pospective comparaison of transient elastography ... guessab.pdf · 1st annual congress of the...
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1st Annual Congress of the Algerian Society of Infectiology and The 5th Congress of Federation Arab Socieies of Clinical
Microbiology and infectious diseases
Pospective comparaison of transient elastography,
Fibrometer,APRI and FIB-4 with liver biopsy for the assessment of fibrosis in chronic hepatitis B
N. Guessab 1, I.ouled Chikh 1, M.Merniz 2 , R. Kerbouche 1 ,0.Drir 1, N. Afredj 1,S.Ait Younes 3, N.Debzi 1 1- Hepatology, University Mustapha Hospital 2- Infectious Diseases, Boudiaf Msila Hospital
3- Pathology, University Nefissa Hamoud Parnet
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Liver fibrosis
• Consequences chronic liver diseases ; CHB +++
• CHB = Dc of significant fibrosis ≥ F2 +++++++ * ≥ F2 = Initiation TRT antiviral
* F4 =Screening of HCC and varices
Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: A systematic review of data published between 1965 and 2013. ozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Globaland regional mortality from 235 causes of death for 20 age groups in 199 0and 2010: A systematic analysis for the Global Burden of Disease Study2010. Lancet 2012;380:2095–2128. Fattovich G , Natural history and prognosis of hepatitis B. Semin Liver Dis. 20 Feb; 23 (1): 47- 58.
F2 F4 F3
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Assessment liver fibrosis
invasive method
Liver biopsy
non-invasive methods
Biomarkers
FibroScan
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OBJECTIFS Objective
study
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Objective
Diagnosis accuracy FibroScan/FibroMeter /APRI/FIB-4
Liver biopsy
Comparison
patients with chronic hepatitis B
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PATIENTS ET METHODES
Patients and methods
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prospective study monocentric 02/01/2014 -03/15/2017
Inclusion criteria
Patients selected for liver biopsy
• Hbe Ag négative , HBV-DNA level ≥ 20.000UI /ml whatever level of ALT
• Hbe Ag positive, HBV-DNA level ≥ 20.000UI /ml, ALT > ULN
• Hbe Ag négative,HBV-DNA level 2000 -20.000UI /ml, ALT> ULN
National Consensus 2012
EASL 2012
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Exclusion criteria
• Age < 16 ans
• Pregnancy
• Ascites
• Abvious Cirrhosis
• HCV, HDV or HIV coinfection
• Previous antiviral treatment
• HCC
• ALT > 5 XULN
• extra hépatic cholestasis
• Implantable cardiac devices
• Patient refuse liver biopsy
• Cardiac insufficiency
• Chronic Rénal insufficiency
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Méthods I
In fasted Patients Biomarkers + FibroScan ( blood samples collected) same day Liver biopsy
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Méthods II
Blood samples
• 1 heparine tube : ALT, AST, GGT, Urea , Alpha-2
macroglobuline
• 1 EDTA tube : Platelets count
• 1 citrate tube: PT
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Méthods III
Wai CT, Greenson JK, Fontana RJ et al. A simple noninvasive index can predict
both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology
2003; 38:518-26.
Sterling RK, Lissen E, Clumeck N, Sola R, Correa MC, Montaner J, et Development
of a simple noninvasive index to predict significant fibrosis in patients with HIV/HCV
coinfection. Hepatology 2006; 43:1317–1325.
APRI
FIB-4
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Méthos IV
FibroMeter : FM virus 3G
• Platelets ,TP, AST, ALT ,Urea, Alpha 2 macroglobuline GGT +
Age , gender
• Résults = Excel = e-mail Echosens (Paris, France )
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Méthods V
Echosens TM Paris type 502
• M or XL probes
• a single examiner
• Usual procedure
FibroScan
M XL
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Méthods VI
Fibroscan Reliability Critèria: • Validated measurements ≥ 10
• Acquisition success rate > 60 % • IQR/LSM ratio < 30%
Unsuccessful results : • No valid measurement • IQR/LSM ratio >30%
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Méthods VII Liver biopsy
• Percutaneous liver biopsy
• HEPAFIX® (Braun Melsungen, Germany Ø15G /1,8mm)
• Menghini technique
• specimens = formol 10 %
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Méthods VIII Liver histology and staging of liver fibrosis
• paraffin embedded
• Four-micrometre-thick sections
• Staining : Hématéine Eosine Trichrome de Masson Sels d’argent
• Length LB specimen established in millimetres
• Two trained pathologists • blinded to the results of Fibroscan/ Fibromètre / APRI/FIB-4 and clinical data. • in case of discrepancies , a consensus was reached .
