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?
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:)
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.
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).
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.
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
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.
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?
The numbers above can go a long way toward indicating whether or not your disease is advanced -
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!!!!
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.
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)
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.
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
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
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.
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......
"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.
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)
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.
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.
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:
Bilirubin total 0.6
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!!
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.
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.
I wanted to give you a better /less sarcastic reply. I actually had written one and decided at the last minute to opt for brevity and snark.
You deserve a better answer though and we all might learn a little from my experience.
First off......I have had a few fibrosure tests. My first was in 2005. When it came out worse than I expected (a stage1/2) I immediately began to search why. I had also run a 5K race, along the lines of a competitive race where I was running full out for 25 minutes or so, close to maximum target heart rate for my age. It turns out that extreme exercise raise ALT. ALT is a key score used in fibrotests. Years back it was also used to evaluate if someone ad had a heart attack; when you destroy muscle tissue (from what I read) these enzymes climb. I have never been able to find out how long they are/remain elevated.
I got a biopsy in 2008; 3 years after my fibrosure stage 1/2 score.
Guess what? My damage was 1/6 ishak. Does anyone believe that in 3 years my liver had repaired itself or even stayed the same?
Fast forward nearly 5 years. I just got another biopsy. Want to know the score?
.....Well wait a minute.
First...this summer I got another fibrosure test In July my ALT was 100 and my fibrosure test score was 85. Hmmmmm what is an 85?
According to the scoring specs;
0.72 – 0.74 = Stage F3 – F4
>0.74 = Stage F4 – Cirrhosis
So.......If I am an 85 it is nothing to be happy about. It is cirrhosis.
I took another one a little more than a week ago. Recall that my ALT was 100 in July 2013. This time it was 150. If you were to infer that I got another bad news fibro test....this time from another manufactuerer, you are correct. Then I got biopsy.
By the way....before I get to that, I will also mention that when my blood was drawn for a metabolic panel this summer, THAT ALT score was 80, the the ALT drawn for the fibrosure was 100. Both drawn at the same time, yeah....even from the same arm. : )
I have to wonder about that much variation; don't you all?
Well, one week later I had a biopsy; 2-3, I'm assuming metavir. I will see tomorrow.
Please recall; 2 fibrotests taken in the past 6 months, both showing cirrhosis.
I'm just telling you, you cannot trust the accuracy of the fibrotests. If your doctor puts faith in these tests....which clearly were not administered correctly, then I am suggesting that perhaps you should consider your faith in this doctor.
Nor am I aware of any 12 week treatment..... any currently approved treatment..... that is available to treat a 1) cirrhotic (based upon your fibrotests) 2) past treatment failure, 3) with (if I understood you) diabetes/ insulin resistance.
What your doctor is offering....I am cynical that there is any good approved method with any hope of success.
It's too late to be brief, and there are also other issues that members mentioned in good posts before me.
I wish you well and I apologize. My sarcasm was not directed towards you, but I admit to being a little unhappy at your doctor's recommendations. I wanted to explain that in this thread.
I just wanted to add, that my FibroSure test had me at Stage 4; cirrhotic. So I then ran, terrified, and got a biopsy for the first time in my life, and it had me at Stage 2, grade 3. My alpha-macro had also been high.
I treated for 28 wks with Victrelis, and slayed the dragon~ good luck to you, with your Treatment, Mark. And congrats to you, Willy, on yr Stage 2. You are in good shape to kick some Hep C buttocks
Willy, thanks for your posts. I finally have read them. Just to clarify, my doc is not wanting to base treatment on Fibrosure. My fibrosis stage on biopsy is 0-1, which after 30 years seems a bit too good. The Fibrosure tests straddling the biopsy were F3 and F4. I'm going to have another in a few days after fasting, no sugar and after several days after playing baseball. Then I'm meeting my doc on the 6th to decide on a course of action. If my liver is ok, then I'll wait for the Sofosbuvir. How you doing?
PD, I finally read your post and very much appreciated it. I'm going for a 3rd Fibrosure later this week after fasting. BTW, I've discovered I'm not diabetic, but fasting before Fibrosure, based on what you say, should provide greater accuracy I would think. My doc gets back from the liver conference in Holland and I see him on the 6th to decide on a course of action. I know you looked at my numbers and suggest my liver is functioning ok. Well, time will tell. Just don't want to wait too long before starting something. This is my 30th year with the disease, I've had two attempts with Roferon and Interferon/Ribavirin... Never tried the pegylated form yet, I have IL28B allele CC so that is good, but have gt 1a which is a negative. Just trying to figure out what condition my liver really is in and whether I should start a Telaprevir based treatment now or wait a few more months for Sofosbuvir which is better tolerated and more effective with less risk. Thanks so much for you thoughts and words!
Both myself and boceprevirgal reported f-4 findings with fibrosure which were disputed with a biopsy showing stage 2. I'm not aware of anybody who would weight the fibrosure tests as equal to biopsy and my results show why. My platelets are mid range by the way; 236 and confirmed in numerous tests.
I am bewildered by the notion of taking a 3rd fibrosure test. Your tests have already shown the sampling error; one a stage 3, one a stage 4. I got my fibrosure this summer and was counseled that they (the trial center) don't put much stock in them. Part of my deal of getting into the trial was my staging had to be assessed; a fibrotest was the cheapest, fastest, least invasive. It also proved to possibly be the least accurate, since looking at my platelets one might assume a non cirrhotic score, as well as my regular physical. Both of my biopsies have been by world class doctors who also co-authored some of the studies presented at liver conferences. I am more confident of the biopsy results than the fibrotest.
My study is going well. I am on my 12th day and I have no dicernable sides yet. At times I imagine the riba is affecting me if I push myself, I may feel a little more winded or if I post and seem a little more opinionated. : ) I ran a 5 K last weekend but that was only 5 days in. I probably would today, as I feel no different but I am swamped with work. I'm sure at some point I will feel the riba.
Bottom line is I am not aware of anyone who would weigh the blood tests near equal for your biopsy score. You have your staging. The question is what to do with it?
You ask for feedback; mine would be wait, based on your biopsy score.
Your past treatment have demonstrated you are a lesser responder to IFN in spite of you being a CC. You have results which prove that from what I understood. (possibly due to insulin resistance)
If you were to wait a few months for the approval of the new drugs you would face treatments with higher chances of success, a lower side effect profile and a possibly lower exposure to IFN in duration.
If I had your biopsy score I would wait even longer. Frankly, I did wait longer. I was a stage 1 five years ago and declined treating until now.
PS..... as a hypothetical...... imagine that I clear in 2 more weeks. Imagine that my ALT drops to 20, down from 150. Now imagine I get a fibrosure test. Ask yourself what score the blood test would present? It could show a decrease from cirrhosis to stage 1 or 2 in a matter of 2 months. Do we believe those results?
I have nothing to gain in trying to explain my viewpoint to you. I'm actually explaining it to anyone who chooses to read this.
Just wanted to let you know I appreciated your post a few weeks ago. Really glad you were able to successfully get through the treatment. I'm still waiting to see if I should give it a go or wait until Sofosbuvir is approved. These last Fibrosures really scared me and I don't think I have as much luxury for waiting as I thought.
Willy, my doc isn't weighing the tests (biopsy, Fibrosure) equally. I have just been worried about the two results. What treatment are you on? Maybe I should just go ahead and start triple therapy knowing that within a year or so I can be 'rescued' if need be by more recent approvals?
Glad to hear your treatment is going well so far. Keep me posted. I'm rootin for ya!
Mark, it sounds to me as though you want to try to treat. You are correct there will be other forms of treatment coming up in the future. You'll get there one way or another. I can see you prefer to get it done sooner. There is nothing wrong with that and my first doctor said he always preferred to try to cure people over waiting.
