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Avatar universal

Here I go again

I recently had a biopsy that states I am stage 4 . My genotype is 3. I wwent through the Pegasus/co-peg tx in 2007 for 3mos. was clear for a year afer Now they want to treat me again for 6mos on a weight based dose. I guess my question is will it help to do this again?

ChristyJo
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Avatar universal
Thank you for the info. I will look for more on the study. It is funny that it is Roche they are one who my new GI doc has gotten me connected with to fund my medication. Thanks again for the info.
Helpful - 0
388154 tn?1306361691
http://www3.interscience.wiley.com/journal/117905614/abstract?CRE

This is a study my doc M lagging has been leading, if you wan´t  the full text  you got to log in, maybe it cost money aswell don´t know for sure!

Potential conflict of interest: Dr. Lagging is a consultant for Schering-Plough, Roche, and Abbott.
fax: +46-31-41 12 56

Funded by:
Swedish Society of Medicine
Swedish Medical Research Council
Swedish Society of Microbiology
Avtal om läkarutbildning och forskning (ALF) Funds; Grant Number: ALFGBG-3149
Roche affiliates in the Nordic region

Abstract
Previous trials investigating the efficacy of treatment durations shorter than the standard of 24 weeks for chronic hepatitis C virus (HCV) genotype 2/3 infections have yielded discordant results. The aims of this investigator-initiated phase III study were to compare the efficacy of 12 or 24 weeks of treatment and to identify patients suitable for short-term therapy. Three hundred eighty-two genotype 2/3-infected patients [intention-to-treat (ITT) population] at 31 centers in Denmark, Finland, Norway, and Sweden were randomized to 12 or 24 weeks of peginterferon -2a (180 g/week) plus ribavirin (800 mg/day). Twelve weeks of therapy was inferior to 24 weeks in the ITT population (sustained viral response [SVR] rates: 59% versus 78%, P < 0.0001) and in the subgroups of patients infected with genotype 2 (56% versus 82%, P = 0.006) or 3 (58% versus 78%, P = 0.0015). These differences were observed regardless of the fibrosis stage. Age and HCV-RNA levels on days 7 and 29 were independent predictors of SVR. Short-term treatment was useful in patients < 40 years old, especially if HCV-RNA was undetectable on day 29, and also in patients 40 years old, provided that HCV-RNA was below 1000 IU/mL on day 7 in addition to being undetectable on day 29. If neither of these two criteria were met for patients 40 years old, 24 weeks of therapy was superior (P < 0.0001). Conclusion: Peginterferon/ribavirin treatment for 12 weeks in HCV genotype 2/3 infection is overall inferior to 24 weeks of treatment but may be useful in some patients with a rapid initial clearance of virus. (HEPATOLOGY 2008.)
Helpful - 0
446474 tn?1446347682
Here is some sample text from a paper that you might find interesting. It is a transcript from "Medical Crossfire" which has been removed from their site but you may find it elsewhere.

"Chronic Hepatitis C - Strategies for Optimizing Current Treatment and the Potential Impact of Emerging Therapies"

PANELISTS
Adrian M. Di Bisceglie, MD
Saint Louis University
Saint Louis, Missouri
Michael W. Fried, MD
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
David R. Nelson, MD
University of Florida
Gainesville, Florida
Mitchell Shiffman, MD
Virginia Commonwealth University Medical Center
Richmond, Virginia
SPECIAL EDITION
Release Date: February 12, 2007 • Expiration Date: February 12, 2008
This activity is supported by an educational grant from Roche Pharmaceuticals.

...The fourth study, the ACCELERATE trial, was coauthored by Dr. Shiffman. “It is the largest of the four studies and included 1,469 patients with genotypes 2 and 3,” observed Dr. Di Bisceglie. The patients were randomized to receive PEG-IFN alfa-2a plus ribavirin for either 16 or 24 weeks. “This study was large enough to allow us to compare responses in genotype 2 and genotype 3,” commented Dr. Di Bisceglie. Among patients with genotype 2, the SVR was 65% at 16 weeks and 82% at 24 weeks. Among patients with genotype 3, the SVR was 65% at 16 weeks and 71% at 24 weeks. Remarked Dr. Di Bisceglie, “Treatment response rates were consistently lower with 16 weeks of treatment.” Having reviewed the data from these four key trials, Dr. Di Bisceglie drew the following conclusions regarding the treatment of patients with genotypes 2 and 3: “First, 800 mg of ribavirin a day is sufficient. Second, there are conflicting data on SVR rates when the treatment duration is less than 24 weeks. Finally, some of the variables that may affect response include the difference between genotype 2 versus genotype 3; the presence of hepatic fibrosis or cirrhosis; and viral load.”

