F1 to F3/F4 in one year: Is it possible?

Hi, everyone! This is actually related to another query I posted recently regarding the Fibroscan test. However, as I didn't get many read-outs on this specific question, I thought I'd post again.

Has anyone heard of people progressing from F1 to F3/F4 in one year, as I seem to have done?

It would help me in dealing with the MDs here if I had a better idea about this. If Willy50, GSDgirl, GoofyDad, and any of my other friends here who have a lot of experience are still around, maybe you can give me a read-out. I'd appreciate it. I just don't know where I'm at with this any more.

Hope I'm not boring everyone with dumb questions.

Thanks.

Mike

[Willy50]

Hey, thanks for the confidence but you may do as well with the I-ching as with my opinion on this topic.  Why?  So much depends....

First, where did you get your first read; was it a biopsy?  Was it a sufficient sample?  How many cores and locations?  Any of these will skew a result.

Next....who evaluated it?  Did you know you can get a second opinion of of the slides from another hepatologist in some cases?  Unfortunately there can be variance from person to person.

My point is; how do you know you were a stage 1?  Is that solid?  If it was one core of a biopsy from a lobe in good shape you could be a stage 1 but if they had taken one from a different area you might have been a stage 2, for instance.

The same situation applies to how you got your most recent evaluation; sorry, I'm not up on that news yet.

I didn't answer the other thread.  I thought Bill did a fine job answering and if I recall copyman was also on point as well.

Is a fibroscan worth the effort?  In my opinion if you are out of the middle ranges and if you have a good technician to provide the scan and interpret it then it can provide data to round out what you already may know.  NONE of these tests are perfect.  Each has their strengths IMHO.  Biopsy is top dog because it provides good differentiation and relative easy interpretation of all ranges of liver staging.  Neither fibroscan or fibrosure will do that.

On the other hand.... what if you used a fibroscan, saw a wide variety of staging differences and decided to get biopsy samples from the ranges?  Contrast that with a simple jab that ends up with either a sample from a good area of the liver or a very very bad are of the liver.  Why extrapolate that and call it a stage 2 (or take your pick)?  A fibroscan and a fibrosure may round out the staging information.  Further, since they are non-invasive one might easily get one every year, thus providing a far better sense of how one is progressing.  You generally won't get that with a biopsy and for good reason.

Biopsies are invasive..... not always safe, expensive and they create scar tissue.  I guess my opinion is that if you get a biopsy also get a fibroscan or fibrosure and then follow up annually with one or both of the non-invasive tests.  My fibrosure cost about $330. US and after my deductable I may have paid about 30 dollars.  Well worth it, I say.  Maybe not quite so worth it in the middle ranges but how else are you going to know when you are entering or leaving the middle stages?

Can it happen?  Go with your knowns.  Make sure you know where you are TODAY, IMHO.  Who cares about theory?  You may be able to make sure your data is solid; if it is then I guess it can happen.  

I just had a friend die of auto-immune lung disease.  In a matter of months they went from breathing with difficulty to failure of the lungs; they became fibrotic.  I wonder; can the immune system go into hyperdrive, or become distracted, or go on vacation?  Maybe it is possible to get rapid progression.  (lol; I am not the guy to ask though....)

My 2 cents, but I really couldn't disagree with what I saw written elsewhere.

best,
Willy

[GSDgirl]

Hey Mike, I didn't answer because I really have no idea.  My gastro did not do a biopsy and I have figured out that he used outdated protocalls all the way around.  So even tho I cleared, I have no idea if or how much damage I have.

Sorry I couldn't be any help.

Denise

[becksta29]

thats what i was saying to you about the biopsy before..that they might have got a good part of the liver and your liver had the damage there at the biopsy but they just might not have hit the right spot.So you might not have progressed alot in 12months it might have always been damaged,maybe got a lil worse in the year,maybe not.
well said willy.

[nygirl7]

I agree. Either way you COULD be at that level and probably should have another biopsy to verify which it is because it's a MAJOR difference for certain.

[WriteItDown]

Mike, all I can tell you is what our doctor told us.

It took my husband 25+ years to go from Stage 0 to Stage 1-2.  We were trying to decide whether he should treat or wait, so we asked, would it be possible for him to progress to Stage 3 or 4 in the two years we would spend waiting for the Telaprevir.  Doc said, unlikely, but not impossible.

By the way, many clinical trials require that you have had a recent biopsy -- I know the one I referred you to does.  Not sure if they pay for it -- they might, though.

[22hamilton]

I can fully understand your bafflement and worry, not entirely sure how you got your stagings-fibro or bx ? Sounds quite similar to something that happened to me recently and the culprit was fresh high levels of inflamation (inflammation) coupled with an increase in steatosis. Heres what happened-biopsy in 06 gave a stage of 3 (ishak,am in uk).Fibroscan april 08 gave fibroscan of 12.4-early cirrhosis. Fibroscan march 09 was 33.5, repeated in apr was 33.2 panic panic panic (on my part !). Biopsy  in aug 09 showed only early cirrhosis (patchy). The strange fibro score came from a fatty, inflamed liver as opposed to severe well established cirrhosis.I was relieved. The fibro can apparently give high scores for reasons other than cirrhosis.
Dont know whether that is helpful to you or not but it lowered my panis a little.
Good luck
Hammond

[Marcia2202]

I still stand by what I said the other day.

You had a biopsy and a fibro test both showing F1

Then you had a FibroScan (done by an inexperienced person) and it showed F3/4

I think that it is highly unlikely that you progressed from F1 to F3/4 within that short a period.

I also think that if you would get into a study, they would most probably do another biopsy.

It doesn't make sense, especially knowing that you maintain a healthy life style.

If you were regularly taking liver damaging medication or boozing your butt off , I would say it was possible. But you aren't!

Go raise heII at the hospital and make them do another scan.

May I ask what the result of your scan was? In FibroScan lingo?