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Méthods IX
Sttage Description
F0 no fibrosis
F1 portal fibrosis without
F2 portal fibrosis and few septa
F3 numerous septa without cirrhosis
F4 Cirrhose
Grade Description
A0
none
A1
mild
A2
moderate
A3
severe
METAVIR scoring system
Fibrosis Necrotico-inflammatoire activity
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Méthods X
significant fibrosis ≥ F2 (F2, F3, F4)
Cirrhosis F4
Two clinically relevant end points
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• SPSS version 21
• Continuous variables = mean ± SD or median [IQR])
• Diagnosis accuracy = Receiver-operating characteristics curves (AUROC)
*AUROC < 0.7 = Insufficient
*AUROC 0.7 -0.8 = Fair
*AUROC 0.8 -0.9 = Good
*AUROC > 0.9 = Excellent
• Optimal cut-off values = 2 different criteria (Youden test)
*Maximizing the sum of sensitivity and specificity
* Maximizing the diagnosis accuracy (% patients diagnosed correctly)
• Cut off = Sensitivity (Ss), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV)
Statistical analysis
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PATIENTS ET METHODES
RESULTS
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RESULTS I 02/01/2014 -03/15/2017
excluded patients n= 12
• inadequate LB (n =1)
•HCV Coïnfection (n =1)
•Contraindication LB (n=2)
•Refusal LB (n =1 )
• abvious Cirrhosis (n =3 )
•Previous antiviral treatment HBV (n =1)
•Inadequate FibroScan (n= 3 )
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RESULTS I Characteristics of patients
• Mean Age : 37.91 [ ± 12.32], [18 – 83] years
• Sex-ratio : 1.74 Men : 63.57% (n = 89)
• Mean body mass index : 25.6 [± 4,6] Kg/m²
• Metabolic syndrome : 7.85% (n= 11)
HBV DNA
Mean
Médian
HBV DNA (UI/ml)
33 444 646,0
90 300
HBV DNA (Log)
7.5
4.95
Hbe Ag negative
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RESULTS II
ALT
N
%
≤ ULN
115
82.14
> ULN
25
17.85
ULN- 2ULN
14
10.0
> 2 ULN
11
7.85
Characteristics of ALT
*
* < 5 ULN
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RESULTS III Characteristics of biopsy specimens
Characteristics
Mean (sd)
Médian
Min- Max
Length (mm)
24,2 (± 9,3)
23,0
7 - 50
Number portal
space
19,8 (±8,9) 18,0 6 - 50
Number of
specimens
2,2 (±1,4) 2,0 1 - 7
Length (mm)
% (N)
≥ 20
67.86 (95)
15 - 20
17.85 (25)
<15
14.29 (20)
85.68% ≥ 15mm
65% ≥ 20mm + ≥ 11 NPS
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RESULTS IV Distribution for METAVIR fibrosis stage
FIBROSIS Number %
F0 4 2.9
F1 75 53.6
F2 28 20.0
F3 26 18.5
F4 7 5.0
fibrosis stage according to
severity
N (%)
No or mild Fibrosis (F0F1)
79 (56.5)
significant fibrosis (≥ F2)
61 (43.6)
Cirrhosis (F4)
7 (5)
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RESULTS V
Distribution Metavir activity grade and steatosis
Activity
Numbre
%
A0
6
4,3
A1
89
63,6
A2
39
27,8
A3
6
4,3
Stéatosis
Numbre
%
S0
70
50,0
S1
63
45,0
S2
6
4,3
S3
1
0,7
Steatosis Activity grade
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RESULTS VI Characteristics Fibroscan
Probe
Success
N (%)
failure N (%)
M
128 (91.42)
12 (8.57)
XL
11 (7.85)
1 (0.7)
Reliability
Critèria
Mean
(sd)
Médian Extrêmes
Value
V M
10.93
(± 2.17)
10
10-20
Acquisition
success
rate (%)
94.86
(± .17)
100
60-100
IQR /LSM
13.65%
(± 5.91)
12%
02-29%
IQR/LSM (%)
N
%
<10
33
23,74
10 - 20
86
61,87
>20
20
14,38
85.61% IQR/LSM ≤ 20%
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PATIENTS ET METHODES
Receiver-operating characteristic curves
(AUROC) FibroScan,FibroMeter,APRI,FIB-4
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RESULTS VI Fibroscan
Receiver-operating characteristic analysis(AUROC)
≥ F2
0.83
0.75 - 0.90
(95% CI)
F4
0.92
0.85 - 0.99
(95% CI)
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Fibrosis
stage
Cut off
Se
(%)
Sp
(%)
PPV
(%)
NPV
(%)
Diagnosis
accuracy (%)
≥ F2
7.2
68,3
93,7
89,1
79,6
82,7
F4
9.6
85,7
87,9
27,2
99,1
87,8
Fibrosis
stage
Cut off Se
(%)
Sp
(%)
PPV
(%)
NPV
(%)
Diagnosis
accuracy (%)
≥ F2
7.2
68,3
93,7
89,1
79,6
82,7
F4
12.5
57,1
96,2
44,4
97,7
94,2
Maximizing the diagnosis accuracy
