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Fibroscan: Is it any good?
Hello again, fellow Medhelpers! Greetings from Buenos Aires, where we avidly await the beginning of spring. The winter down here in the Southern Hemisphere has been too long, and some people here think there won't be any summer at all this year. Global warming, melting ice caps, and all that sorta stuff. Argentines are hysterical. But it sure is unseasonably cold.
I hope I am still remembered by y'all with affection in spite of my past weird and occasionally wicked postings. I certainly haven't forgotten any of you dear people. You have been my port in the storm.
To give a quickie update, I am still without Tx, waiting for my hep MD to make up his mind what to do with me. I think these Argentine medics are kinda scared to do anything, afraid of scandal (can you see the headline: "American Tango Dancer Succumbs to Third-World Hepatitis Treatment"?).
The latest, and the real reason for this post (aside from my penchant for aggravating everyone with my dubious attempts at humor), is that they just got a Fibroscan machine at my hospital, trained a young female medic to run it, and I have been one of its first victims...er, I mean subjects.
The results are crazy and scary. It gave F2/F3. Now, just a year ago a biopsy and a FibroTC (tomography analyzed, see my images page), as well as many blood analyses and ecodopplers and whatnot, gave me as being F0/F1. How the heck can someone with almost normal hepatic enzymes (transaminases), otherwise totally normal blood tests, and scores of F0/F1 a year ago, suddenly be F2/F3? Is this possible? Is it credible? Or is their new Fibroscan machine a piece of junk, despite the cute operator?
Anybody out there with an opinion on this, my latest predicament?
All replies will be appreciated, and the one that is most helpful wins a free trip to Buenos Aires (by kayak and Moped) and three free tango lessons from yours truly (if I'm still above-ground).
Hugs.
Mike
I hope I am still remembered by y'all with affection in spite of my past weird and occasionally wicked postings. I certainly haven't forgotten any of you dear people. You have been my port in the storm.
To give a quickie update, I am still without Tx, waiting for my hep MD to make up his mind what to do with me. I think these Argentine medics are kinda scared to do anything, afraid of scandal (can you see the headline: "American Tango Dancer Succumbs to Third-World Hepatitis Treatment"?).
The latest, and the real reason for this post (aside from my penchant for aggravating everyone with my dubious attempts at humor), is that they just got a Fibroscan machine at my hospital, trained a young female medic to run it, and I have been one of its first victims...er, I mean subjects.
The results are crazy and scary. It gave F2/F3. Now, just a year ago a biopsy and a FibroTC (tomography analyzed, see my images page), as well as many blood analyses and ecodopplers and whatnot, gave me as being F0/F1. How the heck can someone with almost normal hepatic enzymes (transaminases), otherwise totally normal blood tests, and scores of F0/F1 a year ago, suddenly be F2/F3? Is this possible? Is it credible? Or is their new Fibroscan machine a piece of junk, despite the cute operator?
Anybody out there with an opinion on this, my latest predicament?
All replies will be appreciated, and the one that is most helpful wins a free trip to Buenos Aires (by kayak and Moped) and three free tango lessons from yours truly (if I'm still above-ground).
Hugs.
Mike
Hi Mike,
For what it’s worth, I recall Hepatitis Researcher saying that Fibroscan results were very operator-sensitive; that it required a highly-trained individual to make it work correctly. I don’t know if you recall HR; many in here held him in high regard. He as access to one to this day, I believe; even though our FDA still hasn’t officially approved the process.
It seems to produce acceptable results in the E.U. however. Mike, my understanding is that it’s quite possible to advance into and even through late stage fibrosis, and even cirrhosis with normal liver enzymes; in fact, I think that around 25% of patients will have enzymes within reference range.
The question becomes which diagnostic test to trust, I suppose. While many people in here will disagree, the bulk of clinicians still call the needle biopsy the gold standard; until I am persuaded otherwise, I’m going to agree.
If you choose to undergo treatment anyway, none of this is really that important, assuming you treat successfully. Once SVR is achieved, your histology is expected to either maintain it’s current status, or in some instances, improve.
