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
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.Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer [Hadj Hassine, Swanstrom]. See [Fountain-Jones, Sanderson, twitter.com] for analysis of variants potentially created by molnupiravir.
Torti et al., 10 May 2023, prospective, Italy, preprint, 24 authors, study period 8 February, 2022 - 30 April, 2022, this trial compares with another treatment - results may be better when compared to placebo.
Abstract: 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,
Carlo Torti1₸, Pier Paolo Olimpieri2,3, Paolo Bonfanti4, Carlo Tascini5, Simone Celant2,
Danilo Tacconi6, Emanuele Nicastri7, Evelina Tacconelli8, Bruno Cacopardo9, Alessandro
Perrella10, Giovanni Battista Buccoliero11, Giustino Parruti12, Matteo Bassetti13,14, Carlo
Biagetti15, Andrea Giacometti16, Elke Maria Erne17, Maria Frontuto18, Massimiliano
Lanzafame19, Summa Valentina2, Alessandra Spagnoli3, Annarita Vestri3, Giovanni Di
Perri20, Pierluigi Russo2† and Giorgio Palù2†
₸ Corresponding author
† These authors contributed equally to this work
1Department of Medical and Surgical Sciences, “Magna Graecia” University, Catanzaro,
2Italian Medicines Agency, Via del Tritone 181, 00187 Rome, Italy.
3Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome,
4Fondazione IRCCS San Gerardo dei Tintori – University of Milano-Bicocca, Monza, Italy.
5Department of medicine (DAME), Infectious Diseases Clinic, Udine University Hospital,
6 Department of Specialised and Internal Medicine, Infectious Diseases Unit, San Donato
Hospital, Arezzo, Italy.
7 National Institute for Infectious Disease Lazzaron Spallanzani, IRCCS Via portuense 292
00149 Rome, Italy.
8 Infectious Diseases, Department of Diagnostic and Public Health, University of Verona,
37129 Verona, Italy.
9 Department of Internal and Experimental Medicine, University of Catania School of
Medicine, Catania, Italy.
10 Division Emerging Infectious Disease and High Contagiousness, D. Cotugno Hospital,
80131 Naples, Italy.
11 Infectious Diseases Unit, San Giuseppe Moscati Hospital, Azienda Sanitaria Locale
Taranto, 74121 Taranto, Italy.
12 Department of Medicine, Infectious Disease Unit, Pescara General Hospital, Pescara,
13 Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
14 Infectious Diseases Unit, Policlinico San Martino Hospital—IRCCS, Genoa, Italy.
15 Unit of Infectious disease Infermi Hospital, AUSL Romagna, Rimini, Italy.
16 Azienda Ospedaliera Universitaria, Ospedali Riuniti di Ancona, Ancona, Italy.
17 Azienda sanitaria dell’Alto Adige, Central Hospital of Bolzano, Department of Infectious
18 Infectious Diseases Unit – A.O.R. San Carlo - Potenza, Italy.
19 Department of Medical, Infectious Diseases Unit, Santa Chiara Hospital, Trento, Italy.
20 University of Torino, Department of Medical Sciences at the Unit of Infectious Diseases,
Amedeo di Savoia Hospital, Torino, Italy.
This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4444431
Background Comparative data on mortality in COVID-19 patients treated with
molnupiravir or with nirmatrelvir plus ritonavir are scarce and inconclusive. In
particular, no adequately powered studies have demonstrated statistically
significant differences in mortality between the two oral antivirals. We therefore
aimed to provide a comparison of all-cause mortality in community-dwelling
COVID-19 patients treated during the Omicron era.
Methods In this observational study we used data collected in the nationwide,
population-based, cohort of patients registered in the database of the..
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