Evaluation of the Intrahepatic Hepatitis B Virus Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients - Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocellular carcinoma. Current treatments based on nucleoside analogues (NA) achieve virological cure in only 5% of cases at 10 years. The virological persistence of HBV is explained by the persistence of cccDNA (covalently-closed circular DNA) in the nucleus of hepatocytes. Complex and poorly understood interactions between immunological and virological responses explain the persistence of ccccDNA. A better understanding of the immunological and virological interactions of the intrahepatic compartment during chronic HBV infection is needed to better understand the mechanisms of viral persistence and for research and development of new drugs to achieve the goal of a functional cure for HBV (defined as the prolonged loss of Hepatitis B surface antigen (HBsAg) after cessation of treatment, associated with a decrease in intrahepatic cccDNA or its transcriptional inactivation). The intra-hepatic compartment can be explored by liver biopsy. A fine needle aspiration (FNA) technique is used to characterize primary hepatic tumors, with fewer complications than liver biopsy. One study has validated its use for immunological exploration of the intra-hepatic compartment. Finally, a recently published study confirms a correlation between FNA and liver biopsy virological markers in patients with chronic HBV infection. However, no combined immuno-virological study has been carried out to explore this intra-hepatic compartment by FNA in patients with chronic HBV infection. The investigators will assess the intrahepatic compartment of patients chronically infected with HBV (+/- hepatitis Delta (HDV)) to understand the mechanisms of viral persistence and characterize host immune responses to HBV. These investigations will make it possible to determine the immuno-virological profiles of patients who would benefit from intensification of antiviral treatment or, potentially, discontinuation of antiviral therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (≥ 18 years of age)

• Patients chronically infected with hepatitis B virus at any stage of infection

• Nucleoside Analogues-treated or untreated

• Co-infected or not with HDV

• Included in the prospective CirB-RNA study (part of the CirB-RNA university research program) (ID-RCB : 2018-A02558-47, NCT03825458)

• Patient informed of the study and having signed a consent form

Locations
Other Locations
France
Hepatology Department - Hospices Civils de Lyon
RECRUITING
Lyon
Contact Information
Primary
Fabien ZOULIM, PU-PH
fabien.zoulim@chu-lyon.fr
0426109355
Backup
Bénédicte POUMAROUX
benedicte.poumaroux@chu-lyon.fr
04 26 73 27 37
Time Frame
Start Date: 2024-03-08
Estimated Completion Date: 2028-03-08
Participants
Target number of participants: 100
Treatments
Experimental: HBsAg <100 IU/ml
Patients chronically mono-infected with HBV, whose HBsAg is less than 100 IU/ml (patients treated or not with NA)
Experimental: HBsAg between 100 and 3000 IU/ml
Patients chronically mono-infected with HBV, with HBsAg levels \>100 and \<3000 IU/ml (patients treated or not with NA).
Experimental: HBsAg ≥ 3000 IU/ml
Patients chronically mono-infected with HBV, with HBsAg levels ≥ 3000 IU/ml (patients treated or not with NA).
Experimental: Loss of HBsAg (spontaneously or under NA)
Patients with loss of HBsAg (spontaneously or under NA). This group will allow comparison of the HBsAg loss immuno-virological profile with that of patients with active infection and varying levels of HBsAg (groups 1-3 and 5) and aid in identifying of predictors of functional cure. The identification of determinants of HBV functional cure is fundamental and is comparable to investigations that have been carried out in HIV-infected elite controllers.
Experimental: Patients co-infected with HBV and HDV
Patients co-infected with HDV (positive HDV viral load), regardless of HBsAg level (presence or absence of HBV or HDV treatment)
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov