Mutations of the Pre-core Region of Hepatite B Virus (HBV)

Influence of Mutations in the Pre-core Region of Heptatis B Virus (HBV) and Its Promoter on Serum VHB Viral Load in Chronically Infected Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03625258

Acronym

HEPATITEB

Enrollment

200

Registered

2018-08-10

Start date

2009-01-01

Completion date

2017-02-01

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Virus

Keywords

mutations, infected patients

Brief summary

Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. The diagnostic workup included a physical examination.In conclusion, the study results confirmed that the HBV DNA level is associated with liver fibrosis status and that HBV viral load is strongly correlated with BCP and PC mutations, and it demonstrated that the impaired base pairing 1858-1896 mutations at the base of the bulge in the e encapsidation signal is independently associated with high serum HBV DNA levels.

Detailed description

The progression of liver disease in hepatitis B virus (HBV) infection is fostered by active virus replication. Mutations in the basal core promoter (BCP) and precore (PC) regions of the HBV genome are known to have an impact on viral replication. The aim of the present study was to assess the correlation of mutation profiles in the BCP and PC regions with the viral load in HBeAgnegative chronically infected patients. The HBV genotype, BCP/PC mutations, serum HBV DNA levels, and associated serological markers were analyzed in 92 HBeAgnegative chronically infected patients.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Patients included will be chronic carriers (HBsAg + for more than 6 months) of HBV, with detectable serum viral load greater than or equal to 100 IU / mL, included in the queue followed by Drs. Dominique Capron and Eric N'Guyen-Khac. These patients will not be on anti-HBV treatment.

Exclusion criteria

* Patients under 18 years old * Patients with their hepatitis B * Patients with HBV viral load undetectable or less than 100 IU / mL. * Immunosuppressive treatments such as corticosteroids or other * The co-infection with the hepatitis C and / or HIV virus * Patients with cancer

Design outcomes

Primary

Measure	Time frame	Description
Genotype of HBV for which the HBV viral load is a function of pre-core mutations	2-years	The main objective of the study is toevaluate a genotype of HBV for which the HBV viral load is a function of pre-core mutations in chronically infected patients.The HBV markers (including HBsAg, HBeAg and anti- HBe) were measured with chemiluminescent microparticle immunoassays running on an Architect system.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSandrine Castelain, PU-PH

CHU Amiens-Picardie

Outcome results