All the best my friend,

marcia

[mike716]

Thanks for posting in on this, Willy.

In a nutshell, here´s the history:
- Feb. 2008: Diagnosed HCV+, VL above 1 million, GT 1b.
- May 2008: Bx showed A2,F1.
- June 2008: CT for FibroTC, results of FibroTC F0/F1.
- Sept. 2009: Fibroscan - F3/F4.

6 staged bloods have been pretty stable: AST & ALT started at around 45, slowly worked their way up to around 75 in latest test. Platelets stable around 120,000. High GGT around 250.

So, like you say, either the biopsy was wrong or the Fibroscan is wrong. But: maybe both were wrong, and I´m somewhere in between.

If there was a way of doing a diferent test like Fibrosure, I´d go for it. But there isn´t. Not here.

Repeating the FibroTC is tempting, but now I fear the radiation, which I´m scared might have caused the jump in fibrosis.

My hospital won´t do biopsies more frequently than every three years. And I think they won´t do any more once you´ve got cirrhosis.

Where does all this leave me? Your guess is as good as mine.

I´m gonna put a lot of pressure on my hep MD next week to re-do the Fibroscan. But at the same time, it´s clear to me now that I´ve got to find out what Tx options are open to me, right away. And then make the decision to treat.

Mike

[mike716]

Hi, again, Denise! Sheesh, you sure got a raw deal. But I guess if you´ve cleared, it´s not so important. And none of these supposed fibrosis tests seems to be reliable, so why bother?

Mike

[mike716]

My hospital won´t do another biopsy so soon.

M.

[mike716]

Wow, that´s an interesting story. So it was the fat and inflamation (inflammation), and not cirrhosis, that pushed up the Fibroscan score? Hmmm. Sure gives food for thought... It IS sort of similar to what´s happened to me, and gives me added impetus to pressure them into doing another scan.

Thanks a lot for posting that.

M.

[mike716]

13.3 Kpa.

What´s really weird is that the operator told me the results were F2/F3 after the scan, and then they changed it to F3/F4 afterwards. When I queried about it, they told me they kicked it up due to my previous tests. But they were all lower, so how the heck would they influence them to kick it up, rather than down?

None of this makes a whole lotta sense to me. It´s a mad world, my friend.

M.

[Marcia2202]

It seems like they don't know what the heck they are doing.

Why would they kick up the results? Doesn't make sense at all to me.

[Marcia2202]

I'm trying to find data to translate FibroScan to Metavir. I haven't been able to find a table of comparison, but I remember clearly that my doctor said that cirrhosis was 15 KPa and above.

according to that you would be stage 3. But since we know that the readings in the mid stages are not accurate, it could very well be F2.

It would make more sense if you had progressed to stage 2.  

Just my 2 cents. Logically it would work like that in my head Mike.

[mike716]

I went and got the whole test result, with scan pix and Kpa charts and all. Yes, cirrhosis is 15 and above. But many of the individual scans (they have to do at least ten, and in my case they did 17) were above 15, so I guess I have cirrhosis in about half the sample tested (a 2x4cm piece of the liver, as I understand it).

Who knows if they did the scan right or not? I'm pressuring to re-do it. Just wrote a very stern mail to my GP at the hospital. She's a big wig at the health Plan, so maybe she can do something. If not, on Monday I'm gonna go see the Hep Dept. secretary and press to get an interview with the department head. If none of this works, my lawyer says we will send them a legal letter to scare them about a possible malpractice suit. The idea of that cheered me way up. I'd just love to get it on with these %&*$@* at the hospital.

Thanks for your support on this Marcie. I am in your debt. You're a peach!

P.S. Check out my next post: Mike's Confidence Ratings for Fibrosis Tests.

MMMUH (that was a big kiss I just blew to you across the Earth).

M.

[Bali05]

What is a FibroTC ? Never heard of it.
When I was dx in June I did a FibroSure right away. I know they do not offer that
where you are. My FibroSure came back F2. I than spend many weeks trying
to get a FibroScan done in the US. Next to impossible ! So i flew to Germany
literally got out of the plane straight to hospital , did FibroScan and flew back
next day , all just to confirm my FibroSure. The FibroScan came in at 8kpa.
I would have done the same had I done a biopsy.
My bloodwork also speaks for both test results.
In my opinion no important decision  should ever be based on just one test result !
There is always a chance however small that the test was wrong so better be save
than sorry and confirm it with a second opinion if you will. We tend to accept good results like F0-F1 readily and not so good results F3-4 not so readily.
Anyway , when I had a meeting with a very well know Chief Hepatologist he told me
that he has seen it happening in his career that someone advanced to cirrhosis
that fast.
If I were you I would want to find out with certainty what stage my liver is at
asap regardless of treatment.
So push for another FibroScan and in addition I would travel to the closest place
that will allow you to do FibroSure test.
Your health is worth that much if not more.
I recommend to anybody who gets a biopsy to recheck it via FibroScan & FibroSure
since it is very presumptous to call it a "Golden Standard" for a disease that does not
have any standard.

[mike716]

Thank you, Bali, I think your words are very wise.

If I only knew where to get a Fibrosure, or even another Fibroscan (a different machine), I would go there. But where? Do they do Fibrosure in the U.S., do you know? I don,t think it is done anywhere in South America.

Can you tell me how to find out where these two tests are done? Is there a central web page for them. or a company URL I can write to?

FibroTC is a program that does data analysis fron computed tomography images. It has been developed by people ate the university of Sevilla. I had the tomography done here in Argentina, and sent the results to Sevilla to be analyzed. That was one year ago. It gave F0/F1.

Mike

[Willy50]

Here is a PDF from labcorp, the company who makes the fibrosure test;

www.labcorp.com/pdf/08_HCV_Fibrosure_TR_1080.pdf - Similar

You can google Labcorp and find out where you can get the nearest test.  My guess is that it is nearer than you may guess.

