ft in diagnostic of hbv fibromax in the most common liver diseases fibromax: a universal biomarker...
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FibroMax in the most common liver diseasesFibroMax in the most common liver diseases
FibroMax: a universal biomarker of liver disease
1.1. What is FibroMax?What is FibroMax?
2.2. FibroMax in Viral Hepatitis: FibroTest-ActiTestFibroMax in Viral Hepatitis: FibroTest-ActiTest
3.3. FibroMax in Steatosis: SteatoTestFibroMax in Steatosis: SteatoTest
4.4. FibroMax in non alcoholic steato-hepatitis: NashTestFibroMax in non alcoholic steato-hepatitis: NashTest
5.5. FibroMax in alcoholic steato hepatitis: AshTestFibroMax in alcoholic steato hepatitis: AshTest
6.6. Meta-analysisMeta-analysis
In this PresentationIn this Presentation
• 5 tests together to assess liver injuries in HBV, HCV, NAFLD, ALD
What is FibroMax?What is FibroMax?
Patient Profile
ActiTest
FibroTest SteatoTest
AshTest
NashTest
FibroMaxFibroMax
For Fibrosis
For Viral activity
For NASH activity
For ASH activity
For Steatosis
FibroMax in Viral HepatitisFibroMax in Viral Hepatitis
FibroTest-ActiTest presentation
ActiTest
FibroTest SteatoTest
AshTest
NashTest
FibroMaxFibroMax
For Fibrosis
For Viral activity
For NASH activity
For ASH activity
For Steatosis
FibroMax in viral hepatitis B and CFibroMax in viral hepatitis B and C
• For more information please report to following presentations– FibroTest in the diagnosis of HBV, FibroTest: prognostic value in HBV , FibroTest in the diagnosis of
HCV, FibroTest: prognostic value in HCV
Presentations available on www.oneliver.com
• Relationship between FibroTest and the stage of firbosis and between ActiTest and the grade of Activity
FibroMax in SteatosisFibroMax in Steatosis
SteatoTest Presentation
ActiTest
FibroTest SteatoTest
AshTest
NashTest
FibroMaxFibroMax
For Fibrosis
For Viral activity
For NASH activity
For ASH activity
For Steatosis
Bellentani, Dionysos Study, J Hepatol 2001
Population at risk of liver steatosis (Millions)Population at risk of liver steatosis (Millions)
FibroMaxFibroMax
+ Age, Gender
Haptoglobin
Alpha2Macroglobulin
Apolipoprotein A1
Total Bilirubin
Gamma GT
FibroTestFibroTest
Glucose
ALT
Cholesterol
AST
Triglycerides
+ Weight, Height
Biomarker activity in steatosisBiomarker activity in steatosis
Poynard Comp Hepatol 2005Poynard Comp Hepatol 2005
• The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis
Included Patients
Validation group 1 HCV before treatment N=310
Validation group 2 HCV sustained responders
N=201
quasi-normal characteristics with normal liver tests
only 11% grade 2–4 steatosis.
Validation group 3 Alcoholic liver disease N=62
more often male, older, had smaller liver biopsies,
more metabolic risk factors, more extensive fibrosis more grades 2–4 steatosis
Control group Healthy blood donors N=140
Patients included in the 4 groups similar in age with predominance of male subjects (range 61–76%). The prevalence of steatosis greater than 5% (grades 2 to 4) varied from 11% in hepatitis C virus (HCV)
cured patients to 94% in patients with ALD. In all groups, at least one metabolic risk factor was observed in more than 50% of included patients.