....Noting Dr. Shiffman’s work on the ACCELERATE study in patients with genotypes
2 and 3, Dr. Keeffe asked, “What about these patients? Dr. Shiffman, what is your
treatment approach?” Dr. Shiffman replied, “Three small studies suggested that therapy can be shortened in genotype 2 and 3 patients. But the ACCELERATE study, which randomized nearly 1,500 patients and was thus able to avert a beta error because of small sample size, clearly showed that reducing the duration of therapy was associated with an increase in the relapse rate and a reduction in SVR.” Therefore, he offered, “I still hold my genotype 2 and 3 patients to 24 weeks of therapy.”

....“Although broad recommendations are important, it is clear that genotype 3
patients do not respond as well as genotype 2 patients; there is a higher relapse rate in genotype 3 patients. Even among genotype 3 patients, those who have more steatosis, a higher viral load, or more advanced fibrosis, are more likely to relapse.”
“Dr. Fried, let us say you are treating a genotype 3 patient with cirrhosis,” proposed
Dr. Keeffe. “What do you do?” Noting the dearth of good prospective evidence, Dr. Fried nonetheless indicated that he would extend therapy in carefully selected patients. “If the patient is tolerating therapy well and is having a good response, I will definitely think about extending the duration of therapy in the genotype 3 patient who has other negative prognosticators like cirrhosis or steatosis. This approach is somewhat anecdotal, but—” Dr. Fried stopped speaking and observed, “Dr. Shiffman, I see you are shaking your head.” “The data show that rapid response predicts the rate of sustained response,” countered Dr. Shiffman. “If a patient has a rapid response, it does not matter what their degree of fibrosis is, and it does not matter what their weight is. If a patient has a rapid response, the SVR rate is 90%. It is critically important to measure that. If I see that, even in a genotype 3 patient, I treat for 24 weeks.”

As everyone said. Find yourself a good, experienced Hepatologist. Your previous doctor doesn't appear to have been following best practice protocol to have shortened your treatment even if you were RVR.

Cheers!
Hectorsf
Helpful - 0
Avatar universal
CA: And if cirrhotic never shorten, thats kind of odd actually since I´ve heard RVR tops everything such as afroamerican, old age, male gender, high bmi, high vl, fibroses stage you name it  meaning once RVR they should all have the same SVR change correct me if I´m wrong.
-----------------------
I may not be as currento on geno 2's and 3's as yourself, but the last studies I read showed  a statistically meaningful difference between the shorter (12 week) and longer (24 week) course. The commentary was that the short course  was not recommended universally but was a reasonable option if someone was having difficulty with treatment.

Personally, I didn't find the statistical differences that big, and in fact there was another study that showed parity in the two groups with RVR.

But the reason I hedged on the shorter course for someone at stage 4 was not just because cirhossis might be a pre-tx negative predictor, but because someone who is stage 4 has much more to lose in the event of relapse and therefore would have more invested in going the xtra mile unless the data was conclusive that it would not make a difference -- and as stated, I'm not sure on that.

If you have any current studies that would be great.

All the best,

-- Jim
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748940 tn?1233337448
I've heard RVR tops everything

---------------------------------------------------------------------------------------------------------------------------------------------

Conventional wisdom states that RVR does top everything. I'm very interested in seeing the 6 and 12 month post tx PCR's of the large numbers of relapsers and non-responders who predosed and did gain RVR. Of further interest would be comparing the bx scores and SVR rates.

If a majority of them gain SVR, there shouldn't be any doubt.

Helpful - 0
388154 tn?1306361691
I just missed to get in that trial.
Don´t know if they did any biobsy on  g3 g2 at that time it was very much up to what the doc thought I believed.

In Sweden you get treated without have to do biopsy if g2 g3, all g1 gets a biopsy.