Maybe if you engaged in something less ‘Argentinean’, than Tango, they’d be more disposed to treat you :o)? Perhaps breakdancing outside the doctor’s office with the speakers turned to full volume…. LOL, good luck with your decisions—
I’m packing my bags now for a cold, austral spring…
Bill
For what it’s worth, I recall Hepatitis Researcher saying that Fibroscan results were very operator-sensitive; that it required a highly-trained individual to make it work correctly. I don’t know if you recall HR; many in here held him in high regard. He as access to one to this day, I believe; even though our FDA still hasn’t officially approved the process.
It seems to produce acceptable results in the E.U. however. Mike, my understanding is that it’s quite possible to advance into and even through late stage fibrosis, and even cirrhosis with normal liver enzymes; in fact, I think that around 25% of patients will have enzymes within reference range.
The question becomes which diagnostic test to trust, I suppose. While many people in here will disagree, the bulk of clinicians still call the needle biopsy the gold standard; until I am persuaded otherwise, I’m going to agree.
If you choose to undergo treatment anyway, none of this is really that important, assuming you treat successfully. Once SVR is achieved, your histology is expected to either maintain it’s current status, or in some instances, improve.
Maybe if you engaged in something less ‘Argentinean’, than Tango, they’d be more disposed to treat you :o)? Perhaps breakdancing outside the doctor’s office with the speakers turned to full volume…. LOL, good luck with your decisions—
I’m packing my bags now for a cold, austral spring…
Bill
Fibroscan not that accurate for the middle stages.
it is possible that your biopsy took a sample from a good part of the liver with less damage.
Although possible to advance that fast not that common.
I personally would split the difference and lean toward being a stage 1/2.
Looks like you have a good chance to wait for the new drugs coming out in the next few years.
it is possible that your biopsy took a sample from a good part of the liver with less damage.
Although possible to advance that fast not that common.
I personally would split the difference and lean toward being a stage 1/2.
Looks like you have a good chance to wait for the new drugs coming out in the next few years.
Hi Mike,
I don't know if you're treatment naive, or even if you want to treat, but if so and you have any interest in a clinical trial, there's a new protease inhibitor, TMC435, purported to be as good or better than Telaprevir, with a trial location in Buenos Aires.
http://clinicaltrials.gov/ct2/show/study/NCT00882908?term=tmc435&rank=3&show_locs=Y#locn
My husband is in his 10th week of this same trial. He's hoping to be in the lucky 80% that get the trial drug and only have to treat for 24 weeks. Anyway, just a head's up in case you're interested. Guess I can't get the free tango lessons since i know zip about Fibroscan, but probably Bill is a better dancer anyway. ;)
I don't know if you're treatment naive, or even if you want to treat, but if so and you have any interest in a clinical trial, there's a new protease inhibitor, TMC435, purported to be as good or better than Telaprevir, with a trial location in Buenos Aires.
http://clinicaltrials.gov/ct2/show/study/NCT00882908?term=tmc435&rank=3&show_locs=Y#locn
My husband is in his 10th week of this same trial. He's hoping to be in the lucky 80% that get the trial drug and only have to treat for 24 weeks. Anyway, just a head's up in case you're interested. Guess I can't get the free tango lessons since i know zip about Fibroscan, but probably Bill is a better dancer anyway. ;)
What a pleasure too read you! It's been a while. Mike and I just had a good giggle reading your post. (as always, I had to call him to have a look ;-) )
I'm not contesting for the free tango lessons here, it's getting cold and I don't want to be kayaking all the way from Copenhagen to Buenos Aires.
What I have understood is that the fibroscan is accurate in the low and high stages, but not in the middle stages. (Just as copyman mentioned)
Personally I don't think that you could have gone from 0-1 to 2-3 in such a short time.
I myself scored 5,2 (= 0-1 Metavir) after tx. I'm happy with that and since I am SVR now, I'll leave it at that.
If I was you, I would ask them to do a second scan to verify.
Anyway, good to see you around.
Marcia
I'm not contesting for the free tango lessons here, it's getting cold and I don't want to be kayaking all the way from Copenhagen to Buenos Aires.
