利特莫韦在成人造血细胞移植受者体内的群体药动学分析。

IF 4.5 2区 医学 Q2 MICROBIOLOGY
Antimicrobial Agents and Chemotherapy Pub Date : 2025-10-01 Epub Date: 2025-08-22 DOI:10.1128/aac.00697-25
Léna Royston, Carla Kunz, David Tonoli, Pierre Lescuyer, Dionysios Neofytos, Verena Gotta
{"title":"利特莫韦在成人造血细胞移植受者体内的群体药动学分析。","authors":"Léna Royston, Carla Kunz, David Tonoli, Pierre Lescuyer, Dionysios Neofytos, Verena Gotta","doi":"10.1128/aac.00697-25","DOIUrl":null,"url":null,"abstract":"<p><p>We analyzed previously reported oral letermovir plasma concentration measurements from 40 allogeneic hematopoietic cell transplant (HCT) recipients using model-based pharmacometrics analysis. This analysis highlighted that the industry-sponsored phase III study model significantly over-predicted observed letermovir concentrations. Covariates associated with increased oral clearance (CL/F), possibly contributing to this observation, included: higher weight, younger age, and early use after HCT. The clinical significance and mechanistic explanation of relatively lower real-world exposure remains to be elucidated.</p>","PeriodicalId":8152,"journal":{"name":"Antimicrobial Agents and Chemotherapy","volume":" ","pages":"e0069725"},"PeriodicalIF":4.5000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Population pharmacokinetic analysis of letermovir in adult hematopoietic cell transplant recipients.\",\"authors\":\"Léna Royston, Carla Kunz, David Tonoli, Pierre Lescuyer, Dionysios Neofytos, Verena Gotta\",\"doi\":\"10.1128/aac.00697-25\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>We analyzed previously reported oral letermovir plasma concentration measurements from 40 allogeneic hematopoietic cell transplant (HCT) recipients using model-based pharmacometrics analysis. This analysis highlighted that the industry-sponsored phase III study model significantly over-predicted observed letermovir concentrations. Covariates associated with increased oral clearance (CL/F), possibly contributing to this observation, included: higher weight, younger age, and early use after HCT. The clinical significance and mechanistic explanation of relatively lower real-world exposure remains to be elucidated.</p>\",\"PeriodicalId\":8152,\"journal\":{\"name\":\"Antimicrobial Agents and Chemotherapy\",\"volume\":\" \",\"pages\":\"e0069725\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Antimicrobial Agents and Chemotherapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1128/aac.00697-25\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/8/22 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"MICROBIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Antimicrobial Agents and Chemotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1128/aac.00697-25","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/22 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

我们使用基于模型的药物计量学分析分析了先前报道的40例同种异体造血细胞移植(HCT)受者口服利替莫韦的血浆浓度测量。该分析强调,行业赞助的III期研究模型明显高估了观察到的利特莫韦浓度。与口服清除率(CL/F)增加相关的协变量可能有助于这一观察结果,包括:体重增加,年龄较小,HCT后早期使用。临床意义和机制解释相对较低的现实世界暴露仍有待阐明。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Population pharmacokinetic analysis of letermovir in adult hematopoietic cell transplant recipients.

We analyzed previously reported oral letermovir plasma concentration measurements from 40 allogeneic hematopoietic cell transplant (HCT) recipients using model-based pharmacometrics analysis. This analysis highlighted that the industry-sponsored phase III study model significantly over-predicted observed letermovir concentrations. Covariates associated with increased oral clearance (CL/F), possibly contributing to this observation, included: higher weight, younger age, and early use after HCT. The clinical significance and mechanistic explanation of relatively lower real-world exposure remains to be elucidated.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
10.00
自引率
8.20%
发文量
762
审稿时长
3 months
期刊介绍: Antimicrobial Agents and Chemotherapy (AAC) features interdisciplinary studies that build our understanding of the underlying mechanisms and therapeutic applications of antimicrobial and antiparasitic agents and chemotherapy.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信