Effectiveness of Paxlovid in Reducing Severe Coronavirus Disease 2019 and Mortality in High-Risk Patients
Effectiveness of Paxlovid in Reducing Severe Coronavirus Disease 2019 and Mortality in High-Risk Patients
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DOI：
10.1093/cid/ciac443
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发表时间：
2022-07-06
影响因子：
11.8
通讯作者：
Saliba, Walid
中科院分区：
文献类型：
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作者：
Najjar-Debbiny, Ronza;Gronich, Naomi;Saliba, Walid
我们评估了帕昔洛韦在新冠肺炎高危患者中的实际疗效。这项研究表明，在奥美康时代，帕昔洛韦在现实世界中非常有效，并显著降低了死亡和进展为严重COVID-19的风险。背景：基于高危患者蛋白水解酶抑制评估(EPIC-HR)试验的中期分析，帕昔洛韦获得了治疗轻中度冠状病毒病2019年(新冠肺炎)的紧急使用授权。帕昔洛韦的有效性需要在非受控环境中进行评估。在这项研究中，我们使用基于人口的真实数据来评估帕昔洛韦的有效性。方法利用以色列最大医疗保健提供者的数据库，确定2022年1月至2月期间首次严重急性呼吸综合征冠状病毒2型检测呈阳性的18岁及以上成年人，他们是严重新冠肺炎的高危人群，且没有帕昔洛韦的使用禁忌症。患者包括在内，无论他们是否接种了新冠肺炎疫苗。使用COX风险回归估计以帕昔洛韦为时间依赖变量的重症新冠肺炎患者的28天风险比(HR)或死亡率。结果共纳入180351例符合条件的患者，其中仅4737例(2.6%)接受过帕昔洛韦治疗，135482例(75.1%)具有良好的新冠肺炎接种状况。帕昔洛韦和适当的新冠肺炎接种状态都与严重新冠肺炎发生率或死亡率的显著降低相关，调整后的RR分别为0.54(95%可信区间[CI]，0.39-0.75)和0.20(95%可信区间，0.17-0.22)。帕昔洛韦似乎对老年患者、免疫抑制患者和潜在的神经或心血管疾病患者更有效(交互作用P<；0.05对于所有患者)。未发现帕昔洛韦治疗与新冠肺炎接种状态之间存在显著的交互作用。结论本研究表明，在奥美康时代和现实生活中，帕昔洛韦在降低严重新冠肺炎的风险或死亡率方面是非常有效的。
We assessed the real-world effectiveness of Paxlovid in high-risk COVID-19 patients. The study illustrates that Paxlovid is highly effective in real-world settings in the Omicron era and significantly reduced the risk of death and progression to severe COVID-19.Background Paxlovid was granted an Emergency Use Authorization for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), based on the interim analysis of the Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial. Paxlovid effectiveness needs to be assessed in a noncontrolled setting. In this study we used population-based real-world data to evaluate the effectiveness of Paxlovid. Methods The database of the largest healthcare provider in Israel was used to identify all adults aged 18 years or older with first-ever positive test for severe acute respiratory syndrome coronavirus 2 between January and February 2022, who were at high risk for severe COVID-19 and had no contraindications for Paxlovid use. Patients were included irrespective of their COVID-19 vaccination status. Cox hazard regression was used to estimate the 28-day hazard ratio (HR) for severe COVID-19 or mortality with Paxlovid examined as time-dependent variable. Results Overall, 180 351 eligible patients were included; of these, only 4737 (2.6%) were treated with Paxlovid, and 135 482 (75.1%) had adequate COVID-19 vaccination status. Both Paxlovid and adequate COVID-19 vaccination status were associated with significant decrease in the rate of severe COVID-19 or mortality with adjusted HRs of 0.54 (95% confidence interval [CI], .39-.75) and 0.20 (95% CI, .17-.22), respectively. Paxlovid appears to be more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease (interaction P < .05 for all). No significant interaction was detected between Paxlovid treatment and COVID-19 vaccination status. Conclusions This study suggests that in the era of Omicron and in real-life settings, Paxlovid is highly effective in reducing the risk of severe COVID-19 or mortality.