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FW: NATAP: Noninvasive liver fibrosis tests-guidelines needed

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  • alleypat
    Non-invasive markers of liver fibrosis: How to use them in clinical practice? 2 letters to the editor requesting guidelines on the use of non-invasive markers
    Message 1 of 1 , Feb 16 11:14 AM
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      Non-invasive markers of liver fibrosis: How to use them in clinical
      practice?

      2 letters to the editor requesting guidelines on the use of non-invasive
      markers of liver fibrosis.

      Journal of Hepatologt March 2007

      Giada Sebastiani, Alfredo Alberti
      Department of Clinical and Experimental Medicine, University of Padova,
      and Venetian Institute of Molecular Medicine, Padova, Italy

      To the Editor:

      We fully agree with Castera et al. [1] regarding the need to develop and
      validate guidelines for the use of non-invasive markers of liver
      fibrosis in clinical practice. Castera et al. referred to a nationwide
      survey among French hepatologists, indicating that in France, Fibrotest
      is the most used marker, followed by Fibroscan and hyaluronan. Liver
      biopsy was still performed systematically by only 4% of respondants.
      Liver biopsy was considered still necessary in case of discrepancy
      between Fibroscan and Fibrotest. Interestingly, guidelines for the use
      of non-invasive markers in clinical practice were required by 95% of
      respondants. Similarly, a recent survey assessing the consensus among
      Italian hepatologists about when and how to take a liver biopsy in
      chronic hepatitis C showed a great divergence in the management of the
      same group of patients, indicating the need to better define the role of
      biopsy and of non-invasive markers [2]. Our studies describing
      sequential algorithms based on the use of APRI, Fibrotest [3], [4]
      clearly indicate that liver biopsy cannot be completely avoided when a
      precise definition of the stage of liver fibrosis is needed in patients
      chronically infected with HCV or HBV. This may still be essential for
      treatment decisions in special populations of patients, such as those
      with high viraemia, or with contraindications, with normal ALT or not
      highly motivated. In these cases, as well as in many others, the
      distinction among minimal, intermediate or advanced fibrosis may greatly
      help in directing management. Available data indicate that non-invasive
      markers of fibrosis and liver biopsy should be considered as agonists
      and not antagonists towards the common goal of correctly classifying the
      stage of liver fibrosis [5]. This is also true for the combined use of
      Fibrotest and Fibroscan, as reported by Castera et al. [6]. We
      completely agree with these authors that the most accurate non-invasive
      markers should be used as first line assessment, limiting liver biopsy
      to the cases in which they do not agree or have low predictive value.
      Priority should be given to large scale validation studies of these
      algorithms in different patient populations inclusive of all major
      etiologies of chronic liver disease and most frequent cofactors which
      may affect the diagnostic performance of fibrosis markers.

      References
      [1] [1]Castera L, Denis J, Babany G, Roudot-Thoraval F. Evolving
      practices of non-invasive markers of liver fibrosis in patients with
      chronic hepatitis C in France: Time for new guidelines?. J Hepatol.
      2007;46:528-529. Full Text | Full-Text PDF (90 KB) | CrossRef
      [2] [2]Almasio PL, Niero M, Angioli D, Ascione A, Gullini S, Minoli G,
      et al.. Experts' opinions on the role of liver biopsy in HCV infection:
      a Delphi survey by the Italian Association of Hospital
      Gastroenterologists (A.I.G.O.). J Hepatol. 2005;43:381-387. Abstract |
      Full Text | Full-Text PDF (117 KB) | MEDLINE | CrossRef
      [3] [3]Sebastiani G, Vario A, Guido M, Noventa F, Plebani M, Pistis R,
      et al.. Stepwise combination algorithms of non-invasive markers to
      diagnose significant fibrosis in chronic hepatitis C. J Hepatol.
      2006;44:686-693. Abstract | Full Text | Full-Text PDF (175 KB) | MEDLINE
      | CrossRef
      [4] [4]Sebastiani G, Vario A, Guido M, Alberti A. Sequential algorithms
      combining non-invasive markers and biopsy for the assessment of liver
      fibrosis in chronic hepatitis B. World J Gastroenterol, in press.
      [5] [5]Sebastiani G, Alberti A. Non invasive fibrosis biomarkers reduce
      but not substitute the need for liver biopsy. World J Gastroenterol.
      2006;12:3682-3694. MEDLINE
      [6] [6]Castera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser
      M, et al.. Prospective comparison of transient elastography, Fibrotest,
      APRI, and liver biopsy for the assessment of fibrosis in chronic
      hepatitis C. Gastroenterology. 2005;128:343-350. Abstract | Full Text |
      Full-Text PDF (257 KB) | MEDLINE | CrossRef


      Evolving practices of non-invasive markers of liver fibrosis in patients
      with chronic hepatitis C in France: Time for new guidelines?

