Hepatitis C Clinical Trial
Official title:
Incidence of de Novo Hepatocellular Carcinoma After Direct-acting Antiviral Agents for HCV: a Multicenter Prospective Cohort Study From Latin America.
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.
Name of the study:
INCIDENCE OF HEPATOCELLULAR CARCINOMA IN CIRRHOTIC PATIENTS WITH HEPATITIS C INFECTION,
TRETAED WITH DIRECT ANTIVIRAL AGENTS IN LATIN AMERICA: A MULTICENTER PROSPECTIVE COHORT STUDY
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 enrollement. 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.
However, preliminary results presented at the last European Congress of Hepatology in
Barcelona, Spain, and early published in Journal of Heaptology, open up more controversy
regarding the incidence of HCC after virologic cure post DAA. An unexpected higher incidence
and recurrence of HCC after treatment with these new drugs has been observed, opening a
paradox yet unexplained. Of particular interest then, is to clarify and find if there is a
change in the incidence of HCC in HCV cirrhosis after treatment with DAA in our region. It is
relevant on the other hand; that this study would be the first longitudinal cohort study
evaluating the development of HCC in patients with cirrhosis in Latin America. It is then
expected that the results would be extremely important to the medical science from this
region.
Clinical Research Question In patients with HCV cirrhosis treated DAA, is there a change in
the incidence of hepatocellular carcinoma? Primary Objective To evaluate the incidence of HCC
after treatment with DAA in patients with Child Pugh A or B cirrhosis and chronic HCV
infection.
Secondary Objectives
Secondary objectives will be related to:
- Incidence of HCC between cured and uncured of HCV with DAA.
- Impact of routine screening on survival in patients with HCC.
- Risk factors for development of hepatocellular carcinoma in patients with HCV treated
with DAA.
- Adverse events and incidence of cirrhosis decompensation after DAA.
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