Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance
Flisiak et al.,
Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance,
Pharmacological Reports, doi:10.1007/s43440-022-00408-6 (date from earlier preprint)
Retrospective 590 patients in Poland, 203 treated with mulnupiravir, showing lower mortality with treatment.
Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer [Hadj Hassine, Swanstrom]. See [Fountain-Jones, Sanderson, ] for analysis of variants potentially created by molnupiravir.
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.
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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.
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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.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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.
Abstract: Pharmacological Reports
https://doi.org/10.1007/s43440-022-00408-6
SPECIAL ISSUE: ARTICLE
The Post-COVID Era - Advances and Challenges in Pharmacology
Real‑world experience with molnupiravir during the period
of SARS‑CoV‑2 Omicron variant dominance
Robert Flisiak1 · Dorota Zarębska‑Michaluk2,3 · Magdalena Rogalska1 · Justyna Anna Kryńska1 ·
Justyna Kowalska4 · Ewa Dutkiewicz5,6 · Krystyna Dobrowolska2 · Jerzy Jaroszewicz7 ·
Anna Moniuszko‑Malinowska8 · Marta Rorat9 · Regina Podlasin10 · Olga Tronina11 · Piotr Rzymski12
Received: 28 June 2022 / Revised: 12 August 2022 / Accepted: 17 August 2022
© The Author(s) 2022
Abstract
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.
Keywords Molnupiravir · COVID-19 · SARS-CoV-2 · Omicron · Treatment · Real-world experience
Robert Flisiak and Dorota Zarębska-Michaluk contributed equally.
* Robert Flisiak
robert.flisiak1@gmail.com
1
2
Department of Infectious Diseases and Hepatology, Medical
University of Białystok, 15‑540, ul. Żurawia 14, Białystok,
Poland
Department of Infectious Diseases, Jan Kochanowski
University, Kielce, Poland
3
Provincial Hospital, Kielce, Poland
4
Department of Adults’ Infectious Diseases, Medical
University of Warsaw, Warsaw, Poland
5
ZOZ, Busko Zdroj, Poland
6
Jan Kochanowski University, Collegium Medicum, Kielce,
Poland
7
Department of Infectious Diseases and Hepatology, Medical
University of Silesia, Katowice, Poland
8
Department of Infectious Diseases and Neuroinfections,
Medical University of Białystok, Białystok, Poland
9
Department of Forensic Medicine, Wrocław Medical
University, Wrocław, Poland
10
IV‑th Department, Hospital for Infectious Diseases, Warsaw,
Poland
11
Department of Transplantation Medicine, Nephrology,
and Internal Diseases, Medical University of Warsaw,
Warsaw, Poland
12
Department of Environmental Medicine, Poznan University
of Medical Sciences, Poznan,..
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