SteatoTest versus GGT and ALTSteatoTest versus GGT and ALTPoynard Comp Hepatol 2005Poynard Comp Hepatol 2005
• Relationship between ST, GGT and ALT and the grade of liver steatosis in the 3 validation groups
Validation group 1
SteatoTest GGT ALT
Validation group 2
SteatoTest GGT ALT
Validation group 3
SteatoTest GGT ALT
SteatoTest versus GGT and ALTSteatoTest versus GGT and ALTPoynard Comp Hepatol 2005Poynard Comp Hepatol 2005
• Relationship between ST, GGT and ALT and the grade of liver steatosis in the integrated database combining controls, training group and validation groups
AUROC=0.80 AUROC=0.66 AUROC=0.61SteatoTest GGT ALT
SteatoTest UltraSonography Significance
Kappa 0.44 ± 0.06 0.32 ± 0.05 0.02
AUROC 0.78 ± 0.03 0.65 ± 0.03 0.001
SteatoTest versus UltraSonographyPoynard et al, Comp Hepato 2005
• Biopsy as Gold Standard n=304
FibroMax in FibroMax in Non Alcoholic Steato-HepatitisNon Alcoholic Steato-Hepatitis
NashTest
ActiTest
FibroTest SteatoTest
AshTest
NashTest
FibroMaxFibroMax
For Fibrosis
For Viral activity
For NASH activity
For ASH activity
For Steatosis
NashTest: AUROCNashTest: AUROCPoynard et al, BMC Gastro 2006Poynard et al, BMC Gastro 2006
NashTest for NASH ROC for Kleiner Class NashTest for NASH 124 validation cases of CYTOL prospective study
• AUROC NASH = 0.83 (SE=0.04)
-- Nash-- Borderline Nash-- No Nash
NashTest versus BiopsyNashTest versus Biopsy- Poynard et al BMC Gastro 2006- Poynard et al BMC Gastro 2006
• Concordance between NASH predicted by NashTest and predicted by biopsy (in all patients n=257)
BiopsyNT
No Nash Borderline Nash Nash
No Nash 49 11 8
Borderline Nash 46 77 34
Nash 3 8 21
Kappa Statistic 0.33―0.04
Discordance 1 class 99/257=39%
Discordance 2 classes 11/257=4%
NashTest versus BiopsyNashTest versus Biopsy- Poynard et al BMC Gastro 2006- Poynard et al BMC Gastro 2006
• Sensitivity, Specificity and predictive values of NashTest for the diagnosis of NASH (in all patients n=257)
Sensitivity Specificity PPV NPV
No Nash 33% 94% 66%Prevalence= 0.25
81%
Borderline Nash or Nash 88% 50% 74%
Prevalence=0.6272%
Conclusion• In patients with non-alcoholic fatty liver disease, NashTest, a simple and non-invasive biomarker
reliably predicts the presence or absence of NASH.
• Among patients with NAFLD, the new generation of biomarkers such as FibroTest, SteatoTest and NashTest will allow better identification of those at risk and reassurance for patients without fibrosis or NASH.
• Biomarkers as a first-line estimate of injury in chronic liver diseases should reduce the need for liver biopsy
Proposed screening strategy of advanced fibrosis, steatosis and NASH in NAFLD patients.
FibroMax in Alcoholic Steato-HepatitisFibroMax in Alcoholic Steato-Hepatitis
AshTest
ActiTest
FibroTest SteatoTest
AshTest
NashTest
FibroMaxFibroMax
For Fibrosis
For Viral activity
For NASH activity
For ASH activity
For Steatosis
AshTest versus AST/ALT and MaddreyAshTest versus AST/ALT and MaddreyThabut et al, J Hepatol 2006Thabut et al, J Hepatol 2006
• Diagnostic values of AshTest, Maddrey and AST/ALT ratio for the diagnosis of alcoholic hepatitis (225 patients 299 controls)
AshTest AUROC=0.89 AST/ALT AUROC=0.78 Maddrey AUROC=0.78
AshTest versus AST/ALT and MaddreyAshTest versus AST/ALT and MaddreyThabut et al, J Hepatol 2006Thabut et al, J Hepatol 2006
• ROC curves of AshTest, Maddrey and AST/ALT ratio for the diagnosis of alcoholic hepatitis (n=225).
Conclusions Conclusions
In heavy drinkers, AshTest is a simple and non-invasive quantitative estimate of alcoholic hepatitis.
The use of AshTest may reduce the need for liver biopsy, and therefore allow an earlier treatment of alcoholic hepatitis.
AshTest
Maddrey
AST/ALT
Proposed screening strategy of severe alcoholic steatohepatitis (ASH) in excessive drinkers
• ASH screening and treatment strategy
Proposed screening strategy of severe alcoholic steatohepatitis (ASH) in excessive drinkers
• Fibrosis screening strategy in ALD patient