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尼马曲韦-利托那韦对美国退伍军人新冠病毒感染后疾病发展的有效性:一项目标试验模拟。

Effectiveness of Nirmatrelvir-Ritonavir Against the Development of Post-COVID-19 Conditions Among U.S. Veterans : A Target Trial Emulation.

机构信息

Research and Development and Division of Gastroenterology, Veterans Affairs Puget Sound Health Care System, and Division of Gastroenterology, University of Washington, Seattle, Washington (G.N.I.).

Research and Development, Veterans Affairs Puget Sound Health Care System, Seattle, Washington (K.B.).

出版信息

Ann Intern Med. 2023 Nov;176(11):1486-1497. doi: 10.7326/M23-1394. Epub 2023 Oct 31.

DOI:10.7326/M23-1394
PMID:37903369
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10620954/
Abstract

BACKGROUND

COVID-19 has been linked to the development of many post-COVID-19 conditions (PCCs) after acute infection. Limited information is available on the effectiveness of oral antivirals used to treat acute COVID-19 in preventing the development of PCCs.

OBJECTIVE

To measure the effectiveness of outpatient treatment of COVID-19 with nirmatrelvir-ritonavir in preventing PCCs.

DESIGN

Retrospective target trial emulation study comparing matched cohorts receiving nirmatrelvir-ritonavir versus no treatment.

SETTING

Veterans Health Administration (VHA).

PARTICIPANTS

Nonhospitalized veterans in VHA care who were at risk for severe COVID-19 and tested positive for SARS-CoV-2 during January through July 2022.

INTERVENTION

Nirmatrelvir-ritonavir treatment for acute COVID-19.

MEASUREMENTS

Cumulative incidence of 31 potential PCCs at 31 to 180 days after treatment or a matched index date, including cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, endocrine, and general conditions and symptoms.

RESULTS

Eighty-six percent of the participants were male, with a median age of 66 years, and 17.5% were unvaccinated. Baseline characteristics were well balanced between participants treated with nirmatrelvir-ritonavir and matched untreated comparators. No differences were observed between participants treated with nirmatrelvir-ritonavir ( = 9593) and their matched untreated comparators in the incidence of most PCCs examined individually or grouped by organ system, except for lower combined risk for venous thromboembolism and pulmonary embolism (subhazard ratio, 0.65 [95% CI, 0.44 to 0.97]; cumulative incidence difference, -0.29 percentage points [CI, -0.52 to -0.05 percentage points]).

LIMITATIONS

Ascertainment of PCCs using International Classification of Diseases, 10th Revision, codes may be inaccurate. Evaluation of many outcomes could have resulted in spurious associations with combined thromboembolic events by chance.

CONCLUSION

Out of 31 potential PCCs, only combined thromboembolic events seemed to be reduced by nirmatrelvir-ritonavir.

PRIMARY FUNDING SOURCE

U.S. Department of Veterans Affairs.

摘要

背景

COVID-19 与急性感染后许多 COVID-19 后病症(PCCs)的发展有关。目前关于用于治疗急性 COVID-19 的口服抗病毒药物在预防 PCCs 发展方面的有效性的信息有限。

目的

测量奈玛特韦-利托那韦门诊治疗 COVID-19 在预防 PCCs 方面的效果。

设计

比较接受奈玛特韦-利托那韦与未治疗的匹配队列的回顾性目标试验模拟研究。

地点

退伍军人健康管理局(VHA)。

参与者

在 2022 年 1 月至 7 月期间,在 VHA 护理中患有 COVID-19 风险且 SARS-CoV-2 检测呈阳性的非住院退伍军人。

干预措施

奈玛特韦-利托那韦治疗急性 COVID-19。

测量指标

治疗后 31 至 180 天或匹配的指数日期内 31 种潜在 PCCs 的累积发生率,包括心脏、肺部、肾脏、血栓栓塞、胃肠道、神经、心理健康、肌肉骨骼、内分泌和一般状况和症状。

结果

86%的参与者为男性,中位年龄为 66 岁,17.5%未接种疫苗。接受奈玛特韦-利托那韦治疗的参与者与未接受治疗的匹配对照者之间的基线特征在治疗后 31 至 180 天或匹配的指数日期内,31 种潜在 PCCs 的累积发生率无差异,除了静脉血栓栓塞和肺栓塞的综合风险较低(亚危险比,0.65[95%CI,0.44 至 0.97];累积发生率差异,-0.29 个百分点[CI,-0.52 至-0.05 个百分点])外,大多数单独或按器官系统分组的 PCCs 发生率无差异。

局限性

使用国际疾病分类第 10 版代码确定 PCCs 可能不准确。对许多结果的评估可能导致血栓栓塞事件的综合事件因偶然机会而产生虚假关联。

结论

在 31 种潜在 PCCs 中,只有联合血栓栓塞事件似乎被奈玛特韦-利托那韦降低。

主要资金来源

美国退伍军人事务部。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2f8/10620954/facfa66ff672/aim-olf-M231394-AIME202311210-M231394_visual-abstract.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2f8/10620954/facfa66ff672/aim-olf-M231394-AIME202311210-M231394_visual-abstract.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2f8/10620954/facfa66ff672/aim-olf-M231394-AIME202311210-M231394_visual-abstract.jpg

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