      Laurent Castera
      Jacques Denis
      Gerard Babany
      Françoise Roudot-Thoraval
      Services d'Hépato-Gastroentérologie, Centre Hosiptalier, Universitaire
      de Bordeaux, Bordeaux, France
      Service d'Hépato-Gastroentérologie, Centre Hospitalier Sud Francilien,
      Corbeil, France
      Produits Roche, Neuilly sur Seine, France
      Département de Santé Publique, AP-HP, Hôpital Henri Mondor, Créteil,
      France

      To the Editor:

      We read with interest the article by Sebastiani et al. [1] proposing
      stepwise algorithms combining non-invasive markers for the diagnosis of
      significant fibrosis in patients with chronic hepatitis C (CHC). We
      agree with the authors that combining methods may improve diagnostic
      accuracy. Indeed, we have also recently proposed an algorithm combining
      transient elastography (FibroScan®), a new technology allowing
      measurement of liver stiffness, and FibroTest®[2] as first-line
      assessment of liver fibrosis in patients with CHC [3]. Based on this
      algorithm, liver biopsy examination could have been avoided in more than
      75% of patients for the diagnosis of significant fibrosis. It can be
      anticipated that non-invasive markers of fibrosis will become an
      important tool in clinical practice in the near future [4]. However, no
      guidelines regarding the use of these markers are currently available
      and international consensus reports [5], [6] still recommend liver
      biopsy as mandatory before starting antiviral therapy in CHC patients.

      We conducted a nationwide survey aimed at evaluating, in the absence of
      guidelines, the current practices of non-invasive markers of fibrosis in
      naïve patients with CHC and elevated transaminases in France. A
      questionnaire was sent to all French hepatologists taking care of CHC
      patients in April 2006. By July, 546 responses (65%) were received
      (public practice (n=265), academic hospitals (n=147), non-academic
      hospitals (n=118), private practice (n=153), both (n=128)). FibroTest®
      was the most widely used marker (81% of respondents for 66% of their
      patients), then FibroScan® (32% for 60% of their patients), and dosage
      of hyaluronate (17%). Liver biopsy was still performed systematically by
      4% of respondents whereas it was not done anymore by 3%. The respondents
      estimated that liver biopsy was still necessary for the following:
      presence of comorbidities such as alcohol abuse or overweight (72%),
      discrepancy between FibroScan® and FibroTest® or discrepancy between
      markers and clinical judgement (72%), initiation of antiviral therapy in
      patients infected by HCV genotype 1 (48%) or 4 (30%), and suspicion of
      cirrhosis (44%). It was estimated that the use of non-invasive markers
      resulted in a reduced need for liver biopsy in at least (or more than)
      50% of patients by 52% of respondents and in 25-50% of patients by 25%
      (Fig. 1). In addition, 55% of respondents considered that the use of
      non-invasive markers increased the number of treated patients (by 35%).
      Finally, updated guidelines for the use of non-invasive markers in
      clinical practice were required by 95% of respondents.

      The results of the present study clearly show that non-invasive markers
      of fibrosis are widely used in routine clinical practice in France,
      resulting in a significant decrease in the need for liver biopsy. They
      also emphasize the need for new guidelines, as requested by almost all
      respondents. We agree, however, with Sebastiani et al. [7] that with an
      expected rate of misdiagnosis of at least 20%, non-invasive markers will
      likely reduce but not substitute the need for liver biopsy. Thus, the
      most rationale way of using them would be that of a compromise in which
      non-invasive markers would be first used to classify those patients in
      whom they perform with high accuracy, limiting liver biopsy to the
      subset in whom precise non-invasive diagnosis is not possible, due to
      causes of misinterpretation of non-invasive test and/or need for other
      histological diagnosis.

      References

      [1] [1]Sebastiani G, Vario A, Guido M, Noventa F, Plebani M, Pistis R,
      et al.. Stepwise combination algorithms of non-invasive markers to
      diagnose significant fibrosis in chronic hepatitis C. J Hepatol.
      2006;44:686-693. Abstract | Full Text | Full-Text PDF (175 KB) | MEDLINE
      | CrossRef

      [2] [2]Poynard T, Imbert-Bismut F, Munteanu M, Messous D, Myers RP,
      Thabut D, et al.. Overview of the diagnostic value of biochemical
      markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis
      (ActiTest) in patients with chronic hepatitis C. Comp Hepatol. 2004;3:8.

      [3] [3]Castera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser
      M, et al.. Prospective comparison of transient elastography, Fibrotest,
      APRI, and liver biopsy for the assessment of fibrosis in chronic
      hepatitis C. Gastroenterology. 2005;128:343-350. Abstract | Full Text |
      Full-Text PDF (257 KB) | MEDLINE | CrossRef

      [4] [4]Castera L, Pawlotsky JM. Noninvasive diagnosis of liver fibrosis
      in patients with chronic hepatitis C. MedGenMed. 2005;7:39.

      [5] [5]EASL International Consensus Conference on hepatitis C. Paris,
      26-27 February 1999. Consensus statement. J Hepatol 1999;31:3-8.

      [6] [6]NIH Consensus Statement on Management of Hepatitis C: 2002.
      Hepatology 2002;36:S3-20.

      [7] [7]Sebastiani G, Alberti A. Non invasive fibrosis biomarkers reduce
      but not substitute the need for liver biopsy. World J Gastroenterol.
      2006;12:3682-3694. MEDLINE



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