Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence

N/ACompletedNCT03197155

Hospices Civils de Lyon68 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocellular Carcinoma Hepatitis C Direct Acting Antivirals

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017