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A New Biopsy Alternative
December 9, 2003


As a HCV patient I, for one, have not had a biopsy to determine the condition of my liver.

I am fortunate in that I do not feel sick so I am not considering treatment (as a genotype 1a I am waiting for better results with less side effects) . For this reason I don't feel compelled to have the doctors stick a needle into my liver. From the looks of my blood tests and ultrasound, my gastro believes I am doing fine just fine . Though he would prefer that I would get a biopsy, he respects my decision at this time.

Maybe my waiting was not such a bad idea, after all. Now there is a blood test that can give doctors more information than previously available without a biopsy (it has been being used in France for over a year).

So, whether or not you have had a biopsy before, now you may have an alternative to consider for future diagnostic sampling.

Be well,

P.S. Please note that with a biopsy it is the measurement of fibrosis progression that doctors are really interested in. A recent article I sent you showed that milk thistle was scientifically proven once again to be dramatically effective at retarding fibrosis. So, I want to take this opportunity to remind you that you are very wise to take your Maximum Milk Thistle every day, as recommended.

FibroTest and ActiTest Can Distinguish Fibrosis Stage
as Alternative to Liver Biopsy in HCV Patients

Liver biopsy is considered as the gold standard for assessing HCV-related histologic lesions but its sampling error (33% discordance rate for fibrosis stage) and adverse events risks, limit its utility.

Fibrotest-ActiTest are biochemical markers of fibrosis and activity on the French market since September 2002 as an non invasive alternative to liver biopsy in patients with chronic hepatitis C.

The aim of the current study was to assess the predictive value of Fibrotest for the diagnosis of fibrosis stage and activity grade in patients with chronic hepatitis C by an independent prospective multicenter study.

262 consecutive patients with chronic hepatitis C were prospectively included in 6 centers with liver biopsy and biochemical markers the same day.

For 3 patients liver biopsy was not interpretable. Analysis was done in 259 patients, 58% males, mean age 47 years (0.8) Measurement of histological parameters uses METAVIR scoring system. The following biochemical parameters were assessed:

Fibrotest (FT) for fibrosis including a2-macroglobulin, apolipoprotein A1, haptoglobin, ?-glutamyl-transpeptidase (GGT), and total bilirubin, Actitest (AT) for activity including also ALT.

The measurements of histological and biochemical parameters have been made blindly to any other characteristics. Area under the ROC curves (AUROC), accuracy (AC), kappa statistics (K), and Spearman correlation coefficient (SC) were assessed.

The main end point was the AUROC for the diagnosis of bridging fibrosis F2F3F4 vs F0F1.

Study Results

Mean biopsy size was 17mm (0.5), 10 portal tracts (0.4) and 1.1fragment (0.05). F2F3F4 was present at biopsy in 40% and A2A3 in 39%. The mean FT value was 0.19 (0.04) for F0 (n=30), 0.28 (0.02) F1 (n=123), 0.44 (0.04) F2 (n=54), 0.57 (0.03) F3 (n=40) and 0.70 (0.06) (n=12) (all the p<0.05 between all groups, except between F0 and F1 and between F3 and F4 by Dunnett’s multicomparison test).

The diagnostic parameters for FT: F2F3F4 vs F0F1, AUROC= 0.80 (0.03); AC= 72% (p<0.001), kappa= 0.44 (0.06); SC= 0.54 (p<0.001). For the diagnosis of F3 F4 vs F0F1F2, AUROC was 0.82 (0.04). For the diagnosis of F3F4 vs F2 vs F0F1, AC= 62%; K= 0.36 (0.04).

Sensitivity analysis finds no significant differences according to the biopsy quality. AT was associated with activity grades: AUROC=0.71 (0.03); AC=65% (p<0.001); K=0.31 (0.06); SC=0.36 (p<0.001).

The ActiTest AUROC was greater in patients with good quality biopsy (2 or more Regev criteria) vs 0.76 (0.22) vs 0.63 (0.06) in others (<0.05).

Among the 42 patients with 2 stages discordance between FT and biopsy , the discordance was due to false FT-AT in 2 cases (Gilbert disease) and in 13 cases to low quality of liver biopsy (less than 10 portal space). In 25 cases the discordance had no clear explanation


This prospective independent and multicenter study validates the diagnostic value of FibroTest and ActiTest to distinguish patients without fibrosis F0F1 vs patients with fibrosis F2F3F4, as an alternative to liver biopsy in patients with chronic hepatitis C.

The 16% of discordant results with more than 2 stages of fibrosis between the biopsy and FT may be explained by analysis and clinical follow up.


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