Clinical trial NCT03350074: HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy
Official title: Influence of Hepatitis B Virus (HBV) Envelope Glycoprotein Characteristics on HBsAg Clearance on Anti-HBV Treatment by Nucleos(t)Ide Analogues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B virus
PreS/S variability
Anti-HBV treatment
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Clearance of Hepatitis B surface antigen (HBsAg)
timeFrame: May 2016 (manuscript Velay et al., 2016)
Secondary outcomes:
measure: Clearance of Hepatitis B surface antigen (HBsAg)
timeFrame: September 2017 (manuscript Eschlimann et al., 2017)
Other outcomes:
Locations:
Study officials:
References: