Hepatitis B
Conditions
Keywords
hepatitis, HBV, chronic hepatitis, HCC, cirrhosis, quantitative HBsAg, HBsAg inactive carriers
Brief summary
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.
Interventions
OTHERinactive 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.
Sponsors
INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF
Faculté de mathématiques ORLEANS
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of unfavourable liver events | every year, during 5 years for each | 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 . |
Countries
France
Outcome results
None listed