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合并症和心血管问题的丙型肝炎治疗患者使用直接抗病毒药物时药物相互作用的评估——德尔菲共识项目

Evaluation of Drug Interactions in Patients Treated with DAAs for Hepatitis C Therapy with Comorbidities and Cardiovascular Issues-A Delphi Consensus Project.

作者信息

Borghi Claudio, Ciancio Alessia, Gentile Ivan, Perrone Filardi Pasquale, Pasqualetti Patrizio, Brillanti Stefano

机构信息

Internal Medicine, Department of Medical and Surgical Sciences, Policlinic S. Orsola-Malpighi, University of Bologna, 40126 Bologna, Italy.

Gastroenterology Unit, Department of Internal Medicine, Città della Salute e delle Scienza di Torino (Molinette), University of Turin, 10126 Turin, Italy.

出版信息

J Clin Med. 2022 Nov 25;11(23):6946. doi: 10.3390/jcm11236946.

DOI:10.3390/jcm11236946
PMID:36498521
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9737105/
Abstract

Orally administered direct-acting antivirals (DAAs) have dramatically changed the possibility of curing HCV (hepatitis C virus) infection, with the two principal HCV regimens based on the combination of glecaprevir + pibrentasvir (GLE-PIB) and sofosbuvir + velpatasvir (SOF-VEL). A combination of drugs containing NS3/4A protease inhibitors, as well as the fact that almost all HCV patients can be treated at present, may expose patients to a higher rate of drug-drug interactions (DDIs). The hepatitis C treatment recommendations from the EASL (European Association for the Study of the Liver) state that, prior to starting treatment with a DAA, a detailed drug history should be taken; yet, the decision on managing the potential DDIs is not always clear. For this reason, a group of Italian cardiologists and hepatologists promoted a survey among colleagues to assess the controversial issues when treating patients with chronic hepatitis C taking concomitant cardiovascular drugs, aiming to reach a consensus on the best practice to apply when treating a patient with chronic hepatitis C who is taking concomitant drugs for cardiovascular diseases. Two consecutive questionnaires were proposed between June and July 2022 to a qualitative Expert Panel (EP) of 14 gastroenterologists, infectologists, hepatologists, and internists, with statistical analyses performed on 100% of the responses for both questionnaires. Agreement among experts was assessed following the Delphi method as developed by the RAND Corporation. The interviewed experts consider DDIs a critical clinical problem to be evaluated in HCV patients. Therefore, dose changes, drug substitution, and discontinuation of concomitant cardiovascular drugs should be discouraged, even if planned for a relatively short period. Since oral DAAs have different DDIs profiles, hepatologists should prefer the antiviral DAA combination presenting the lowest instance of potential interactions.

摘要

口服直接抗病毒药物(DAA)极大地改变了治愈丙型肝炎病毒(HCV)感染的可能性,目前主要有两种基于glecaprevir + pibrentasvir(GLE-PIB)和索磷布韦 + 维帕他韦(SOF-VEL)联合使用的HCV治疗方案。包含NS3/4A蛋白酶抑制剂的药物组合,以及目前几乎所有HCV患者都可接受治疗这一事实,可能使患者面临更高的药物相互作用(DDI)发生率。欧洲肝脏研究协会(EASL)的丙型肝炎治疗建议指出,在开始使用DAA治疗之前,应详细了解用药史;然而,对于如何处理潜在的DDI,决策并不总是明确的。因此,一群意大利心脏病专家和肝病专家在同事中开展了一项调查,以评估在治疗合并使用心血管药物的慢性丙型肝炎患者时存在争议的问题,旨在就治疗合并心血管疾病药物的慢性丙型肝炎患者时的最佳实践达成共识。在2022年6月至7月期间,向由14名胃肠病学家、传染病专家、肝病专家和内科医生组成的定性专家小组(EP)提出了两份连续的调查问卷,并对两份问卷的所有回复进行了统计分析。专家之间的共识按照兰德公司开发的德尔菲法进行评估。受访专家认为DDI是HCV患者中需要评估的关键临床问题。因此,即使是计划在相对较短的时间内进行,也不应鼓励改变剂量、更换药物或停用合并使用的心血管药物。由于口服DAA具有不同的DDI特征,肝病专家应优先选择潜在相互作用发生率最低的抗病毒DAA组合。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ade/9737105/07f7b483ad11/jcm-11-06946-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ade/9737105/4618d2dd7470/jcm-11-06946-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ade/9737105/07f7b483ad11/jcm-11-06946-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ade/9737105/4618d2dd7470/jcm-11-06946-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ade/9737105/07f7b483ad11/jcm-11-06946-g002.jpg

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