ifi-institute for Interdisciplinary Medicine, Hamburg, Germany.
University Hospital Frankfurt, Frankfurt am Main, Germany.
J Hepatol. 2018 Apr;68(4):663-671. doi: 10.1016/j.jhep.2017.11.009. Epub 2017 Nov 11.
BACKGROUND & AIMS: Ledipasvir/sofosbuvir (LDV/SOF) for 8 to 24 weeks is approved for the treatment of chronic hepatitis C virus infection (HCV). In the ION-3 study, 8 weeks of LDV/SOF was non-inferior to 12 weeks in previously untreated genotype 1 (GT1) patients without cirrhosis. According to the Summary of Product Characteristics (SmPC), 8-week treatment may be considered in naïve non-cirrhotic GT1-patients. However, there are only limited data on the effectiveness of an 8-week regimen of LDV/SOF under real-world conditions. The aim of the present study was to characterise patients receiving 8 weeks of LDV/SOF compared to those receiving 12 weeks of LDV/SOF, and to describe therapeutic outcomes in routine clinical practice.
The German Hepatitis C-Registry is a large national real-world cohort that analyses effectiveness and safety of antiviral therapies in chronic HCV. This data set is based on 2,404 patients. Treatment with SOF/LDV (without RBV) for 8 or 12 weeks was initiated on or before September 30, 2015.
Overall, 84.6% (2,034/2,404) of the safety population (intention-to-treat-1 [ITT1]) and 98.2% (2,029/2,066) of the per protocol (PP) population achieved sustained virological response at week 12 (SVR12). In the 8-week group, 85.1% (824/968) of ITT1 and 98.3% (821/835) of PP patients achieved SVR12, while in the 12-week group, 85.5% (1,210/1,415) of ITT1, and 98.1% (1,208/1,231) of PP patients achieved SVR12. When treated according to the SmPC, 98.7% (739/749) of the patients achieved SVR12 (PP). Relapse was observed in 9.5% (2/21) of cirrhotic patients treated for 8 weeks (PP).
Under real-world conditions a high proportion of eligible patients receiving 8-week LDV/SOF treatment achieved SVR12. Relapse occurred more frequently in patients who did not meet the selection criteria according to the SmPC.
In a large real-world cohort of patients mainly treated by physicians in private practice in Germany, shorter HCV treatment (8-week) resulted in equivalent cure rates to 12-week treatment in genotype 1 HCV-infected patients. Thus, shorter treatment can be recommended in these patients which would substantially reduce costs of therapy. Clinical Trial number: DRKS00009717 (German Clinical Trials Register, DRKS).
雷迪帕韦/索磷布韦（LDV/SOF）治疗慢性丙型肝炎病毒（HCV）感染的疗程为 8 至 24 周。在 ION-3 研究中，无肝硬化的初治基因型 1（GT1）患者中，8 周 LDV/SOF 治疗与 12 周治疗相比非劣效。根据产品说明书（SmPC），8 周的治疗可能适用于初治非肝硬化 GT1 患者。然而，在现实环境下，关于 LDV/SOF 8 周疗程有效性的数据有限。本研究的目的是描述接受 LDV/SOF 8 周治疗的患者与接受 LDV/SOF 12 周治疗的患者的特征，并描述常规临床实践中的治疗结果。
德国丙型肝炎登记处是一个大型的全国性真实世界队列，分析慢性 HCV 抗病毒治疗的有效性和安全性。该数据集基于 2404 名患者。SOF/LDV（无 RBV）8 或 12 周治疗于 2015 年 9 月 30 日或之前开始。
总体而言，安全人群（意向治疗 1 [ITT1]）的 84.6%（2034/2404）和方案人群（PP）的 98.2%（2029/2066）在第 12 周（SVR12）时达到持续病毒学应答。8 周组中，ITT1 的 85.1%（824/968）和 PP 的 98.3%（821/835）达到 SVR12，12 周组中，ITT1 的 85.5%（1210/1415）和 PP 的 98.1%（1208/1231）达到 SVR12。按照 SmPC 治疗时，749 名患者中的 98.7%（739/749）达到 SVR12（PP）。8 周治疗的 21 例肝硬化患者中有 9.5%（2/21）出现复发（PP）。
在真实世界环境下，接受 LDV/SOF 8 周治疗的符合条件的患者中，相当大比例的患者达到 SVR12。不符合 SmPC 选择标准的患者复发率更高。
在德国，主要由私人执业医生治疗的基因型 1 HCV 感染患者的大型真实世界队列中，较短的 HCV 治疗（8 周）与 12 周治疗的疗效相当。因此，对于这些患者可以推荐更短的治疗方案，这将大大降低治疗成本。临床试验编号：DRKS00009717（德国临床试验注册处，DRKS）。
