FibroTest: FibroTest: predictivepredictive value in value in HBVHBV

1.1. Diagnosis and clinical optionsDiagnosis and clinical options

2.2. FibroTest: a 4-years prognostic studyFibroTest: a 4-years prognostic study

In this PresentationIn this Presentation

Diagnosis and clinical optionsDiagnosis and clinical options

Results interpretable no risk of false positive/negative

Not interpretable Risk of false

positive/negative*

Repeat Test or perform

elastography/ biopsyNo biopsy mandatory

Treatment TreatmentOr follow-up**

Follow-up** with FibroTest

Treatment Or follow-up

95% 5%

(For liver injuries Assessment)

Diagnosis and clinical optionsDiagnosis and clinical options

Positive serologyPositive serology

Poynard et al, Comp Hepatol 2004

5 years prognostic value5 years prognostic value

FibroTest

Ngo et al, Hepatology AASLD 2007 Ngo et al, Hepatology AASLD 2007 - Patients and Methods- Patients and Methods

Aim To prospectively assess the 4-year prognostic value of FibroTest-ActiTest staging compared to biopsy and to HBV-DNA for predicting cirrhosis decompensation and survival.

Patients and method

Prospective hospital-based cohort of chronic hepatitis B patients (n=504) (consecutive Ag HBs positive patients with baseline FibroTest-ActiTest HBV DNA measurements)

Mean age 42 yrs,71% males, 30% asian AgHBe+ 18%

HBV-related complications (main end-point): liver-related death liver transplantation liver failure (ascites, jaundice, hepatic encephalopathy) variceal bleeding, hepatocellular carcinoma

Ngo et al, Hepatology AASLD 2007 Ngo et al, Hepatology AASLD 2007 - Results- Results

• 4-year survival without HBV related complications according for FibroTest severity groups

0.00

0.25

0.50

0.75

1.00

0 10 20 30 40 50 60 70 80Follow-up (months)

Sur

viva

l with

out H

BV

com

plic

atio

ns

-- Minimal fibrosis-- Moderate fibrosis-- severe fibrosis

Surv

ival

with

out c

ompl

icati

ons

months

Baseline FT value n HBV

complications

Survival without HBV

complications

0.00-0.31 263 2 98.9 (97.5-1.00)

0.32-0.58 127 4 91.7 (82.9-1.00)

0.59-1.00 114 26 72.2 (62.9-81.6)

All 504 32 97.9 (94.9-1.00)

• 4-year survival without HBV related death according for FibroTest severity groups

0.00

0.25

0.50

0.75

1.00

0 10 20 30 40 50 60 70 80Follow-up (months)

Sur

viva

l with

out H

BV

rela

ted

deat

h

-- Minimal fibrosis-- Moderate fibrosis-- severe fibrosis

Surv

ival

with

out c

ompl

icati

ons

months

Baseline FT value n HBV related

death

Survival without HBV

complications

0.00-0.31 263 0 100

0.32-0.58 127 0 100

0.59-1.00 114 15 84.2 (76.8-91.6)

All 504 15 86.9 (80.2-93.5)

Ngo et al, Hepatology AASLD 2007 Ngo et al, Hepatology AASLD 2007 - Results- Results

• Better AUROCs for FibroTest versus HBV-DNA for 4-years survival without HBV complications or death

AUROC: 4 years without complications

FTAUROC (95%CI)

HBV-DNAAUROC (95%CI) p

0.89 (0.82-0.94) 0.57 (0.40-0.70) <0.001

AUROC: 4 years without death

FTAUROC (95%CI)

HBV-DNAAUROC (95%CI) p

0.95 (0.91-0.97) 0.55 (0.38-0.68) <0.001

Ngo et al, Hepatology AASLD 2007 Ngo et al, Hepatology AASLD 2007 - Results- Results

0.00

0.25

0.50

0.75

1.00

0.00 0.25 0.50 0.75 1.00

1-Specificity

Sensi

tivity

Sens

ivity

Specificity

-- FibroTest-- HBV DNA

0.00

0.25

0.50

0.75

1.00

0.00 0.25 0.50 0.75 1.00

1-Specificity

Sensi

tivity

Sens

ivity

Specificity

-- FibroTest-- HBV DNA

• Similar AUROCs for FibroTest and Biopsy of 4-year survival without HBV complications and death

FTAUROC (95%CI)

Liver biopsyAUROC (95%CI)

p

0.99 (0.90-0.99) 0.97 (0.93-0.99) 0.32

Ngo et al, Hepatology AASLD 2007 Ngo et al, Hepatology AASLD 2007 - Results- Results

Ngo et al, Hepatology AASLD 2007 Ngo et al, Hepatology AASLD 2007

ConclusionsConclusions

FibroTest’s prognostic value Possible combinations of FT

4-year prognostic value similar to that of liver

biopsy better to that of HBV-DNA

With baseline viral load To improve prediction for

DeathComplications