What I have understood is that the fibroscan is accurate in the low and high stages, but not in the middle stages. (Just as copyman mentioned)
Personally I don't think that you could have gone from 0-1 to 2-3 in such a short time.
I myself scored 5,2 (= 0-1 Metavir) after tx. I'm happy with that and since I am SVR now, I'll leave it at that.
If I was you, I would ask them to do a second scan to verify.
Anyway, good to see you around.
Marcia
You ask: Anybody out there with an opinion on this, my latest predicament?
First of all ask yourself how the machine is benefitting you...How would you use the info from the FIBROSCAN first of all if it were very accuate.Would you treat if you were a stage 1?...maybe at stage 2 ?...and they say you should treat before stage 3 because its well know at stage it harder to SVR,my thoughts are you have enough info now to go ahaed and fight the good fight..
good to see you posting
r.s
First of all ask yourself how the machine is benefitting you...How would you use the info from the FIBROSCAN first of all if it were very accuate.Would you treat if you were a stage 1?...maybe at stage 2 ?...and they say you should treat before stage 3 because its well know at stage it harder to SVR,my thoughts are you have enough info now to go ahaed and fight the good fight..
good to see you posting
r.s
Excellent reading on Biopsies
http://www.clinicaladvances.com/article_pdfs/gh-article-200812-nudo.pdf
http://www.clinicaladvances.com/article_pdfs/gh-article-200812-nudo.pdf
If you do not trust your FibroScan results I would repeat it.
Since it is non invasive it is easy to do.
Also would do a FibroSure blood test .
Since it is non invasive it is easy to do.
Also would do a FibroSure blood test .
I can't answer your question and am only hoping that there is a 'booby' prize of say, one tango lesson and one kayak 'round the lake and back???
It's lovely to see you poste again, and I can testify that similar strangely cold weather is happening in NZ (although this does happen every 4 years or so); it's still too cold to join the yakety-yak kayak club or kayak down the Puhoi River (mmm okay more of a tidal creek....).
I know many don't 'feel' when their liver starts seriously deteriorating, but I did. I had continual scans and blood tests 6 monthly, and things were slowley but definitely altering with both. I would repeat your tests in the near future as a comparison. A combination of scans and blood tests told me a story, combined with how I felt.
Hope you can wait for the newer drugs, but it is a hard call..
It's lovely to see you poste again, and I can testify that similar strangely cold weather is happening in NZ (although this does happen every 4 years or so); it's still too cold to join the yakety-yak kayak club or kayak down the Puhoi River (mmm okay more of a tidal creek....).
I know many don't 'feel' when their liver starts seriously deteriorating, but I did. I had continual scans and blood tests 6 monthly, and things were slowley but definitely altering with both. I would repeat your tests in the near future as a comparison. A combination of scans and blood tests told me a story, combined with how I felt.
Hope you can wait for the newer drugs, but it is a hard call..
From Clinical Care Options
"...Some advantages of elastography are that it can be performed in a nonfasting state, it can be performed rapidly with a usual examination time of fewer than 5 minutes, a median value can be calculated from 10 successful acquisitions, the prediction of disease recurrence has been validated in patients undergoing liver transplantation, the elastography score appears to correlate nicely with hepatic venous pressure gradient and the development of esophageal varices, and the score appears to increase with advancing model for end-stage liver disease or Childs-Pugh score, both signs of advancing cirrhosis.
However, possible confounders to the performance of successful and accurate elastography include excess visceral fat or adiposity; the development of hepatic steatosis, which can confound the measurements of elastography by increasing the stiffness of the liver; and cholestasis, which can also increase or alter the perceived stiffness of the liver.
