Division of Rheumatology, Multispecialist Medical Department, ASST Grande Ospedale Metropolitano Niguarda, p.zza Ospedale Maggiore 3, 20162, Milan, MI, Italy.
Bicocca Bioinformatics Biostatistics and Bioimaging Centre-B4, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
Clin Drug Investig. 2023 Oct;43(10):763-771. doi: 10.1007/s40261-023-01304-4. Epub 2023 Sep 22.
Remdesivir is an antiviral agent, which was shown to be safe and effective in treating early COVID-19, but its favourable impact in hospitalised patients with non-critical disease is still under investigation. The present study aimed to assess the effectiveness and safety of remdesivir as a treatment for hospitalised patients with COVID-19 by a propensity score analysis of observational data.
In this monocentric retrospective cohort study, the effectiveness and safety of a 5-day course of remdesivir (200 mg intravenously at Day 1, then 100 mg from Days 2-5) in association with the standard of care were assessed in comparison with the standard of care only. The primary endpoint was the proportion of recovery on Day 14.
Of 3662 eligible inpatients who tested positive for the severe acute respiratory syndrome coronavirus 2 genome by nasopharyngeal swab at admission, 861 (24%) non-critical patients were included in a propensity score analysis and 281 (33%) were exposed to remdesivir. In total, 242/281 (86.1%) and 435/580 (75.0%) patients recovered in exposed and non-exposed, respectively, with a relative improvement of 11.1% (95% CI + 5.8 to 16.5%; unadjusted odds ratio: 2.07, 95% CI 1.40-3.05, p = 0.0001; after adjustment by propensity score weighting, odds ratio: 1.92, 95% CI 1.30-2.83, p = 0.001). In treated patients, 1 (0.03%) anaphylactic reaction and 1 (0.03%) acute reaction during drug injection were reported, and 24 (8.5%) patients stopped the treatment due to adverse reactions. No significant differences were found with respect to the secondary efficacy endpoints (in-hospital all-cause death, need for intensive care treatments, clinical improvement score at Day 28) and safety endpoints (any and serious adverse reactions).
A 5-day course of remdesivir in association with the standard of care effectively promoted recovery from COVID-19 among non-critical in-hospital patients and had an acceptable safety profile.
瑞德西韦是一种抗病毒药物，在治疗早期 COVID-19 方面已被证明是安全有效的，但它在非重症住院患者中的有利影响仍在研究中。本研究旨在通过观察性数据的倾向评分分析评估瑞德西韦作为 COVID-19 住院患者治疗药物的疗效和安全性。
在这项单中心回顾性队列研究中，将瑞德西韦（第 1 天静脉注射 200mg，然后第 2-5 天每天 100mg）与标准治疗联合使用 5 天的疗效和安全性与仅接受标准治疗进行了比较。主要终点是第 14 天的康复比例。
在 3662 名因急性呼吸窘迫综合征冠状病毒 2 基因组检测呈阳性而接受鼻拭子检测的入院患者中，有 861 名（24%）非重症患者被纳入倾向评分分析，其中 281 名（33%）接受了瑞德西韦治疗。在暴露组和未暴露组中，分别有 242/281（86.1%）和 435/580（75.0%）患者康复，相对改善率为 11.1%（95%CI：5.8-16.5%；未调整的优势比：2.07，95%CI：1.40-3.05，p=0.0001；经倾向评分加权调整后，优势比：1.92，95%CI：1.30-2.83，p=0.001）。在接受治疗的患者中，有 1 例（0.03%）发生过敏反应，1 例（0.03%）在药物注射过程中发生急性反应，有 24 例（8.5%）因不良反应停止治疗。在次要疗效终点（住院期间全因死亡、需要重症监护治疗、第 28 天临床改善评分）和安全性终点（任何和严重不良反应）方面，均无显著差异。
瑞德西韦联合标准治疗可有效促进非重症住院患者 COVID-19 的康复，且安全性良好。
