Section of Hepatology, University Hospital Leipzig, Leipzig, Germany.
UBN/Practice, Berlin, Germany.
Aliment Pharmacol Ther. 2019 Apr;49(8):1052-1059. doi: 10.1111/apt.15222. Epub 2019 Mar 15.
Glecaprevir/pibrentasvir is a pangenotypic direct-acting antiviral regimen approved for treating adults chronically infected with hepatitis C virus (HCV). There are limited real-world data on glecaprevir/pibrentasvir to date.
To evaluate the effectiveness and safety of glecaprevir/pibrentasvir under real-world conditions in the German Hepatitis C-Registry (DHC-R).
The DHC-R is an ongoing, non-interventional, multicentre, prospective, observational cohort study that monitors patients with chronic HCV infection. Data were collected from patients who initiated glecaprevir/pibrentasvir and completed a screening visit on or after 2 August 2017. The primary effectiveness endpoint was sustained virological response at post-treatment Week 12 (SVR12). Safety and tolerability were also assessed.
As of 15 July 2018, 586 patients received glecaprevir/pibrentasvir and had documented SVR12 data, treatment discontinuation, loss to follow-up or HCV reinfection. Five hundred and fifty-two patients (94%) received on-label treatment. At baseline, most on-label patients were infected with HCV genotype 1 (53%) or 3 (33%), HCV treatment-naïve (90%), without cirrhosis (94%), and treated for 8 weeks (93%). Five hundred and thirty-four patients (96.7%) achieved SVR12 (intention-to-treat [ITT] analysis). By modified ITT analysis (excluding patients who discontinued and did not achieve SVR12 or patients lost to follow-up), the SVR12 rate was 99.4% (n/N = 534/537). There was one documented virological failure (relapse) and two documented HCV reinfections. One hundred and forty-two (26%) adverse events (AEs) and 9 (2%) serious AEs occurred; 2 (<1%) AEs led to treatment discontinuation. All patients treated off-label (N = 34) achieved SVR12.
Glecaprevir/pibrentasvir was highly effective and well tolerated under real-world conditions. Clinical trial number: DRKS00009717 (German Clinical Trials Register, DRKS).
格卡瑞韦/哌仑他韦是一种泛基因型直接作用抗病毒药物，适用于治疗慢性丙型肝炎病毒（HCV）感染的成年人。迄今为止，关于格卡瑞韦/哌仑他韦的真实世界数据有限。
在德国丙型肝炎登记处（DHC-R）的真实环境下评估格卡瑞韦/哌仑他韦的有效性和安全性。
DHC-R 是一项正在进行的、非干预性的、多中心、前瞻性、观察性队列研究，监测慢性 HCV 感染患者的情况。数据来自于 2017 年 8 月 2 日或之后开始接受格卡瑞韦/哌仑他韦治疗并完成筛查访视的患者。主要疗效终点为治疗后第 12 周的持续病毒学应答（SVR12）。同时还评估了安全性和耐受性。
截至 2018 年 7 月 15 日，586 例患者接受了格卡瑞韦/哌仑他韦治疗，并记录了 SVR12 数据、治疗中断、失访或 HCV 再感染。552 例（94%）患者接受了标签内治疗。基线时，大多数标签内患者感染 HCV 基因型 1（53%）或 3（33%），HCV 初治（90%），无肝硬化（94%），治疗 8 周（93%）。534 例患者（96.7%）达到 SVR12（意向治疗[ITT]分析）。通过改良 ITT 分析（排除治疗中断且未达到 SVR12 或失访的患者），SVR12 率为 99.4%（n/N=534/537）。有 1 例记录的病毒学失败（复发）和 2 例记录的 HCV 再感染。142 例（26%）发生不良事件（AE），9 例（2%）发生严重 AE；2 例（<1%）AE导致治疗中断。所有接受标签外治疗（N=34）的患者均达到 SVR12。
在真实环境下，格卡瑞韦/哌仑他韦具有高度有效性和良好耐受性。临床试验编号：DRKS00009717（德国临床试验注册处，DRKS）。