This slide compares the predictive value of elastography vs other noninvasive tests. The table shows that the area under the receiver operating characteristic curve (AUROC), which is a measure of the performance characteristic of any given testing modality, appears to be comparable between elastography and some of the other serum markers, including APRI and FibroTest; indeed, these tests all appear to have an AUROC in the 80% range. However, when one combines FibroTest and elastography, the AUROC curve appears to improve to nearly 90%, and this may very well be the future of noninvasive testing. In other words, combining serum tests with elastography may result in superior performance regarding staging fibrosis. However, it should be cautioned that the largest multicenter study to date, presented at the 2009 European Association for the Study of the Liver meeting, found that hepatic elastography appeared to be ineffective at diagnosing significant fibrosis but more effective at excluding the presence of cirrhosis. Therefore, its discriminatory value for advanced fibrosis was less effective than its ability to exclude the presence of cirrhosis.
http://webcasting.clinicaloptions.com/p41385522?session=356153307
"...Some advantages of elastography are that it can be performed in a nonfasting state, it can be performed rapidly with a usual examination time of fewer than 5 minutes, a median value can be calculated from 10 successful acquisitions, the prediction of disease recurrence has been validated in patients undergoing liver transplantation, the elastography score appears to correlate nicely with hepatic venous pressure gradient and the development of esophageal varices, and the score appears to increase with advancing model for end-stage liver disease or Childs-Pugh score, both signs of advancing cirrhosis.
However, possible confounders to the performance of successful and accurate elastography include excess visceral fat or adiposity; the development of hepatic steatosis, which can confound the measurements of elastography by increasing the stiffness of the liver; and cholestasis, which can also increase or alter the perceived stiffness of the liver.
This slide compares the predictive value of elastography vs other noninvasive tests. The table shows that the area under the receiver operating characteristic curve (AUROC), which is a measure of the performance characteristic of any given testing modality, appears to be comparable between elastography and some of the other serum markers, including APRI and FibroTest; indeed, these tests all appear to have an AUROC in the 80% range. However, when one combines FibroTest and elastography, the AUROC curve appears to improve to nearly 90%, and this may very well be the future of noninvasive testing. In other words, combining serum tests with elastography may result in superior performance regarding staging fibrosis. However, it should be cautioned that the largest multicenter study to date, presented at the 2009 European Association for the Study of the Liver meeting, found that hepatic elastography appeared to be ineffective at diagnosing significant fibrosis but more effective at excluding the presence of cirrhosis. Therefore, its discriminatory value for advanced fibrosis was less effective than its ability to exclude the presence of cirrhosis.
http://webcasting.clinicaloptions.com/p41385522?session=356153307
It seems a pretty big jump that needs to be verified one way or the other. Knowing that around here we all consider the biopsy the 'gold standard' - is there any chance since they currently have you in watch and wait mode you can get another one? As said previously knowing for certain now that it is much better to treat while your stage is lower...if it has had that drastic a jump I'd sure want to know about it.
Enjoy the springtime we are just heading into fall but it feels like winter already and we've even just had snow already. Gross. Just plain gross!
Enjoy the springtime we are just heading into fall but it feels like winter already and we've even just had snow already. Gross. Just plain gross!
Hi, Bill! Thanks for your reply. Sure, I remember HR, a great guy.
Well, who knows if my hospital's operator is any good. She can't have much experience, since they just got the machine. But I tend to trust the folks over there, at least on the technical side.
Re having normal enzymes and still progressing, I've read that myself. But in my case it's not just the enzymes that have been low (50-70 range), but biopsy and FibroTC and ultrasound (checking liver size) and ecodopplers (looking at portal vein flow) that have been normal or nearly so. It's hard to believe that they were all wrong and the Fibroscan is right.
Of course, a year has passed. But can I be progressing that fast, from F1 to F3 in one year, after being stably F1 for years? Seems unlikely, don't you think?
Re treatment, my hep MD has all along been telling me that we are going to wait for the new Tx meds like protease inhibitor, as I am a bad subject for regular Tx because of my genotype (1b) and my age (65), and because I live alone. Now, however, because of these Fibroscan results, he's suddenly scared and is talking about Tx without PIs in a few months. I just don't know what to think.
I like your idea of doing break dancing at the hospital outside the doc's office. If I can get hold of some big speakers I may give it a try. And if you're on your way down here, take a pair of shorts. The summer is brutal.
Cheers!
Mike
Well, who knows if my hospital's operator is any good. She can't have much experience, since they just got the machine. But I tend to trust the folks over there, at least on the technical side.
