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Real-world clinical outcomes of treatment with molnupiravir for patients with mild- to-moderate coronavirus disease 2019 during the Omicron variant pandemic

Suzuki et al., Research Square, doi:10.21203/rs.3.rs-2118653/v1
Oct 2022  
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Progression -8% Improvement Relative Risk Sotrovimab  Suzuki et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Retrospective 1,929 patients in Japan No significant difference in progression c19early.org Suzuki et al., Research Square, October 2022 Favorssotrovimab Favorscontrol 0 0.5 1 1.5 2+
Sotrovimab for COVID-19
41st treatment shown to reduce risk in May 2023, now with p = 0.002 from 25 studies, recognized in 38 countries. Efficacy is variant dependent.
Lower risk for mortality, ICU, and hospitalization.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Retrospective 1,921 patients in Japan, showing no significant difference in progression with sotrovimab use.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.11-3, BA.4, BA.54, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.15, and no efficacy for BA.26, XBB, XBB.1.5, ХВВ.1.9.17, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.
risk of progression, 8.3% higher, OR 1.08, p = 0.73, treatment 672, control 1,257, adjusted per study, multivariable, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Suzuki et al., 5 Oct 2022, retrospective, Japan, preprint, 53 authors. Contact: shibatay@fmu.ac.jp.
This PaperSotrovimabAll
Real-world clinical outcomes of treatment with molnupiravir for patients with mild- to-moderate coronavirus disease 2019 during the Omicron variant pandemic
Yasuhito Suzuki, Yoko Shibata, Hiroyuki Minemura, Takefumi Nikaido, Yoshinori Tanino, Atsuro Fukuhara, Ryuzo Kanno, Hiroyuki Saito, Shuzo Suzuki, Yayoi Inokoshi, Eiichiro Sando, Hirofumi Sakuma, Tatsuho Kobayashi, Hiroaki Kume, Masahiro Kamimoto, Hideko Aoki, Akira Takama, Taku Iizuka, Takamichi Kamiyama, Masaru Nakayama, Kiyoshi Saito, Koichi Tanigawa, Masahiko Sato, Yuichi Waragai, Toshiyuki Kambe, Norio Kanzaki, Teruhisa Azuma, Hiromasa Okamoto, Keiji Sakamoto, Yuichi Nakamura, Hiroshi Ohtani, Mitsuru Waragai, Shinsaku Maeda, Tokiya Ishida, Keishi Sugino, Wataru Abe, Yasuhiko Tsukada, Tomoyoshi Lee, Ryuki Yamada, Riko Sato, Takumi Onuma, Hikaru Tomita, Mikako Saito, Natsumi Watanabe, Mami Rikimaru, Takaya Kawamata, Julia Morimoto, Ryuichi Togawa, Yuki Sato, Junpei Saito, Kenya Kanazawa, Sugihiro Hamaguchi, Ken Iseki
doi:10.21203/rs.3.rs-2118653/v1
Background It is unclear whether molnupiravir has a bene cial effect on vaccinated patients infected with the Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We here evaluated the e cacy of molnupiravir in patients with mild-to-moderate coronavirus disease 2019 (COVID-19) during the Omicron variant surge in Fukushima Prefecture, Japan. Methods We enrolled patients with mild-to-moderate COVID-19 who were admitted to hospitals between January and April, 2022. Clinical deterioration after admission was compared between molnupiravir users (n = 281) and non-users (n = 1,636). Results The molnupiravir users were older (P < 0.0001), and had greater rates of history of chronic respiratory disease (P = 0.039), hypertension (P < 0.0001), dyslipidemia (P < 0.0001), diabetes mellitus (P < 0.0001), and cardiac disease (P = 0.003) than the non-users. The clinical deterioration rate was signi cantly lower in the molnupiravir users compared to the non-users (3.92% vs 7.46%; P = 0.021). Multivariate logistic regression analysis demonstrated that receiving molnupiravir was a factor for preventing deterioration (odds ratio 0.426; 95% con dence interval 0.208-0.871; P = 0.019), independent of receiving the SARS-CoV-2 vaccine. Furthermore, in 259 patients who were selected from each group after matching on the propensity score, the rate of deterioration was signi cantly lower among those receiving molnupiravir compared to those not receiving molnupiravir (3.86% vs 9.65%; p = 0.008). Conclusion This real-world study demonstrates that molnupiravir contributes to the prevention of deterioration in COVID-19 patients after hospitalization during the Omicron variant phase.
Author contribution Conception and design: Yasuhito Suzuki and Yoko Shibata. Analysis and drafting the manuscript: Yasuhito Suzuki and Yoko Shibata. Data curation: all authors. Final approval of the manuscript: all authors. Ethic This study was performed in line with the principles of the Declaration of Helsinki. The protocol was approved by the local ethical committee. Consent to publication The authors seen the nal version of the manuscript and approved submission for publication.
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We ' 'here evaluated the efficacy of molnupiravir in patients with mild-to-moderate coronavirus ' 'disease 2019 (COVID-19) during the Omicron variant surge in Fukushima Prefecture, Japan.\n' 'Methods\n' ' We enrolled patients with mild-to-moderate COVID-19 who were admitted to hospitals between ' 'January and April, 2022. Clinical deterioration after admission was compared between ' 'molnupiravir users (n\u2009=\u2009281) and non-users (n\u2009=\u20091,636).\n' 'Results\n' ' The molnupiravir users were older (P\u2009&lt;\u20090.0001), and had greater rates of ' 'history of chronic respiratory disease (P\u2009=\u20090.039), hypertension (P\u2009&lt;\u2009' '0.0001), dyslipidemia (P\u2009&lt;\u20090.0001), diabetes mellitus (P\u2009&lt;\u20090.0001), ' 'and cardiac disease (P\u2009=\u20090.003) than the non-users. The clinical deterioration rate ' 'was significantly lower in the molnupiravir users compared to the non-users (3.92% vs 7.46%; ' 'P\u2009=\u20090.021). Multivariate logistic regression analysis demonstrated that receiving ' 'molnupiravir was a factor for preventing deterioration (odds ratio 0.426; 95% confidence ' 'interval 0.208–0.871; P\u2009=\u20090.019), independent of receiving the SARS-CoV-2 vaccine. ' 'Furthermore, in 259 patients who were selected from each group after matching on the ' 'propensity score, the rate of deterioration was significantly lower among those receiving ' 'molnupiravir compared to those not receiving molnupiravir (3.86% vs 9.65%; p\u2009=\u2009' '0.008).\n' 'Conclusion\n' ' This real-world study demonstrates that molnupiravir contributes to the prevention of ' 'deterioration in COVID-19 patients after hospitalization during the Omicron variant ' 'phase.</jats:p>', 'DOI': '10.21203/rs.3.rs-2118653/v1', 'type': 'posted-content', 'created': {'date-parts': [[2022, 10, 5]], 'date-time': '2022-10-05T18:37:20Z', 'timestamp': 1664995040000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Real-world clinical outcomes of treatment with molnupiravir for patients with mild- to-moderate ' 'coronavirus disease 2019 during the Omicron variant pandemic', 'prefix': '10.21203', 'author': [ { 'given': 'Yasuhito', 'family': 'Suzuki', 'sequence': 'first', 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