Clinical trial NCT02025842: Hepatitis B Virus HBeAg-negative Genotype D Patients and Hepatocellular Carcinoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Hepatitis B
Keywords: Hepatocellular carcinoma
Hepatitis B
Lead sponsor: Azienda Ospedaliera San Camillo Forlanini
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2000 to December 2013, 745 HBV-infected patients were included in the database. Of these, 438 were excluded: 226 did not fulfil the diagnosis of CHB, 75 had HBeAg-positive CHB, 20 had received NUC for \<18 months, 26 had HCC diagnosed before or within the first 18 months of therapy, and 61 presented a different HBV genotype. Thirty patients had decompensated cirrhosis. A total of 306 HBeAg-negative genotype D patients were selected and included in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: risk for hepatocellular carcinoma
timeFrame: follow-up of 62.5 months (range, 18 to 112 months),
Secondary outcomes:
measure: survival
timeFrame: follow-up of 62.5 months (range, 18 to 112 months),
Other outcomes:
Locations:
Study officials:
affiliation: AO San Camillo Forlanini
name: Adriano M Pellicelli, MD
role: PRINCIPAL_INVESTIGATOR
References: