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

Completed

• Conditions: Hepatocellular Carcinoma; Hepatitis B

• Registration Number: NCT02025842
• Lead Sponsor: Azienda Ospedaliera San Camillo Forlanini

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2000-01
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2013-12-31
• Last Update Submitted: 2013-12-31
• Study First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
risk for hepatocellular carcinoma	follow-up of 62.5 months (range, 18 to 112 months),	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.

Secondary Outcome Measures

Name	Time	Method
survival	follow-up of 62.5 months (range, 18 to 112 months),	survival in cirrhosis and chronic hepatitis B patients