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Avatar universal

Need Advice on Tx course

I know many of you have done tx 2, 3 times and have a lot of experience, so I trust your judgements. I really need some help here.

I recently had my 12 week PCR. I was previously 55,967,000 and dropped to 19,000. That is a great drop and I am pleased. ( I am 1A, so 48 weeks required )But now, all my doctor agree that 18 months, possibly longer GGGRRR> of tx will be required.

Now here's the part that is confusing. Early into the tx,like the 3rd week my PCR dropped to 303,000 which means 9 weeks later ( at the 12 week mark )I didn't really drop that much.

I e-mailed Dr. Cecil and asked for his advice. His opinion is that I need double doses of Peg or I should switch to daily infergen.

I am also having progression in my cryo. So, I will be seeing another specialist about possibly adding another drug to tx the cryo during the Peg treatmemts.

My questions to slow responders > would it be beneficial to do double doses of Peg at this point or switch to infergen? My doctors seem to think I should continue the current 180 per week and just extend the tx.

Also Dave, I know you did that additional drug for your cryo and I would like to know at what point into tx did you clear the HCV and cryo? were you also a late responder to the Peg? And do I need to be clear of HCV to start the rutuxin? The Hemo said she has mixed feelings on using this drug, but we will talk about it if I still have cryo at 6 months. meanwhile, I am getting a second opinion on the cryo and doing a lot of praying.

Thanks ahead of time for all your resposes. ((( Sue ))
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Avatar universal
I'm entering this long and interesting thread late, but one observation is the fact that you're at stage 0 fibrosis didn't come into the discussion until near the end of the thread.

Since you already decided to treat, there's no reason to go into a detailed discussion of "to treat or not to treat" with someone at stage 0 fibrosis. Suffice it to say that there are good arguments on both sides.

But my feeling is that if someone with stage 0 fibrosis decides to treat, they should only continue treatment if: (1) viral load statistics point to a very good chance of SVR; and (2) side effects are very manageable.

In other words, why put yourself through the difficulties of treatment (and risks of permanent side effects) with a low chance of SVR when your fibrosis level could probably allow you to wait a few years for hopefully better and safer treatments.

It seems to me that much of the advice so far would (double-dosing, infergen, extended treatment, etc.) would be more appropriate for someone with at least stage 2 and probably stage 3 fibrosis. Again, why put yourself through these more agressive, measures, with their potential side effects, when newer and safer drugs hopefully will be available within 5 years.

I'm not saying you should stop treatment, just consider your options, and if you do continue, consider how agressive you want to treat, given your cryo, etc.

Personally, I've had a very rocky 14 weeks on treatment and fortunatly was virus free at week #6. Being geno 1, age 58,
and stage 3/4, I have no choice but to continue treatment, which will probably last 72 weeks if I can tolerate it.  

However, given my experience with tx so far, and the unknown of permanent sides, if I had stage 0 fibrosis, I can honestly say I'd probably quit treatment now and wait for something better.

Good luck whatever you decide to do.
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Avatar universal
Hi Susan;
        As I said, I do not think that cryo presents itself right away. I think it's just like the sleeping Dragon, it lays low just like the dragon. For some reason, when the immune system goes whacky, it rears it's ugly head and then begins to do the damage.

Many of these 40% that test positive for cryos, could have a silent version ( no symptoms ) which could pop up years later. My doctor says you don't have cryoglobulemia until you have the symptoms. But if you do test positive, you have the potential at some point to develope the disease. This is how it was explained to me.

If you go to Janis & Friends web site, there are many people over there that have cryoglobulemia. ( A good friend of mine from Janis's cleared the Hep virus, but still has cryo )

She probably should have treated longer than 6 months, but couldn't continue. She was a 3a > should have done at least 48 weeks with cryo. I think she will be retreating the cryo again after her break.

This is a very small forum and maybe that's why you only know two people with cryo. I know a lot of people with the cryo and keep adding them to the list all the time. It's becoming more common because people are finally being tested.


((((( Sue))))))
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Avatar universal
But if 40% of HCV patients test postive for cyroglobulins, wouldn't you expect many more cases of full-blown cryoglobulenemia?

To my knowledge, you and TwoTells are the only regular posters on this forum who have full-blown cryoglobulenemia.  I would think there would be a lot more than that if your theory was correct.

Susan
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Avatar universal
Hello Ina;
           You have brought up some very interesting remarks on tx and on cryo. I too, have read about 40% of HCV people test positive for cryo. You are right, most docs do not test for it. So, there could possibly be many undiagnosed cases out there.

As far as testing positive for cryoglobins and not actually having cryoglobulemia > well, here's my take on it for what it's worth. I think the cryoglobins floating around in the blood stream, may in fact just do nothing for many years ( Just like the Hep C virus ) People are infected, but have no symptoms for many years.

Then, just like the ugly old dragon > for one reason or another the immune system goes whacky and the cryos begin attacking nerves, kidneys & blood vessels. It's at this point, I believe it developes into full blown cryoglobulemia.

( this is just my personal opinion ) I have no data to back it up. Just my thoughts. ((((((( Sue )))))))


  
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Avatar universal
I commented on this earlier on this thread.  According to my doctor (and confirmed by research I've found), over 75 percent of people with HCV test positive for cryoglobulins.  I'm one of those people, but both of my GI have emphatically told me, over and over again, that I do not have cryoglobulenemia.

Cryoglobulins in the blood flucuate like a viral load.  Sometimes they're higher than other times.  When I have more time, I'll try to locate and post the information about 75% of HCV patients having cryoglobulins in their bloodstream.  

Susan
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Avatar universal
Can you send me an e-mail? I have a paper/study that you might find of interest.

TnHepGuy
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Avatar universal
Has anyone had experience with testing negative for cryo and then testing positive?  For years it was negative and then positive again which helped me decide to tx.  Now I'm at 19/24 and I test negative again.  The doctors don't have straight answers.  Does the cryo actually go away?  The doctors tell me once you are positive, you can have false negatives.  Anyone have some good insight into this?

-cbee
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Avatar universal
to the best of my knowledge there is no such project underway. In the unlikely event I actually get the source data from the Reddy et al study I'll post the more detailed breakdown. The drug companies already have access to most of the available data : if you look at the disclosures statements for most of these studies (including the Reddy one) you'll see Roche or Schering as the funding source. The trouble is they don't provide access to what they have. Putting together a publicly accessible database is a huge job, which is why it makes sense to have them pay for it. You'd need lawyers to bless the medical-release forms that would enable the database to obtain your records and to ensure the right privacy-protection mechanisms were in place, nurses or equivalent to interpret the results and convert them from the various lab-specific formats to a uniform representation, statisticians  to determine the analytical models used for prediction and a gaggle of programmers to make it actually work.

The total predictive value of all this data is unknown, precisely because no one has looked. I've never seen a study that tried to assemble all SVR-related factors (the various host factors TN listed) plus  viral factors such as the ISDR sequence of the virus you're carrying, into a comprehensive model and assess its predictive power. It may well be that even though we don't yet understand the biological mechanism of tx success/failure we have identified enough of the asssociated factors to be able to predict outcome with some accuracy, This will never happen as long as we continue to throw away most of the information content of the available data - as in the crude VL cutoffs TN mentioned. The most likely abusers of such a database would not be the drug companies but insurance companies and government-funded health plans. If your predicted chances of success are low enough they probably wouldn't give you the chance to try.
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Avatar universal
Yes, not only am I treatment niave, my BMI is 20, I am 44 and premenapausal, so still having plenty of estrogen, and I am fairly thin. My biopsy in 2002 showed stage 0/1 no fibrosis grade 2 inflammation. I have many factors in my favor.

