真实世界中尼马曲韦/利托那韦预防 2019 年冠状病毒病相关住院的有效性：加拿大魁北克省的一项基于人群的队列研究。

Real-World Effectiveness of Nirmatrelvir/Ritonavir on Coronavirus Disease 2019-Associated Hospitalization Prevention: A Population-based Cohort Study in the Province of Quebec, Canada.

机构信息

Institut National d'Excellence en Santé et Services Sociaux (INESSS) du Québec (Québec National Institute for Excellence in Health and Social Services), Quebec City, Quebec, Canada.

Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Center, Quebec City, Quebec, Canada.

出版信息

Clin Infect Dis. 2023 Sep 18;77(6):805-815. doi: 10.1093/cid/ciad287.

DOI:10.1093/cid/ciad287

PMID:37149726

Abstract

BACKGROUND

Nirmatrelvir/ritonavir has shown to reduce COVID-19 hospitalization and death before Omicron, but updated real-world evidence studies are needed. This study aimed to assess whether nirmatrelvir/ritonavir reduces the risk of COVID-19-associated hospitalization among high-risk outpatients.

METHODS

A retrospective cohort study of outpatients with SARS-CoV-2 between March 15 and 15 October 2022, using data from the Quebec clinico-administrative databases. Outpatients treated with nirmatrelvir/ritonavir were compared with infected ones not receiving nirmatrelvir/ritonavir using propensity-score matching. Relative risk (RR) of COVID-19-associated hospitalization within 30 days was assessed using a Poisson regression.

RESULTS

A total of 8402 treated outpatients were matched to controls. Regardless of vaccination status, nirmatrelvir/ritonavir treatment was associated with a 69% reduced RR of hospitalization (RR: .31; 95% CI: .28; .36; number needed to treat [NNT] = 13). The effect was more pronounced in outpatients with incomplete primary vaccination (RR: .04; 95% CI: .03; .06; NNT = 8), while no benefit was found in those with a complete primary vaccination (RR: .93; 95% CI: .78; 1.08). Subgroups analysis among high-risk outpatients with a complete primary vaccination showed that nirmatrelvir/ritonavir treatment was associated with a significant decrease in the RR of hospitalization in severely immunocompromised outpatients (RR: .66; 95% CI: .50; .89; NNT = 16) and in high-risk outpatients aged ≥70 years (RR: .50; 95% CI: .34; .74; NNT = 10) when the last dose of the vaccine was received at least 6 months ago.

CONCLUSIONS

Nirmatrelvir/ritonavir reduces the risk of COVID-19-associated hospitalization among incompletely vaccinated high-risk outpatients and among some subgroups of completely vaccinated high-risk outpatients.

摘要

背景

奈玛特韦/利托那韦在奥密克戎出现之前已被证明可降低 COVID-19 的住院和死亡风险，但仍需要更新的真实世界证据研究。本研究旨在评估奈玛特韦/利托那韦是否降低高危门诊患者 COVID-19 相关住院的风险。

方法

这是一项回顾性队列研究，纳入 2022 年 3 月 15 日至 10 月 15 日期间魁北克临床管理数据库中的 SARS-CoV-2 门诊患者数据。使用倾向评分匹配比较接受奈玛特韦/利托那韦治疗的门诊患者与未接受奈玛特韦/利托那韦治疗的感染患者。使用泊松回归评估 30 天内 COVID-19 相关住院的相对风险（RR）。

结果

共纳入 8402 例接受治疗的门诊患者与对照组相匹配。无论疫苗接种状态如何，奈玛特韦/利托那韦治疗与住院 RR 降低 69%相关（RR：0.31；95%CI：0.28；0.36；需要治疗的人数[NNT] = 13）。在未完成初级疫苗接种的门诊患者中，效果更为显著（RR：0.04；95%CI：0.03；0.06；NNT = 8），而在完成初级疫苗接种的患者中未发现获益（RR：0.93；95%CI：0.78；1.08）。在具有完整初级疫苗接种的高危门诊患者亚组分析中，奈玛特韦/利托那韦治疗与严重免疫功能低下门诊患者（RR：0.66；95%CI：0.50；0.89；NNT = 16）和 6 个月前至少接种最后一剂疫苗的高危门诊患者（RR：0.50；95%CI：0.34；0.74；NNT = 10）住院 RR 降低相关。