Molaei Emad, Molaei Ali, Hayes A Wallace, Karimi Gholamreza
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Naunyn Schmiedebergs Arch Pharmacol. 2024 Jun;397(6):3829-3855. doi: 10.1007/s00210-023-02927-2. Epub 2024 Jan 5.
Remdesivir (RDV) is the mainstay antiviral therapy for moderate to severe COVID-19. Although remdesivir was the first drug approved for COVID-19, information about its efficacy and safety profile is limited in a significant segment of the population, such as people with underlying diseases, the elderly, children, and pregnant and lactating women. The efficacy and safety profile of RDV in disease progression, renal impairment, liver impairment, immunosuppression, geriatrics, pediatrics, pregnancy, and breastfeeding in COVID-19 patients was evaluated. The databases searched included Embase, Scopus, and PubMed. Only English language studies enrolling specific subpopulations with COVID-19 and treated with RDV were included. Thirty-nine clinical trials, cohorts, cross-sectional studies, and case series/reports were included. Most supported the benefits of RDV therapy for COVID-19 patients, such as lessening the duration of hospitalization, alleviating respiratory complications, and reducing mortality. Adverse effects of RDV, including liver and kidney impairment, were, for the most part, moderate to mild, supporting the safety profile of RDV therapy. RDV therapy was well tolerated, no new safety signals were detected, and liver function test abnormalities were the most common adverse events. Moreover, RDV, for the most part, was effective in managing the complications of COVID-19 and reducing mortality in these patients, except for patients with kidney impairment. Future studies, including RCTs, should include these subpopulations of patients to avoid delays associated with receiving proper medication through compassionate use programs.
瑞德西韦(RDV)是治疗中度至重度新型冠状病毒肺炎(COVID-19)的主要抗病毒疗法。尽管瑞德西韦是首个被批准用于治疗COVID-19的药物,但在很大一部分人群中,如患有基础疾病的人、老年人、儿童以及孕妇和哺乳期妇女,关于其疗效和安全性的信息有限。对RDV在COVID-19患者的疾病进展、肾功能损害、肝功能损害、免疫抑制、老年病、儿科、妊娠和母乳喂养方面的疗效和安全性进行了评估。检索的数据库包括Embase、Scopus和PubMed。仅纳入了招募特定COVID-19亚人群并接受RDV治疗的英文研究。共纳入了39项临床试验、队列研究、横断面研究以及病例系列/报告。大多数研究支持RDV治疗对COVID-19患者的益处,如缩短住院时间、减轻呼吸道并发症以及降低死亡率。RDV的不良反应,包括肝肾功能损害,大多为中度至轻度,这支持了RDV治疗的安全性。RDV治疗耐受性良好,未检测到新的安全信号,肝功能检查异常是最常见的不良事件。此外,除肾功能损害患者外,RDV在很大程度上对管理COVID-19的并发症和降低这些患者的死亡率有效。未来的研究,包括随机对照试验,应纳入这些亚人群患者,以避免通过同情用药计划接受适当药物治疗时出现延误。