My high vl and the cryo are definately not in my favor. But, I am going to continue tx and keep believing that this dragon will be gone.

The plan now is to have viral loads every 30 days, so we will know when I clear. Then, we will consult Dr. Ahmed from Stanford Liver center. He's been treating HCV for many years. He also is the Head of the transplant unit. I trust his judgements.

We will also consult my hemo and the rheumy when all the test results for cryo and vascultis come back. So, in about another 2-3 weeks I will know exactly where I stand. Thanks again for all your great links and posts. I do appreciate it.

((((((( Sue )))))))))
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Avatar universal
I was going to bring up that national database issue.  I think it is a must, but I am afraid that if we allow the drug co. to obtain and handle that input, that some numbers might get manipulated...are you working on this project?
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Avatar universal
TwoTells...Yes, cryo is indeed tricky.  The only reason I was even tested for it was because of the numbness/tingling.  But as you pointed out, that's also a very common HCV symptom without cryo.  It was initially hard for me to understand how it was possible that I don't have cryoglobulenemia when I test low-postive for the cryoglobulins.  But I have absolutely NONE of the symptoms except for the numbness/tingling, and even that has disappeared during the past month or so (thanks to some supplements I'm taking).

Ina...That's why I think you shouldn't necessarily conclude that you have cryo.  If your asymptomatic, then you're probably just part of the majority of HCV sufferers who carry a low level of cryoglobulins.

Susan
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Avatar universal
I have read the same thing that you mentioned, Susan, about many people having cryoglobulins in the blood.  I also have read that many people with cryoglobulins in the blood are not 'symptomatic' and therefore don't have 'cryoglobulinemia' or vasculitis.  The amount of cryo in the blood has alot to do with whether you are symptomatic or not.  My level was very high and dramatically worsened by the INF which is a rare phenomena.  I also developed a severe neuropathy documented by a neurologist.  In most people the cryo goes away when the virus clears but comes back when and if the virus comes back.  In one study Tn shared a while ago, I believe in 80% with cryo clear the cryo when they clear the virus and the other 20% don't.  What is also tricky is that some of the symptoms of cryoglobulinemia (symptomatic) like peripheral neuropathy and joint problems can occur in people who have HCV without cryo.  False negatives on the cryocrit are not unusual either, because these proteins can stick to the labware (precipitate out of the sample) when they cool even slightly.  The cryo thing is best handled by a Hematologist.
Take care,  Dave
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Avatar universal
I am so glad to hear from you! I guess you're probably out enjoying life and catching those van Gogh exhibits? Anyway, don't be a stranger! Your input has always been most valuable.
Lauren
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Avatar universal
In the second study (Domenico Sansonno et al) they mentioned increased viremia (increased viral load) with the Rituxan alone and  suggested the potential synergistic value of treating with Rituxan and anti-viral therapy (at the same time).  That is essentially what my experience may demonstrate, ie. that the Rituxan and Peg-interferon/Ribavirin may work best together.

Have a blessed day,  Dave
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Avatar universal
Thank you for the kind words and for asking about me.

I hope all is doing well in your folks necks-of-the-woods and that 'willing's '1-person post-tx study is coming along nicely.

I've jumped back into life head first and it has left little time for things Hep C-related. I still try and check on the latest releases of info and studies and continue peek in here from time-to-time. As far as my physical recovery goes, I'm 4 1/2 months post-tx now and only recently have my white counts returned to normal range. And I'm one of the 15-20% who take a long time for the red counts to rebound (5-10% never do), so at this point I'm still slightly anemic - though the counts are still moving upward, just at a snail's-neck pace. Other than that particular problem, some degraded eyesight and very occasional and intermittent bone pain in my hip, there haven't been too many lingering physical manifestations from the tx.


