a Director of Hepatology, Assistant Professor of Medicine , Texas Tech University Health Sciences Center El Paso , El Paso , TX , USA.
b Chief, Gastroenterology and Hepatology, Professor of Medicine , University of Miami Miller School of Medicine , Miami , FL , USA.
Expert Opin Pharmacother. 2018 Mar;19(4):413-419. doi: 10.1080/14656566.2018.1444030. Epub 2018 Mar 7.
Glecaprevir/pibrentasvir is a fixed-dose combination regimen of a new generation NS3/4A inhibitor and an NS5A inhibitor with potent antiviral activity against all hepatitis C virus (HCV) genotypes. This regimen offers a shorter course of therapy (8 weeks) for selected patients regardless of genotype and has demonstrated high virological efficacy for retreatment of individuals who previously failed an NS5A containing regimen. Glecaprevir and pibrentasvir are minimally excreted by the kidneys; thus this regimen can safely be used in individuals with severe chronic kidney disease (CKD), including those undergoing hemodialysis. Areas covered: This review covers the mechanism of action, pharmacokinetics, clinical applications, efficacy, and safety profile of glecaprevir/pibrentasvir. It also covers key phase 2 and 3 clinical trials that led to licensure of this regimen. Expert opinion: Glecaprevir/pibrentasvir is the latest antiviral regimen licensed in the United States for treatment of HCV infection. Although several other direct-acting antiviral agents (DAAs) are currently available, glecaprevir/pibrentasvir has some unique characteristics that expand treatment options for HCV infection, including patients with comorbidities such as advanced stage CKD or prior treatment failure to antiviral regimens containing other DAAs.
格卡瑞韦/哌仑他韦是一种新型 NS3/4A 抑制剂和 NS5A 抑制剂的固定剂量组合方案，对所有丙型肝炎病毒 (HCV) 基因型均具有强大的抗病毒活性。无论基因型如何，该方案都为选定的患者提供了更短的治疗疗程（8 周），并且对于先前含有 NS5A 的方案治疗失败的个体，显示出很高的病毒学疗效。格卡瑞韦和哌仑他韦极少通过肾脏排泄；因此，该方案可安全用于患有严重慢性肾脏病 (CKD) 的个体，包括正在接受血液透析的患者。涵盖领域：这篇综述涵盖了格卡瑞韦/哌仑他韦的作用机制、药代动力学、临床应用、疗效和安全性概况。它还涵盖了导致该方案获得许可的关键 2 期和 3 期临床试验。专家意见：格卡瑞韦/哌仑他韦是美国最新获得许可的治疗丙型肝炎感染的抗病毒方案。尽管目前有几种其他直接作用抗病毒药物 (DAA) 可用，但格卡瑞韦/哌仑他韦具有一些独特的特征，扩大了丙型肝炎感染的治疗选择，包括患有合并症（如晚期 CKD 或先前对包含其他 DAA 的抗病毒方案治疗失败）的患者。