Re having normal enzymes and still progressing, I've read that myself. But in my case it's not just the enzymes that have been low (50-70 range), but biopsy and FibroTC and ultrasound (checking liver size) and ecodopplers (looking at portal vein flow) that have been normal or nearly so. It's hard to believe that they were all wrong and the Fibroscan is right.
Of course, a year has passed. But can I be progressing that fast, from F1 to F3 in one year, after being stably F1 for years? Seems unlikely, don't you think?
Re treatment, my hep MD has all along been telling me that we are going to wait for the new Tx meds like protease inhibitor, as I am a bad subject for regular Tx because of my genotype (1b) and my age (65), and because I live alone. Now, however, because of these Fibroscan results, he's suddenly scared and is talking about Tx without PIs in a few months. I just don't know what to think.
I like your idea of doing break dancing at the hospital outside the doc's office. If I can get hold of some big speakers I may give it a try. And if you're on your way down here, take a pair of shorts. The summer is brutal.
Cheers!
Mike
Hi, Copyman! Thanks for answering. I like your averaging out to F1/F2. Makes sense.
The problem here is that my hep MD, who has all along been saying we will wait for the new drugs, is scared now by the Fibroscan results and says we should start regular Tx in a couple of months. He's done a flip. Somehow, I've got to talk him and the hospital into re-testing me with Fibroscan and/or doing other tests. They refuse to do a new biopsy before 3 years go by (1 1/2 years to wait).
I'm gonna try and get the folks in Sevilla who did the FibroTC for me a year ago to do another one now. But that won't be easy to do, and I'm not happy about all this radiation from the tomography. Matter of fact, if I have suddenly progressed to F3 from F1, I wonder if it isn't the radiation from the three CT scans last year that caused it.
It's a real predicament.
Cheers!
Mike
The problem here is that my hep MD, who has all along been saying we will wait for the new drugs, is scared now by the Fibroscan results and says we should start regular Tx in a couple of months. He's done a flip. Somehow, I've got to talk him and the hospital into re-testing me with Fibroscan and/or doing other tests. They refuse to do a new biopsy before 3 years go by (1 1/2 years to wait).
I'm gonna try and get the folks in Sevilla who did the FibroTC for me a year ago to do another one now. But that won't be easy to do, and I'm not happy about all this radiation from the tomography. Matter of fact, if I have suddenly progressed to F3 from F1, I wonder if it isn't the radiation from the three CT scans last year that caused it.
It's a real predicament.
Cheers!
Mike
Thanks for the info on the trial,WriteItDown. I'll check it out. Do you think this TMC435 is as good as Boceprevir (which I hear is better than Teleprevir)?
Yes, I am treatment naive. Up to now, the plan was to wait and see. First, wait and see if the disease is progressing. Then, wait and see about doing Tx with new and better drugs.
The trouble with doing a trial down here is the rescue drugs. The hospitals either don't have them or make you pay, and maybe don't know how to handle them. The docs are also not up on all the subtleties of antiviral treatment like testing viral load frequently and changing drug quantities during Tx. It's risky doing a trial here, I think. If they've only got access to a VL test that goes down to 50 rather than 10, what's the point of doing VL at 4 or 8 weeks? You can't trust the results of the VL test to tell you if you've cleared the virus. Stuff like that. On the other hand, it could be a better choice than doing regular Tx at my hospital.
80% are getting the trial drug? That's a big percentage. Looks hopeful.
Is the 24 weeks because of your husband's genotype, or are they really testing genotype 1 people, too, for SVR at 24 weeks with the PI? Are these PIs so effective that they can stop Tx after 24 weeks without relapses? I wonder.
Anyway, good luck. I hope he clears. My fingers are crossed for him.
Don't worry about the free trip to B.A. You wouldn't have liked the sea crossing in a kayak anyway.
Cheers!
Mike
Yes, I am treatment naive. Up to now, the plan was to wait and see. First, wait and see if the disease is progressing. Then, wait and see about doing Tx with new and better drugs.
