Aa
Aa
A
A
A
Close
86075 tn?1238115091

Tallblonde

hi, hate to be so public in telling you this, but I have no other way really.....you and I have always been in "somewhat" the same boat in terms of how we've been dealing with our disease, anyway, I had a fibroscan today, like a few other members here....and I think it would be great for you to get one too, great relief off my mind and there are no big gauge needles to deal with! You probably know it's a scanning procedure, that gives you images of the entire liver...anyway, don't know if you do, but if so, Ina has my info and I could get you in touch with the good doctor, it's here in Los Angeles in a fairly beutiful setting...hope youre well...

Just taking a chance, don't even know if youre still reading...maybe so...
116 Responses
Sort by: Helpful Oldest Newest
Avatar universal
Willing, I know you are gone on a trip, but I still like to answer.
I know earlier Berg papers used PCR's down to 50I/U, but in this paper all references are down to 10/IU, at least this is how I read it, and the lady that provided the link in the first place, ZAAZA something, read it with her broken German the same.
Berg wrote that further studies are needed indeed.
Under Abb 3 he said, that those were his own observations, meaning that a significant number of pt's who had been presumed neg with PCR down to 50/IU, were the entire length of tx really low level pos.

He said that random studies have shown that EVR's neg with a 10/IU test, have a 80% chance of SVR...in Europe of course.
They also have shown the benefits of LVR's to extend to 72 weeks. Abb 7 compares SVR rates 72 weeks vs 48 weeks.

I wish I could explain each picture, but it just takes me too long.

I want to write quickly about geno 2,3 in case somebody comes along and reads.
SVR for geno 2 and 3 depends just like geno 1 on the initial viral drop.
They did 4 random studies, with 700 pt's total.
All RVR's had gotten against recommendations a higher Riba dose, weight adjusted, and tx was not compromised by 12 or 16 week duration. SVR rate was approx. 80%.
Without RVR the relapse rate was up 50%, even though riba was dose adjusted, and pt's were tx for 24 weeks.
Weight based Riba, approx 12mg/kg is recommended for geno 2/3 as well.

There is more to say about Geno 2/3, but the thread is old, and I am not sure if anybody is reading.

Thanks Kathy, if you or bill have any questions, let me know.
I hope somebody can dig this study up in English.
It sure is a job putting it in writing. On the phone I could explain it in a few minutes.


Ina


Helpful - 0
Avatar universal
Bill, hope you check back in here.  Excellent stuff.  I have treid a couple of times to email you but it always gets returned.  Try to contact me at my screenname at aoldotcom and maybe that will work.

Thank you all for such an enlightening discussion, and especially to Ina.  A lot of work went into the reading itself and the treansation is super.  All my college German flew the coop.
frijole
Helpful - 0
Avatar universal
Ina : many thanks for poring over all this! It seems to an informed and sharpened tx algorithm - an interesting counterpoint to the one-size fits all SOC. The importance of rapid RVR strikes rings true from observations on this board - and argues for making the tx decision only after you know whether you're part of that elite club.  I'm on my way to the airport for a trip and won't get a chance to look at this for a while, but (1) I would bet there's an English version, possibly on one of the CME sites like medscpe (2) it still isn't clear to me how much new <10 data is being released here. The original TMA papers were based in small counts (~20 as I recall). Berg's own earlier paper on the importance of VL at 12 was based on <50. I think it's important to understand whether we now have data that sheds more light  on the outcome odds of those with low-level VL.  Being clear with a high-sensitivity test at (4,8,12) has always been and continues to be good news. However up to now there hasn't been much guidance on how bad things look if you're not clear.  Specifically,  what do yor SVR odds look like if you choose to continue notwithstanding  low-level VL at 8 or 12? Anyway, thanks again for your analysis - I'll try to dig into this  a bit more when I get back.

This paper is a good example of what can be done by just collecting and analyzing "current" tx data. Even more could be done by releasing tx data to open analysis - something I believe patients should *DEMAND* when they sign consent forms for clinical trials (we're the damm lab rats after all; we should  ensure our data is available to all  instead of locked up to protect some drug company's stock price or academic lab's competitive edge).  It's always irritated  that tx analyses like Drusano's and Shiffmann's tend to be based on old/stale data...

Jim: thanks for that tea pointer - I've gotten that African bush tea before but had no idea Starbucks had it. However, I have to confess my fantasies of  carnal knowledge of a donut are just that - if I actually ate one it would take me a week to recover...
Helpful - 0
Avatar universal
Here is a summary of the German study.
We had discussions along these lines last year when goofy was trying to determine his EOT.

