Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany and German Center for Infection Research (DZIF), Partner-site Hannover-Braunschweig, Germany.
IFI-Institute for Interdisciplinary Medicine, Hamburg, Germany.
Aliment Pharmacol Ther. 2017 Mar;45(5):688-700. doi: 10.1111/apt.13925. Epub 2017 Jan 12.
Treatment of chronic hepatitis C genotype 3 (GT3) is more challenging compared with other genotypes. Since 2014, several new treatment regimens have been approved but sometimes based on limited data.
To validate the use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection under real-word conditions.
The German Hepatitis C-Registry is a large national non-interventional real-world study for patients with chronic hepatitis C. A total of 1322 GT3 patients were enrolled (211 untreated and 1111 treated patients).
Between February 2014 and September 2015, five different treatment strategies have been used (PegIFN+RBV, PegIFN+RBV+SOF, SOF+RBV, DCV+SOF±RBV, LDV/SOF±RBV). Treatment uptake and use of treatment concepts changed markedly and rapidly during the study influenced by new approvals, guideline recommendations, and label updates. PegIFN-based therapies constantly declined while DCV-based therapies increased with one interruption after the approval of LDV/SOF, which was frequently used until new guidelines recommended not using this combination for GT3. Per-protocol SVR ranged from 80.9% in the PegIFN+RBV group to 96.1% in PegIFN+RBV+SOF treated patients. Treatment-experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF+RBV but a high SVR of 90-95% for DCV+SOF±RBV. The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV containing regimens.
Real-world data can validate the effectiveness and safety for treatment regimens that had previously been approved with limited data, in particular for specific subgroups of patients. The present study demonstrates how rapid new scientific data, new treatment guidelines, new drug approvals and label changes are implemented into routine clinical practice today.
与其他基因型相比，治疗慢性丙型肝炎基因型 3（GT3）更具挑战性。自 2014 年以来，已经批准了几种新的治疗方案，但有时这些方案的依据是有限的数据。
在真实环境下验证抗病毒治疗慢性丙型肝炎 GT3 感染的使用、有效性和安全性。
德国丙型肝炎登记处是一项针对慢性丙型肝炎患者的大型全国性非干预性真实世界研究。共纳入 1322 例 GT3 患者（211 例未治疗和 1111 例治疗患者）。
在 2014 年 2 月至 2015 年 9 月期间，使用了五种不同的治疗策略（PegIFN+RBV、PegIFN+RBV+SOF、SOF+RBV、DCV+SOF±RBV、LDV/SOF±RBV）。受新批准、指南建议和标签更新的影响，治疗的采用和治疗方案的使用发生了显著而迅速的变化。基于 PegIFN 的治疗方案持续下降，而基于 DCV 的治疗方案则随着 LDV/SOF 获得批准后的一次中断而增加，该方案直到新指南建议不要将其用于 GT3 时才被广泛使用。方案治疗 SVR 从 PegIFN+RBV 组的 80.9%到 PegIFN+RBV+SOF 治疗患者的 96.1%不等。有肝硬化的治疗经验的患者，SOF+RBV 的 SVR 为 68%，但 DCV+SOF±RBV 的 SVR 为 90-95%。安全性分析显示，含 RBV 的方案发生不良事件和血红蛋白下降的情况更多。
真实世界的数据可以验证之前基于有限数据获得批准的治疗方案的有效性和安全性，特别是对特定的患者亚组。本研究展示了新的科学数据、新的治疗指南、新的药物批准和标签变化是如何在今天被快速纳入常规临床实践的。
