Hepatitis B Virus HBeAg-negative Genotype D Patients and Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— HBV/HCC  

Official title:

Long-term Nucleoside/Nucleotide Treatment of Hepatitis B Virus HBeAg-negative Genotype D Patients and Risk of Hepatocellular Carcinoma:Evidence From the CLEO Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025842
• Other study ID #: 02
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: December 31, 2013
• Start date: January 2000
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Azienda Ospedaliera San Camillo Forlanini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate the impact of liver fibrosis and other variables [e.g., age, sex, virological response (VR), and previous resistance to nucleoside/nucleotide analogue (NUC) therapy] on Hepatocellular carcinoma incidence in an Italian population of genotype D HBeAg-negative CHB patients treated with long-term NUC therapy.

Description:

Hepatocellular carcinoma (HCC) usually develops in patients with chronic liver disease, particularly patients with liver cirrhosis. Chronic hepatitis B (CHB) is one of the most frequent underlying causes of HCC. Several studies have demonstrated that variations in the hepatitis B virus (HBV) genotype have different effects on HCC. HBV genotypes C and D had lower responses to interferon-based therapy and higher frequencies of basal core promoter mutations than genotypes A and B.For this reason, HBV genotypes C and D seem to lead to more severe liver disease, including cirrhosis, compared with the other HBV genotypes. Because liver cirrhosis is one of the strongest HCC risk factors in CHB patients, antiviral therapy may prevent the development of liver complications such as HCC. The aim of this study is to evaluate the impact of liver fibrosis and other variables, such as age, sex, virological response (VR), and resistance to nucleoside/nucleotide analogue (NUC) therapy, in a population of genotype D HBeAg-negative CHB patients treated with long-term NUC therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Only chronic hepatitis B or compensated cirrhosis HBeAg-negative genotype D patients were included in this study.The patients were included in this study if they were =18 years old and had received treatment with nucleoside/nucleotide for a period of at least 18 months.

Exclusion Criteria:

• Patients with Hepatocellular carcinoma diagnosed before or during the first 18 months of nucleoside/nucleotide therapy, as well as patients coinfected with hepatitis D, hepatitis C, or HIV, were excluded. Patients with decompensated cirrhosis were excluded because of the low number of cases observed.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Camillo Forlanini

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk for hepatocellular carcinoma	The primary endpoint of the study was the development of Hepatocellular carcinoma. We assessed the risk of development of hepatocellular carcinoma according to liver status, viral response to treatment, and the presence of previous resistance to NUC therapy.	follow-up of 62.5 months (range, 18 to 112 months),	Yes
Secondary	survival	survival in cirrhosis and chronic hepatitis B patients	follow-up of 62.5 months (range, 18 to 112 months),	Yes