Post-marketing surveillance study on the effectiveness and safety of molnupiravir in high-risk COVID-19 outpatients: a prospective case series study
Rattachement africain : pt, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: Molnupiravir, approved for treating mild to moderate COVID-19 in adults, aims to reduce hospitalisation and mortality rates. Although it was withdrawn from the market after the present study was conducted, understanding its long-term effects remains pertinent. We aimed to assess the real-world effectiveness and safety of molnupiravir in high-risk COVID-19 outpatients. METHODS: This prospective, multicenter, noninterventional, postmarketing cohort study enrolled high-risk COVID-19 outpatients with mild to moderate COVID-19, eligible under national prescribing criteria, who initiated molnupiravir within five days of symptom onset and were ineligible for first-line antiviral therapy. Patients were consecutively enrolled from eight Portuguese study sites and monitored for three months. Effectiveness was assessed by all-cause mortality and hospitalisation through day 29. Safety was evaluated by the incidence, severity, and causality of adverse events (AE), coded using MedDRA terminology and assessed via the WHO-UMC system. Data were collected through structured patient questionnaires and electronic health records. Statistical analysis was descriptive; proportions were reported with 95% confidence intervals (CI), and comparisons between groups were performed using appropriate statistical tests. RESULTS: By day 29 post-treatment initiation, no deaths were reported (n = 0; 0%; 95%CI = [0,26]), and all patients were either at home or institutionalised, with favourable outcomes. Out of the 12 patients enrolled, eight (67%; 95%CI = [35,90]) reported at least one AE, with the median time to the first AE being five days (range 5-7 days). Half of the patients (n = 6; 95%CI = [21,79]) reported AE deemed possibly or probably related to molnupiravir, involving nausea (25%), dizziness (17%), bitter taste (17%), and headache (17%). These AE were more commonly observed in older individuals and those overweight, indicating a potential influence of these factors on AE occurrence. CONCLUSIONS: Molnupiravir appears to show good safety and effectiveness, offering an alternative for high-risk COVID-19 outpatients ineligible for first-line therapy. Despite its market withdrawal, ongoing research into its long-term effects is crucial to potentially repurpose it for other viral infections.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Post-marketing surveillance study on the effectiveness and safety of molnupiravir in high-risk COVID-19 outpatients: a prospective case series study
- Date Crossref
- 25/04/2025
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Universidade do Porto pays non établi dans la noticeUniversité ou école supérieure
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Decision Sciences (United States) pays non établi dans la noticeEntreprise
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Centre for Health Technology and Services Research pays non établi dans la noticeStructure de recherche
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Rede de Química e Tecnologia pays non établi dans la noticeOrganisation à but non lucratif
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Hospital de São João pays non établi dans la noticeÉtablissement de santé
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Hospital de Santo António pays non établi dans la noticeÉtablissement de santé
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Centro Hospitalar de Vila Nova de Gaia pays non établi dans la noticeÉtablissement de santé
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San Antonio College pays non établi dans la noticeUniversité ou école supérieure
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Centro Hospitalar de Lisboa Ocidental pays non établi dans la noticeÉtablissement de santé
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Hospital do Divino Espírito Santo pays non établi dans la noticeÉtablissement de santé
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Faculty of Medicine of the University of Porto Department of Community Medicine pays non établi dans la noticeUniversité ou école supérieure
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RISE-Health pays non établi dans la noticeInstitution
Universidade do Porto, Decision Sciences (United States) et Centre for Health Technology and Services Research, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.