Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence

Completed

• Conditions: Hepatocellular Carcinoma; Hepatitis C; Direct Acting Antivirals

• Registration Number: NCT03197155
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-01-31
• Study Completion: 2017-03-31
• Status Verified: 2017-06
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study First Posted: 2017-06-23
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatocellular recurrence event	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.