So far I have only been successful in getting into a trial with Sofosbuvir (7977) and Ledipasvir (5885) with riba. I am in the 24 week arm. It appears to me that 12 weeks seems to be pretty effective in G-1 naives.
This may become the first approved interferon free treatment, but who knows? Abbvie is also very close as well. At one time they thought they might be first.
Wow, you are lucky. I wasn't able to get into that trial because of my prior interferon experience. They either want treatment naive or those who have failed pegylated interferon. I'm neither. Well, thanks for your response and good luck. I'm seeing my hepatologist on the 6th. This time I'm going to make sure we're communicating very clearly!
Well, had my third Fibrosure blood draw this morning, this time with Quest instead of LabCorp and also after fasting. Been taking zinc, vitamin D and no B-complex. Seeing my hepatologist on Monday who went to Amsterdam for the liver conf. Should be an interesting visit. I'm wondering if there is a way to get a Fibroscan done, just recently approved by the FDA. Other than the last Fibrosure tests, my blood numbers are seemingly ok except for somewhat elevated AST and ALT. Well, hopefully this last Fibrosure will shed some light on the state of my liver. Oh yeah, I will make sure the doc palpates my liver on Monday!
Hi and thanks for your previous comments. I just had a third blood draw today for Fibrosure after fasting and no vitamin B complex. I also used a different lab. Should be interesting to see how that comes out.
Hi Willy, how's it going? Had my 3rd Fibrosure (just cause I'm a glutton for punishment) without having anything that might cause transaminase irritations. Also fasted and used a different lab. Just kinda curious. I might propose to my doc to see if we could do a Fibroscan. I'm sure gonna ask that he palpate my liver. I read your comments with interest. Right now I feel pretty good having gotten over a nasty cold and it doesn't seem to me that I have cirrhosis. Kinda leaning towards waiting, but will see the doc this Monday. We'll see what transpires. Are you gt 1a?
Well, a few things changed in the 3rd Fibrosure which I received today, but not really in a way I had hoped. The changes between the 2nd and 3rd Fibrosure tests are noted below:
Fibrosis score: 0.83 ---> 0.76
Fibrosis stage: F4 ---> F4
Necroinflammatory score: 0.88 ---> 0.88
A2M: 389 ---> 390
Haptoglobin: 55 ---> 64
Apolipoprotein A-1: 127 ---> 149
Bilirubin: 0.7 ---> 0.7
GGT: 63 ---> 56
ALT: 175 ---> 178
So some numbers changed in a somewhat significant way: GGT and Apolipoprotein and in a good direction I think. Rather disappointed though. I had not had a drop of alcohol, fasted and even had some milk thistle and a few aspirin for a bit of time before the blood test. My doc seems inclined to have more faith in the biopsy, but it is puzzling and concerning that the Fibrosure results have been rather consistent. Any comments are more than welcome. Thanks.
Rec'd your PM - thanks. APOA1 improvement is good -
Your consistent A2M elevation is a bit puzzling, but I suspect that it's the primary culprit in these test scores. You obviously have quite a bit of inflammation - and that's doubtlessly contributing as well. Inflammation is the more consistently reliable of the two FS scores.
I'm a layman, albeit a fairly well-researched one - and my money says that you do NOT yet have cirrhosis, FibroSure scores notwithstanding. Boceprevir, Idyllic, Willy and Rivil and others here are also experienced, knowledgeable old-timers - and I think that we're all telling you essentially the same thing:
Believe the biopsy - and go ahead and treat if you're ready. Or wait for kinder-gentler if there's one around the corner....but with your necroinflammatory score I wouldn't wait more than a few months. Just my two cents' worth -
PD, thanks for you post. Just finished speaking with a very good friend and very good doctor. He mentioned that taking Krill Oil can reduce the inflammation. He's giving my labs to another Hep C specialist to look at, but this specialist said that you can forget the Fibrosure. It does have a rather low positive predictive value, but the consistency of the results suggests that something is going on. I'm also puzzled as to the A2M score. Well, going to see the doc on Wed. I try to get updates on the rumor mill insofar as Sofosbuvir approval is concerned. Rather frustrating ... one month out after the NDA was filed. It would be great if they approve it in the next 2-3 months. If you hear anything about that, please let me know and thanks to all of you who help worriers like me!
