研究动态
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Nirmatrelvir/ritonavir用于治疗免疫功能低下的早期症状COVID-19成年患者的真实体验。

Nirmatrelvir/ritonavir for the treatment of immunocompromised adult patients with early-stage symptomatic COVID-19: A real-life experience.

发表日期:2023 Sep
作者: José María Caso, Mario Fernández-Ruiz, Francisco López-Medrano, José Manuel Caro-Teller, Manuel Lizasoain, Rafael San-Juan, Marina Fayos Pérez, Isabel Rodríguez-Goncer, Jose Tiago Silva, José María Aguado
来源: JOURNAL OF MEDICAL VIROLOGY

摘要:

不论接种状况如何,严重2019年冠状病毒病(COVID-19)仍然是免疫功能受损患者的相关发病率之一。尽管尼马替维/利托那韦(NMV/r)的疗效已被证实,但对这个高危人群的药物相互作用(DDIs)及安全性仍存在一些顾虑。我们旨在评估接受NMV/r治疗的免疫功能受损患者的临床疗效,以及DDIs和治疗出现的不良事件(TEAEs)的发生情况。这项回顾性观察性研究包括自2022年4月至8月期间在我们中心接受NMV/r治疗的所有具有某种形式的免疫抑制并实验室确诊COVID-19的患者。主要结果是临床状态恶化(在一个经过验证的临床进展评分基准上从基线增加≥1分)在治疗开始后+7天和+28天时。安全性结果包括任何TEAE和潜在严重的DDIs的发生率。我们纳入了110位患者。免疫抑制的主要原因是血液肿瘤(58.2%)(主要是多发性骨髓瘤[22.7%]和非霍奇金淋巴瘤[13.6%]),活动性化疗(30.0%)和造血干细胞移植(14.5%)。在+7天和+28天时观察到4例(3.6%)和5例(4.5%)患者的临床恶化。只有一个患者在+28天时SARS-CoV-2聚合酶链反应检测呈阳性。在56.4%的患者中至少观察到一种潜在严重的DDI。TEAE的发生率为10.9%,尽管只有两名患者(1.8%)需要提前停用NMV/r。应该考虑在COVID-19患者中早期开始NMV/r治疗,特别注意相互作用的药物。©2023韦伯期刊有限公司。
Regardless of vaccination status, progression to severe coronavirus disease 2019 (COVID-19) is still a relevant cause of morbidity among immunocompromised patients. Despite the proven efficacy of nirmatrelvir/ritonavir (NMV/r), concerns remain regarding the potential for drug-to-drug interactions (DDIs) and the safety in this at-risk population. We aimed to evaluate the clinical outcomes of immunocompromised patients treated with NMV/r, as well as the occurrence of DDIs and treatment-emergent adverse events (TEAEs). This retrospective observational study included all the patients with some form of immunosuppression and laboratory-confirmed COVID-19 that received NMV/r at our center from April to August 2022. The main outcome was worsening of the clinical status (increase of ≥1 point from baseline in a validated clinical progression scale) by Days +7 and +28 after the initiation of therapy. Safety outcomes included the rates of any TEAE and potentially severe DDIs. We included 110 patients. Main causes of immunosuppression were hematological malignancy (58.2%) (mainly multiple myeloma [22.7%] and non-Hodgkin lymphoma [13.6%]), active chemotherapy (30.0%) and hematopoietic stem cell transplantation (14.5%). Clinical worsening by Days +7 and +28 was observed in four (3.6%) and five patients (4.5%), respectively. Only one patient had a positive SARS-CoV-2 polymerase chain reaction test at Day +28. At least one potentially severe DDI was observed in 56.4% of the patients. The rate of attributable TEAEs was 10.9%, although only two patients (1.8%) required premature discontinuation of NMV/r. Early initiation of NMV/r therapy should be considered in immunocompromised patients with COVID-19, with particular attention to interacting medications.© 2023 Wiley Periodicals LLC.