From the Division of Community Medical Services (R.A., A.P., S.Y., D.S., A.H., D.N.), the Branch of Planning and Strategy (Y.W.S., M.H., E.B., G.L.), and the Clalit Research Institute, Division of Innovation (J.G.W., N.D., R.B., Y.B.-S.), Clalit Health Services, Tel Aviv, the Maximizing Health Outcomes Research Lab, Sapir College, Sderot (R.A.), the Department of Bioinformatics, Jerusalem College of Technology, Jerusalem (M.H.), the Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology, Haifa (G.L.), and the School of Public Health, Faculty of Health Sciences (R.S., M.F., R.B.) and Software and Information Systems Engineering (N.D.), Ben-Gurion University of the Negev, Beersheba - all in Israel; and the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration, Harvard Medical School and Clalit Research Institute (N.D., R.B.), and the Department of Biomedical Informatics, Harvard Medical School (N.D.) - both in Boston.
N Engl J Med. 2022 Sep 1;387(9):790-798. doi: 10.1056/NEJMoa2204919. Epub 2022 Aug 24.
The oral protease inhibitor nirmatrelvir has shown substantial efficacy in high-risk, unvaccinated patients infected with the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Data regarding the effectiveness of nirmatrelvir in preventing severe coronavirus disease 2019 (Covid-19) outcomes from the B.1.1.529 (omicron) variant are limited.
We obtained data for all members of Clalit Health Services who were 40 years of age or older at the start of the study period and were assessed as being eligible to receive nirmatrelvir therapy during the omicron surge. A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of nirmatrelvir treatment with hospitalization and death due to Covid-19, with adjustment for sociodemographic factors, coexisting conditions, and previous SARS-CoV-2 immunity status.
A total of 109,254 patients met the eligibility criteria, of whom 3902 (4%) received nirmatrelvir during the study period. Among patients 65 years of age or older, the rate of hospitalization due to Covid-19 was 14.7 cases per 100,000 person-days among treated patients as compared with 58.9 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.27; 95% confidence interval [CI], 0.15 to 0.49). The adjusted hazard ratio for death due to Covid-19 was 0.21 (95% CI, 0.05 to 0.82). Among patients 40 to 64 years of age, the rate of hospitalization due to Covid-19 was 15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.74; 95% CI, 0.35 to 1.58). The adjusted hazard ratio for death due to Covid-19 was 1.32 (95% CI, 0.16 to 10.75).
Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.
口服蛋白酶抑制剂奈玛特韦在未接种疫苗的高危 SARS-CoV-2 感染患者中显示出显著疗效。关于奈玛特韦预防 B.1.1.529（奥密克戎）变异株引起的严重 COVID-19（新冠肺炎）结局的有效性数据有限。
我们获取了在研究期间年满 40 岁的克里夫利健康服务的所有成员的数据，并评估他们在奥密克戎激增期间有资格接受奈玛特韦治疗。使用具有时间依赖性协变量的 Cox 比例风险回归模型，调整社会人口因素、共存疾病和以前的 SARS-CoV-2 免疫状态后，估计奈玛特韦治疗与 COVID-19 住院和死亡的相关性。
共有 109254 名患者符合入选标准，其中 3902 名（4%）在研究期间接受了奈玛特韦治疗。在 65 岁及以上的患者中，治疗组因 COVID-19 住院的发生率为每 100000 人天 14.7 例，而未治疗组为每 100000 人天 58.9 例（调整后的危险比，0.27；95%置信区间 [CI]，0.15 至 0.49）。COVID-19 死亡的调整后危险比为 0.21（95%CI，0.05 至 0.82）。在 40 至 64 岁的患者中，治疗组因 COVID-19 住院的发生率为每 100000 人天 15.2 例，而未治疗组为每 100000 人天 15.8 例（调整后的危险比，0.74；95%CI，0.35 至 1.58）。COVID-19 死亡的调整后危险比为 1.32（95%CI，0.16 至 10.75）。
在 65 岁及以上的患者中，接受奈玛特韦治疗的患者 COVID-19 住院和死亡的发生率明显低于未接受治疗的患者。在年轻成年人中没有发现获益的证据。
Zotero 插件