The trouble with doing a trial down here is the rescue drugs. The hospitals either don't have them or make you pay, and maybe don't know how to handle them. The docs are also not up on all the subtleties of antiviral treatment like testing viral load frequently and changing drug quantities during Tx. It's risky doing a trial here, I think. If they've only got access to a VL test that goes down to 50 rather than 10, what's the point of doing VL at 4 or 8 weeks? You can't trust the results of the VL test to tell you if you've cleared the virus. Stuff like that. On the other hand, it could be a better choice than doing regular Tx at my hospital.
80% are getting the trial drug? That's a big percentage. Looks hopeful.
Is the 24 weeks because of your husband's genotype, or are they really testing genotype 1 people, too, for SVR at 24 weeks with the PI? Are these PIs so effective that they can stop Tx after 24 weeks without relapses? I wonder.
Anyway, good luck. I hope he clears. My fingers are crossed for him.
Don't worry about the free trip to B.A. You wouldn't have liked the sea crossing in a kayak anyway.
Cheers!
Mike
Hiya, Marcy! Long time, no see. Where the heck are ya? Polynesia? Africa? The Malayan Archipelago? Wonderful, wonderful Copenhagen?
It's gratifying to know that you and Mike got a giggle from my post. It's hard to know in this digital world if jokes are working. Audience feedback is always appreciated.
I'm going to do what you suggest and pressure the hospital to do another Fibroscan. I think they owe it to me. There's just no way to make sense out of all these contradictory test results.
Oh, and...I think you're wise to drop out of the competition for the kayak trip to B.A. I don't really recommend it.
Hugs!
Mike
It's gratifying to know that you and Mike got a giggle from my post. It's hard to know in this digital world if jokes are working. Audience feedback is always appreciated.
I'm going to do what you suggest and pressure the hospital to do another Fibroscan. I think they owe it to me. There's just no way to make sense out of all these contradictory test results.
Oh, and...I think you're wise to drop out of the competition for the kayak trip to B.A. I don't really recommend it.
Hugs!
Mike
Hi, Rocker. It's been a while. How ya doin?
Sure, if I know it's accurate I would go ahead and treat. I don't think there's any question about that. I just don't know what to believe, the previous tests or this one.
Mike
Sure, if I know it's accurate I would go ahead and treat. I don't think there's any question about that. I just don't know what to believe, the previous tests or this one.
Mike
Trouble is, my hospital doesn't have the Fibrosure test. I'm not even confident I can get them to repeat the Fibroscan.
I doubt you are F3,this is the exact reason why they say the FIBRO is not accuate in the early stagesLokks like to me you are still F1,unless you drink like fish ieven doubt you are close to F2,you have to get more FIBRO done for sure to make the waiting decision.Id go with BOCEPREVIR if it wrer me cause i just did 36 weeks of it...anf they let you do resuse drugs and not skin rashes
Hi, Kris! Well sure, sweety, you can have a tango lesson any time you want. And if you've got the lake and the kayak, I'm your man! Now, I can't promise how soon we'll get back, natch...
I think it's the melting ice caps causing this cold weather. And there are reports that the glaciers down here are starting to disappear. No one seems to care much, though. Personally, I think the human species is committing hara-kiri cause of all the evil it's done. Freudian guilt and like that. But don't quote me.
I sure want to wait for those new drugs, but if I'm really F3 so fast I probably shouldn't wait any longer. I just can't figure out how I could jump from a stable F1 to an F3. And I don't feel a thing. Matter of fact, I've never felt better. Weird.
I think their machine jammed, or they plugged it in wrong, or the girl running it forgot her glasses or had a hangover.
Otherwise, I'm a gonner. I better find a lawyer and write my will. I'm leaving everything to the A.R.A.M.P. (Association for Revenge Against the Medical Profession).
Mike
I think it's the melting ice caps causing this cold weather. And there are reports that the glaciers down here are starting to disappear. No one seems to care much, though. Personally, I think the human species is committing hara-kiri cause of all the evil it's done. Freudian guilt and like that. But don't quote me.
