Real-world effectiveness of nirmatrelvir-ritonavir and molnupiravir in non-hospitalised adults with Covid-19: a population-based, retrospective cohort study cohort study.

IF 10.9 1区 医学 Q1 INFECTIOUS DISEASES Clinical Microbiology and Infection Pub Date : 2024-11-04 DOI:10.1016/j.cmi.2024.10.026
Anselm Jorda, Dominik Ensle, Hubert Eser, Florentin Glötzl, Benjamin Riedl, Marton Szell, Arschang Valipour, Alexander Zoufaly, Christoph Wenisch, Doris Haider, Heinz Burgmann, Florian Thalhammer, Florian Götzinger, Bernd Jilma, Robin Ristl, Ursula Karnthaler, Markus Zeitlinger
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Abstract

Objectives: The real-world effectiveness of the oral antivirals nirmatrelvir-ritonavir and molnupiravir against the SARS-CoV-2 Omicron variant remains uncertain. We aimed to estimate their effectiveness in non-hospitalised adults with Covid-19.

Methods: This retrospective cohort study used data from the Municipal Department for Public Health Services of Vienna, Austria, to identify non-hospitalised adults with confirmed SARS-CoV-2 infection between Jan-2022-May-2023. Nirmatrelvir-ritonavir users were compared with untreated controls and molnupiravir users with untreated controls by calculating adjusted risk differences (aRDs) using a covariate-adjusted logistic regression model with inverse probability weighting. Outcomes were hospitalisation and all-cause death within 28 days.

Results: We identified 113,399 eligible cases (90,481 untreated controls, 12,166 nirmatrelvir-ritonavir users, and 10,752 molnupiravir users). Over 96% of the patients were immunised by previous infection or vaccination. In the nirmatrelvir-ritonavir analysis, the estimated risk of hospitalisation was 0.57% (95%CI, 0.35-0.78) in nirmatrelvir-ritonavir users and 1.09% (95%CI, 0.86-1.32) in untreated controls (aRD -0.53%; 95%CI, -0.77--0.28). The estimated risk of death was 0.0% (95%CI, 0.0-0.0) in nirmatrelvir-ritonavir users and 0.13% (95%CI, 0.08-0.18) in untreated controls (aRD -0.13%, 95%CI, -0.18--0.08). The number needed to treat to prevent hospitalisation and death was 190 (95%CI, 130-356) and 792 (95%CI, 571-1289), respectively. These statistically significant aRDs were restricted to the subgroup of patients ≥60 years. In the molnupiravir analysis, the estimated risk of hospitalisation was 1.36% (95%CI, 0.95-1.77) in molnupiravir users and 1.16% (95%CI, 0.93-1.39) in untreated controls (aRD 0.2%; 95%CI, -0.08-0.49). The estimated risk of death was 0.12% (95%CI, 0.01-0.23) in molnupiravir users and 0.14% (95%CI, 0.06-0.21) in untreated controls (aRD, -0.01%; 95%CI, -0.08--0.06).

Conclusions: Among outpatients aged ≥60 years with Covid-19 in an Omicron-dominated era, treatment with nirmatrelvir-ritonavir was associated with a lower risk of hospitalisation and all-cause death within 28 days, albeit with wide confidence intervals and high numbers needed to treat. This finding was not observed in molnupiravir users and younger nirmatrelvir-ritonavir users.

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尼马瑞韦-利托那韦和莫仑匹拉韦对非住院成人 Covid-19 患者的实际疗效:一项基于人群的回顾性队列研究。
目的:口服抗病毒药物尼马瑞韦-利托那韦和莫仑匹拉韦对 SARS-CoV-2 Omicron 变体的实际疗效仍不确定。我们的目的是评估这两种药物在非住院成人 Covid-19 患者中的疗效:这项回顾性队列研究使用了奥地利维也纳市公共卫生局的数据,以确定 2022 年 1 月至 2023 年 5 月期间确诊感染 SARS-CoV-2 的非住院成人。通过使用带反概率加权的协变量调整逻辑回归模型计算调整后风险差异(aRDs),将尼马瑞韦和利托那韦使用者与未接受治疗的对照组进行比较,将莫仑吡拉韦使用者与未接受治疗的对照组进行比较。结果为住院治疗和 28 天内全因死亡:我们发现了 113,399 例符合条件的病例(90,481 例未经治疗的对照组、12,166 例尼马瑞韦-利托那韦使用者和 10,752 例莫仑匹韦使用者)。96%以上的患者曾因感染或接种疫苗而获得免疫。在对尼马瑞韦-利托那韦的分析中,尼马瑞韦-利托那韦使用者的估计住院风险为0.57%(95%CI,0.35-0.78),未经治疗的对照组为1.09%(95%CI,0.86-1.32)(aRD-0.53%;95%CI,-0.77--0.28)。尼马瑞韦-利托那韦使用者的估计死亡风险为0.0%(95%CI,0.0-0.0),未经治疗的对照组为0.13%(95%CI,0.08-0.18)(aRD -0.13%,95%CI,-0.18--0.08)。预防住院和死亡所需的治疗人数分别为 190(95%CI,130-356)和 792(95%CI,571-1289)。这些具有统计学意义的aRD仅限于年龄≥60岁的亚组患者。在对molnupiravir的分析中,molnupiravir使用者的估计住院风险为1.36%(95%CI,0.95-1.77),未经治疗的对照组为1.16%(95%CI,0.93-1.39)(aRD为0.2%;95%CI,-0.08-0.49)。莫仑吡韦使用者的估计死亡风险为0.12%(95%CI,0.01-0.23),未接受治疗的对照组为0.14%(95%CI,0.06-0.21)(aRD,-0.01%;95%CI,-0.08--0.06):结论:在奥米克隆占主导地位的时代,在年龄≥60岁的门诊Covid-19患者中,使用尼马瑞韦-利托那韦治疗与较低的住院风险和28天内的全因死亡有关,尽管置信区间较宽,需要治疗的人数较多。在使用莫仑吡韦的患者和较年轻的尼马瑞韦-利托那韦患者中没有观察到这一结果。
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来源期刊
CiteScore
25.30
自引率
2.10%
发文量
441
审稿时长
2-4 weeks
期刊介绍: Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.
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Real-world effectiveness of nirmatrelvir-ritonavir and molnupiravir in non-hospitalised adults with Covid-19: a population-based, retrospective cohort study cohort study. A phase 3 randomized trial of sulopenem vs. ertapenem in patients with complicated intraabdominal infections. Re: 'Heightened incidence of adverse events associated with a live attenuated varicella vaccine strain that lacks critical genetic polymorphisms in ORF62' by Kang et al. Epidemiology of human metapneumovirus among children with severe or very severe pneumonia in high pneumonia burden settings: the PERCH study experience. 'Measurement of circulating viral antigens post-SARS-CoV-2 infection in a multicohort study' - Author's reply.
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