Mark..... I've posted a few times. Not much more I can add but here are my actual results;
I've told you I doubt the fibrosure/fibrotest results. The reason is that they do not actually test for lack of fibrosis or the range from 0 fibrosis to cirrhosis.
Instead they used blood tests in algorithm to approximate a damage staging score.
I told you my results; 2 very high fibrotests which alleged F-4 cirrhosis.
My biopsy showed F-2 staging and my platelets have NEVER left normal range
I got my 1 and 2 week results. I am still detected but below quantification (<25 copies)
As I extrapolated..... what would happen if a person cleared..... would not their fibrotest scores immediately reverse?
My ALT was 150 6 weeks ago, 130 trial start day, 43 at 1 week and 21 (if I wrote it down right) at week 2.
I'm not going to waste money proving this theory, but IF I were to take the same fibrosure either you or I took today .... it would probably show me to be a stage 1. My nurse....when I hypothesized this idea with my week 1 results guessed me a stage on had I fibrotested that day.(based on a 43 whereas I am now a 21 as of 5 days ago)
Does anyone think that a biopsy would show me to miraculously have reverted 3 stages in 3 weeks?
I continue to question the accuracy of the fibrotest;
1) it's utility in providing clear guidance in providing info so as to decide; treat or wait,
2) or whether it should be favored over a biopsy in making that decision (no matter how many fibrotests you take).
For many people a fibrotest is better than nothing.
In your case.... given you have a F-0-1 biopsy..... I fear that *nothing* is better than a fibrotest. : )
I hope you interpret that last sentence correctly. I have feared that given that you have now taken 3 such tests..... that you are thinking that their value might supercede the value of your 1 biopsy.
Your liver damage staging is provided by your biopsy, NOT those blood tests. Your experience (I think mine also shows similar poor predictive results) shows you should not trust your fibrosure test results.
If I have been crabby about it, I apologize, but I don't understand ordering tests which already for you proved poor predictive ability.
Willy, no need to apologize for anything and I appreciate your comments. I guess my thoughts were to explore how sensitive FibroSure was to changes in fasting, vitamins, etc. It would seem to fairly reliably indicate active inflammation and my high Ferritin level supports that. I hadn't mentioned that the pathologist who reviewed the biopsy tissue is 80 or 81 years old and that a year ago, an ultrasound revealed "several small scattered shadowing areas in the liver" which the tech thought could be surgical clips (which I highly doubt). 30 years ago I had Hodgkin's disease and my medical care was significantly mismanaged (I won't bore you with the details) ... fortunately I survived incorrect initial treatment, a poor follow-up involving a relapse which my radiation oncologist did not discover (my gastro did) and finally chemo which cured me. I vowed I would never let that type of mismanagement happen again and yet, I'm beginning to think I may have. While I have previously told my doc I'd prefer to get the next treatment when it has a much better chance of success, such as with multiple types of inhibitors, I didn't think thinks would possibly deteriorate as they very well might have. I don't know what those shadowing areas could be and that was a year ago. The only response to it was the biopsy which as you know revealed fairly benign fibrosis and inflammation scores. But there is a consistency with the Fibrosure such as a high alpha 2 macroglobulin value which I figured is the main culprit that elevated the scores.
In any event, I can at least wait until Wed. and will have a zillion questions. I don't know what I'll decide, but the ultrasound of a year ago is worrisome and I will probably want to get a better assessment of my liver's condition at a minimum.
Thanks for your help and thoughts. Your decreasing enzyme levels are quite dramatic and encouraging and also make me realize how long mine have been elevated. :)
FWIW my ferratin at least was normal. I have managed to bring it down a little. It had just been out of range.
