Direct-acting Antiviral Therapy Decreases Hepatocellular Carcinoma Recurrence Rate in Cirrhotic Patients With Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Hepatocellular recurrence event
研究概览
简要总结
Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. The impact of DAA exposure on hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced fibrosis remains to be clarified.
Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission, subsequently treated or not with a DAA combination, were included. Clinical, biological, and virological data were collected at first HCC diagnosis, at remission and during the surveillance period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •first HCC diagnosed by invasive or non-invasive criteria following the American Association for the Study of Liver Diseases (AASLD) guidelines during the study time horizon
- •complete remission after hepatocellular carcinoma treatment defined by the European Association for the Study of the Liver (EASL) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment
排除标准
- •prior history of hepatocellular carcinoma before January 2009
- •liver transplantation before hepatocellular carcinoma diagnosis
- •presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging
- •history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis
- •hepatic decompensation
- •human immunodeficiency virus (HIV) coinfection.
结局指标
主要结局
Hepatocellular recurrence event
时间窗: From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017
The primary outcome (hepatocellular recurrence event) is evaluated using imaging surveillance data at different time points during follow-up (every 3 months within the first year following HCC remission and every 3 to 6 months thereafter) after the first HCC remission.
次要结局
未报告次要终点