Follow-up of HBsAg Inactive Carriers Study (PIBAC)

The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Other: inactive carrier

• Study Type: Interventional
• Enrollment (Actual): 619
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13616
    • Ch General Du Pays D'Aix
  • Avignon, France, 84902
    • CH d'Avignon
  • Beaumont, France, 63110
    • Clinique de la Chataigneraie
  • Besancon, France, 25000
    • Medical Center Besancon
  • Bourgoin Jallieu, France, 38300
    • Clinical Center Bourgoin Jallieu
  • Bry sur Marne, France, 94360
    • Hopital Sainte Camille
  • Caen, France, 14033
    • Ch de Caen
  • Corbeil essonnes, France, 91100
    • Ch Sud Fracilien Jean Jaures
  • Creil, France, 60109
    • CH Creil
  • Creteil, France, 94000
    • CH de Créteil
  • Gonesse, France, 95503
    • CH de Gonesse
  • Grasse, France, 06130
    • Clinique du Palais
  • Hyeres, France, 83407
    • CH d'HYERES
  • Jossigny, France, 77600
    • Ch de Lagny Marne La Valee
  • La Roche sur yon, France, 85925
    • CHD Vendée
  • Le Mans, France, 72037
    • CH du Mans
  • Lyon, France, 69009
    • Medical Center La Sauvegarde
  • Meaux, France, 77104
    • CH de Meaux
  • Melun, France, 77011
    • CH Melun
  • Montelimar, France, 26126
    • CH Montélimar
  • Montfermeil, France, 93370
    • Ch de Montfermeil
  • Montpellier, France, 34070
    • Clinical Center Montpellier
  • Nanterre, France, 92000
    • Medical Center Nanterre
  • Orleans, France, 45067
    • CHR d'Orleans
  • Paris, France, 75007
    • Medical Center Paris 7
  • Pau, France, 64000
    • CH de Pau
  • Perpignan, France, 66046
    • Hopital Saint Jean
  • Pringy, France, 74374
    • Ch de La Region Annnecienne
  • Saint Brieuc, France, 22027
    • CH Saint Brieuc
  • Saint Denis, France, 93200
    • CH de Saint Denis
  • Vannes, France, 56017
    • CH de Vannes
  • Villeneuve Saint Georges, France, 94190
    • Chi Villeneauve Saint Georges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HBsAg + since one year or more.

  • HBeAg -, anti-HBe antibodies +
  • HBV-DNA < 20000 UI/ml on all dosages realized during past year (ultra-sensitive PCR with a detection threshold < 20 UI/ml), at least 2 dosages during past year.
  • AST and ALT transaminases < ULN on all dosages realized during past year (at least 3).
  • Age > 18 and < 70
  • We will include consecutively all encountered patients (consultation, hospitalization) and diagnosed as HBsAg inactive carriers in each participating center.

Exclusion Criteria:

• anti-VHC antibodies +
• anti-VHD antibodies +
• anti-VIH antibodies +
• genetic hemochromatosis
• liver cirrhosis on liver biopsy or with non-invasive methods (Fibrometer, Fibroscan, Fibrotest, Hepascore …)
• Past or present treatment against HBV
• Ultrasonic diagnosis of HCC or Portal Hypertension
• non compliant patient whom 5 years follow-up seems uncertain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inactive carriers	Other: inactive carrier; Yearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended. Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of unfavourable liver events	The primary outcome that the study was designed to evaluate is the incidence of unfavourable liver events (chronic hepatitis B, liver cirrhosis, HCC) in a cohort of patients presumed to be " HBsAg inactive carriers ".	every year, during 5 years for each

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Collaborators: INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF; Faculté de mathématiques ORLEANS
• Investigators: Principal Investigator: Xavier CAUSSE, CHR Orléans

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2014
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): February 4, 2022

Study Registration Dates

• First Submitted: September 15, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: HCC; cirrhosis; HBV; hepatitis; chronic hepatitis; quantitative HBsAg; HBsAg inactive carriers
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis
• Other Study ID Numbers: CHRO -2014-02