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Avatar universal

FibroSure and biopsy

Last summer or thereabouts, I had a Fibrosure test which indicated a score of F3 which was quite high compared to previous assessments of my liver.  My doc then decided we should do a liver biopsy which showed a fibrosis score of 0-1.  We decided to do another Fibrosure test 2 weeks ago which I discovered yesterday was F4 Cirrhosis.  Yikes.  Well, I did a little further digging and discovered that the Fibrosure test requires 10-12 hours of fasting ... no one had told me this and in both cases I had eaten regular meals.  Would digesting food skew the results so dramatically?
Because of this last test, my doc wants to start me on Telaprevir+PegIfn+Ribavirin.  Only prior treatments were with regular Interferon and Ribavirin.  I have the IL28B allele CC.  Should I go ahead and do the TPR treatment or wait for Sofosbuvir or do another Fibrosure test this time after fasting?
72 Responses
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1654058 tn?1407159066
Not an expert, but there are some on here who will respond. I thought the biopsy was the most accurate assessment. What does your doctor say about that?
BTW - does anyone know for sure? Isn't fibroscan the one that is subjective according to the experience of the technician?
Your doctor should be able to give you more into. I'd ask more questions.
Best to ya! Karen:)
Helpful - 0
Avatar universal
It's also my understanding that the liver biopsy is the gold standard.  Did
you tell your doctor about eating before your fiberosure test? With results
as varied as that... I would be on the phone right now to your doctor telling
him/her you ate before the tests if this is the case.  Do you want to treat
24 weeks or 48 weeks?  Start by calling your doctor today.
Helpful - 0
4113881 tn?1415850276
I agree with crossroadsec about the biopsy being the most accurate. Also, I have read many who were diagnosed with different fibrosis scores with the biopsy being the correct reading. If your going to take the FibroSure serious, you need to retake it after having fasted if that's required IMO.

Heres some info I pulled on how inaccurate the Fibrosure test is:

1). HCV FibroSURE misclassified 39% of patients (26 of 66) with minimal-stage disease on biopsy (F0 = 12; F1 = 14) as false-positive F2-4 (F2 = 13; F3 = 7; F4 = 6). Of the 13 patients misclassified as F3 or 4 by HCV FibroSURE, 6 of 12 were F0, and 7 of 14 were F1 according to biopsy. FIBROSpect II misclassified 34% of patients (25/73) with F0-1 (F0 = 9; F1 = 16) as F2-4. None of the 18 patients with F2-4 according to biopsy were misclassified as false-negative F0-1 by HCV FibroSURE; 1 of 22 (4%) with F2 by biopsy was misclassified as F0-1 by FIBROSpect II. Of the 84 patients with both panel results available for analysis, 67 (80%) were classified correctly as F0-1 or F2-4 with relatively good agreement (κ = 0.60). For the 52 patients with biopsies ≥15 mm, both panels demonstrated excellent sensitivity (1.00 for both), with a trend for an improved AUROC with FIBROSpect II compared with that with HCV FibroSURE (0.94 vs 0.89; P = 0.40; Table 2 and Figure 2).

http://www.medscape.com/viewarticle/589349_3
Helpful - 0
4113881 tn?1415850276
I know its hard to ignore a test that says your stage 4...I would have a hard time ignoring it at least. Its one of those things where your just going to have to make a decision however I wish I remembered the username because there's someone on this site with the same issue...Fibrosure said stage 4....had a biopsy that said 1.  At the very least Id ask for a new Fibrosure under the proper fasting conditions.
Helpful - 0
766573 tn?1365166466
Can you post more about your health and how your other labs look.
The Fibrosure is only one possible indicator of cirrhosis. There are biochemical markers such as platelets, INR and the like - that may or may not be apparent. That your doctor would like to leap into treatment without more data is unsettling. I know if I were treatment naive and I had the CC IL28B allele I would at least ask about Victrelis. Did your doctor explain that the CC genotype is associated with better rapid virological response (RVR) and SVR?

I realize you are wondering if what you ate and when had an impact on your FibrosSure result but I guess I am seeing the situation with a considerably different view. Your doctor (ideally) should have been able to explain this. Is there a particular reason why you have had no other type of assessment of your liver function other than the FibroSure?

You are right though - this brochure about the Fibrosure says you should fast for 8 hours. There are lots and lots of threads on here related to the disparity of the FibroScan (FibroSure) and compare/contrast to a biopsy

In the PDF it says:
Discordance between liver biopsy and FibroTest/ ActiTest results
were primarily due to sampling errors associated with small biopsies 15 mm indicating greater concordance when biopsy sampling errors were reduced.

In a recent publication by Poynard et al, discordance of two or more stages between FibroTest and liver biopsy (n=154 discordant samples) was caused by errors in sampling or interpretation of the liver biopsy associated with biopsy size and steatosis more than 60% of the time (97/154) and to errors in the biochemical test in less than 10% of cases (13/154). The reason for the discordance could not be determined in 44/154 samples

http://www.fairfoundation.org/news_letter/2010/02june/Fibrosure..pdf


Here are a few threads:
http://www.medhelp.org/posts/Hepatitis-C/Fibroscan-vs-Biopsy/show/1800504

Bali has lot of insight
http://www.medhelp.org/personal_pages/user/979080
Helpful - 0
Avatar universal
This is something that needs to be figured out. What type of doctor are you seeing? Also so you know the fibroscan and fibrosure test are two completely different tests, fibrosure is done by drawing blood.