As far as the Reddy study, I'm cautious to draw a true direct parallel to BostonGirl's case since she has tx'ed prior (though I don't know if she relapsed or was a non-responder) and the patients used here were tx-naive. But in the attempt to make this study useful in her particular case, I chose to use the data from the 'Week 12' area of the chart because, even though she reached the >2 log drop by Week 4, she currently falls into the >2 category for Week 12 by virture of her PCR not showing clear at that later point in time. With that being the case, she then would have a 60% chance of her Week 24 PCR being clear and an overall 26% chance for SVR (based upon a 48 week tx).

Add onto all of this that she's tx'ed unsuccesfully twice before and has cryo - and that 26% SVR figure may be optomistic, at best (unless her prior tx'ing was sub-optimal due to initial under-dosing, dose reductions, etc - in which case she could effectively be considered 'tx-naive' to a full-dose tx regime). So, being that I'm from the school of "tx once, tx best-you-can", I think 72 weeks of closely monitored tx would be her best shot at waving goodbye to this invader once-and-for all.


TnHepGuy
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Avatar universal
It appears that this K. Reddy may be the same guy who did my biopsy and started my treatment- and later recommended the 48wk titrated extension.  Does he work at U of Penn?  It's not important, just interesting to me.  Later,  Dave
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Avatar universal
Here's a link for a controlled study on Rituxin (Rituximab) for people with HCV and Cryoglobulinemia:
http://www.bloodjournal.org/cgi/content/full/101/10/3818
God Bless,   Dave
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Avatar universal
I would like to thank all of you who responded to this question. It is a bit complicated and I am still sorting through all the data. There's a lot of great information at this site and I really do appreciate all who post the studies, articles, and give their personal opinions. I thank you all from the bottom of my heart.

As far as treating prior to this go round > No, I have never treated with any interferons. This is my first shot at it. I have been on full dosages the entire 14 weeks, never reduced. I was put on procrit instead. I refused reductions, so they gave me procrit right away.

When first diagnosed with Hep C in 2002, I was doing alternative tx's, for a couple of years ( with great success ) But by the end of 2004 my viral load skyrocketed, I got really sick and everything else just seemed to go down hill from there. My herbal regimen did not change, I was eating organic, kept a low body weight > doing all the right stuff, but it just wasn't working anymore for me.

I will keep you all posted on what decisions we have made. Right now I am continuing the full dose Peg tx and setting my goal for at least 72 weeks. I only want to do this once.

Thanks again everyone and God Bless you all for this forum.

(((((( Sue )))))))
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Avatar universal
yes, that very small study is chugging along, though I think my Dr.'s might be getting a tad irritaded by my procrastination. Life is good.

you're right about my being overly optimistic about the 60%. However, I also believe the 26% is unduly pessimistic and that the best estimate of Sue's current outlook lies somewhere between those two points. The trouble is the tables don't give a complete breakdown  : how many of those 242 patients who had a >2 drop by week 4 were still detectable at 12 ? and how many of the 133 who were detectable at 12 had benefited from a >2 drop by week 4 ? By picking either 26% or 60% you're throwing away part of the available information. I wrote to Reddy to see whether he would release the actual vl counts( probably not, I've tried with Roche before). The best prediction would use all the available information, including actual VL counts rather than binary cuttoffs, but this requires the actual data...it's unfortunate drug companies are so closed to making it available.
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Avatar universal
I'm glad you wrote to Reddy and I hope you get a complete response.

I, too, was concerned when looking at the percentages, that patients can overlap and 'bounce' in and out of various categories. To come up with 'true' SVR figures, they would need to have a more exacting breakdown that would separate them all the way through the study, as you suggest.

The good news for BostonGirl is that she is tx-naive. The bad news is her extremely high starting VL figure - though the encouraging news there is the very large, continuing VL drop by week #12. As far as the other 'big' factors that go into SVR predictors (liver histology, age, sex, BMI) - only one of these is obvious. Assuming the others are in her favor (no higher than Stage 1 liver damage, age 45 or below, normal BMI), then I would suggest that she monitor her VL every 4 weeks past week #12 to best determine when the point of undetectability is reached, then tack on a minimum of 36 weeks more of tx. If liver histology is an issue, then I would consider going for the full 72 - both for SVR chances and for potential histological improvement via the interferon.


