FIBROSpect II

[SteveHepC]

I did a test called Fibrosure a few years ago. The results were completely skewed due to my having a Mechanican Heart Valve. The test showed Stage 4 Cirrosis, and a subsequent MRI showed no liver damage. My Doctor should have not even ordered that test. Apparently, one of their markers is INR (PT), and since I'm on Coumadin, the results were wrong.

Now there is FIBROSpect II. Has anyone out there had any experience with this test, it's accuracy in determining fibrosis levels, and does it matter that I'm on Coumadin?

[SteveHepC]

Thank you both so much for your input. It really helps to have this dialog. I'm am definetely waiting for my chance at Fibroscan. It is really taken off in Europe, and it's accuracy seems to have been authenticated. Also, I'll do the research on trans jugular biopsy, and discuss it with the good Doctor.

Everybody have a great Christmas!

Steve

[mremeet]

Yes I'm aware that the fibrosure is touted as being more accurate at the ends of the scale and not so accurate in the middle. And my hepatologist was aware of that and told me the same thing, but he still said that it was not reliable enough to rely upon as the sole "diagnosticator". He agreed to write me a script for one, but he said "If you really want one ok, I don't mind writing you a lab order for a fibrosure. But if you really want to know what's going on with your liver, another biopsy is in order." I didn't want another biopsy because my last one was so awful (student doctor performed etc), I wanted a non-invasive and easy (and painless!) way to gage my fibrosis instead. Here are my results:

2001 liver biopsy results: F1
2005 fibrosure results: F0
2006 fibrosure results: F2/F3
2006 biopsy results: F1

So as you can see the fibrosure initially stated I had zero fibrosis 4 years after my biopsy said F1 (within the range of fibrosis the test is supposed to be accurate). Then only one year later another fibrosure says I'm verging on F3 - three stages in one year! Then because of the scare I got out of that "F3-ish" fibrosure result, and also because the Vertex trial required a biopsy (and would not accept the fibrosure test in lieu of the biopsy due to its inaccuracy), I got another biopsy...and low and behold it said I'm back at F1 where I started in 2001 with my last biopsy. So my liver damage according to the biopsy is once again within the range the fibrosure is supposed to be accurate, but yet it was way off (not that I believed I had progressed 3 stages in one year anyway).

Anyway, the bottom line is that you can't trust these simple blood marker tests. The stakes are too high, the only method with sufficient accuracy and confidence is a biopsy or perhaps fibroscan once that becomes widely available.

[copyman]

hey steve, labs look good. i was in no way suggesting you have cirrhosis because of the fibrosure. i know how you feel about having to know what damage you have. it is very smart to want to know and make the right decision about treating now or waiting for the better meds to come out. there are biopsies for people that are in danger for bleeding out, low platelets, blood thinners, etc. it is called a trans jugular biopsy. if you can wait until next year most of the radiology centers should have the fibroscan machines available.

[SteveHepC]

All I really know is thaat when confronted by My Doctor, the Fibrosure folks at Lab Corp and the Developer said the test was not reliable when done on someone with a Mechanical Aortic Valve, and they were very upset that he had ordered it for me without letting them know. He was suspicious about damage since my ALT and AST were in normal range, and my Albumin and Total Protein were in the higher part of normal range (lower suggests damage). Then, when the CT scan and MRI both showed that my Liver was "unremarkable", he threw the Fibrosure test away. He will not do a Biopsy because of the risk/reward factor...........I could bleed out, as he says. The MRI showed no abnormalities or enlargement of the Liver, sleen normal, no extrahepatic biliary obstruction, no ascites. Goggle MRI of a cirrotic Liver and check out how it looks compared to normal. It's distorted.

Since I'm 2b with a VL of >2 million, I'm not under any delusion that I have no fibrosis. But being 68, I need to know how bad it is before I decide to treat again. Again, here are my test results from 2 weeks ago. Ranges in (): HCV test positive - Genotype 2b - VL >2 million
Glucose, Serum 92 (65-99)....Bun 16 (5-26), Bun Creatinine Ratio 20 (8-27), Sodium, Serum 139 (135-148), Potassium, Serum 4.5 (3.5-5.5) Carbon Dioxide, Total 27 (20-32 Calcium 9.3 (8.5-10.6),
Protein Total 7.8 (6.0-8.5), Albumin, Serum 4.8 (3.6-4.8), A/G Ratio 1.6 (1.1-2.5), Bilirubin, Total 0.6 (0.1-1.2), ALK 79 (25-160), AST 40 (0-40), ALT 38 (0-55). That's the lowest my ALT has been in 2 years. Prior to treatment in 2004, my ALT was 150 and AST 92. My GGT was always normal except during treatment.
Many thanks for all your comments and info.

