Division of Gastroenterology and Hepatology, University Hospital Zurich, Switzerland.
Division of Gastroenterology, Kantonsspital St. Gallen, Switzerland.
Swiss Med Wkly. 2021 Jan 19;151:w20399. doi: 10.4414/smw.2021.20399. eCollection 2021 Jan 18.
In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and treatment outcomes under real-life conditions. We report data from Switzerland from an ongoing, multinational postmarketing observational study on the pangenotypic treatment regimen of glecaprevir (GLE; NS3/4A protease inhibitor) and pibrentasvir (PIB; NS5A inhibitor), coformulated as GLE/PIB.
Adults infected with chronic HCV genotypes 1–6 were eligible to participate in the postmarketing observational study if they started GLE/PIB at the treating physician’s discretion. The primary objective was to evaluate the effectiveness of GLE/PIB based on sustained virological response 12 weeks after completion of treatment (SVR12); secondary outcomes included patient-reported outcomes (Fatigue Severity Scale, Work Productivity and Activity Impairment Questionnaire, Pictorial Representation of Illness and Self Measure tool) and safety data.
In Switzerland, 109 patients were enrolled, and 107 patients received ≥1 dose GLE/PIB (94.4% non-cirrhotic; 43.9%/14.0%/29.0%/13.1% GT1/GT2/GT3/GT4; 89.7% treatment-naïve; 91.6% assigned to an 8-week GLE/PIB regimen). Overall, 95 of 98 patients with sufficient follow-up data (96.9%) achieved SVR12 (95% confidence interval [CI] 91.4% to 99.0%), and 91.6% in the safety population (including six non-virological failures). The three treatment failures were due to relapse. All three failures were GT3, without cirrhosis and treatment naïve. Patient-reported outcomes improved as well. GLE/PIB was well tolerated with no serious adverse events and no adverse events leading to discontinuation or interruption of GLE/PIB treatment.
These real-world effectiveness and safety data of GLE/PIB in patients from Switzerland were consistent with those seen in the multinational registration trials. (Trial registration number: Clinicaltrials.gov: NCT03303599.).
在丙型肝炎病毒（HCV）感染的泛基因型治疗时代，来自上市后观察性研究的数据对于更好地了解特定国家使用的治疗模式和真实情况下的治疗结果至关重要。我们报告了来自瑞士的一项正在进行的、多国上市后观察性研究的数据，该研究评估了格卡瑞韦（GLE；NS3/4A 蛋白酶抑制剂）和哌仑他韦（PIB；NS5A 抑制剂）联合制剂 GLE/PIB 的泛基因型治疗方案。
如果符合条件的慢性 HCV 基因型 1-6 感染的成年患者经治疗医生决定开始 GLE/PIB 治疗，则有资格参加上市后观察性研究。主要目的是基于治疗完成后 12 周的持续病毒学应答（SVR12）评估 GLE/PIB 的疗效；次要终点包括患者报告的结果（疲劳严重程度量表、工作效率和活动障碍问卷、疾病描绘和自我测量工具）和安全性数据。
在瑞士，共纳入 109 例患者，其中 107 例患者接受了至少 1 剂 GLE/PIB 治疗（94.4%非肝硬化；43.9%/14.0%/29.0%/13.1%GT1/GT2/GT3/GT4；89.7%初治；91.6%接受 8 周 GLE/PIB 方案）。总体而言，98 例有足够随访数据的患者中有 95 例（96.9%，95%置信区间 [CI]91.4%至 99.0%）达到 SVR12，安全性人群中有 91.6%（包括 6 例非病毒学失败）。3 例治疗失败归因于复发。所有 3 例失败均为 GT3，无肝硬化且初治。患者报告的结果也有所改善。GLE/PIB 耐受性良好，无严重不良事件，也无导致 GLE/PIB 治疗停止或中断的不良事件。
来自瑞士患者的 GLE/PIB 的真实世界疗效和安全性数据与多国注册试验中的数据一致。（临床试验注册编号：Clinicaltrials.gov：NCT03303599。）