I sure want to wait for those new drugs, but if I'm really F3 so fast I probably shouldn't wait any longer. I just can't figure out how I could jump from a stable F1 to an F3. And I don't feel a thing. Matter of fact, I've never felt better. Weird.
I think their machine jammed, or they plugged it in wrong, or the girl running it forgot her glasses or had a hangover.
Otherwise, I'm a gonner. I better find a lawyer and write my will. I'm leaving everything to the A.R.A.M.P. (Association for Revenge Against the Medical Profession).
Mike
Thanks very much for that excerpt from CCO, Mike Simon. However, not only does it make the Fibrotest sound unreliable, but the article itself is ambiguous. How can the test be 80% effective and at the same time "ineffective at diagnosing significant fibrosis"? Can you make sense out of this?
Mike716
Mike716
Hi, hon! Nice to hear from you. It's been a while...
Like I said, the hospital won't consider another biopsy until 3 years have passed, which is a year and a half from now. If I'm really progressing this fast, it'll be too late then. I really don't know what to do, but I'm not gonna just sit around. They've gotta do something to straighten this out.
Yeah, I heard from my brother in Manhattan that the bad weather was already upon you there. I've had a trip back planned for this fall, but I'm sure not looking forward to any snow. Phooey!
Hugs and kisses,
Mike
Like I said, the hospital won't consider another biopsy until 3 years have passed, which is a year and a half from now. If I'm really progressing this fast, it'll be too late then. I really don't know what to do, but I'm not gonna just sit around. They've gotta do something to straighten this out.
Yeah, I heard from my brother in Manhattan that the bad weather was already upon you there. I've had a trip back planned for this fall, but I'm sure not looking forward to any snow. Phooey!
Hugs and kisses,
Mike
Hi Mike,
Thanks for the good wishes for my husband. He is lucky to be doing very well, having only mild sx on treatment. Like you, he watched and waited for quite a few years, and decided to treat only when his latest biopsy showed some progression. He did not want to treat for 48 weeks if he could help it, and he also preferred not to wait for the new drugs, since he wanted to just get it done, and now was a decent time personally for us. So the trial came along, we were told that TMC435 looked extremely promising, and he went for it.
I can't tell you how it compares to Telaprevir or Boceprevir. It's a Phase IIb trial, and I don't imagine they'll have those numbers for quite some time. I know Medivir and Tibotec have high hopes for it. And I can point you to the sources we used to make our decision.
Here's the basic info:
http://www.medicalnewstoday.com/articles/147661.php
Pretty much the same info presented in a nice visual format:
http://www.natap.org/2009/ISHLVD/ISHLVD_16.htm
And, the motherlode of all good info on TMC435, a paper by a chemist at McGill. This is pretty dense reading, but it's really informative, especially the sections entitled "Clinical Development," "Side Effects and Contraindication," and "Current Opinion":
http://74.125.47.132/search?q=cache:PtkttmEeApQJ:www.biomedcentral.com/content/pdf/cd-1029613.pdf+tmc435+side+effects&cd=2&hl=en&ct=clnk&gl=us&client=firefox-a
As for trial protocol, you're right about the rescue drugs: they are reducing ribavirin for anemia, and not allowing Procrit, though we were told that in an emergency the doctors would use it if necessary, and do all they could to get him to stay on the drugs. Other stuff like anti-depressants, sleeping aids, etc., are given freely. As for viral load tests, I believe you would automatically get frequent viral load tests, I think they are sensitive to 10 iu/ml. However, you do not have access to this info until after the trial is over, since it is double blinded.
In terms of treatment length, the trial is ONLY for genotype 1, and if you receive the trial drug you treat for 24 weeks. You only go to 48 is you are in the SOC arm (20%). They are obviously hoping to get good SVR rates with a 24 week treatment.
If you are interested and I can answer any other questions I'd be happy to do so.
Thanks for the good wishes for my husband. He is lucky to be doing very well, having only mild sx on treatment. Like you, he watched and waited for quite a few years, and decided to treat only when his latest biopsy showed some progression. He did not want to treat for 48 weeks if he could help it, and he also preferred not to wait for the new drugs, since he wanted to just get it done, and now was a decent time personally for us. So the trial came along, we were told that TMC435 looked extremely promising, and he went for it.