(note on very high VL figures: - I think the Hep C medical/research community is doing a great disservice by lumping anyone above the 2,000,000 mark into a single category of 'high' VL. For example, mine was 2,400,000 going into tx, putting me at the low end of 'high'. Yet someone such as BostonGirl (with a VL of 56,000,000) is catagorized (as far as studies and trials go) the same. This seems rather unreasonable given how well known the inverse relationship is between VL and SVR. I think a more detailed approach of three or more categories would be of benefit to researchers, doctors and patients - giving all a more useful info to work with and therefore a more focused approach to tx).




TnHepGuy
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Avatar universal
Here's a new study that may be somewhat applicable in your case: <a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_052305_b.html">Correlations Between Rapid Virologic Response (RVR), Early Virologic Response (EVR) AND Sustained Virologic Response (SVR) in HCV Genotype 1 Patients Treated with Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin"</a>. (I say "somewhat applicable" since in this study they used tx-naive patients and in your case you have already done tx on multiple occasions. Even so, I believe that the data here can be useful for your decision making.)


You experienced a >2 log decrease by week 12. The chart in the above study shows that the 23% of patients who received a >2 log decrease by week 12 (but did not become undetectable) had an overall SVR rate of 26% for a 48 week tx time-frame.

Given that you've tried tx before, the fact that you have cryo  and the low SVR odds (26%) shown here for 48 weeks on tx-naives, I'd think that a full course of 72 weeks should be considered in your case. You'd (of course) want to get another PCR done no later than week 24, to be sure that your viral load has continued decreasing (hopefully to undetectable). And make sure that your doc will be proactive in keeping your dosages at full amounts via early intervention with Procrit and/or Neupogen, should either of those be needed based upon your bloodwork.


As far as doubling the dosage of the interferon, there have been conflicting reports in the past about it's effecacy, but here is a new study showing positive results: <a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_051805c.html">Double-dose Peginterferon Alfa-2b Plus Weight-based Ribavirin for Retreatment of African-American Non-Responders with Hepatitis C</a>.

Here is another new study you may find of interest: <a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_051605a.html">Sustained Virologic Response (SVR) with Peginterferon Alfa- 2b (PegIntron) Plus Ribavirin Weight-based Dosing in Previous Interferon/ribavirin HCV Treatment Failures: Week 12 Virology as a Predictor of SVR in the EPIC3 Trials</a>

Also, here's a recent study looking at: <a href="http://www.natap.org/2005/HCV/050305_02.htm">Treatment with peg-interferon alfa-2b and ribavirin of hepatitis C virus-associated mixed cryoglobulinemia: a pilot study</a>



May God's blessings and mercy be upon you.


TnHepGuy

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Avatar universal
it is nice to see you are still checking up on MH, the wealth of information you share is invaluable and irreplaceble. I wish you had time for more visits.
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Avatar universal
I never actually saw any numbers on reduced odds for people with cryo reaching SVR, but the GI's all seemed convinced of it.  This is the link for a study on the safety and efficacy on Rituximab for Cryo:
http://www.bloodjournal.org/cgi/content/full/101/10/3827
Take care,  Dave
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Avatar universal
Did you know that more than 75% of people with HCV test positive for cryoglobulins?  I'm one of them, but I don't have cryoglobulenmia, according to both of my GI's.  I'm wondering if you're just someone, like me, who has simply tested positive for it.  

If you still have the copy of your cryocrit lab results, could you please tell me exactly what it says?

Here's what mine says from my 12/04 test:


Cryo Quantitative Bl              63          (>50 = High)


By the way, when I was first tested for cryo 18 months ago, the result was 83.  But like everything else (viral load and enzymes), it has decreased.

Any thoughts?

Susan
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