RESULTS VI Cut off FibroScan
Maximizing the sum of sensitivity and specificity
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RESULTS VII FibroMeter
Receiver-operating characteristic analysis (AUROC)
≥ F2
F4
0.69
0.60 - 0.78
(95% CI)
0.79
0.66 - 0.92
(95% CI)
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RESULTS VIII APRI
Receiver-operating characteristic analysis (AUROC)
≥ F2
0.69
0.60 - 0.78
(95% CI)
F4
0.77
0.56 - 0.97
(95% CI)
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RESULTS IX FIB-4
0.66
0.57 - 0.75
(95% CI)
0.89
0.80 - 0.98 (95% CI)
≥ F2 F4
Receiver-operating characteristic analysis (AUROC)
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DISCUSSION Discussion
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Fibroscan in CHB
Results of Studies Evaluating the Performance of Transient Elastography for the Diagnosis of Liver Fibrosis
EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis: Journal of Hepatology 2015.
Study
Our study 139 0.83 0.92
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Fibroscan in CHB
cut off ≥ F2
EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis: Journal of Hepatology 2015.
Study Diagnosis occuracy(%)
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Fibroscan in CHB
cut off ≥ F2
EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis: Journal of Hepatology 2015.
Study Diagnosis occuracy(%)
139
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Fibroscan in CHB
cut off = F4
EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis: Journal of Hepatology 2015.
Study Diagnosis
occuracy(%) Diagnosis
occuracy(%)
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Fibroscan in CHB
cut off = F4
EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis: Journal of Hepatology 2015.
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FibroMeter in CHB
the Performance of FM for the Diagnosis of Liver Fibrosis
-Zhou K, Gao CF, Zhao YP, Liu HL, Zheng RD, Xian JC, et al. Simpler score ofroutine laboratory tests predicts liver fibrosis in patients with chronichepatitis B. J Gastroenterol Hepatol 2010;25:1569–
1577. -Francoise Degos, Paul Perez, Bruno Roche, Amel Mahmoudi, Julien Asselineau, Hélène Voitot ,Pierre Bedossa, for the FIBROSTIC study group. Diagnostic accuracy of FibroScan and comparison to liver fibrosis biomarkers in chronic viral hepatitis: A multicenter prospective study (the FIBROSTIC study).Journal of Hepatology 2010 vol. 53 j 1013–102 -Vincent Leroy, Nathalie Sturm, Patrice Faure, Candice Trocme, Alice Marlu, Marie-Noëlle Hilleret, Françoise Morel, Jean-Pierre Zarski. Prospective evaluation of FibroTest, FibroMeter, and HepaScore for staging liver fibrosis in chronic hepatitis B: Comparison with hepatitis C. Journal of Hepatology 2014 vol. 61 j 28–34 -Alexandra Ducancelle, MD, PhD, Vincent Leroy, MD,wz Julien Vergniol, MD,y Nathalie Sturm, MD,wz Brigitte Le Bail, MD,zJean Pierre Zarski, MD,w Eric Nguyen Khac, MD, PhD,Dominique Salmon,MD,Victor de Ledinghen, MD,and Paul Cale`s. A Single Test Combining Blood Markers and Elastography is More Accurate Than Other Fibrosis Tests in the Main Causes of Chronic Liver Diseases. J Clin Gastroenterol Volume 00, Number 2017
Study
Our study 0.69 0.77
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APRI in CHB The Performance of APRI for the Diagnosis of Liver Fibrosis
meta-analysis HBV Xiao G et al. Hepatology 2015;292-302
Our study 0.69 0.79
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FIB-4 in CHB the Performance of FIB-4 for the Diagnosis of Liver Fibrosis
Meta analyse HBV Xiao G et al. Hépatologie 2015; 292-302
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DISCUSSION Conclusion
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0ur study shows
• FibroScan is an accurate method for the diagnosis of fibrosis stage in patients with chronic hepatitis B
• On the contrary, FibroMeter, APRI and FIB-4 are not a good tool for predicting significant fibrosis and cirrhosis in hepatitis B-related fibrosis.