If you want to try to figure out how to make it work, good luck with it, but so far using the test as a contrarian indicator would have been more accurate. : )
If I was terse my concern was that a doctor was using a weak test to "sell" you a treatment today, when in all likelihood you had a large safety zone in waiting; even if it was 6 months to treat w/ sofosbuvir and SOC.
I believe this would offer a relatively short wait, a higher cure rate, a shorter and safer treatment. I cannot quite fathom the urgency to treat with current triple therapy when you have demonstrated poor results with past SOC based treatment.(all I know is that you failed; not by how much, but you have mentioned diabetes, making me wonder about insulin resistance and it's role in potential diminished interferon response)
Good luck in whatever you choose....
I am so far quite happy with my choice, and my treatment is just the most current "best in class", but I believe they will get better still and in relative short order.
Mark, for anything that it may be worth to you - since you and I have p.m'd about this as well. I entirely agree w/Willy. He's 'nailed' the major points in your case - and is giving you good, sound advice. I hope that you can soon 'calm down' that A2M level. Here's a related article:
what was your haptoglobin on your Fibrosures , just curious....
As I stated earlier it is not only my experience , that of many other forum members and that of high ranking hepatologists that the Fibrosure blood test can be highly inaccurate. Than what good is it other than making $$ for the labs.
I did one 1 year post SVR it came back F4. I wanted to hear an explanation
from a hepatologist Dr. Douglas Dietrich at Mt Sinai (they do transplants there)
He examined me by doing a FibroSCAN looking at labs and all history.
He laughed because they just had another patient a week prior with a totally
wrong FibroSure and this happens frequently....
He told me my liver was totally fine no fibrosis to worry about.
I insisted on those blood values alpha 2 macros high ect... he said
to go see a hematologist if it bothered me but it wasn`t my liver.
Guys, thanks so much for your comments! My wife says I often "pre-worry" .. I guess I've been looking at the totality of information and that ultrasound sounds concerning. My doc says he doesn't want to base any treatment on a Fibrosure and thinks waiting for Sofosbuvir is probably best (I see him on Wed.) BTW, I don't have diabetes, so the high a2m may be due to something else, perhaps hemochromatosis? Afterall, a positive predictive value of Fibrosure is 61%, is not very high but something is causing the a2m to be high. In any event, I hope the Sofosbuvir is approved soon. Please send your good vibes to the FDA! I really appreciate your comments and thoughts.
Well folks, my doc and I agreed that I should start on Triple therapy. If I tolerate it and it's effective, great. If not, then the newer drugs will be available as a backup. I know some of you might think I should wait, but assuming I have some fibrosis, it is best to arrest it now before it gets any worse. I want to get rid of this before my 30th year of having it on July 7. I must say I feel excited, yet kinda glum at the same time. Why didn't he push me to do this 2 years ago? N-e-way, the sooner I get rid of it, the happier I'll be. Did anyone see the new paper on reversing cirrhosis?
Sounds good , nothing like having a plan.
Wishing you minimal sides and a great response to tx.
You are a CC so that`s a big plus.
You will be just fine you will see.
Just go with the flow and make sure you take your
meds on time and that you run the bloodwork correctly.
Good luck to you and hoping that your sx are minimal. I think your reasoning is very sound. If there is treatment available now that has a good chance for success why wait? That was the reasoning that came into play for me. Even though newer drugs are around the corner, there is something that can be done now. Best wishes for success.
Mark, you are an amazing guy! I missed this whole thread until today, but just read all of it and I'm really impressed with your ability to calmly handle a fair bombardment (at least it looks that way when you read it all at once) of strong views, mostly seeming to tell you what you didn't really want to hear. Bravo to you for your very open manner in discussing it all and listening to the other views without getting upset. I laughed at your wife's saying you "pre-worried" – that's the same thing I say to my husband! It is frustrating for those of us who can take things as they come, but it seems to be a deeply embedded part of a person and not easy to change.
