目的:比较莫努比拉韦的疗效,奈马特雷韦-利托那韦,和sotrovimab不治疗,以防止在社区感染SARS-CoV-2的高风险患者入院或死亡。
方法:使用安全匿名信息链接(SAIL)数据库对非住院成年COVID-19患者进行回顾性队列研究。
方法:在SAIL数据库(包含匿名的安全可信研究环境,个人,威尔士人口的人口规模电子健康记录(EHR)数据),英国。
方法:社区成人COVID-19患者,住院和死亡的风险更高,在2021年12月16日至2022年4月22日期间,SARS-CoV-2检测呈阳性。
方法:Molnupiravir,奈马特雷韦-利托那韦,和sotrovimab在社区由当地卫生委员会和威尔士国家抗病毒服务。
方法:SARS-CoV-2检测阳性28天内全因入院或死亡。
方法:Cox比例风险模型,治疗状态(治疗/未治疗)作为时间依赖性协变量,并根据年龄进行了调整,性别,合并症的数量,威尔士多重剥夺指数,和疫苗接种状况。次要亚组分析按治疗类型进行,合并症的数量,以及2022年2月20日之前和之后,当时omicronBA.1和omicronBA.2是威尔士的主要亚变体。
结果:在2021年12月16日至2022年4月22日之间,有7,103名高危患者符合纳入研究的条件。其中,2,040人接受了莫努普拉韦治疗(359人,17.6%),奈马特雷韦-利托那韦(602,29.5%),或索特罗维玛(1079,52.9%)。治疗组患者年龄较小(平均年龄53岁vs57岁),有较少的合并症,接受四剂或更多剂量COVID-19疫苗的比例更高(36.3%vs17.6%)。在阳性测试的28天内,628例(9.0%)患者入院或死亡(84例接受治疗,544例未经治疗)。主要分析表明,与未接受治疗的参与者相比,接受治疗的参与者在28天内的任何时间点住院或死亡的风险较低。与未治疗的参与者相比,接受治疗的参与者调整后的危险率降低了35%(95%CI:18-49%)。没有迹象表明一种治疗优于另一种治疗,也没有证据表明没有或只有一种合并症的患者在28天内住院或死亡的风险降低。在用sotrovimab治疗的患者中,2022年2月20日前后的事件发生率相似(5.0%vs4.9%),各时间段间sotrovimab的风险比无显著差异.
结论:在社区COVID-19的高风险成人患者中,那些接受莫诺比拉韦治疗的患者,奈马特雷韦-利托那韦,或sotrovimab的住院或死亡风险低于未接受治疗的患者.
To compare the effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab with no treatment in preventing hospital admission or death in higher-risk patients infected with SARS-CoV-2 in the community.
Retrospective cohort
study of non-hospitalized adult patients with COVID-19 using the Secure Anonymised Information Linkage (SAIL) Databank.
A real-world cohort
study was conducted within the SAIL Databank (a secure trusted research environment containing anonymised, individual, population-scale electronic health record (EHR) data) for the population of Wales, UK.
Adult patients with COVID-19 in the community, at higher risk of hospitalization and death, testing positive for SARS-CoV-2 between 16th December 2021 and 22nd April 2022.
Molnupiravir, nirmatrelvir-ritonavir, and sotrovimab given in the community by local health boards and the National Antiviral Service in Wales.
All-cause admission to hospital or death within 28 days of a positive test for SARS-CoV-2.
Cox proportional hazard model with treatment status (treated/untreated) as a time-dependent covariate and adjusted for age, sex, number of comorbidities, Welsh Index of Multiple Deprivation, and vaccination status. Secondary subgroup analyses were by treatment type, number of comorbidities, and before and on or after 20th February 2022, when omicron BA.1 and omicron BA.2 were the dominant subvariants in Wales.
Between 16th December 2021 and 22nd April 2022, 7013 higher-risk patients were eligible for inclusion in the
study. Of these, 2040 received treatment with molnupiravir (359, 17.6%), nirmatrelvir-ritonavir (602, 29.5%), or sotrovimab (1079, 52.9%). Patients in the treatment group were younger (mean age 53 vs 57 years), had fewer comorbidities, and a higher proportion had received four or more doses of the COVID-19 vaccine (36.3% vs 17.6%). Within 28 days of a positive test, 628 (9.0%) patients were admitted to hospital or died (84 treated and 544 untreated). The primary analysis indicated a lower risk of hospitalization or death at any point within 28 days in treated participants compared to those not receiving treatment. The adjusted hazard rate was 35% (95% CI: 18-49%) lower in treated than untreated participants. There was no indication of the superiority of one treatment over another and no evidence of a reduction in risk of hospitalization or death within 28 days for patients with no or only one comorbidity. In patients treated with sotrovimab, the event rates before and on or after 20th February 2022 were similar (5.0% vs 4.9%) with no significant difference in the hazard ratios for sotrovimab between the time periods.
In higher-risk adult patients in the community with COVID-19, those who received treatment with molnupiravir, nirmatrelvir-ritonavir, or sotrovimab were at lower risk of hospitalization or death than those not receiving treatment.