Possible Differences in HCC Course Depending on DAA Treatment

NCT05376943 | Unknown FDA Drug

• 1 other identifier: AKBE/118/2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND It is estimated that around 71 milion people live with chronic hepatitis C virus (HCV) infection. This may lead to the development of liver cirrhosis and hepatocellular carcinoma (HCC). Liver cirrhosis is considered as one of the most common risk factors of hepatocellular carcinoma (HCC). HCC is seventh most common cancer worldwide. The treatment of HCV with direct-acting antivirals (DAAs) has led to the increase of sustained virological response (SVR) rates to more than 90%. It is suggested that the virus eradication reduces, but not eliminates the risk of HCC. This concerns especially patients with liver cirrhosis or previous HCC history. There are reports of early occurrence of HCC after the DAA treatment. Therefore, patients undergoing successful HCV treatment should be monitored for the possibility of hepatoccelular carcinoma occurrence. AIM OF THE STUDY In this study the investigators aimed to assess the occurrence of HCC after direct acting antiviral HCV treatment and evaluate whether the course of HCC and liver function differ among the population of patients treated with DAAs and those who were not receiving the therapy with DAA. MATERIAL AND METHODS This is the observative, cohort, retrospective study which will be performed in several clinical centres in Poland. The inclusion criteria are: hepatocellular carcinoma diagnosis, age \>18 years old. The investigators will collect both epidemiological (age, gender, comorbidities, alcohol abuse) and clinical data (serum bilirubin, alanine, aspartate aminotransferase, platelets, gammaglutamyltransferase, alkaline phosphatase and alpha-fetoprotein level, Child-Pugh and MELD score, imaging tests, liver biopsy and elastography, if performed). In all patients, the HCV infection and co-infections will be assessed. In those who underwent the DAA treatment, the composition of the therapy and response to the treatment will be evaluated. Statistical analysis will be performed in subgroups of patients undergoing DAA treatment and without the therapy. The distribution of continuous variables will be analysed by the Shapiro-Wilk test. Quantitative data will be analysed using the Mann-Whitney U test or Kruskal-Wallis ANOVA when appropriate. Qualitative data will be compared using the χ² test or the Fisher exact test. Correlations between quantitative variables will be assessed using the Spearman correlation coefficient. P value will be set at \<0.05. FUNDING: No remuneration is provided for participation in the study

Conditions

Carcinoma, Hepatocellular; Hepatitis C Virus Infection, Response to Therapy of; Drug Effect; Drug Side Effect; Hepatitis C, Chronic; Liver Cirrhosis

Keywords

hepatocellular carcinoma; hepatitis C; direct-acting antiviral agents

Outcome Measures

Primary Outcomes (1)

• The occurrence of HCC after direct acting antiviral HCV treatment.

  1 year

Secondary Outcomes (2)

• The comparison of the course of HCC among the population of patients treated with DAAs and those who were not receiving the therapy.

  1 year

• The difference in liver function tests among the population of patients treated with DAAs and those who were not receiving the therapy.

  1 year

Study Arms (2)

Patients diagnosed with HCC after receiving direct acting antiviral HCV treatment

In this group there will be patients with the diagnosis of hepatocellular carcinoma, who underwent direct acting antiviral treatment. We will collect both epidemiological (age, gender, comorbidities, alcohol abuse) and clinical data (serum bilirubin, alanine, aspartate aminotransferase, gammaglutamyltransferase, alkaline phosphatase and alpha-fetoprotein level, Child-Pugh and MELD score, imaging tests, liver biopsy and elastography, if performed). The HCV infection and co-infections will be assessed and also the composition of therapy and the response to treatment will be evaluated.

Drug: Direct Acting Antivirals

Patients diagnosed with HCC who were not receiving direct acting antiviral HCV treatment

In this group there will be patients with the diagnosis of hepatocellular carcinoma, who were not receiving direct acting antiviral treatment. We will collect both epidemiological (age, gender, comorbidities, alcohol abuse) and clinical data (serum bilirubin, alanine, aspartate aminotransferase, gammaglutamyltransferase, alkaline phosphatase and alpha-fetoprotein level, Child-Pugh and MELD score, imaging tests, liver biopsy and elastography, if performed). The HCV infection and co-infections will also be assessed.

Interventions

Direct Acting Antivirals DRUG

Our observational study will assess the exposure to direct acting antivirals - the specific drugs, dose, duration of the therapy and the effect of the treatment.

Patients diagnosed with HCC after receiving direct acting antiviral HCV treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected from several clinical centres in Poland.

You may qualify if:

• hepatocellular carcinoma diagnosis
• age \>18 years old

You may not qualify if:

• age \<18 years old

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C; Drug-Related Side Effects and Adverse Reactions; Hepatitis C, Chronic; Liver Cirrhosis

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; Chemically-Induced Disorders; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Central Study Contacts

Agnieszka J Lembas

CONTACT

+48609751306; a.bartosiewicz@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: May 17, 2022
• Study Start: May 10, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2021-09

Locations

PL (1)