I saw a GP, told him I wanted the test.  He had never heard of it.  I asked where he had his lab tests done?  He provided the name and phone.  I phoned them and asked if they could provide the test.  It turns out they hadn't heard of it but they connected me to one of the "big dogs" at the lab (it is a small one; I live in a town of 60,000 people).  He said sure, they could do it, it just wasn't ordered much.

I did the blood draws, they sent them out and I had the results in several days.

IF YOU DO THIS..... make sure you observe the fasting recommended pre blood draws for the most accuracy and so it compares every time you get a test.
Poor prep = UN-useful results.

I also agree that you are comparing apples to oranges.  I'm not so sure you progressed so fast.  Do more legwork and find out.  

A trial WOULD be a great way to get a biopsy and get the TX at a good price.  IF indeed your staging is where you think it is it is probably time to treat.  

If a biopsy proves otherwise you always have the right to withdraw.  IF it proves you are a stage 3 you will be in a position to do a shorter trial with the likelihood of better chances at SVR.  Sounds like a win-win.

best
Willy

[mike716]

Thanks, Willy. Good ideas. I'll check out the Fibrosure possibility today.

I haven't done this kind of work since a year ago because I had a bad experience trying to get the Fibrotest (another biomarker) done. I contacted Biopas, the company in France that does it, and they put me in touch with a company in Argentina that's their rep. This rep was totally unhelpful, and got me snagged with the "doctor's order" problem. It may sound absurd, but I couldn't get any of the MDs I know to order the test. They never heard of it and were reluctant to get involved. I asked the Fibrotest rep in Argentina to recommend an MD to write the order, but they stopped communicating with me.

Without actually living in a country like Argentina you can't really know what it's like. People are scared of anything they don't understand, and they don't like dealing with foreigners on medical matters as they can't judge the consequences.

But I'll try to get a Fibrosure done. Maybe I'll have better luck this time. At the moment, I'm trying to get a second hep MD at my hospital to discuss the situation with me (my regular hep MD is reacting badly to the Fibroscan F3/F4 results).Then I thought I'd pressure the hospital to repeat the Fibroscan, just in case the machine wasn't working right the first time. At the same time, I'm trying to locate another machine, even if it's back in the U.S. (not easy, I hear, as it hasn't been approved there).

Is it okay to do another biopsy only a year and a half after the first one? My hospital doesn't want to. OTOH, like you say, if I went back to the States maybe I could get it done as the first step in a trial. It's an idea.

Anyway, it looks like I've still got alternatives. I'm starting to come out of shock from the Fibroscan results and will be putting all this very helpful info together and making some decisions as soon as I feel more objective. For the past week I've just been scared and not thinking very well.

Mike

[Willy50]

FYI:  The trial that write it down suggested is going to offered in argentina.  The link is in your other thread;
Argentina
Not yet recruiting
Buenos Aires, Argentina
Not yet recruiting
Derqui, Argentina
Not yet recruiting
Capital Federal, Argentina
Not yet recruiting
Paraguay, Argentina
----------------------------------------------------------

I believe that the efficacy is similar to Telaprevir and they provide a free biopsy.

IF you want in..... you'd best get in place.  By the time the trials *appear* to be open the slots have been filled.  I still think that a fibrosure could help solidify your certainty about your staging.... but.... you may never know till ya get a biopsy.
Generally though, as people get closer to cirrhosis their labs also convey that.

You can also keep an eye open for other fibroscan trials.  they might provide a biospy and a scan.  Who know? There could be another FDA trial coming or from a competitor (fibrospect, etc)

best,
Willy

[mike716]

Do you know if there is anyone else in the States who does the Fibrosure test besides Labcorp, or how to go about finding out? (I think Labcorp is just one of the labs authorized to do it. There ought to be others. And if I could get in touch with the people who control it, maybe they could tell me if there's a lab in Argentina doing it.)

M.

[Willy50]

I'm off to work but....

No, I think you are thinking about it wrong.  Any lab can do it if the have an account w/ labcorp.

They look up on line what the specs are; say.

5 small vials of blood (CC's are spelled out) and the means of shipping them are spelled out; frozen, kept cool?  I have no idea.  They fed x them out and Lab corp (and/or affiliate in SA) probably just faxes, e-mails the results.

That's how it is in los estados unidos.  I've no idea about S.A. or B.A.

It just may be easier than you think.  You may be able to e-mail labcorp in the USA and seek info on your situation; nearest site.  Getting the order is up to you, but it could be that the people who did the "Fibro TC" could assist you given your situation.

best,
Willy

[Bali05]

When I told my GP I wanted a FibroSure done he had no clue what I was talking
about even misspelled it on his Rx pad.
Didn`t you say you have an apartment in NYC ?
I would get on a plane come to the los estados unidos draw blood , fly back
results take about a week and get them on  the phone.
If there is one thing I learned since I was dx in June that is you have to be
proactive and do not waist time. The goal is to put this thing behind you
as good and fast as possible and continue to live a happy life.
For FibroScan you can try Dr. Afdahl in Boston they doing atrial compairing
it to biopsy (biopsy required). Other than that I did not find a FibroScan in
the US but in Germany for 150 EURO.They did excellent job.

[franke566]

Hello Mike.  It's been a while.  I am F3-4 on the fibrosure-according to a few months back.  My new Hepatologist re-confirmed I am in End Stage and said another Biopsy was out of the question because it could further harm what little good liver I have left.
Did you ever explore the Ultra Fast Cat Scan?  I had a gall stone and so my gall bladder was removed and the surgeon took a peek at my liver-said it was shot.
Heart probs keep me from or off the transplant list and I survive by taking lactulose and Hepatic Aid...for now.  Good luck!

[mike716]

Hiya, Frank! Long time no see (haw-haw).

Really? Calls F3/F4 'end-stage disease"? I think that's going a little too far. After all, declared cirrhosis is F4, one stage after F3/F4, and plenty of people live a long time with compensated cirrhosis. This "end-stage disease" stuff puts my back up. So far as I know, "end-stage" means liver doesn't work at all any more. Any F3 parts of your liver are still providing liver function, and that's NOT end-stage.

