fribroSure vs Biopsy?

[Doofus_jones]

Can anyone comment on the merits or differences between this two tests? Is there an accepted medical opinion that one is significantly more reliable than the other?

Wishing you all well.

Doofus

[HectorSF]

Here is the official European Association for the Study of the Liver consensus regarding the assessment of the degree of liver disease...

Journal of Hepatology 2011 vol. 55 j 245–264

Clinical Practice Guidelines

"EASL Clinical Practice Guidelines: Management of hepatitis C virus infection"

4.4.4. Assessment of liver disease severity
Assessment of liver disease severity is recommended prior to
therapy. Identifying patients with cirrhosis is of particular importance, as their likelihood of responding to therapy and post-treatment prognosis are altered, and surveillance for HCC is required.
Assessment of the stage of fibrosis by biopsy is not required in
patients with clinical evidence of cirrhosis. Since significant fibrosis may be present in patients with repeatedly normal ALT, evaluation of disease severity should be performed regardless of ALT
patterns. Endoscopy to rule out esophageal varices and portal
hypertension should be performed in patients with known
cirrhosis.
Liver biopsy remains the reference method. The risk of severe
complications is very low (1/4000–10,000), but biopsy remains
an invasive procedure. Histological features (necroinflammation = grading; fibrosis = staging) should be reported using a
structured, semi-quantitative method. Various scoring systems
have been validated for use in chronic hepatitis C. The most
widely used in Europe are METAVIR, Scheuer, Ishak, and Knodell’s
HAI [63]. Metavir and Scheuer’s scores are more reproducible and
less prone to observer variation, but less discriminant both for
fibrosis and for necroinflammation than Ishak and Knodell [64].
Based on the abundant literature in chronic hepatitis C, alternative, non-invasive methods can now be used instead of liver
biopsy in patients with chronic hepatitis C to assess liver disease
severity prior to therapy at a safe level of predictability.

***Transient elastography (TE) can be used to assess liver fibrosis
in patients with chronic hepatitis C, provided that consideration is
given to factors that may adversely affect its performance such as
obesity, age, and biochemical necroinflammatory activity. TE
results should be evaluated relative to interquartile range and to
the success rate of measurements. TE performs better at detecting
cirrhosis than lesser degrees of fibrosis.

Commercial or brand names for these tests are:
TE: Fibroscan
Tests including indirect markers of fibrosis: Fibrotest™
Tests including direct markers of fibrosis: Enhanced Liver Fibrosis Test ELF™; MP3™, Fibrospect II™

Tests including combinations of indirect and direct markers of fibrosis:
Hepascore™; Fibrometer™

The well established panels of biomarkers of fibrosis can be
broadly categorized as those that include commonly performed
biochemical and hematological tests, such as ALT, AST, prothrombin time, platelets (APRI, AST/ALT ratio, Forns Index); those that
include specific indirect markers of liver fibrosis, such as a-2
macroglobulin; those that incorporate only direct markers of liver fibrosis, or combinations of direct and indirectmarkers.

Sufficient evidence exists to support the view that simple and
combination algorithms perform well in the detection of signifi-
cant fibrosis (METAVIR score F2-F4). Thus, their use in patients
with chronic hepatitis C can be recommended for this purpose.
They all perform less well in the detection of lesser degrees of
fibrosis. The combination of blood tests or the combination of TE and a blood test improve accuracy and reduce the
necessity of using liver biopsy to resolve uncertainty. However,
they increase the cost.

