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• W2000527425 abstract "Sirs, We read with great interest the systematic overview of Smith and Sterling on non-invasive methods of fibrosis analysis in chronic hepatitis C.1 The authors must be congratulated for this attempt to review a rapidly increasing number of publications. However, this overview has several flaws, including lack of exhaustivity, and inappropriate methodology, leading to misleading comments and conclusions. The lack of exhaustivity is particularly unfair for FibroTest studies published through December 1, 2008. The authors missed four validation studies,2–5 and seven comparison studies: two vs. APRI significant in favour of FibroTest including a meta-analysis,6, 7 one vs. Forns also significant in favour of FibroTest,8 two vs. Fibroscan,9, 10 one vs. glycomics,11 one vs. proteomic,12 and one vs. other panels.13 In comparison with non patented markers such as APRI, or Forns’ index, FibroTest has demonstrated significantly higher diagnostic and prognostic values. Furthermore, two studies including repeated measurements have demonstrated same impact of treatments than that observed with paired biopsies.2, 3 The methodology used by the authors to assess and compare the accuracy of biomarkers is inadequate. To improve the classical general STARD criteria, we identified 62 items to assess more specifically the methodological quality of fibrosis biomarkers.14, 15 One of them, the spectrum effect, is particularly important and was not discussed in this overview.16 According to stage prevalence, the FibroTest AUROC varied (P < 0.001) from 0.67 (only stage F2 as advanced fibrosis and only F1 as non-advanced fibrosis) to 0.98 (only F4 as advanced fibrosis and only F0 as non-advanced fibrosis). If AUROCs are standardized according to this spectrum effect, the so called ‘grey zone between F1 and F2’ disappeared. In fact, biopsy of 25 mm has the same grey zone between F1 and F2.16 An example of this spectrum effect is the artificial low AUROC of FibroTest in HCV patients with normal transaminases. In this group of patients, most of the fibrosis stages are METAVIR F0, F1 and F2 and biopsy itself would have low AUROC between F1 and F2.17 Several authors’ comments about FibroTest and ActiTest are not correct. ActiTest since its first validation has been developed for the specific diagnosis and grading of necro-inflammatory activity. ActiTest is incorrectly classified as a fibrosis marker by the authors in their Table 1. In Myers et al. study, the original FibroTest and ActiTest have been used without any change. The authors incorrectly stated that ‘the components of FibroTest are not readily available and have limited applicability because two components, haptoglobin and bilirubin, can give false positive results’. The definition of ‘readily available’ is not given, but FibroTest is now available in 40 countries, available in most laboratories in few days, have been already prescribed in more than 400 000 subjects, and is recommended by French health authorities as first line biomarkers in adult patients with chronic hepatitis C.18–21 Neither APRI, Forns’ index nor FIB4 have been validated by this independent authority. We recognized that they are causes of non-interpretability of FibroTest, but the risk of false positive/negative result is very low and the rate of applicability of FibroTest significantly higher than other validated markers such as Fibroscan.9 The overall applicability has been repeatedly observed to be greater than 95% both in patients and in controls.9, 13, 14, 20–22 Finally, we agree with one of the authors’ main conclusions that determination of the degree of liver fibrosis is essential for determining the need for treatment and for determining prognosis in patients with chronic HCV infection. We disagree with the other conclusions. Biopsy remained the best standard only when everything else failed.23 More evidence-based reviews of the updated literature,14, 15, 21 including independent reviewers,18, 19 strongly suggest that at least one nonroutine biomarker has demonstrated diagnostic and prognostic performances better than routine biomarkers and is at least equivalent to a 25 mm length biopsy. Declaration of personal interests: Thierry Poynard is the inventor and has a capital interest in Biopredictive, the company marketing FibroTest. Mona Munteanu and Fabienne Drane are employees of Biopredictive. The patients belong to the public organization Assistance Publique Hôpitaux de Paris. Declaration of funding interests: None." @default.
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• W2000527425 date "2009-11-02" @default.
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• W2000527425 title "Appropriate evidence-based data overviews demonstrate the diagnostic and prognostic performances of FibroTest in patients with chronic hepatitis C" @default.
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• W2000527425 doi "https://doi.org/10.1111/j.1365-2036.2009.04115.x" @default.
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