Also: No more biopsies at F3/F4? I'm not so sure about that. Have to ask my hep MD, but I think they still do it. Maybe not such a great idea, though, huh? Liver's suffered enough without putting needles into it, I suppose.

Well, according to the Fibroscan I'm now in the F3/F4 club, so we'll see who outlasts who .

Mike

[GoofyDad]

My hepatology dude (at a major transplant center) says bx can be off as far as two stages. That's the extreme of course - I'd guess it's useally much more accurate. If we accept that the fibroscan could be off too, and leave some room for progression - this could all make sense - unfortunately.

Is there an explanation for the platelets? That strikes me as low - and concerning. What is normal range?

Same hepatology dude thought we might do a bx a few years after SVR if insurance would pay. Insurance was his concern - not liver damage - and I'm F4.

Sorry this is a bit negative- - but I know you would want me to be straight.

Take care tango man. And indeed, when I said "get lucky" I meant the ol' game of hide the salami :)

[mike716]

Actually, that's the current hypothesis of my hepMD: that the biopsy underestimated the fibrosis, and now the Fibroscan is overestimating it. It may be true for all I know, but It's just a little too convenient for my liking. Sorta lets everybody out. Nothing's exactly what it seems, all can be fudged to fit the circumstances.

I tend more to the other extreme: that all the tests were right and that I've progressed from F1 to F3/F4. But then I have faith in the FibroTC, for some reason. And it gave me F0/F1, with some focuses of F2, F3, and F4 (see my images).

I think I've talked my hospital into repeating the Fibroscan, and I'm gonna ask them to point it at a different part of my liver if they can. On my FibroTC images (particularly 2-8 through 2-11), it looks like the worst part of my liver is just where the Fibroscan was done: the part nearest the ribs. That could very well explain the change from F1 to F3/F4. The F1 biopsy might have hit a good spot through luck, and the FibroTC is an average of the whole liver, which even though there were sectors with F2, F3, and F4, averaged out to F1 (lots of F0 sectors, too).

Anyway, I'm gonna keep on this, both because I don't want to Tx until there are authorized PIs, and because I think it's time we patients took all this ambiguous and contradictory testing and diagnosis process a little into our own hands. The pill-pushers (i.e. "doctors") have made a real mess of it. It's time it got straightened out, don't you think? And of course the MDs and their goldmine medical corporations have no incentive to straighten it out. They're getting rich on all the tests.

Mike

[mike716]

The normal range for platelets is given by my lab as 150,000 to 400,000. 120,000 is not good, but according to my hepMD there are a lot of hep patients with a lot worse. Of course, it's a negative sign for Tx. No question there.

Your hep dude sounds like a real ringer. Maybe they're all like that in the States. It's why I rather like it fown here, where nobody is talking costs (except for the Fibroscan). And even if I had to pay for a biopsy myself, I can get it done for maybe $300. (I paid a mere $250 for the two complete liver CTs last year!)

Re the tango scene: I'm off to a new class tonight. Lots of young ladies I'm told, lythe and good dancers. As long as I can still dance, why not?

M.

[franke566]

One can be F4 and not be classifeed as in End Stage Liver Disease Mike.  In my case I have cirrhosis, portal-hypertension between the Liver and Spleen, Esophageal (spelling) varices and bouts of mental encephalapathy but the Fibrosure shows F3-F4 for fibrosis and cirrhosis (bridging).  In my case the risk of biopsy was too great at F4-to each their own. Frank

[mike716]

Is there a standard limit beyond which they won't do any more biopsies?

[Rockerforlife]

My nurse told me they will only do BX every 5 years in Canada

[mike716]

I meant fibrosis stage limit.

Re time limit, 5 years is a looong time to wait. My hospital generally won't do them more frequently than every 3 years, which I think is a general principle most places. What excuse do they give in Canada for the 5 year time limit?

[Rockerforlife]

OPPS...your right i am sorry...i meant to say 3 years between BX,i remember now because i was sceduled to do a BX for my Boceprevir trial and i didnt need one because i had one less that 3 years ago before with my first SOC trial,ot sure on the  fibrosis stage limit. but i think if you hit the later stages they wont do one
Arnet you a geno 2?..

[Rockerforlife]

Have you considered this trial?....its open and taking on clients


In a 4-week Phase I combination study conducted in 81 treatment-naive patients with chronic HCV, R7128 demonstrated significant short-term antiviral activity with safety and tolerability comparable to placebo with standard of care. Up to 88 percent of patients achieved undetectable levels of HCV (<15 IU/ml) after only 4 weeks of treatment with R7128 1000mg bid and the standard of care, compared to 18.75 percent treated with the standard of care alone.   -- In the harder to treat populations of genotype 2 or 3 patients who had not responded to previous therapy, results with R7127 1500mg twice-daily in combination with the standard of care showed that 90 percent of patients achieved undetectable levels of HCV(<15 IU/ml) after 4 weeks, compared to 60 percent in the standard of care arm.    



http://www.news-medical.net/news/2009/04/26/48859.aspx

[Rockerforlife]

The above link is results of phase 1...this is the ongoing phase 2

http://www.clinicaltrials.gov/ct2/show/NCT00869661?term=RO5024048&rank=2

[merryBe]

sorry to hear of your trouble Mike...I've had similar developments. In my opinion the MELD and a good ultra sound will tell the tale better than risking another biopsy.

there is more then one stage of each stage so to speak, so I like the assessments that include more specific formulea and take into account your blood work in accessing stage/grade. A needle biopsy is not always accurate. Which type biopsy did they do...was it one core or 3? Needle biopies can be off by as much as one stage, and so can fibroscans.

