NCT03775798

Incidence of de Novo Hepatocellular Carcinoma After Antiviral Agents for HCV.

Status unknown Last updated 19 December 2018

What this trial tests

trial testing Direct antiviral agents for hepatitis C in Hepatitis C in 2,200 participants. Status unknown.

Timeline

1 May 2016

Primary endpoint
1 December 2020

1 January 2021

Quick facts

Lead sponsor	Austral University, Argentina
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	2,200
Start date	1 May 2016
Primary completion	1 December 2020
Estimated completion	1 January 2021
Sites	1 location across Argentina

Drugs / interventions tested

• Direct antiviral agents for hepatitis C — full drug profile →

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →
• Cirrhosis — all drugs for Cirrhosis →
• Antiviral Drug Adverse Reaction — all drugs for Antiviral Drug Adverse Reaction →

Sponsor

Austral University, Argentina

Who can join

18 and older, any sex, with Hepatitis C or Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main risk factor for development of hepatocellular carcinoma (HCC) is cirrhosis of any etiology, with an annual incidence risk between 1-6%; currently the leading cause of death in patients with cirrhosis and the 2nd cause of death by cancer worldwide. Chronic hepatitis C (HCV) is the first single cause associated to cirrhosis and HCC in the Western world.

With the advent of new direct antiviral agents (DAA) of chronic HCV infection, virological cure generally exceeds 90% of the cases. Previous studies have shown that the incidence of HCC is lower in patients with virologic cure after treatment with pegINF schemes. However, recently published data, open up more controversy regarding the incidence of HCC after virologic cure with DAA. An increasing incidence of HCC after virologic cure in patients treated with DAA has been observed, opening a paradox yet unexplained.

This project proposes to answer the following clinical research question: in patients with HCV cirrhosis treated with DAA, is there a change in the incidence of hepatocellular carcinoma? To answer this question a prospective longitudinal cohort study of patients with Child Pugh A-B cirrhosis will be held at 3 years minimum follow-up.

A minimum of 210 patients will be included with clinical or histological or non-invasive diagnosis of cirrhosis Child Pugh A or B, with HCV treated with DAA and without hepatocellular carcinoma at the time of enrollment. From this cohort, patients who develop HCC during follow-up will be identified. Routine screening will be done through ultrasound every 6 months in all subjects enrolled and the diagnosis of HCC will be according to recommendations of European and American guidelines.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Disease Progression in Patients With Hepatitis C Virus Infection Treated With Direct-Acting Antiviral Agents.
   Mendizabal M, Piñero F, Ridruejo E, Herz Wolff F, et al · · 2020 · cited 50× · PMID 32113892 · DOI 10.1016/j.cgh.2020.02.044
2. Decompensated cirrhosis and liver transplantation negatively impact in DAA treatment response: Real-world experience from HCV-LALREAN cohort.
   Ridruejo E, Piñero F, Mendizabal M, Cheinquer H, et al · · 2020 · cited 6× · PMID 32749710 · DOI 10.1002/jmv.26383