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临床试验/NCT07687758
NCT07687758已完成不适用

Prediction of Risk of Hepatic Decompensation and Hepatocellular Carcinoma in Advanced Fibrotic or Cirrhotic Patients With Chronic Hepatitis C After Sustained Virologic Response

Siriraj Hospital1 个研究点 分布在 1 个国家目标入组 571 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
571
试验地点
1
主要终点
Development of de novo hepatocellular carcinoma

研究概览

简要总结

This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Patients treated at Siriraj Hospital between 2013 and 2023 were included if they had compensated advanced chronic liver disease and documented SVR12. The study compared FIB-4, APRI, ALBI, and aMAP scores calculated at SVR12 for prediction of hepatocellular carcinoma during long-term follow-up. The primary aim was to identify a very-low-risk subgroup in whom hepatocellular carcinoma surveillance might potentially be de-escalated.

详细描述

This was a single-center retrospective cohort study conducted at Siriraj Hospital, Thailand. Consecutive adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated interferon-free sofosbuvir-based direct-acting antiviral therapy between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion were included. Compensated advanced chronic liver disease was defined according to Baveno VII criteria, including histologic F3/F4 fibrosis, vibration-controlled transient elastography greater than 10 kPa, or clinical evidence of portal hypertension.

Baseline demographic, clinical, laboratory, and transient elastography data were collected from electronic medical records. The FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12. Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy, failure to achieve SVR12, or incomplete medical records precluding outcome assessment were excluded.

The primary outcome was de novo hepatocellular carcinoma during follow-up. Predictive performance of the non-invasive scores was assessed using time-to-event analysis, Kaplan-Meier methods, Cox proportional hazards regression, and time-dependent receiver operating characteristic curves at 1, 3, 5, and 8 years.

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

入选标准

  • Age 18 years or older
  • Chronic hepatitis C virus infection treated with direct-acting antiviral therapy
  • Documented sustained virological response at 12 weeks after treatment completion
  • Evidence of compensated advanced chronic liver disease before direct-acting antiviral therapy, defined by at least one of the following: histologic F3 or F4 fibrosis, vibration-controlled transient elastography >10 kPa, radiologic features compatible with advanced fibrosis or cirrhosis, or clinical or endoscopic evidence of portal hypertension
  • Minimum follow-up of 12 months after sustained virological response

排除标准

  • Incomplete or missing medical records precluding outcome assessment
  • Known or suspected hepatocellular carcinoma before initiating direct-acting antiviral therapy
  • Failure to achieve sustained virological response at 12 weeks

结局指标

主要结局

Development of de novo hepatocellular carcinoma

时间窗: From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.

Occurrence of newly diagnosed hepatocellular carcinoma after achievement of sustained virological response (SVR12). Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy were excluded.

次要结局

  • Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma(At 1, 3, 5, and 8 years after SVR12)
  • Predictive accuracy of the APRI score for de novo hepatocellular carcinoma(At 1, 3, 5, and 8 years after SVR12)
  • Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma(At 1, 3, 5, and 8 years after SVR12)
  • Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma(At 1, 3, 5, and 8 years after SVR12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tawesak Tanwandee

Professor of Medicine

Mahidol University

研究点 (1)

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