IAME, Université Paris Cité, IAME, Inserm, F-75018, Paris, France.
Laboratoire de Virologie, Institut des Agents Infectieux de Lyon, Centre National de Référence des Virus Respiratoires France Sud, Hospices Civils de Lyon, Lyon, France.
CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2027-2037. doi: 10.1002/psp4.13051. Epub 2023 Oct 11.
The role of antiviral treatment in coronavirus disease 2019 hospitalized patients is controversial. To address this question, we analyzed simultaneously nasopharyngeal viral load and the National Early Warning Score 2 (NEWS-2) using an effect compartment model to relate viral dynamics and the evolution of clinical severity. The model is applied to 664 hospitalized patients included in the DisCoVeRy trial (NCT04315948; EudraCT 2020-000936-23) randomly assigned to either standard of care (SoC) or SoC + remdesivir. Then we use the model to simulate the impact of antiviral treatments on the time to clinical improvement, defined by a NEWS-2 score lower than 3 (in patients with NEWS-2 <7 at hospitalization) or 5 (in patients with NEWS-2 ≥7 at hospitalization), distinguishing between patients with low or high viral load at hospitalization. The model can fit well the different observed patients trajectories, showing that clinical evolution is associated with viral dynamics, albeit with large interindividual variability. Remdesivir antiviral activity was 22% and 78% in patients with low or high viral loads, respectively, which is not sufficient to generate a meaningful effect on NEWS-2. However, simulations predicted that antiviral activity greater than 99% could reduce by 2 days the time to clinical improvement in patients with high viral load, irrespective of the NEWS-2 score at hospitalization, whereas no meaningful effect was predicted in patients with low viral loads. Our results demonstrate that time to clinical improvement is associated with time to viral clearance and that highly effective antiviral drugs could hasten clinical improvement in hospitalized patients with high viral loads.
抗病毒治疗在 2019 年冠状病毒病住院患者中的作用存在争议。为了解决这个问题,我们同时使用效应室模型分析鼻咽病毒载量和国家早期预警评分 2(NEWS-2),以将病毒动力学与临床严重程度的演变联系起来。该模型应用于 DisCoVeRy 试验(NCT04315948;EudraCT 2020-000936-23)中随机分配至标准治疗(SoC)或 SoC+瑞德西韦的 664 例住院患者。然后,我们使用该模型模拟抗病毒治疗对临床改善时间的影响,临床改善定义为 NEWS-2 评分低于 3(住院时 NEWS-2<7 的患者)或 5(住院时 NEWS-2≥7 的患者),区分住院时病毒载量低或高的患者。该模型可以很好地拟合不同的观察到的患者轨迹,表明临床演变与病毒动力学相关,尽管存在个体间的巨大差异。瑞德西韦的抗病毒活性在病毒载量低或高的患者中分别为 22%和 78%,不足以对 NEWS-2 产生有意义的影响。然而,模拟预测,抗病毒活性大于 99%可使高病毒载量患者的临床改善时间缩短 2 天,而与住院时的 NEWS-2 评分无关,而对低病毒载量患者则无明显效果。我们的研究结果表明,临床改善时间与病毒清除时间相关,高效的抗病毒药物可能会加速高病毒载量住院患者的临床改善。