{"title":"Ensitrelvir for the treatment of COVID-19: A systematic review of evidence.","authors":"Saeed Khorramnia, Seyed Hamid Pakzad Moghadam, Ali Sarkoohi, Mojgan Mohajeri Iravani, Amirhossein Orandi, Samrand Fattah Ghazi, Shahla Noori Ardabili, Ebadallah Shiri Malekabad, Zia Navidi","doi":"10.7883/yoken.JJID.2024.372","DOIUrl":null,"url":null,"abstract":"<p><p>Ensitrelvir is a novel antiviral drug that has been evaluated for its effectiveness against Coronavirus disease 2019 (COVID-19). This study aims to gather relevant evidence regarding the efficacy and safety of ensitrelvir in patients diagnosed with COVID-19. A systematic search was conducted in databases including PubMed, the Cochrane Library, Web of Science, and Scopus to identify pertinent studies on ensitrelvir's role in COVID-19 treatment up to September 2024. Nine studies were included in the analysis, comprising two retrospective studies, two phase 1 trials, three phase 2/3 trials, and two phase 3 trials. The findings indicated that ensitrelvir is associated with a reduced risk of death and shorter hospital stays for COVID-19 patients compared to control groups. Additionally, ensitrelvir demonstrated the ability to lower SARS-CoV-2 viral titers and RNA levels while accelerating the time to viral clearance compared to placebo. Reported adverse events were predominantly mild, with no serious adverse events noted. Ensitrelvir exhibited consistent pharmacokinetics across different populations, eliminating the need for dose adjustments. Ensitrelvir appears to be an effective and safe option for managing mild to moderate COVID-19 infections. However, further studies are needed to establish its efficacy and safety in treating COVID-19.</p>","PeriodicalId":14608,"journal":{"name":"Japanese journal of infectious diseases","volume":" ","pages":""},"PeriodicalIF":1.1000,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Japanese journal of infectious diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7883/yoken.JJID.2024.372","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
Abstract
Ensitrelvir is a novel antiviral drug that has been evaluated for its effectiveness against Coronavirus disease 2019 (COVID-19). This study aims to gather relevant evidence regarding the efficacy and safety of ensitrelvir in patients diagnosed with COVID-19. A systematic search was conducted in databases including PubMed, the Cochrane Library, Web of Science, and Scopus to identify pertinent studies on ensitrelvir's role in COVID-19 treatment up to September 2024. Nine studies were included in the analysis, comprising two retrospective studies, two phase 1 trials, three phase 2/3 trials, and two phase 3 trials. The findings indicated that ensitrelvir is associated with a reduced risk of death and shorter hospital stays for COVID-19 patients compared to control groups. Additionally, ensitrelvir demonstrated the ability to lower SARS-CoV-2 viral titers and RNA levels while accelerating the time to viral clearance compared to placebo. Reported adverse events were predominantly mild, with no serious adverse events noted. Ensitrelvir exhibited consistent pharmacokinetics across different populations, eliminating the need for dose adjustments. Ensitrelvir appears to be an effective and safe option for managing mild to moderate COVID-19 infections. However, further studies are needed to establish its efficacy and safety in treating COVID-19.
Ensitrelvir是一种新型抗病毒药物,已被评估其对2019冠状病毒病(COVID-19)的有效性。本研究旨在收集有关ensitrelvir治疗COVID-19患者的有效性和安全性的相关证据。系统检索PubMed、Cochrane Library、Web of Science、Scopus等数据库,确定截至2024年9月ensitrelvir在COVID-19治疗中的相关研究。9项研究纳入分析,包括2项回顾性研究、2项1期试验、3项2/3期试验和2项3期试验。研究结果表明,与对照组相比,恩司替韦与COVID-19患者的死亡风险降低和住院时间缩短有关。此外,与安慰剂相比,ensitrelvir显示出降低SARS-CoV-2病毒滴度和RNA水平的能力,同时加快了病毒清除的时间。报告的不良事件主要是轻微的,没有严重的不良事件。恩西瑞韦在不同人群中表现出一致的药代动力学,消除了剂量调整的需要。Ensitrelvir似乎是治疗轻至中度COVID-19感染的有效和安全的选择。但其治疗新冠肺炎的有效性和安全性有待进一步研究。
期刊介绍:
Japanese Journal of Infectious Diseases (JJID), an official bimonthly publication of National Institute of Infectious Diseases, Japan, publishes papers dealing with basic research on infectious diseases relevant to humans in the fields of bacteriology, virology, mycology, parasitology, medical entomology, vaccinology, and toxinology. Pathology, immunology, biochemistry, and blood safety related to microbial pathogens are among the fields covered. Sections include: original papers, short communications, epidemiological reports, methods, laboratory and epidemiology communications, letters to the editor, and reviews.