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Do Hepatitis C Patents Still Need A Liver Biopsy ?
Alternatives to a biopsy: non-invasive biomarkers of liver diseaseNew research is looking at whether results from laboratory tests can be used in place of a biopsy. This could easily change the way that hepatitis C (HCV) is managed in the future. Studies using combinations of these lab results suggest they are useful for identifying serious liver damage, but it remains controversial whether they are a reliable substitute for a liver biopsy.
Should Liver
Biopsy Be Recommended Only as a Second Line Test in Chronic Hepatitis C
Patients?
In 2001,
FibroTest ActiTest (FT-AT),
a panel of biochemical markers, was found to have high diagnostic value for
fibrosis
(FT range 0.00–1.00) and necroinflammatory histological activity (AT range
0.00–1.00). Results · A total of 16 publications were identified. · An integrated database was constructed using 1,570 individual data, to which applied analytical recommendations. T · The control group consisted of 300 prospectively studied blood donors. · For the diagnosis of significant fibrosis by the METAVIR scoring system, the areas under the receiver operating characteristics curves (AUROC) ranged from 0.73 to 0.87. · For the diagnosis of significant histological activity, the AUROCs ranged from 0.75 to 0.86. · At a cut off of 0.31, the FT negative predictive value for excluding significant fibrosis (prevalence 0.31) was 91%. · At a cut off of 0.36, the ActiTest negative predictive value for excluding significant necrosis (prevalence 0.41) was 85%. · In three studies there was a direct comparison in the same patients of FT versus other biochemical markers, including hyaluronic acid, the Forns index, and the APRI index. · All the comparisons favored FT (P < 0.05). · There were no differences between the AUROCs of FT-AT according to genotype or viral load. · The AUROCs of FT-AT for consecutive stages of fibrosis and grades of necrosis were the same for both moderate and extreme stages and grades. · A conversion table was constructed between the continuous FT-AT values (0.00 to 1.00) and the expected semi-quantitative fibrosis stages (F0 to F4) and necrosis grades (A0 to A3). Conclusions In closing, the authors write, “Based on these results, the use of the biochemical markers of liver fibrosis (FibroTest) and necrosis (ActiTest) can be recommended as an alternative to liver biopsy for the assessment of liver injury in patients with chronic hepatitis C.” “In clinical practice, liver biopsy should be recommended only as a second line test, i.e., in case of high risk of error of biochemical tests.” Groupe Hospitalier Pitie-Salpetriere, 47-83 Boulevard de l'Hopital, Paris, France. 07/20/05
Reference
Role of Liver
Biopsy Examination in Chronic Hepatitis C Whether a liver biopsy examination is necessary in all HCV-infected patients is controversial. The 2002 National Institutes of Health Consensus Statement considers the liver biopsy examination to be a “useful part of informed consent,” and in most patients with chronic hepatitis C, “the value of pretreatment liver biopsy outweighs its risks.” Patient groups in which the role of biopsy examination is more debatable are patients with persistently normal alanine transaminase (ALT) levels and those with genotypes 2 and 3. In those with clinical evidence of cirrhosis or portal hypertension, a liver biopsy examination may add little further information unless an additional diagnosis is suspected, and may be associated with more complications. The biopsy examination remains the most reliable method to assess the extent of necroinflammatory activity (grade) and fibrosis (stage). The degree of fibrosis has prognostic value in predicting treatment response, although this effect has diminished as therapies have improved, and may influence the timing of antiviral therapy. Individuals with more severe histologic disease are at greater risk for liver-related complications, in the short term, than those with early disease. A person with early histologic disease may choose to defer treatment, awaiting more effective or easier-to-tolerate therapies. It is recommended that a biopsy examination be considered in those who are over the age of 40, those who wish to defer treatment, or those in whom the risk-benefit of antiviral therapy is unclear. Recently, fibrosis indices calculated by using a combination of biomarkers such as the Fibrotest (Fibrosure; Biopredictive, Paris, France), Forns’ index, or the AST/platelet ratio index have been proposed as an alternative to liver biopsy examination. These indices appear most accurate at the extremes of the fibrosis spectrum (minimal fibrosis and bridging fibrosis/cirrhosis). The authors conclude, “With the increased understanding of hepatic fibrogenesis, new biomarkers of matrix metabolism that predict accurately fibrosis and risk for fibrosis progression are likely to be identified, and the future role of the liver biopsy examination in managing patients with chronic HCV infection is likely to change.” Recommended Reading Bravo A, Sheth S, Chopra S. Liver biopsy. N Engl J Med 2001;344: 495-500. Rossi E, Adams L, Prins A. Validation of the FibroTest biochemical markers score in assessing liver fibrosis in hepatitis C patients. Clin Chem 2003;49: 450-454. 07/08/05
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Reviewed Feb 20 2008