HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy

Completed

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT03350074
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Hepatitis B virus (HBV) infection remains difficult to eradicate with about 240 million people living with HBV chronic infection. HBsAg clearance, correlated with a good clinical prognosis, is difficult to achieve even with antiviral treatments (3-14 %). HBV envelope proteins are essential for entry into hepatocyte and are targeted by the immune system. Molecular characteristics of HBV envelope proteins may favour better viral fitness at the entry step into hepatocytes and/or HBV escape from host immunity. Here we investigated whether variability of HBV envelope proteins can contribute to the differential responses to anti-HBV treatment in patients with HBsAg clearance or persistence.

Detailed Description

Our study is a retrospective study of patients with chronic hepatitis B virus, selected exclusively at the University Hospital Center of Nancy in the Department of Hepato-Gastroenterology (HGE). the patient inclusion criteria were as follows: Adult patients with chronic hepatitis B, treated with nucleos(t)ide analogues, mono-infected with HBV (without co-infection with HCV, HIV and HDV). For each patient included, biological, clinical and therapeutic data were collected retrospectively. Patients with loss of viral load on treatment were included in this study. Among them, patients showed either a clearance of HBsAg on treatment ("responders") or the control patients showed a persistence of HBsAg on treatment ("non-responders", control patients).

Study Timeline

• Study Start: 2013-11-05
• Primary Completion: 2016-05-01
• Status Verified: 2017-09
• Study Completion: 2017-09-01
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-11-20
• Last Update Submitted: 2017-11-20
• Study First Posted: 2017-11-22
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• adults
• patients with chronic hepatitis B
• treated with nucleos(t)ide analogues
• mono-infected with HBV (without co-infection with HCV, HIV and HDV)

Exclusion Criteria

• minor
• pregnant women
• patients with VHC or VHD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clearance of Hepatitis B surface antigen (HBsAg)	May 2016 (manuscript Velay et al., 2016)	Subgroup of patients infected by HBV genotype D

Secondary Outcome Measures

Name	Time	Method
Clearance of Hepatitis B surface antigen (HBsAg)	September 2017 (manuscript Eschlimann et al., 2017)	Subgroup of patients infected by HBV genotype A