I can't tell you how it compares to Telaprevir or Boceprevir. It's a Phase IIb trial, and I don't imagine they'll have those numbers for quite some time. I know Medivir and Tibotec have high hopes for it. And I can point you to the sources we used to make our decision.
Here's the basic info:
http://www.medicalnewstoday.com/articles/147661.php
Pretty much the same info presented in a nice visual format:
http://www.natap.org/2009/ISHLVD/ISHLVD_16.htm
And, the motherlode of all good info on TMC435, a paper by a chemist at McGill. This is pretty dense reading, but it's really informative, especially the sections entitled "Clinical Development," "Side Effects and Contraindication," and "Current Opinion":
http://74.125.47.132/search?q=cache:PtkttmEeApQJ:www.biomedcentral.com/content/pdf/cd-1029613.pdf+tmc435+side+effects&cd=2&hl=en&ct=clnk&gl=us&client=firefox-a
As for trial protocol, you're right about the rescue drugs: they are reducing ribavirin for anemia, and not allowing Procrit, though we were told that in an emergency the doctors would use it if necessary, and do all they could to get him to stay on the drugs. Other stuff like anti-depressants, sleeping aids, etc., are given freely. As for viral load tests, I believe you would automatically get frequent viral load tests, I think they are sensitive to 10 iu/ml. However, you do not have access to this info until after the trial is over, since it is double blinded.
In terms of treatment length, the trial is ONLY for genotype 1, and if you receive the trial drug you treat for 24 weeks. You only go to 48 is you are in the SOC arm (20%). They are obviously hoping to get good SVR rates with a 24 week treatment.
If you are interested and I can answer any other questions I'd be happy to do so.
I have never fully understood how the Confidence Interval is determined or the AUROC.
I understand this article/slide set to say that the FibroTest is capable of distinguishing F0 and F1 from F2, F3, F4 but the FibroTest is not as good at discriminating within the F2, F3, F4 group. "Therefore, the FibroTest score may be useful in terms of excluding severe or minimal liver disease but performs less well in the intermediate ranges of fibrosis(Clinical Care).
The Elastography/Fiborscan, according to the multicenter study presented at the 2009 European Association, wasn't accurate at diagnosing significant fibrosis. It did however accurately diagnose cirrhosis. My understanding is that the FibroTest and the Fibroscan may not diagnose mid stage fibrosis nearly as well as they do zero or minimal fibrosis and cirrhosis.
Mike
I understand this article/slide set to say that the FibroTest is capable of distinguishing F0 and F1 from F2, F3, F4 but the FibroTest is not as good at discriminating within the F2, F3, F4 group. "Therefore, the FibroTest score may be useful in terms of excluding severe or minimal liver disease but performs less well in the intermediate ranges of fibrosis(Clinical Care).
The Elastography/Fiborscan, according to the multicenter study presented at the 2009 European Association, wasn't accurate at diagnosing significant fibrosis. It did however accurately diagnose cirrhosis. My understanding is that the FibroTest and the Fibroscan may not diagnose mid stage fibrosis nearly as well as they do zero or minimal fibrosis and cirrhosis.
Mike
What was the kPa score on your FibroScan ?
This the value the machine gives you. It is calculated out of 10 readings
and represents the average.
I have seen different interpretations of this in terms of converting it Metavir Fs.
Either way you need another test I think. It sounds like the FibroScan operator
was inexperienced but you could have had a sampling error during biopsy as well.
If you can not get a FibroSure done and the FibroScan operator is inexperienced
the only thing left is another biopsy to see if you can wait for new drugs.
This the value the machine gives you. It is calculated out of 10 readings
and represents the average.
I have seen different interpretations of this in terms of converting it Metavir Fs.
Either way you need another test I think. It sounds like the FibroScan operator
was inexperienced but you could have had a sampling error during biopsy as well.
If you can not get a FibroSure done and the FibroScan operator is inexperienced
the only thing left is another biopsy to see if you can wait for new drugs.
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