Institut Arnault Tzanck, Saint-Laurent-du-Var, France.
Hôpital Saint Eloi, Montpellier, France.
Dig Dis Sci. 2021 Mar;66(3):881-898. doi: 10.1007/s10620-020-06234-1. Epub 2020 Apr 18.
Treatment of hepatitis C virus (HCV) has been dramatically improved with the introduction of direct-acting antiviral agents (DAAs). Universal access to pangenotypic DAAs was provided in France from 2017, expanding the type of patients treated. Real-world studies are important to confirm effectiveness and safety in clinical practice, particularly in vulnerable populations.
To assess real-world effectiveness and safety of sofosbuvir-based therapy in adults with chronic HCV infection before and after universal access to DAAs in France.
This multicenter, non-interventional, prospective study assessed the effectiveness, safety, patient-reported outcomes and adherence with sofosbuvir-based regimens from October 2015 to July 2016 (Period 1: sofosbuvir-based therapy excluding sofosbuvir/velpatasvir) and from October 2017 to July 2018 (Period 2: pangenotypic sofosbuvir/velpatasvir-based therapy).
Baseline data were documented for 1029 patients. Overall, 797 (77%) had sustained virologic response data available ≥ 9 weeks after treatment completion. Per protocol response was high (97%) irrespective of age, alcohol consumption, recreational drug use, or HIV/HCV coinfection. Adverse events occurred in approximately 25% of patients with the majority experiencing Grade 1 or 2 events. Sofosbuvir-based regimens improved health-related quality of life from baseline to end of treatment in patients with data at all timepoints. Overall, 99% of patients reported total or almost total adherence to therapy.
Sofosbuvir-based therapy, including pangenotypic sofosbuvir/velpatasvir, is effective for the treatment of HCV in real-world clinical practice. This is an important step towards HCV elimination.
随着直接作用抗病毒药物（DAA）的引入，丙型肝炎病毒（HCV）的治疗得到了显著改善。自 2017 年以来，法国普及了泛基因型 DAA，扩大了治疗患者的类型。真实世界的研究对于在临床实践中确认有效性和安全性非常重要，尤其是在弱势群体中。
评估法国普及 DAA 前后，基于索非布韦的治疗方案在慢性 HCV 感染成人患者中的真实世界疗效和安全性。
这是一项多中心、非干预性、前瞻性研究，评估了 2015 年 10 月至 2016 年 7 月（第 1 期：不包括索非布韦/维帕他韦的基于索非布韦的治疗）和 2017 年 10 月至 2018 年 7 月（第 2 期：泛基因型索非布韦/维帕他韦的治疗）期间，基于索非布韦的治疗方案的疗效、安全性、患者报告的结果和治疗依从性。
共记录了 1029 例患者的基线数据。总体而言，797 例（77%）患者在治疗结束后≥9 周时可获得持续病毒学应答数据。根据方案，无论年龄、饮酒、滥用娱乐性药物或 HIV/HCV 合并感染如何，应答率均较高（97%）。约 25%的患者出现不良反应，大多数患者为 1 级或 2 级事件。在所有时间点都有数据的患者中，基于索非布韦的治疗方案从基线到治疗结束均改善了健康相关生活质量。总体而言，99%的患者报告了对治疗的完全或几乎完全依从。
基于索非布韦的治疗方案，包括泛基因型索非布韦/维帕他韦，在真实世界的临床实践中对 HCV 的治疗是有效的。这是消除 HCV 的重要一步。