Also I know someone who has been doing the fibroscans, got one of the 1st machines made...and his assesment after a couple of years of doing them is that the few technicians out there are
A, vastly undertrained,
and B. they do not usually scan the whole liver either, which takes time, and patience as the machines are very finicky.

Also C., the liver on these new scans is proving to be at several stages simultaneouly, meaning areas of stage 2 and stage 4 often coexist, and sometime one lobe bears the brunt more than the other. He is a leader in the field so I believe him on all counts.

Ergo I wouldn't get too alarmed until more tests are done. If you have an good ultra sound (40 minutes mine took, not the 10 minutes some techs do) you can see the changes pretty clearly with the newer equipment. The outline itself of stage is readily evident, being somewhat bumpy and lumpy, sort of like a cauliflower would look in profile.
I would suggest you try to obtain an ultra sound, and have a MEld score done.
How's your bilurubin...that is another thing to keep an eye on.

mb

[mike716]

Thanks for the trial URL. I seem to remember people here saying that Phase II trials were risky, and to wait for a Phase III.

I am geno 1b.

M.

[Rockerforlife]

Maybe phase 2 old trials using the SOC drugs,but these PI are the cats A.SS

[mike716]

Hi, Merry! It's been a while. Nice to hear from you.

What is MELD? Sorry to say I've never heard of it.

My biopsy was one core, and not a very big one (1.4 cm, if I recall rightly).

Gee, I wish I could get a really thorough ultrasound like what you describe. Unfortunately, I have to take what I can get (at the hospital), and so far it's been of the 3-minute variety. I'm going in for an ecodoppler (looks at portal vein diameter and flow as well as liver size) on the 18th, and I'll ask the MD who does it if he can go slow and get me a good read-out on the liver surface like you suggest. But getting anything out of these hospital people is like pushing a boulder uphill. They are terribly over-worked.

The Fibroscan info is interesting. It's more or less what my hep MD has told me, to try and make sense out of all this conflicting data. I can easily imagine the Fibroscan scanning a part of the liver that's at a different stage from other parts, just like the biopsy. But it would be weird if it averaged 13.3 kPa (F3/F4) in the part it scanned, and there was F1 in the rest. Too big a discrepancy, seems to me. Something's not right.

Of course, as you say, the biopsy could have underestimated. So maybe I was really F2 18 months ago, and now I'm F3 (or something like that). Who knows? It's all like shooting clay pigeons. Too much chance involved.

I just found a test called ASt-to-platelet ratio (APRI) in the scientific litterature. Seems to be almost as good as biopsy and Fibroscan for discriminating between early-stage and late-stage fibrosis (although maybe not so good at the in-between stages). It's easy to do, I just pick the data out of my blood analyses and plug them in. And it does give results similar to all the other tests (that is, went from F1 to F3/F4 in 18 months).

What is most disturbing about this super-fast fibrosis progression is that I don't know the cause, and so can't do anything about it. There must be some objective reason why I am progressing so much faster than others. If I could only find it I couls stop doing it, maybe. I mean, I'm actually very healthy for my age (65). So why is this happening to me?

It's a real mind-boggler.

Mike

[mike716]

I'm reserving judgment until the post-Tx VL reports come out. Like, how many of those who SVRed are gonna relapse?

[Rockerforlife]

If you SVR24 ,odds are less than 1% you relapse.

[mike716]

Based on how many patients studied in follow-up, and for how long?

[Rockerforlife]

Sorry..its 1% for SVR after one year ,for 6 months post its 3% ...this is well documented.,,,now as fro SVR rates with PI drugs,the data is not in for one year post TX yet

[Bali05]

just curious what do they call 7kPa ,8kPa,9kPa and 10 kPa in Metavir Fs
at your clinic ?

[mike716]

My Fibroscan results came with a color-coded chart comparing kPa to Metavir, but I don't have it here with me in the ciber cafe. I'll check those figures for you when I get home, and post back tomorrow (if I don't forget; my memory is shot!).

Mike

[Trish77]

"Sorry..its 1% for SVR after one year ,for 6 months post its 3% ...this is well documented.,,,now as fro SVR rates with PI drugs,the data is not in for one year post TX yet"

What are you talking about here???  

[mike716]

Hi again, Bali. Here's what the chart that came with my Fibroscan results gives for kPa conversion to Metavir:
F1  14.5kPa

Hope this helps.

Mike

[mike716]

For some unknown reason, the rest of the figures were cut when I posted this, so I'll try again.

F1 - less than 7kPa
F2 - 7 to 9.5kPa
F3 - 9.5 to 12.5kPa
F3/F4 - 12.5 to 14.5kPa
F4 - above 14.5kPa

Cheers!

[Bali05]

A man and his word. Thanks for checking this for me I really appreciate it.
As you know we have all these differents tests that have their problems
and on top of that there is room for interpretation.

Here are my 10 readings:
kpa
7.8
8.2
8.7
7.8
9.3
8.9
8.2
7.0
7.8
7.1
average 8.0

According to your chart I should be a straight F2 just like my FibroSure blood test.
Not one reading was in F3 territory yet they told me I was F2-F3.
In the end we know that all these test are just trying to get us a little closer
but are not 100%. But if you combine FibroScan with FibroSure you can get
90% accurate which is about what the biopsy claims to be unless they
make a sampling error. I asked rexx73 in switzerland to do the same
but I guess that will have to wait.

Thanks again for confirming these numbers.

By  way I am a geno 4 currently thinking of doing Alinia (Nitazoxanide)+ SOC.
Should you decide to treat with no other option I would definately through
Alinia in the mix. There will be new results of  trials currently ongoing for geno1
beginning of 2010.

[mike716]

Glad the Fibroscan-to-Metavir conversions were useful to you.

What is Alinia?

[Bali05]

Not only that I also calculated by APRI (spelling) for the last 1.5 years
and it goes like this : 0.36 , 0.30 , 0.33 , 0.44 (platelets went to 204 from 234)
Thanks for all that info can`t have enough ways to double and triple check
all these results.

