Effectiveness of 8-Week Glecaprevir/Pibrentasvir for Treatment-Naive, Compensated Cirrhotic Patients with Chronic Hepatitis C Infection
Effectiveness of 8-Week Glecaprevir/Pibrentasvir for Treatment-Naive, Compensated Cirrhotic Patients with Chronic Hepatitis C Infection
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DOI：
10.1007/s12325-020-01301-5
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发表时间：
2020-04-11
影响因子：
3.8
通讯作者：
Wick, Nicole
中科院分区：
文献类型：
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作者：
Flamm, Steven L.;Kort, Jens;Wick, Nicole
Glecaprevir/pibentasvir（G/P）于2019年9月26日获得美国食品药品监督管理局批准，用于治疗初治（TN）丙型肝炎病毒（HCV）感染的代偿性肝硬化（CC）患者，持续8周。来自EXPEDITION-8研究的证据表明，在343例TN/CC患者中，8周G/P治疗后12周（SVR 12）达到了98%的意向治疗（ITT）持续病毒学应答率。本研究的目的是证明G/P 8周治疗在基因型1-6 TN/CC HCV患者中的首次美国真实世界有效性。方法从2017年8月至2018年11月期间开始8周G/P治疗的73名TN/CC患者的数据以电子方式从Trio Health网络的提供者和专业药房收集并分析。肝硬化由FIB-4 > 5.2确定或由医生报告。主要结局为符合方案（PP）SVR 12。结果60%的患者为男性，平均年龄59岁，体重指数（BMI）30，谷草转氨酶（AST）105，谷丙转氨酶（ALT）101 IU/ml。HCV基因型（GT）：GT 1型81%（59/73），GT 2型10%（7/73），GT 3型5%（4/73），GT 4型3%（2/73），GT 6型1%（1/73）。8%（6/73）的患者同时使用质子泵抑制剂（PPI），15%（11/72）的基线病毒载量> 6 MM IU/ml。0例患者停药，2例患者报告失访，1例病毒学失败。PP 12周持续病毒学应答（SVR 12）率为99%（70/71），意向治疗（ITT）SVR 12率为96%（70/73）。结论：早期的实际经验表明，8周G/P方案在不同的初治、代偿性哮喘美国人群中具有较高的有效性。
Introduction Glecaprevir/pibrentasvir (G/P) was approved on 26 September 2019 by the US Food and Drug Administration for 8-week duration in treatment-naive (TN) hepatitis C virus (HCV)-infected patients with compensated cirrhosis (CC). Evidence from the EXPEDITION-8 study demonstrated that 8 weeks of G/P achieved a 98% intent-to-treat (ITT) sustained virologic response rate 12 weeks post treatment (SVR12) in 343 TN/CC patients. The aim of this study is to demonstrate the first US real-world effectiveness of G/P 8-week treatment in genotype 1-6 TN/CC HCV patients. Methods Data from 73 TN/CC patients who initiated 8 weeks of G/P treatment between August 2017 and November 2018 were collected electronically from providers and specialty pharmacies of the Trio Health network and analyzed. Cirrhosis was determined by FIB-4 > 5.2 or was physician reported. The primary outcome was Per Protocol (PP) SVR12. Results The majority (60%) of patients were male, with (mean values): age 59 years, body mass index (BMI) of 30, aspartate aminotransferase (AST) 105, and alanine aminotransferase (ALT) 101 IU/ml. HCV genotypes (GT) were: GT1 81% (59/73), GT2 10% (7/73), GT3 5% (4/73), GT4 3% (2/73), and GT6 1% (1/73). Eight percent (6/73) of patients had concurrent proton pump inhibitor (PPI) use, and 15% (11/72) had a baseline viral load > 6 MM IU/ml. Zero patients discontinued, two patients were reported as lost to follow-up, and there was one virologic failure. PP sustained virologic response at 12 weeks (SVR12) rate was 99% (70/71), and the intent-to-treat (ITT) SVR12 rate was 96% (70/73). Conclusions Early real-world experience indicates high effectiveness of the 8-week G/P regimen in a diverse treatment-naive, compensated cirrhotic US population.