Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence

NCT03197155 | Completed

• 1 other identifier: 69HCL17_0400
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma; Hepatitis C; Direct Acting Antivirals

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Direct Acting Antivirals against hepatitis C virus infection DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France developing a first HCC and receiving or not a direct-acting antiviral combination therapy after HCC remission between January 2009 and March 2016 were considered.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 23, 2017
• Study Start: June 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share