Alinia is made by Romark Pharm. The active ingredient is Nitazoxanide.

Romark has trial labs in Egypt which happens to be predominately geno 4.

(Lucky me)

They found out by accident while treating HIV patients with Alinia for diarreah (diarrhea)

that it had antiviral properties. They than ran trials with it against HCV.

It improved SVR rate in geno 4 from standard 48wk SOC 50-60% to 79%  with

triple therapy of 36wk SOC and no additional major side effects from Alinia.

They also did a tiny monotrial with Alinia for 6 months and out of 23 people 4 SVRd

that`s 17.4% without SOC (lucky bastards !) So it definately shows antiviral

capabilities. Also in laboratory tests it did not create resistance in the virus and

is expected to do the same in clinical use.Now this is all geno 4.

It has also shown improved response rate for geno 1s who previously failed.

There is a phase 2 trial going on for geno 1 copying the Egypt trials in the US

and there will be some results beginning next year. Many hepatologists have discredited

it because the trials originally where held in Egypt ( far away ,geno 4, and moslem

country god forbid !!???)

Anyway  the people currently working on geno 1 trial with Nitazoxanide are highly

respected hepatologists in the country and on top of that if Roche decides to partner

with Romark and gets an FDA approved trial based on the trials in Egypt than those

would have to be credible information don`t you think ?

Just google Nitazoxanide genotype 4 you will find all the info.

It also appeared in the March 2009 issue of Gastroentereology.

[mike716]

Thanks for the info on Alinia. I've been reading Medhelp posts about Alinia all morning, mostly from previous years. It seems that numerous Medhelpers have Tx-ed with Alinia, including Gauf, who achieved SVR with an Alinia/SOC/CAM regime, after four previous unsuccessfull treatments. So Alinia sound like a pretty good thing, plus it can be scripted for right now.

I've emailed the contact person at Romark to see what's up. However, there seem to be other manufacturers of the stuff. Kinda confusing (so what else is new?).

I had a Fibroscan repeat yesterday: same results as a week ago. So now it's pretty certain that I'm F3/F4, which means the either the biopsy a year ago lied, or I am the fastest progressor in the history of the disease. No one will ever know which [grin/groan].

You seem to be in pretty good shape, with platelets above 200k and APRI below 0.5. I even you [uh-oh, gotta watch that].

I will be posting an APRI thread with full details and links later today.

Cheers!

Mike

[Bali05]

" I even you [uh-oh, gotta watch that]. "

Do not understand what you are trying to say ?



Here is what I know :

Alinia brand (nitazoxanide) is made in Belgium for Romark and is FDA approved.
you will need a precscription in the US & Canda,parts of Europe.
It is very very expensive.

Nizonide (generic Alinia) made by Lupin Pharm. in India being sold by Canadian online
pharmacies much much cheaper. Only difference to brand 2% of inactive ingredients
like fillers ect.. according to pharmacist.

Without prescription you can get Nizonide from freedompharmacy.com directly
from India approx $100 for 2 months supply (reg. brand Alinia is $1,100/per month!!)
Other generic name is Nitarid (India) or Daxon (Mexico)

I currently have both sitting on my desk still deciding on tx.

Was thinking of trying mono Alinia first but the more I read about this virus

I come to the conclusion that being tx naive I want to hit it full force to get maximum

SVR chances.

[mike716]

Sorry, my writing sometimes comes out wrong. What I meant to say was "I envy you" because of your low APRI and good platelets. The "uh-oh" is because I have to stop envying people who are not as sick as I am.

Many thanks for Alinia purchase data.

I am Tx naive, too, so I know what you are going through. So many different treatment plans, so many different trials, so many decisions and too little real information to base them on. It's a can of worms.

I agree that it's probably best to hit it with all you can right off. Repeating Tx, the odds go down, I think.

The two plans that look the best to me right now are [Medhelp member] Gauf's plan (heavy 48-week SOC + Alinia + CAMs), which worked for him on his 4th Tx, and the Schering-Plough Boceprevir+SOC+eltrombopag trial (coming up). That is, if one is not going to wait for PI approval. Maybe you can wait, if you are young enough and aren't afraid of rapid disease progression. However, that is dangerous, as I found out to my everlasting chagrin (F2 to F3/4 in 18 months, after stable years).

Many important hep MDs like Dr. Dietterich tell everyone to treat immediately, regardless of stage or age. Some data support him. Others don't. Like I said, it's a can of worms.

But I think if I had your APRI and platelets, and if all else was okay and there were no symptoms, and you are fairly young (under 50), maybe I would wait for new drug approval. That was my thinking until I shot up to F3/F4. I just was unlucky and got caught by a sudden rapid progression.

Anyway, thanks again for the Alinia data. That might be a choice for me.

Mike

[Bali05]

Well there is always something. I do have symptoms. They are so weird that so
far no one could figure out what it is. Yet I am being told I amstill in good shape.
That is not howI feel at all.
It is a mixed blessing because without symptoms I would not have found out
I have the disease because nobody tests for it. I had a motorcycle accident 2 years
ago with major orthopedic surgery . Do you think they test hep C ? Of course not.
So for me it started with GI problem beginng of 2009 . IBS like than abdominal pain
burning and stabbing. Saw 6 doctors until one located in Chinatown (chinese have
lots of hepatitis) did the test as a routine.That was in June. I still have daily burning
in the middle , left and right of ribs comes and goes. My whole abdomen sometimes
feels like your pushing tiny needles in it. While exploring tx options I did alternative
protocoll . Right nowI am trying Dr. Zhang chinese herbs and I also have an appointment
with Burt Berkson in New Mexico. I simply do not leave any stone unturned.

You wrote before you are the kind of guy that likes a plan B option built in.

Me to.

Plan A:   Alinia + SOC
Plan B: Retreat with PIs later if plan A fails

Not sure if waiting for PIs and possible retreat with Alinia would be better.