Being that you didn't fast before hand I wouldn't rely on that test. Also are there other signs of cirrhosis? a CBC should help decide that. The biopsy is the gold standard that Hepatologist rely on... Your talking about treating for 48 weeks instead of 24, I would sure want this cleared up soon.

Good luck
Helpful - 0
Avatar universal
Mark,
Some of us are very familiar with the FibroSure blood test.  I've taken it several times, researched it extensively - and would be glad to share what I've learned with you.  The primary reason for fasting is to get an accurate blood sugar (glucose) reading - which is a component of the FibroSure algorythm and scoring.  Meanwhile I do agree with Idyllic, who has written.
If you (Mark) can post the following, it would help us to respond to you more knowledgeably...only as laymen and fellow liver patients, of course.  We are not medical professionals, and there is no substitute for the expertise of a doctor who is treating you.
What are your platelets?
Your PT or INR?
Your bilirubin?
Your albumin?
The numbers above can go a long way toward indicating whether or not your disease is advanced -
Helpful - 0
Avatar universal
I really appreciate all who commented.  Yes, the biopsy is the 'gold standard', but as my doc said, it too is subject to sampling errors.  His research assistant called LabCorp to inquire about the significance of not fasting and the person she spoke to agreed with the doctor that it shouldn't make a difference insofar as a cirrhosis reading is concerned.  I'm not sure I agree and will continue to investigate.  In the meantime, I've been galvanized to start Telaprevir, PegIfn and Ribavirin.  If that doesn't do the job, then in about a year, Sofosbuvir plus the others should.  My alpha 2 macroglobulins were high and that also makes the Fibrosure score higher, but it could also be high because of diabetes which HCV patients often acquire.  I'm still reeling from this, but also excited about starting a treatment.  Never had PegIfn before and I have the CC allele for IL28B gene so there's a decent chance that I could be cured.  I had thought that I could wait a bit longer for the newer regimens to be approved, but my doc, who had previously said we have time now wants to start therapy.  No baseball playing for me this spring!  Arghhhh.

Thanks again all.  I really appreciate your comments!!!!
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Avatar universal
Thanks for that info.  I know that Fibrosure has its problems, but I didn't know they were quite that bad.  Thanks for getting that info.
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Avatar universal
Thanks Idyllic.  I think it was indicated above, that after the first Fibrosure, he did another biopsy and we followed that with another Fibrosure.  Biopsy --- good, Fibrosure --- bad.  I'm not treatment naive, per se as I've had Interferon 15 years ago with Ribavirin.  I've never had Pegylated Interferon though which is much more effective.  He's considering a 12 week course.  I'm game.
Helpful - 0
1747881 tn?1546175878
Minimum treatment duration with telaprevir is 24 wks, 12 wks of tela/inf/riba followed by 12 wks of inf/riba and that is only if you respond well to the meds, patients with cirrhosis are recommended to to 48 wks, 12 wks tela/inf/riba followed by 36 wks of inf/riba. I had to do 48 wks due to my response (wasn't UND at 4 wks of treatment)
Helpful - 0
Avatar universal
Platelets, 267 [140-415]
Bilirubin, total 0.7 [0.0-1.2]
Albumin, 4.4 [3.5-5.5]

Those are my latest numbers associated with the Fibrosure.  Thanks.
Helpful - 0
Avatar universal
How are you doing now and how was taking PegInterferon?  My doc says he has many patients who get through it without any problems and he said he'll watch me like a hawk.
Helpful - 0
1747881 tn?1546175878
2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.
Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.

2.7.2 Duration of Treatment—Previously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf

Treatment Futility Rules: All Patients
HCV-RNA  Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin

Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.

Treatment-naïve patients with cirrhosis who have undetectable HCV RNA (Target Not Detected) at weeks 4 and 12 of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total

http://pi.vrtx.com/files/uspi_telaprevir.pdf .
Helpful - 0
1747881 tn?1546175878
I got through it pretty good, no rash, hgb never got below 10, don't get me wrong, it was no walk in the park but doable, now I am SVR (8 months post tx) and doing good
Helpful - 0
Avatar universal
I want to add that my fibrosure was 0.96 which was clearly cirrhotic (though I did not fast) the fibrosure included my INR and platelets. My platelets were low and I was a "bleeder" so the Dr. would not do a biopsy.
I itched a lot, was sleeping 12 hours a day and had a number of other symptoms that confirmed that I was cirrhotic.

I have heard on this forum from more than one person that Doctors are performing biopsies less often than they had. I am not sure why since it does seem to be the most accurate test unless the patient has low platelets and they don't want to risk bleeding.
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Avatar universal
So your doctor thinks your cirrhotic? Your a prior treatment failure but he considering a 12 week treatment... Has he had anything to say about your blood counts as your platelets are really good being cirrhotic... Wishing you the best......
Helpful - 0
1815939 tn?1377991799
Welcome to the forum.