They expect protease inhibitors to change the landscape, but don't expect them to be available for another 3-4 years.

They say RVR trumps everything, followed by the all important viral load going into tx.
This applies to all geno types.

The threshold what determines high or low load has been lowered to 400.000.The lower the viral load, the greater the chance of SVR, (Abb 5).

A RVR, having started tx with a high load, has a greater chance of relapse.

Fibrosis stage must also taken into account when recommending shorter therapy.

Table 1 on page 12 at the left bottom, are geno 1, tx for 48 weeks, tested with TMA down to 10, and had a low viral at start of tx.
It simply says RVR's were over tx,
EVR's were correctly tx,
and LVR's (slow responders) were under tx.
Nonresponders need to tx longer and stronger, but no guidelines are in place as of yet. Approx. 20% of geno 1 don't respond, and approx 5% of geno 2&3 don't respond.

RVR is defined as viral load <10/IU by week 4, and can safely tx for 24 weeks, (Abb 6).
EVR is defined as viral load >10/IU by week 4, but <10/IU by week 12, and needs to tx for 48 weeks.
LVR (slow response) is defined as viral load >10/IU by week 10-12, but <10/IU by week 24, and needs to extend to 72 weeks,(Abb 1 page 12).

Even geno 1 that have met all criteria, RVR, low viral load, have been tx for 18 weeks, and achieved SVR 95% of the time.

Let's not forget they are Europeans, who have higher SVR rates period.

Willing look at page 13...Was heisst "HCV-RNA negative"?
What means HCV-RNA negative?
Standard practice used to be PCR's down to 50/IU . In retrospect, after the more sensitive TMA's down to 10/IU had been introduced, they saw on these retrospective studies, that a significant number of pt's over the entire tx period had a low level of viremia (Abb 2). They presume that many pt's were called relapsers, while in reality they had never achieved undetected.

Pt's with small viremia by week 4, defined as <50/IU, but >10IU have a high relapse rate and should not shorten tx, but tx for 48 weeks.

There is more to say about Geno 2&3 and riba dosing.
I try to do that tomoorow.
If there are any questions, point me to the page and paragraph, and hopefully I can clarify.

Ina

Helpful - 0
Avatar universal
It's 3AM, I keep getting after thoughts.
I think you are correct, some geno 1, provided they fit the criteria of low load, and minimal fibrosis, may walk away doing 18-24 weeks if they are RVR. The 4 week trial you suggested is a good idea for some....now we only have to find the doctors to play along, and the insurance companies to pick up the tab for constant testing.
I think Susan would fit the bill for a trial run. She could potentially walk away with 18 weeks of tx.
Hahaha, she won't like it that I even suggested tx.
Forgive me Susan.

Ina
Helpful - 0
Avatar universal
For those pt's that are slow responders, but negative to <10/IU by 24 weeks, the extension from 48 weeks to 72 weeks, can benefit them significantly, (Abb 7).

Ina
Helpful - 0
Avatar universal
The only studies I see so far are studies for geno 1 slow responders...48 weeks versus 72 weeks...referenced 10-12...and all they said was 4 randomised studies were done.

Geno 2&3 has study references, that's tomorrow, or later.

Willing...(Abb 2 should have said Abb 2 and 3)
Abb stands for picture.

Ina
Helpful - 0
Avatar universal
Now that my metabolic syndrome has worsened from the treatment drugs, would it be an imposition if you baked up a lower carb donut? I'll bring the coffee and Ina can just bring herself for being so kind to translate from the motherland. Speaking of tea, have you tried "Roobios". Nice sweet flavor without caffeine. Not  even technically a tea but from an African Bush. A blend goes under the name "Red Bush Tea" at Starbucks. Tastes good straight or with milk or soy milk. I think first heard about Roobios here from TallBlonde and Rocker. Remember Rocker? Do miss that guy. Speaking of which -- and back to the real teas - a recent study suggested that putting milk in tea undues all the good stuff teas do. Possibly why heart disease is less in Japan than England. You really make donuts? I'm impressed.

-- Jim
Helpful - 0
Avatar universal
Ina: not that I know of. The neurologist ordered it as follow up when I noticed numbness in hands/feet and then I never went back to actually do the draw until your post today. If it wasn't for all the helpful reminders on this board (Susan about the teas, Jim about the bx 2nd opinion, Califa about the B12, you about the RA) I'd be in big trouble.

