Lloyd,
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,
Ralph
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
Conclusions
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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