"I had a Fibrosure test which indicated a score of F3 which was quite high compared to previous assessments of my liver.  My doc then decided we should do a liver biopsy which showed a fibrosis score of 0-1.  We decided to do another Fibrosure test 2 weeks ago which I discovered yesterday was F4 Cirrhosis. "  

"I'm not treatment naive, per se as I've had Interferon 15 years ago with Ribavirin.  I've never had Pegylated Interferon though which is much more effective.  He's considering a 12 week course. "

And from your profile: "Had two prior attempts at curing but both failed.  First one was an experimental protocol which started with high dose Roferon.  Viral load went undetected until dose reduction.  2nd treatment attempt was with Ribavirin and I was not responsive to it. "
-----------------------------------------------

Something is wrong with this picture.

You had 2 fibrosure tests that showed F3 and F4 respectively and a biopsy that showed Stage 1. You need to get a better idea of what stage your liver is really at. As the others have pointed out, treatment for stage 4 (cirrhosis) is 48 weeks. And that is on the new triple treatment regimens.

What kind of treatment is your doctor proposing that is only 12 weeks long? As far as I know, there is no Hep C Genotype 1 treatment regimen that is 12 weeks long and that is currently approved for treatment for the general public. Plus, you said he is talking about Pegasys, Ribavine, and Incivek. With cirrhosis, that is 48 weeks of treatment.

The other thing is, you are not treatment naive. You treated twice before. You have a history of a viral breakthrough and also of being a non-responder (or perhaps a null responder). If you were a null responder or a non-responder or if you had a viral breakthrough, then you will need to do 48 weeks of treatment even if you do not have cirrhosis.

So I am not sure where your doctor is coming up with 12 weeks. Both  your past history of having a viral break through and of being a non-responder, and your liver fibrosis stage of 4 (cirrhosis) (if that is correct), mean you need to treat 48 weeks with Interferon, Ribavirin, and Incivek, if those are the drugs you are going to treat with. As a previous non-responder, you would treat 48 weeks  even if you have zero fibrosis. If you have cirrhosis, that is another reason you would treat 48 weeks. So you actually have 2 reasons that will cause you to treat for 48 weeks.

What kind of doctor is this that you are treating with. If you have cirrhosis you should be treating with an experienced and knowledgeable  Hepatologist.
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Avatar universal
Treatment decison should not be made on Fibrosure test alone. Perhaps the doc feels biopsy only samples one small part of liver where Fibrosure might give better idea of liver damage, but doc shouldn't rush into treatment because of Fibrosure result.
I would have another pathologist look at biopsy slides for his opinion on fibrosis. And would consult with a Hepatologist (liver specialist)

best of luck
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Avatar universal
Glad to hear that.  How long had you had Hep C and what condition was your liver in prior to the therapy?  Had you ever had previous therapy for it that didn't work?  Thanks.

MarkFly1
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Avatar universal
Actually, he's quite good and does research in the field.  He may want me to participate in an experimental protocol.  Having IL28B gene CC, I should do better and the reason for earlier breakthroughs was because the concentration of interferon decreases markedly over the course of just a few hours.  He's also thinking, that if I fail this treatment, I would then qualify for newer ones (like Sofosbuvir) which requires being either treatment-naive or having had a peg-ifn failure.  Kinda screwy that people in my class (treatment experienced without peg) can't qualify right away for newer regimens, but this TPR may cure me and if not, the newer, possibly interferon free regimens could.
Helpful - 0
Avatar universal
Not fasting would have only minimal impact on a Fibrosure score...the only component affected would be serum glucose.  IF you still scored below 100 on glucose, then you can consider the original score valid...otherwise you need to re-take.

You wrote:
Platelets, 267 [140-415]
Bilirubin, total 0.7 [0.0-1.2]
Albumin, 4.4 [3.5-5.5]

Coincidentally these are nearly identical to my tests from last week:
Mine were:
Platelets 271
Bilirubin total 0.6
Albumin 4.3

Someone else can chime in, but this suggests a well-functioning liver.  You COULD still be cirrhotic, but well compensated.  With these numbers - and a biopsy that says you're okay - my money says you're okay;  believe the biopsy!!
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Avatar universal
I think it is good advice.  ALL STAGE 4 cirrhotics, as gauged by 2 invalid fibrotests, AND when accompanied by a stage 1 liver biopsy, when urged to treat immediately should consult a hepatologist. Sometimes a second opinion is in order.

Run Forest, run.
Helpful - 0
979080 tn?1323433639
I have met more than one hepatologists that say the FibroSure
test is not worth the paper it is printed on.
Beginning of the year (1.5 year post tx)  I had yet another Fibroscan resulting in F0 and a FibroSure F4. I showed the FibroSure to Dr. Douglas Dietrich who used to post here and who did my FibroScan. He told me to through it out and enjoy life including drinking alcohol in moderation.
Apparently they routinely see erroneous results with the FibroSure.

b
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