral strategy, Science, doi:10.1126/science.abn0048.science.org, doi.org.

7. twitter.com, twitter.com/LongDesertTrain/status/1597353291868155906.twitter.com/LongDesertTrain/status/1597353291868155906.

8. Waters et al., Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: the special case of molnupiravir, Environmental and Molecular Mutagenesis, doi:10.1002/em.22471.wiley.com, doi.org.

9. 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.

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risk of symptomatic case, 24.2% lower, RR 0.76, p = 0.06, treatment 78 of 763 (10.2%), control 103 of 764 (13.5%), NNT 31, MITT.

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

Alpizar et al., 8 Sep 2023, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 18 authors, trial NCT04939428 (history) (MOVe-AHEAD).

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