Jim: depends on what Ina reports back. If that Berg paper releases the results of a new large-population study with VL measured to <10, which it seems to,  then VL in the 10-50 range will become predictive of outcome. Up to now, to the best of my knowledge there hasn't been any data on which to base interpretation of a VL < 50.   Even with that new data, a VL in the 2-10 range will be uninformative until studies track the outcome of patients who manifest in that range. Then presumably it's on to the PBMC and real-time PCR techniques.. Basically my point is that a measurement is only meaningful when you can compare it with a distribution of outcomes (and BTW I'll make that a jelly-filled donut).
Helpful - 0
Avatar universal
Are you then conceding their importance at least during treatment? As to EOT, I suppose the importance lies in identifying those that are in the TMA positive subset of PCR negatives.  Since this entire subset will relapse -- at worst administering an EOT TMA will not keep false hope alive any longer than it should; and at best some action might be taken sooner such as re-treatment, a follow-up biopsy, selling the house, etc. That's quite a long article, so unless Ina focuses on some very short sections, I doubt we will get much further on that unless someone wants to go through the computer translation process.

-- JIm
Helpful - 0
Avatar universal
Just got in after a very long day at work.  I'm ready for bed, but will respond tomorrow to your post.  Please check back later...
Helpful - 0
Avatar universal
uh - I'm starting to feel like one of those polar bears in the North Atlantic - it really is just a (short) matter of time till there *are* large scale studies  against which to interpret the results of high-sensitivity VL tests (and if this article is reporting a large new data set collected at a sensitivity of 10 there's bound to be an English version somewhere). However, I'm willing to bet a donut you won't find any treatment recommendations hinging on the importance of a high-sensitivity test at EOT (even if this shows you in fact never cleared) or post-tx...
Helpful - 0
Avatar universal
I got it and made a hard copy. I will start reading tonight and summerize every paragraph. Understanding is easy, translating is a little harder.
I am busy all day tomorrow, but can do at least some on Wed.
I want to do this right, so cut me some slack. I may translate over several days.

Willing, you don't have cryo, right? Why do you think you need an RA, unless of course you have some rheumatic issues? Is there a connection between HCV and RA that I am not aware of?

Ina
Helpful - 0
Avatar universal
Tell me a little more about your acupunturist like how long, how much, how its' going, for what and what is his/her training. So are you going for the Chinese herbal tea, etc. -- wasn't sure? Might help the ole immune system stabalize. I've been thinking about it myself but will wait until my one-year post treatment test comes in negative. Then I'll see but of course with frequent enzyme testing and with someone with references like maybe Zhang, Misha Cohen, etc.
Helpful - 0
Avatar universal
Tell me a little more about your acupunturist like how long, how much, how its' going, for what and what is his/her training. So are you going for the Chinese herbal tea, etc. -- wasn't sure? Might help the ole immune system stabalize. I've been thinking about it myself but will wait until my one-year post treatment test comes in negative. Then I'll see but of course with frequent enzyme testing and with someone with references like maybe Zhang, Misha Cohen, etc.
Helpful - 0
Avatar universal
Ya, das est de study, I think. If you open it in acrobat, then save it to a text file, you can use any number of online translators -- including the google translator -- to turn it into English. I did such just too lazy to break it into the dozen or so posts required given the thread limitation. But basically, Berg says I'm right and Willing's wrong regarding the more sensitive tests. LOL. I'd better go hide now :)

-- Jim
Helpful - 0
87972 tn?1322661239
Ooops, here is the link I promised.

http://www.hepatitis-bw.de/HepatitisCBergIndividualisierung2006.pdf

(I'm on dial-up, and I get so impatient for the page to load,I forgot to add the link :-)).
Helpful - 0
Avatar universal
Guten tag - whoa.. your level of organization is truly impressive! I'm doing well if I can remember my age. It sure sounds like with the possible exception of the stubborn platelets things are normalizing very well (and thanks for bringing up RA - I was supposed to get tested but keep forgetting to pick up the blood order - I'm gonna go NOW  before I forget again).  Was that BobK you were referring to ? That was quite a  success story - I think that kind of reversal may even be worth the pain of tx regardless of SVR outcome.

I believe this is the study Jim was referring to
http://www.hepatitis-bw.de/HepatitisCBergIndividualisierung2006.pdf
(boy, do I miss the html..)

