Interferon/Ribavirin-Free Sofosbuvir Based Treatment Regimens In Patients With Advanced Liver Disease - Results Of A Real-Life Austrian Ribavirin-/Interferon Free Cohort (AURIC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Number of patients with sustained virologic response (SVR)
研究概览
简要总结
Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4)
详细描述
From end of 2013 303 HCV-monoinfected patients with advanced liver disease (F3/4) were treated with interferon (IFN)-free and RBV-free SOF-based regimens. During this period only 7 patients received additional RBV. These patients were not included in this analysis. Only patients who completed 12 weeks of treatment-free follow up until July 2015 were included in this analysis. In Austria, prescription of DAAs is restricted to specialized treatment centers. Data are obtained by 6 participating centers and submitted to the central database forming for of the Austrian Ribavirin- and Interferon-free cohort (AURIC). Incoming data are reviewed by the staff of the hepatitis study group of the Dept. of Medicine III, Medical university of Vienna.The treatment regimens consisted of SOF/DCV, SOF/SMV, and SOF/LDV. The duration of treatment was based on a response guided approach at the discretion of the treating physician (12 or 24 weeks).
Sixty six patients who had started therapy before August 2014 received SMV or DCV as part of a named patient program, SOF was prescribed. For the remaining patients all drugs were prescribed and paid for by the Austrian social insurance.
This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C:
Sustained virologic response (SVR) defined as undetectable HCV-RNA after 12 weeks of treatment free follow up
Virological breakthrough/relapse defined as reappearance of HCV on treatment/during follow up
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens
排除标准
- •other disease with poor prognosis (ie. metastatic cancer, heart failure)
- •participation in a clinical trial
结局指标
主要结局
Number of patients with sustained virologic response (SVR)
时间窗: 12 weeks treatment free follow up
SVR is defined by the undetectability of HCV-RNA after 12 weeks of treatment free follow up
次要结局
- Number of patients with liver events (Mortality, Hepatic decompensation, Variceal Bleeding,Hepatocellular Carcinoma, Need for Liver Transplantation) on longterm clinical outcome(3 years)
- On treatment predictability of SVR(12/24 weeks of treatment + 12 weeks of follow up)
研究者
Peter Ferenci
Prof.
Medical University of Vienna