title: An accurate definition of the status of inactive hepatitis B virus carrier by a combination of biomarkers (FibroTest-ActiTest) and viral load.
abstract: BACKGROUND
  The combination of transaminases (ALT), biopsy, HBeAg and viral load have classically defined the inactive status of carriers of chronic hepatitis B. The use of FibroTest (FT) and ActiTest (AT), biomarkers of fibrosis and necroinflammatory activity, has been previously validated as alternatives to biopsy. We compared the 4-year prognostic value of combining FT-AT and viral load for a better definition of the inactive carrier status.
  
  
  RESULTS
  1,300 consecutive CHB patients who had been prospectively followed since 2001 were pre-included. The main endpoint was the absence of liver-related complications, transplantation or death. We used the manufacturers' definitions of normal FT (< = 0.27), normal AT (< = 0.29) and 3 standard classes for viral load. The adjustment factors were age, sex, HBeAg, ethnic origin, alcohol consumption, HIV-Delta-HCV co-infections and treatment.
  
  
  RESULTS
  1,074 patients with baseline FT-AT and viral load were included: 41 years old, 47% African, 27% Asian, 26% Caucasian. At 4 years follow-up, 50 complications occurred (survival without complications 93.4%), 36 deaths occurred (survival 95.0%), including 27 related to HBV (survival 96.1%). The prognostic value of FT was higher than those of viral load or ALT when compared using area under the ROC curves [0.89 (95%CI 0.84-0.93) vs 0.64 (0.55-0.71) vs 0.53 (0.46-0.60) all P<0.001], survival curves and multivariate Cox model [regression coefficient 5.2 (3.5-6.9; P<0.001) vs 0.53 (0.15-0.92; P = 0.007) vs -0.001 (-0.003-0.000;P = 0.052)] respectively. A new definition of inactive carriers was proposed with an algorithm combining "zero" scores for FT-AT (F0 and A0) and viral load classes. This new algorithm provides a 100% negative predictive value for the prediction of liver related complications or death. Among the 275 patients with the classic definition of inactive carrier, 62 (23%) had fibrosis presumed with FT, and 3 died or had complications at 4 year.
  
  
  CONCLUSIONS
  In patients with chronic hepatitis B, a combination of FibroTest-ActiTest and viral load testing accurately defined the prognosis and the inactive carrier status.
authors.affiliation: Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, Université Paris VI, CNRS UMR 8149, Paris, France.
authors.forename: Yen
authors.initials: Y
authors.lastname: Ngo
authors.forename: Yves
authors.initials: Y
authors.lastname: Benhamou
authors.forename: Vincent
authors.initials: V
authors.lastname: Thibault
authors.forename: Patrick
authors.initials: P
authors.lastname: Ingiliz
authors.forename: Mona
authors.initials: M
authors.lastname: Munteanu
authors.forename: Pascal
authors.initials: P
authors.lastname: Lebray
authors.forename: Dominique
authors.initials: D
authors.lastname: Thabut
authors.forename: Rachel
authors.initials: R
authors.lastname: Morra
authors.forename: Djamila
authors.initials: D
authors.lastname: Messous
authors.forename: Frederic
authors.initials: F
authors.lastname: Charlotte
authors.forename: Françoise
authors.initials: F
authors.lastname: Imbert-Bismut
authors.forename: Dominique
authors.initials: D
authors.lastname: Bonnefont-Rousselot
authors.forename: Dominique
authors.initials: D
authors.lastname: Rousselot-Bonnefont
authors.forename: Joseph
authors.initials: J
authors.lastname: Moussalli
authors.forename: Vlad
authors.initials: V
authors.lastname: Ratziu
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
mesh_terms: D015415:Biomarkers / Q000032:analysis; D002353:Carrier State / Q000175:diagnosis*; D019694:Hepatitis B, Chronic / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D011379:Prognosis; D012189:Retrospective Studies; D019562:Viral Load
chemical_list: D015415:Biomarkers