I agree with all the great advice you've gotten from the regulars above, and I also agree that its a very good time to treat, mostly because you are clearly eager to be done with this virus. Best wishes to you, and be sure to read up on the sx so you can be prepared if they do hit you. Btw, I had HCV from 1984 on, failed an early tx with just interferon, was dx'd with cirrhosis (by biopsy) in 2004, did 15 months if tx with interferon and ribavirin and relapsed, then finally did 48 weeks of triple tx and achieved SVR. I'm now 8 months post-EOT. You can do it too?!
Wow Ceanothus, you've cut me to the quick! You are a tenacious one and I'm very impressed. I'm so happy for you now that you're SVR and I really appreciate your support. Yes, I've worried and it's not clear what state my liver is in and now it's only a few months away from either Simeprevir or Sofosbuvir and yes, I've kicked myself for part of the miscommunications with my doc and not clarifying my views more clearly, and not starting the triple therapy 2 years ago. But I also know that during those two years the medical community has become much more aware of the potential hazards of the telaprevir and now know how to better evaluate and observe patients for possible adverse events. Had I started two years ago, given my strong drive to rid myself of these freeloaders (my history of 8 months taking interferon even though I was non-responsive on the 2nd attempt) I probably would have tenaciously continued taking the telaprevir even if I did have adverse reactions. Patients who did that are now dead! So, in the end, things are looking up. It will interrupt a few baseball seasons this summer and fall, but I think having this thing for 30 years is long enough!
What genotype were you? Again, thanks for your support and all the others who have contributed to this thread. I fault no one as everyone has helped me to make this decision. Those who are already clear are especially noble to take the time to help others! I hope that I'll be in a position to do that also and have the character to continue making a contribution regardless of my status. Thanks again!
I WAS type 1a! It's so cool to be able to use the past tense. It actually is still something I have to stop and correct myself on, but I'm catching myself pretty quickly now, so I think I've almost gotten used to the idea of it being over. I know that stubborn thing too. My 15-month tx was one of those - I wasn't UND when I was supposed to be but my vl had dropped a lot so I pleaded with my doc to let me try to keep going. I did finally get to UND and then kept going so I had the same total time of being UND as those who did it on the normal schedule. I hoped it would work but the virus was back strong just 6 weeks after tx ended. I'm so glad this one really did work for me. I hope it works as well for you!
as a person who has had every test I thin k there is,there coming up with all sorts of new things they have a fibroscam,I mean fibro scan youhave to do your own research as to the reliability,still the golden test always has been and still is is a Biopsy,all the rest are blind Data.
Not sure why you refere to it as blind data, or why do you think is a scam. Fibroscan has beed FDA approved. There is really no need for extreme invasive diagnostic methods especially for determining the status of a liver prior to HCV tx
Biopsy is not very accurate either since is showing a reading from one spot only. It is not really a reflection of the health of the liver as a whole
Thanks for the comments. One thing the Fibrosure showed me was a high iron level. Something to further check out. The good thing about the situation is that if for whatever reason I cannot continue with the Telaprevir+, new treatments are right around the corner. Type 1a can be a bit more difficult to get rid of, but I went undetectable pretty quickly back in 95 for a few months until a dose reduction. Having never had pegylated interferon not to mention Telaprevir, I'm pretty optimistic, but it's nice to have some options. Ceanothus, I hope your energy levels come back soon. Check out some research of recent vintage on fibrosis regression using inhibitors. There is a bright sun on the horizon!
Got my viral load today. Last year it was 4 million ---log 6.6. Now it is 233884 --- log 5.37. Down a factor of 20. I know these loads can vary quite a bit, but I'm just gonna keep taking Vitamin D, Zinc and Vitamin B12. Really happy it was this low!
Not to spoil you excitement but I had similar values. I had 1.5 mil, than down to 150000, I had vitamins, zinc, milk thistle, freash juices, you name it and than 6 months later virus was up again to 1.5mil.