Recommendations
(1) Liver disease severity should be assessed prior to therapy
(B1).
(2) Identifying patients with cirrhosis is of particular importance, as their prognosis and likelihood to respond to therapy are altered, and they require surveillance for HCC (A1).
(3) As liver disease can progress in patients with repeatedly
normal ALT levels, disease severity evaluation should be
performed regardless of ALT levels (B2).
(4) Assessment of the severity of liver fibrosis is important in
decision making in patients with chronic hepatitis C (A1).
(5) Liver biopsy is still regarded as the referencemethod to assess
the grade of inflammation and the stage of fibrosis (A2).
(6) Transient elastography (TE) can be used to assess liver
fibrosis in patients with chronic hepatitis C (A2).
(7) Non-invasive serum makers can be recommended for the
detection of significant fibrosis (METAVIR score F2–F4) (A2).
(8) The combination of blood tests or the combination of transient elastography and a blood test improve accuracy and
reduce the necessity of using liver biopsy to resolve uncertainty.

http://www.easl.eu/assets/application/files/4a7bd873f9cccbf_file.pdf
------------------------------------------------------------------------------------------
Here is the AASLD Practice Guideline from 2009 (soon to be update)

AASLD POSITION PAPER

Liver Biopsy

This position paper has been approved by the AASLD and represents the position of the association.

http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/Liver%20Biopsy.pdf

For overview of biopsy HCV Advocate

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Biopsy.pdf

Hector

[copyman]

My opinion as someone who had all three tests done, FibroSURE, FibroSCAN & Biopsy were all close to same result,  having me on the low end of liver damage.

I only had one biopsy and FibroSCAN but had many FibroSURE tests done. The FibroSURE tests always came back close to previous test.

I think it has been proven that the FibroSURE test is only reliable on the low & high end of the scale. It is not that accurate for the middle stages.

Actually some things I have read said the "FibroScan" is also not that reliable for middle stages. That leaves the biopsy,  I guess that is why they say the old fashion biopsy , "gold standard" is the most accurate & reliable way to access liver damage.

Best of luck

[his3707]

I had two quest hepascores done and 1 fibrosure to monitor liver condition while waiting on a better treatment to come out.  The two hepascores came back f0-f1 but the second test was creeping up to f2.  when I had the fibrosure it came back f4 chirossis.  Then I had a biopsy and it came back f1-2.   Needless to say I got motivated to treat.  I lost confidence in the blood markers.  I had these tests run 6 months apart.  I am relying on the biopsy for the true results.    

[Dannyboi7]

I concur with you on that and there is studies to back that up.From my own personal experience I  only had 1 fibroscan done and ulra sounds done.The ultra sounds didn't show anything.Fibroscan only got a 70% accuracy which showed a probability of a f2-f3.I did APRI scoring and AST/ALT ratio to see if it matched the  fibroscan results.From all these results I figured I was a f2 or less.It gave me a general idea.

[willbb]

Fibroscan is fairly good  at predicting late stage damage(cirrhosis)  but the error rate is approx.25% in middle stage damage.

Fibrotest .. is better at predicting at either end of damage  and also has errors at middle stages.

Biopsy is still considered the gold standard fibrosis marker,,however considered an invasive procedure also with known error factors for diagnosis

Good luck...

Will
.

[willbb]

All:
Also
In the future biopsy will be used less and less IMO. The efficacy of the medications today has greatly  improved making the need for biopsy less crucial for patient and doctor treatment desicions.

Also the  sophistication of the" fibrosure along with fibroscan" (often used in conjuction) is greatly improving   giving clinicians very good indications of liver damage(fibrosis) making the invasive procedure of biopsy even less prevalent.

Add to the fact in the future the therapy for HCV in all likelihood be even more efficient with less side effects and shorter treatment times(possibly >90%)  there will even be less need for biopsy  

All just my opinion......

Will
.

[Doofus_jones]

Thanks to all who posted here for your thoughtful and valuable opinions. I have had both fibroscan and biopsy (which was pretty painless and felt routine) I believe I was somewhat dismissive of the less invasive options probably simply on a "no pain no gain" instinct.

Does anyone know whether Gilead or Abbott would accept results from non invasive testing as acceptable data for trial qualification?

[copyman]

"Does anyone know whether Gilead or Abbott would accept results from non invasive testing as acceptable data for trial qualification?"

Not sure how it is now but when I did the incivik trial they only accepted the biopsy. Participants had to have a biopsy within last year to qualify.