I do not like trials because they usually have a placebo arm and I would not want
that additional chance being naive right now.

[mike716]

I hear you about not liking trials. It's not just the placebo arm threat. There's also the blinding (not telling you what's going on until it's over), and the matter of escape drugs for side effects. The whole trial thing puts me off. But righht now it's the only way to get the PIs.

I am likewise stuck on which to try first, SOC+Alinia or PI trial. It's a really hard call. I'm going to keep collecting information and talking to MDs about it, for the moment. If you come up with anything that tips the scales, please let me know, and I will do likewise.

Mike

[Rockerforlife]

In the BOC trial they tell you all the way tru your numbers.

[merryBe]

hi again Mike, sorry for delayed answers, been busy lately..

the MELD  was developed to help ascertain the severeities within end stage LD and to prioritize and push the sickest patients to the top of transplant wait lists, but it's still a helpful item before you reach end stage, if for no other reason than that it lets you know whether you are getting towards the end or not.
Meld is a ratio of INR, creatinine and bilurubin, you can do the calc. yourself by typing in MELD calculator. Score ranges from 6-40.....if you are 6 or under you still have an OK time line as a rule. The doc who developed the formula proved it's pretty right on, meaning that his predictors were accurate...as the scores go up the time line to morbidity are calculated and are accurate. Ergo someone with say a Meld of 30 will get a transplant before someone with a score of 29, even if the 29 patient has been waiting longer.

One thing about the fibroscan, extra abdominal weight also throws them off...it's harder to get an accurate read on those who have it, and unfortunately many HCV people do have wide waistlines do to endocrine dysfunction as well as adipose redistribution the virus is known for.

Also, the test you mentioned APRI I am not familiar with, but I'm wondering how accurate would it be for patients while treating...not very since the platelets are normally throw way off by treatment. So only give this test creedence if you are not on treatment drugs.

mb  

[IAmTheWalrus]

Just a point of reference on MELD: Most hospitals don't try to put patients on the transplant list until MELD is >10 or >15.  Most transplants occur at MELD between 20 and 30 due to donor shortages. My own experience on the waiting list is that most patients with MELD >20 are very sick. They start getting all kinds of symptoms like jaundice, ascites, variceal bleeds, encephalopathy, etc.

Good luck (tango-wise and salami-wise)

[Marcia2202]

I just wanted to add that Dr. D.'s video is now a few years old. Before the PI's showed such good results. I don't know, but I would assume that he would tell people to wait for the PI's, if their liver damage is not too progressed and unless they are geno 3.  It looks like they have not found a PI that works on geno 3 yet.

Personally, I would go for a PI trial, if I was a geno 1. For all I know, you would still have to treat for 48 weeks with the alinia. And I don't think it is as potent as the PI's. With the PI's you have the chance to only treat for half the time. The less time on the drugs, the better....

[mike716]

Do you know the MELD calculation formula? Or should I just use one of the website calculators?

M.

[mike716]

Yes, there are people for whom Fibroscan is not accurate: cholestatics (fat & obese), too-small inter-rib space, etc. However, I am thin, don't drink more than a glas of wine with supper, and have lots of intercostal space. So there's nothing obvious to rule out the accuracy of the Fibroscan result. Which doesn't necessarily mean it's the last word, either. It only sees 1/500th of the liver.

You're right about the APRI test: it's probably no good for people on Tx. It's a tool for following fibrosis progression, not for following viremia (which is what Tx attacks).

Lastly, I just checked my blood tests, and there's only one where they did my NR. So I won't be able to do a time MELD study. But I'll do it for the one I do have. Thanks for the idea.

Mike

[mike716]

Is that the case for all the Boceprevir trials, that is, a sort of company policy?

M.

[mike716]

Thanks, Brent!

[WriteItDown]

I think you might want to start cutting out that glass of wine at dinner.... it can't be helping your liver.

[mike716]

Hiya, Marcy. How's the weather in Indonesia, Denmark, the West Indies, or wherever the heck you are right now? Here in tangoland it's raining and cold. So much for the summer in the Southern Hemisphere!

Is that conclusive now about the Pis, that geno 1b only treats for 24 weeks? I saw that a recent trial had a big 24-week arm and that results were good in it, but I wonder if the 48-week results aren't still better? I haven't been following all the trials, so I don't really know. What do you think?

Anyone else know what the latest is on treatment time with the PIs (Boceprevir, Telaprevir, or any of the others)?

Mike

[Rockerforlife]

My trial gave my all my PCR results but some trial dont.I the boceprevir phase 2 trials there was a10% SVR difference between the 24 wk and the 48

[mike716]

I probably should, but I get so depressed in the evening that without the wine I can't even eat. Not sure which is worse: the damage that a glass of wine could cause, or the night-time depressions.

According to my calculations, a four-ounce glass of wine contains 1.2 grams of alcohol (based on the wine being 10% alcohol and having approximately the same density as water). The stuff I've read about alcohol and HCV says that more than 50 grams can hurt you if you have HCV. Let's say that's an underestimation, and that even a quarter of that can hurt you. It's still 50/4 = 12.5 grams, which is the equivalent of around ten glasses of wine (if my calculations are correct). So how bad can one glass be?

Mike

[mike716]

10%, huh? That's still a pretty big difference. In the trials you don't have a choice about it, but if I were dosing myself I'd do the 48 weeks (that is, if I was handling the anemia and sides okay).

[WriteItDown]

Mike, that sounds bad!  You're making me want to give you a hug!  Maybe you need anti-depressants, have you considered them?  I think especially if you're considering treatment, you might need to get those two ducks into your row.  I don't think you're supposed to drink at all on treatment.  It messes with the drugs. And also, since the interferon can cause bad depression, if you're already having that problem, you probably ought to try to straighten it out beforehand.

Hope I'm not depressing you further.... :)

[mike716]

Don't worry, nothing you can say would depress me, sweety.