I think the levels are always fluctuating in this way and no vitamins are in fact changing the levels!!! That did not make a difference for the level of fibrosis either, had severe fibrosis when I started tx
Hard to believe it after all the healthy life style I was having :)
I stopped any vitamins during the Telaprevir phase and couple of months after that but now I am back taking my vit D 50,000 units once per week. Levels dropped somehow since I started tx so I thought I will top up. I aslo tried vit b12 injection once per week. And now I am also on zinc as I have done a zinc test last week and I could hardly taste it so time for a top up as well :)
Thanks for your comment. I know the levels will fluctuate, but you never know how Zinc and Vit D might impact how your innate immune system responds to a viral infection. I had Hodgkin's Lymphoma in 83 and 85 so I can appreciate your situation. Did your doc say to stop taking the vitamins during tx? Are you on Telaprevir? In any case, good luck with your tx. Just got word of my insurance covering the meds which should be delivered next week. Excited about starting. :)
I was on Telaprevir for 12 weeks and now I have another 18 weeks to go ( I am doing the long haul of 48 weeks)
Although dr was ok with vit when I am on interferon and Riba they said they prefer I do not take anything else during the 12 weeks of Telaprevir. I guess mainly because nobody really knows how ant supplement will impact tx. There are studies on vit B12, vit D, zinc, etxc and dual tx but nothing on triple tx yet. It is still pretty new.
I even called the manufacturer and they only told me to speak with the doctor or with the pharmacist. As if the doctor will have somehow different stream of information?? !!!!
So I preferred not to take anything during those 12 weeks. I made the most to avoid even panadol.
I can only hope lymphoma will also be gone by the end of tx. Not easy on Telaprevir but I have done really well considering.. I was on the couch sometimes 2-3 days at the time but I kept working full time (luckily we had the xmas holidays at that time)
I did prepare though for tx quite thoroughly: I had every single thing for every single side effect you can think of and as a result I did not have to use any, lol.
But prior of starting I was on lots of raw food for 4 months, plus mega vit d and zinc. Also I have done several sessions with a psychologist working on anger and some sessions of hypnotherapy for side effects. All in all maybe I was just lucky but I only had a rash around the knuckles for 10 days and a few headaches at the start. Plus the anemia and tiredness of course. Good luck and I wish you an easy tx
Thanks Diana for that info. Impressive and encouraging that you made it through the entire 12 week Telaprevir portion. Were you undetectable at 4? And what genotype are you? I'll have to also get various lotions and prepare so I don't have to use any. LOL. I'm just emotionally preparing that other than my niece's wedding, I'm just gonna focus on resting and doing work. I work from home so that helps alot. I may go to a ball game now and then and I'm hoping to get one more game in tomorrow and maybe one or two more depending on symptoms. How long was it before you became/felt anemic? Thanks for your response ... it really helps.
Just wanted to congratulate you on starting Tx and I hope you have a very smooth treatment with few side effects. Also wishing you SVR.
I treated with Inf., Riba, and Incivek. I was DET at 4 weeks so I had to do 48 weeks. I was UND at 8 weeks and remained that way throughout the rest of Tx. I finished Tx Aug. 25, 2012 and attained SVR (official in Feb. 2013).
Treatment was no picnic but it certainly was doable. If you have side effects, just post them here and we will help. There are plenty of us who treated with Incivek and we have a lot of remedies for side effects.
I can tell you I am elated to be virus free and, like Ceanotyus, I am still getting used to it, that it is a reality. I can tell you that I feel 1000% better than I felt before treatment. I have a ton of energy and never get any fatigue now whatsoever (fatigue was a huge problem for me before Tx). I now have pep, zip, energy, motivation. It is great. I feel better than I have felt for 20 years. I am back out in the garden working and doing all sorts of things I had not done for several years. I can stand all day and not get tired. I could even go back to work (I am 67 and i retired earlyu due to all of the extrahepatic manifestations I was having ... fatigue, joint pains, back pain, etc.) But now I could go back to work if I so desired. So life is good. I al telling you all of this so that you will know of more success stories.