From just looking at the pretty pictures it looks he's recommending 72 for anyone in the range 10-3000 IU at 12 but I couldn't make out how extensive is the data supporting his recommendation (how large a sample has he tested at the new level of sensitivity) nor what the 48->72 SVR improvement was for those who pushed through to 72 (in his earlier data the improvement was real but not that impressive).

Helpful - 0
87972 tn?1322661239
Hi Ina, I think this is the German link that is in question. It came from Zazza>Jim>Bill>Ina>, through both boards, LOL! Anyway, take a look and see what you can make of it?

Bill
Helpful - 0
Avatar universal
I just read this whole thread again, can't find the link to the German study.

Also want to mention, that southernboy tx 5 times. His viral load always came down, but he never made it to zero.
HR said he had developed so many resistant strains, another approach without a third or fourth drug would not be successful. Last I heard they were working on a new regimen.

Ina
Helpful - 0
Avatar universal
Hi, yes I was happy to see you, but didn't post to you, because you never stick around.
I surely miss your links, what a bummer.
Yeah, I am ecstatic, 0-1 or 1...those are good numbers, and when I hit the dumps, which I do on a regular basis, I tell myself...but I am SVR, it was worth it.
There was a guy here long time ago who also tx for 2 years, but relapsed. He reversed from 3 to O. Treating 2 years gives better odds, but a guarantee it is not.

My Albumin 3 month ago was 4.5.
I keep charting everything, TSH, Alt's etc.
The only thing that is not budging are the platelets. They are stuck at tx levels, around 170-180. Before tx 220. And 15 years ago 300... you see they came down slower, Albumin took the lead in my case.
This is not my liver keeping them there, it's the bone marrow. I am not concerned, just making a statement.

During tx my ALT and AST reversed, with the AST being always about 10 points higher. At my last CMP 3 month ago they have come almost together.

My Rheumatoid factor is down to 30, before tx consistently for 15 years between 100-150.
This is actually very unsual. Every cryo SVR, after a short downward spike, regained their pre tx RA.

Not sure why I am telling you all those numbers...guess I am in a jabber mood.

As a matter fact I was planning to read that article, but please don't ask for a word for word explanation, just a summary.

Did you ever make contact with HR?

Ina
Helpful - 0
Avatar universal
tater - thanks for the kind words above - hope you are doing well.

Bill - good to hear you're doing so great -  you sound better than Tony the Tiger! Hang in there - you've got  great attitude and great wind in your sails (let's pray goof doesn't pick up on that) for the road ahead (and I thought DDW was June..)

Kathy: good question... HCV's low-fidelity replication strategy comes from of an error-prone polymerase so mutations in the polymerase itself could be expected to result in a higher error rate and thus more mutations. In general, as best I can make out,  little is known about what characteristics of the virus are correlated with tx success/failure (except for a long-running argument between French and Japanese researchers about the ISDR  that seems to come down to different patient populations : http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=17133546

I think one of the best pieces of news to come out the vx trials is that the escape mutation rate seems pretty low.. the subset of virions that managed to mutate past it is small enough that even just more more targeted drug (like one of the forthcoming polymerase inhitors) should be enough to leave a very small viral population for the ifn. Still speculation, but I'd expect the next DDW or AASLD to report on small studies of combo HCV-targeted drugs.

Jim: Wunderful, wunderful, dast is krystal klear..here's where we need the benefit  of a german-reading forum member. Perhaps Ina will oblige. I'm delighted to see more studies publishing more frequent and more sensitive VL tests (another plus from the vx data) - but until this becomes standard practice having tests more sensitive than the published large-scale studies still leaves you wondering how to interpret them and provides limited help for the two key tx decisions (quit? extend?) - as Kathy's case makes clear..

INA : 0-1 ? Are we ecstatic or what! Congratulations
Helpful - 0
Avatar universal
Stop butting in...I love you two fat females.
Only the fear of diabetes has stopped me from joining you.
Everything I like is illegal, immoral and fattening...so says one of those wooden things that you buy in the National Parks.

Ina
Helpful - 0
87972 tn?1322661239
Hi Vicki!

Thanks for the good words. I understand from another thread that you'll be going in shortly for your 12 month-post work-up; although it sounds like you got it Slam-Dunk, I just wanted to offer my best wishes to you as well. Let us know how things go, OK?

Best to ya,

Bill
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis Social Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.