I'm already taking around 3g of Lorazepan (Valium) a day, just to keep going and to be able to sleep. The wine is a sort of kicker. I can cut it out if I have to, but right now I need it.

It's not so much the hep that's getting me, it's the horrible treatment I'm receiving at my hospital. Everything seemed just fine until two weeks ago, when it was revealed that my hep MD had goofed, telling me my liver was fine and I shouldn't treat until the PIs are approved. Now, after the Fibroscan showed F3/F4, he's backpeddling and covering himself, and he won't let me  talk to anyone else (afraid I'll spill his beans). I don't know where to turn. Maybe I can sort things out at the hospital, but I'm afraid to treat with someone who makes mistakes and won't admit them.

On Friday I'm going to see a hep MD at anotherhospital. But it's three hours away, and I have no health plan there.

All this is making me rather distraught, ergo the Valium and the wine. But I'm still going to the gym and to tango class, so I guess I'm not too freaked. Not yet, anyway.

Don't worry about me. There are so many people worse off. And, what the heck, I've had a pretty good life, and I'm 65. If it's over soon, so be it. I always felt it would be better to go out on a good note than just peter off in pain at the end.

But we shall see. I'm still fighting.

Mike

[Rockerforlife]

I chose the boceprevir trial over the 72 week SOC even tho my insurance would pay for all my meds for the SOC and i knew i had a 80% chance of getting the boceprevir,When i was seeing and hearing about the power of the PI`s over the SOC,it was a no brainer for me,i took a gamble and so far im winning

[Rockerforlife]

I heard that relapsers who do SOC and try again with 72 weeks dont have much better chance of SVR ,this was also a big factor why i chose the PI.

[mike716]

If you don't SVR with SOC, or relapse, are your chances reduced for Boceprevir+SOC?

[Bali05]

About the PIs. We all would like them to be here today.

I keep hearing about them to be available in 2011.

Who can say for sure when we will have access to these drugs ?

It is estimated,when this and that happens and so on ........

Do we effectively know with certainty that these drugs

combined with 24wk SOC promising 80%SVR  are

going to be available in 2011. Or is it possible due to some delay

it will be 2012 or 2013  ?

If we seriously consider waiting a year makes a difference to some.

Is it going to be the beginning of 2011 or end ? We are almost in 2010

so it could just be 1 year additional wait or 2 years if it is towards the end of 2011

or 3 years if we go into 2012.

Does anybody no for sure ?

I asked a chief hepatologist that is familiar with Alinia trials for geno 4:

Q:
    If I turn out to be a nonresponder or relapser on Alinia+SOC would Telepravir be a possibility for retreatment of geno 4 in the future
    when it becomes available?
    
A:   Yes - the sustained virologic response rate is in the 40% range for nonresponders and 60-70% range for relapsers.

Just wonder where he got that data from. This must be geno 1 data applied to
me (geno 4) since there is very limited to no data for geno 4 and PIs.

[Rockerforlife]

YOU ASKED:

If you don't SVR with SOC, or relapse, are your chances reduced for Boceprevir+SOC?

Well im still UN 3months post and i cleared 2 weeks after taKING the BOC,so far so good,ill let you know by Jan 05-2010....

i dont think the virus has a snowballs chance in hell with this killer drug Boceprevir

[IAmTheWalrus]

This from UNOS website:
------------------------------------------------------------------------------------(http://www.unos.org/SharedContentDocuments/MELD_PELD_Calculator_Documentation.pdf)
-----------------------------------------------------------------------------------
The MELD score is calculated using the following formula:

MELD Score = 0.957 x Loge(creatinine mg/dL) + 0.378 x Loge(bilirubin mg/dL) + 1.120 x Loge(INR) + 0.6431

Multiply the score by 10 and round to the nearest whole number. Laboratory values less than 1.0 are set to 1.0 for the purposes of the MELD score calculation.

The maximum serum creatinine considered within the MELD score equation is 4.0 mg/dl (e.g. if you enter 4.3 for serum creatinine the formula will calculate 0.957 x Loge(4.0) for the serum creatinine portion of the MELD formula).

[franke566]

Hi Mike,  I took a while to get back to you until after my visit with my Hepatologist and this is what he told me.  Liver Biopsies in the U.S. have long been the Gold Standard used as the final determination of the over all health of ones Liver BUT it
is far from perfect and considered "Old School" even antiquated by Newer Medicine
and younger specialists.  In my case I had a Gall stone removed and the surgeon with my Hepatologist visually got to get a pretty good look at the condition of my liver from
the top side and it is totally cirrhotic in appearance.  That, combined with the Ecos, past biopsy, fibrosure-fibrospect and esophageal varices, bouts of mental encephalapathy, ascites etc. determined that I am in end stage and a biopsy could be destructive or at best only confirm what he already knows,  So being F3-F4 on the fibrosure doesn't mean a thing to him.  He told me that too often patients put too much emphasis on a Biopsy and or Fibrospecht or Fibrosure-I can't remember if he said both were the same.
I had a ventricular infarction that presented during a nuclear stress test last November
and I had a nuclear stress one year before that showed nothing.  I asked my cardiologist:  So I had a heart attack sometime between the last test and this one?  
The cardio said possibly-or this one could just be a shadow.  So he allowed me to have the gall stone removed. I survived but continuing chest pain prompted an angiogram and it turns out I do have an infarction w ischemia and the cardio said:  Had I known that I wouldn't have cleared you 4 surgery last year.  I agree since the pain they thought was caused by a small gall stone turns out to be my heart. LOL.
  

[mike716]

Thanks, Brent!

[mike716]

I agree. I wouldn't trust those figures too much. Butr the important thing is that, yes, apparently the PIs are an eventuality for everyone who hasn't SVRed, whether from SOC, Alinia, non-resonse, relapse, or whatever. They look like the big second chance.

M.

[mike716]

I'm so sorry to hear about all your problems, Frank. It makes my own seem like nothing. It sounds, at least, like you are in good hands.

M.