Wow, you all are great and so supportive! This makes me very optimistic. I haven't started quite yet. The meds are being delivered on Wed. by UPS and I take them to the doc to create the treatment plan, etc. I've done injections before, but it's good to get the low-down. Do you know how long you've had it and what genotype you were? The closer I get to starting, the more excited I am. Lately, I've felt very fatigued ... could be the weather, but I know in general, I tire more easily than years ago. I've had these freeloaders for almost 30 years and before that had Hodgkin's disease. I can barely remember (sort of) what it felt like before I had these health issues. Your stories of all that energy are really helping me to keep my eyes on the prize! Thanks so much!
My Hepatologist and my pharmacist said it was okay to keep taking all of the vitamins and supplements I was taking (Stress Vit. B, Vit. A, Vit. E, Vit. D, Calcium, Antioxidants, Omega 3-6-9). In fact, some studies have noted that taking Vit. D increased SVR rates.
I am a 1b with a CT and regarding tx, well, I had a bit of a different journey. My second day of Telaprevir I was having really strong headaches and I was really sick as a result throwing up all day long. So the doc stopped my Telaprevir at middle of second day and gave me a lead in of 4 weeks. At the end of that I had a drop of almost 3 log so down to around 1700. After I started Telaprevir, I was UND after 4 weeks (total of 8 weeks though since start of tx)
I am only doing the 48 weeks because my doctor thinks is a better choice since I have severe fibrosis. I have been on a reduced Interferon dose of 135 since week 9 and I had 2 instances where I had to reduced to 90. On top of that I had to give interferon a miss in week 19 as blood values were too low. In US you might get a different support regarding low neutrophils levels but here in NZ dose reduction is the first approach.
I think I got anemic pretty much after 2-3 weeks but it is not so bad. I had a minimal dose reduction in Riba for one week when my hemoglobin was 8.8 but even then I was not feeling much. Some short breath during the Telaprevir phase plus that we had the summer at that time and I could not stand the heat
If I remember anything else significant I will let you know
Glad to hear you are on track to start your tx. Nausea is a fairly common early sx of the Incivek, so its a good idea to have a plan in place if it comes up. It hit me super hard in the middle of the second week and it rapidly became impossible to keep the meds down. It's very important not to miss any doses of the Incivek (to avoid viral mutation and breakthrough) so I was really glad I was able to reach my team quickly and get a new Rx for Ondanesetron within a couple of hours. I never would have made it without that drug. I would be gagging with severe nausea, dissolve one tiny pill on my tongue, and within 20 minutes the nausea was gone and I actually felt like eating again. Either get it in advance or make sure your doc will be reachable at any hour you might need it! Good luck!
Thanks for all this info. One fly in the ointment, is that I just started getting a touch of diverticulitis/osus which can resolve in the early stages if I give my system a rest ... hope it doesn't delay the start of tx. I'm looking forward to Wednesday and getting the meds and making the tx plan with my doctor. I will ask him about this nausea drug. I'll have to keep awareness of anemia...played baseball today and we won our first game! I hope I can get at least one more in...possibly three days after I start. Don't know if that's realistic. Again, thanks for all the tx experiences...that helps me prepare.
Thanks for that info. Well, I started today! Got the peg interferon injection around 2:30 or so and taking my first pills tonight at 7PM. Twice daily dosing of 1125 mg. telaprevir and the Ribavirin. So far, not too bad ... feeling an increase temp. on my face, but I know it'll be a bit worse tomorrow. Really happy to have started! Getting my viral load checked in two weeks and doc says I can play baseball if I'm up to it as long as I use plenty of sunscreen.
I know that the CONCISE and PROVE trials showed that 12 wks of therapy can work for some people. That is, 12 total for all three drugs. I guess we'll see how things evolve, but I'm hoping to be undetectable at 2 wks. My viral load as of about 2.5 weeks ago was 233,000 which is pretty low for me. A year ago it was 4M.
Do you have more energy and such since getting through it all?
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