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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Clearance of Hepatitis B surface antigen (HBsAg)

Time frame: May 2016 (manuscript Velay et al., 2016)

Subgroup of patients infected by HBV genotype D

Secondary outcomes

Clearance of Hepatitis B surface antigen (HBsAg)

Time frame: September 2017 (manuscript Eschlimann et al., 2017)

Subgroup of patients infected by HBV genotype A

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Influence of Hepatitis B Virus (HBV) Envelope Glycoprotein Characteristics on HBsAg Clearance on Anti-HBV Treatment by Nucleos(t)Ide Analogues

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: Nov 22, 2017
Registry last updated: Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed