Evaluation of the Agreement between Fibrotest, Fibroscan and APRI for the Assessment of Significant

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Evaluation of the Agreement between Fibrotest,
Fibroscan and APRI for the Assessment of
Significant or Severe Liver Fibrosis in HIV/HCV
Coinfected Patients Participating in the
Prospective ANRS C013 - HEPAVIH  French Cohort
Study

• Y. Benhamou, M.A. Loko, M. Winnock, P. Sogni, G.
  Pialoux,
• C. Katlama, M.A. Valantin, D. Neau, F. Dabis, D.
  Salmon
• 4th IAS Conference , Sydney, Australia, 22-25
  July 2007

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BACKGROUND

• Several non invasive methods have been developed
  as an alternative to liver biopsy for the
  assessment of liver fibrosis.
• Among these, FibroTest, APRI and transient
  elastography (FibroScan), although not yet
  validated, are commonly used to assess liver
  fibrosis in HIV-HCV co-infected patients.
• Whether these different methods agree for the
  diagnosis of significant or severe liver fibrosis
  remains unknown.

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AIM

• To assess the agreement between FibroTest , APRI
  and FibroScan , taken two-by-two, for the
  determination of significant (F 2) or severe (F
  3) liver fibrosis in HIV-HCV co-infected
  patients.

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METHODS

• Cross sectional study (ANRS CO13 HEPAVIH
  prospective French Cohort )
• Patients
• Positive HCV RNA
• No current anti-HCV therapy
• Biological samples available within 6 months of
  Fibroscan performance.

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METHODS (2)

• Non-invasive methods
• Transient elastography (FibroScan, FS)
• - measures liver stiffness
• - expressed in Kilopascals (KPa)
• FibroTest (FT)
• - biochemical marker-based algorithm
• a2 macroglobulin, haptoglobin, gGT, bilirubin,
  apolipoprotein A1
• APRI score
• based on aspartate transaminases and platelet
  counts
• AST(IU/ULN) x 100 / platelets (109/L)

Wai et al. Hepatology, 200338518-526
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METHODS (3)

• Thresholds for scoring liver fibrosis
• Significant Severe
• ( F 2) (F 3)
• FibroScan (KPa) gt 7.1 gt 9.5
• FibroTest Index gt 0.48 gt 0.58
• APRI gt 1.5 - - - - -

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METHODS (4)

• Agreement, measured by the kappa coefficient, was
  considered as
• poor 0 0.20
• fair 0.21 0.40
• moderate 0.41 0.60
• good 0.61 0.80
• very good 0.81 1.00

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RESULTS

• Characteristics of patients (N154)
• Age (yrs) 44 (26-64)
• Gender ( male) 80
• CD4 counts (/mm3) 440 (47-1877)
• Current antiretroviral treatment
  () 91.6
• HCV genotype
• 1 55.3
• 2 or 3 23.4
• other 21.3
• Median (range), N ()

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Prevalence of significant (F 2) vs minimal
liver fibrosis depending on the test used
()
Fibrotest (FT) Fibroscan (FS) APRI
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Agreement for the diagnosis of significant liver
fibrosis ( F 2)

• FibroScan Kappa CI
• APRI
• FibroTest
• FibroTest Kappa CI
• APRI

(95 )
(N,)
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Prevalence of severe (F 3) liver fibrosis
depending on the test used
()
()
Fibrotest (FT) Fibroscan (FS)
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Agreement for the diagnosis of severe liver
fibrosis (F 3)

• FibroScan Kappa CI
• FibroTest

(95 )
(N,)
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Disagreement between Fibrotest and Fibroscan (gt
1 point of fibrosis)

• Significant fibrosis 39 patients 25.3
• Severe fibrosis 47 patients 31

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Causes of disagreement between Fibrotest and
Fibroscan for severe fibrosis 47 patients
Fibrotest gt FibroScan FibroScan gt
Fibrotest N 42/47 (89)
N 5/47 (11) - ATAZANAVIR ?
bilirubin (N19) - incomplete -
inflammatory syndrome (N2) information
(N5) - hemolysis (N3) - acute hepatitis
(N1) - incomplete information (N15)
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Agreement for diagnosis of significant liver
fibrosis (F gt2)

• Patients treated by Atazanavir NOT included
  (N95)
• FibroScan Kappa CI
• APRI
• FibroTest
• FibroTest Kappa CI
• APRI

(95 )
(N,)
(95 )
(N,)
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Agreement for diagnosis of severe liver fibrosis
(F gt 3)
Patients treated by Atazanavir NOT included
(N95) FibroScan Kappa
CI FibroTest
(N,)
(95 )
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CONCLUSION (1)

• In HIV-HCV co-infected patients, poor to fair
  agreement between APRI, FibroTest and FibroScan
  for grading significant or severe fibrosis.
• APRI seems to underestimate significant fibrosis
  as compared to other tests
• Between FibroTest and FibroScan, disagreement of
  more than one point
• 25 for significant fibrosis (F gt 2)
• 31 for severe fibrosis (F gt 3)
• fibrosis stage higher by FibroTest than by
  FibroScan in 89

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CONCLUSION (2)

• Agreement improved when patients receiving
  atazanavir were not considered.
• At least, in such patients, liver fibrosis is
  better evaluated by Fibroscan.
• A limitation of our study is that these tests
  have not yet been compared with the gold standard
  assessment obtained by a liver biopsy.
• Such a study is on going in order to optimize the
  use of non-invasive methods of fibrosis
  evaluation that are becoming important
  treatment-decision making tools.