Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence

Study Overview
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Brief Summary
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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.

Official Title
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Direct-acting Antiviral Therapy Decreases Hepatocellular Carcinoma Recurrence Rate in Cirrhotic Patients With Chronic Hepatitis C

Conditions
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Hepatocellular Carcinoma, Hepatitis C, Direct Acting Antivirals

Intervention / Treatment
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* Drug: Direct Acting Antivirals against hepatitis C virus infection


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Direct Acting Antivirals against hepatitis C virus infection|The cohort includes cirrhotic patients infected with HCV and successfully treated for their first history of hepatocellular carcinoma. Some of these patients were treated with direct-acting antivirals for their HCV infection while the others did not receive any direct-acting antivirals treatment during the follow-up period.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatocellular recurrence event | 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. | From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017 |