Steve

[copyman]

i agree and disagree with what you say. i have been seen by 2 of the top hepatologists in the country and they did say the fibrosure "at the low end and high end" can be relied on along with others bloodtest & markers to be close to real damage.
agreed that having a bx would be the best test but still is not without flaws, i.e. sample size, sample from one area only, pathologist that reads them, etc. still better then a fibrosure but bx only around 85-90% accurate.
since the fibroSCAN reads the whole liver it will probably end up being the best test in the future.

I had all three tests 1 month apart and all were close.

[dlr2007]

I don't trust FibroSpect II either- mine was a score of 60, which put me at about Stage 3. I had a bx which came back as Stage 1- quite a difference- and quite a relief! Until we can all get fibroScan's- biopsy is the best option. Good luck!
-Dee

[mremeet]

I've had two fibrosures and they generally did not correlate well with my two biopsies. They're not trustworthy and most knowledgeable doctors do no rely on them as the sole diagnostic test for determining liver fibrosis. I would strongly suspect that the fibrospect has similar flaws, and I would not trust it for something as important as determining fibrosis stage. Just get a liver biopsy and be done with it, and make sure they extract a sample of sufficient size to ensure an accurate reading.

[copyman]

i see that on my lab slip but what does the transplant part have to do with someone that had a Mechanical Aortic Valve? i agree that the results of an INR test will be skewed from blood thinners but should have no bearing on a fibrosure test. if your test result was an F4 and the fibrosure is most accurate and F1 & F4 i would want a fibroscan or biopsy to make sure it was not right. can you post some of your other labs, platelets,etc

[SteveHepC]

Look at your Fibrosure test results again. At the bottom of the first page, under "Limitations". Transplant patients is listed as a condition which may lead to inaccurate quantitive predictions of fibrosis. If Fibrospect II is the same, there's no sense in my even considering it.

[SteveHepC]

Many thanks for that info. Duke is much closer to Louisiana, and would allow me to pay a much overdue visit to my best friend in Greenville, SC. However, cost has to be considered. I will cantact Duke on Monday to find out. With the LA option, the procedure cost isn't a problem, but the trip would be triple.

[copyman]

there are at least 3 locations on the east coast. duke univ, virginia & boston. and i think one in NY so there might be 4 total

[SteveHepC]

I have decided to do Fibroscan, even if I have to fly to Los Angeles from North Louisiana. I know about the availability of that procedure from a friend I made on this forum. After the holidays, I'll immediately take care of business.

Thanks,

Steve

[kittyface]

Hi, I'm with copyman on this one.  My hunch is that Fibrospect II uses the same test parameters as Fibrosure.  Even if you had no contraindicating condition, these tests are 80% accurate at either end of the scale:  F1 and F4.  They are less accurate in predicting the middle stages - F2 and F3.  Also they don't measure inflammation, only fibrosis.

My Fibrospect II results were halfway between F0 and F1 but I'm not 100% confident in this analysis.  The next method will be fibroscan.

In what part of the country do you reside?   I heard there's a fibroscan near LA.

Kittyface

[copyman]

if you dont / cant get a biopsy then wait until next year and get a fibroscan when it becomes FDA approved. this is the email response i got from the fibroscan manufacturer:

thank you for you interest in the Fibroscan
we are currently under FDA investigation we hope to be validate for use in USA current Semester 2 in 2008
best regards
cecile guiducci

[SteveHepC]

I'm not sure about PT. I do know that they sent my Doctor a letter, explaining to him that the test was not for folks with a Mechanical Aortic Valve, and apparently, that is part of their professional literature. The valve and the PT might affect those first three markers you listed. They acted like they were concerned that I was going to use those results, and do something wrong, then sue them.

If the tests are that similar, I can't use the Fibrospect II either.

[copyman]

It is basically the same test. Are you sure about the PT being part of the fibrosure?  I'm looking at my test results and nowhere on here is PT used as a marker. It uses these 6 markers:

Alpha 2-macroglobulins
Haptoglobin
Apolipoprotein
Bilirubin, total
GGT
ALT