Infection Control and Prevention Unit, Lady Davis Carmel Medical Center, Haifa, Israel.
Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Clin Infect Dis. 2023 Feb 8;76(3):e342-e349. doi: 10.1093/cid/ciac443.
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.
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.
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.
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.
根据评估蛋白酶抑制剂治疗高危人群 COVID-19（EPIC-HR）试验的中期分析，帕克洛维德被授予治疗轻度至中度 2019 年冠状病毒病（COVID-19）的紧急使用授权。需要在非对照环境中评估帕克洛维德的有效性。在这项研究中，我们使用基于人群的真实世界数据来评估帕克洛维德的有效性。
使用以色列最大的医疗保健提供者的数据库，确定 2022 年 1 月至 2 月期间首次检测到严重急性呼吸综合征冠状病毒 2 阳性的所有 18 岁或以上的成年人，这些成年人有患严重 COVID-19 的高风险，且无帕克洛维德使用禁忌。无论 COVID-19 疫苗接种状态如何，患者均被纳入。Cox 风险回归用于估计 28 天内严重 COVID-19 或死亡率的风险比（HR），帕克洛维德作为时间依赖性变量进行检查。
总体而言，纳入了 180351 名符合条件的患者；其中，仅有 4737 人（2.6%）接受了帕克洛维德治疗，135482 人（75.1%）有足够的 COVID-19 疫苗接种状态。帕克洛维德和充分的 COVID-19 疫苗接种状态均与严重 COVID-19 或死亡率降低显著相关，调整后的 HR 分别为 0.54（95%置信区间 [CI]，0.39-0.75）和 0.20（95% CI，0.17-0.22）。帕克洛维德在老年患者、免疫抑制患者和患有潜在神经或心血管疾病的患者中似乎更有效（所有交互 P<0.05）。未检测到帕克洛维德治疗与 COVID-19 疫苗接种状态之间的显著交互作用。
本研究表明，在奥密克戎时代和现实环境中，帕克洛维德在降低严重 COVID-19 或死亡率风险方面非常有效。