Yes as you said new studies has shown at least for g3 that you should have low vl lessthan 400k  baseline vl and RVR if you should treat shorter than 24 weeks.

And if cirrhotic never shorten, thats kind of odd actually since I´ve heard RVR tops everything such as afroamerican, old age, male gender, high bmi, high vl, fibroses stage you name it  meaning once RVR they should all have the same SVR change correct me if I´m wrong.

ca
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Avatar universal
Oh my MD is a GI specialist as of right now I have  a GI a clinical pharmacist and my PCP I also have an oncologist for something unrelated to this.
Helpful - 0
748940 tn?1233337448
CA,

I remember reading about the 12 to 16 wk tx trials for genos 2 and 3 in Europe sponsored by Schering Plough. The stated 'angle' on the deal was attempted cost reduction.

Do you know if any bx criteria was used for accepting people in the studies?  It seems pretty clear now that geno 3's with stage IV fibrosis are not good candidates for reduced duration.


Max  
Helpful - 0
748940 tn?1233337448
Best wishes on a successful treatment this time around. I have a tx buddy with geno 3a who is doing 48 wk course of treatment because he, too, has stage 4 fibrosis.

I noticed you're over on the Front Range. CO has a good advocacy organization:

http://hepc-connection.org/

They could direct you to face to face meetings in the Denver area. Sitting down with someone who has a good understanding of the issues might be very helpful.

Again, best wishes,

Max

Helpful - 0
179856 tn?1333547362
It's very hard to really believe how this could have happened to you - the undertreating and the relapse. I would be very curious to see what number you were tested to however generally at the one month, six month and year tests it should have been positive.

You don't really mean you are going to a PCP doctor when you say MD do you?  You should definitely be being seen by a heptologist with this far advanced liver damage.  You cannot afford another screw up coming along and advising you something as stupid as "you can quit early you are responding well" not with stage 4. That's a pretty darn basic fact.

Is there any possibility at all that you were reinfected somehow? It's just so incredibly rare for somebody to be UND at 6 months and then positive after a year it seems bizarre - cut short treatment or not!
Helpful - 0
Avatar universal
Thank for all comments. I am confused about all of this. I now have a different doctor a much better one who I now feel she has my best intrests in mind. At 6mos they did bloodwork, the viral , I was cleear as the MD said. I recently did the 1yr test and my numbers were going back up . Prior to any tx they were in the high 1 million. As anyone I was feeling pretty hopeful. I might add that prior to tx I never had a Biopsy just an ultrasound. The first Dr ( a GI specialist)  stated that due to my fast acceptance of the medication and based on research he felt he could stop me at the 3 mo.s mark. Maybe I should have researched myself more , I was just glad to not be ugh anymore. My present MD is and was surprised at the biopsy, I was just in shock. It is a lot to process because I thought I was really done. They have told me that this is a rare case and my new Doctor recently went back east  to some conferance and she took my case with her. I am hopeful.Again thanks to all , this is something I will need to learbn more about as this is my body and having gone the route of just trusting all that was said to me did not quite work out,. I hope that with my crazy questuions I may gain more knowledge and may even learn what to ask the doctors. So thanks
Helpful - 0
179856 tn?1333547362
"I don't think there's a big likihood of becoming UND in 4 wks with stage 4 and only treating someone with advanced liver disease for 3 months?   "

I'm wondering what was the sensitivity of the test you had done down to saying you were truly UND as a stage 4 I can't imagine a doctor would have advised that you stop treatment early either.  In fact, I'd imagine they would do everything they could to have you continue all the way through as patients with cirrhosis (and also some resistant geno3s) are the very hardest to treat of all. I agree with the other guys that the short course was most likely NOT in your best interest whatsoever.

I hope you find a very good, very aggressive doctor this time and aren't retreating with the same one as before.

Regardless I would definitely make sure this time that you treat for at least 48 weeks if I was you.  Just because the test 'shows' UND doesn't mean you truly are - you understand that right?  Your body needs the proper amount of time to train the immune system to keep on killing any remnants that might remain (not in your bloodstream but hiding in your liver for example)....and personally I"ve always never really agreed with short term treatment because to me that seems like a pretty huge gamble and not one I'd want to take with advanced liver damage at all.

Good luck this time with treatment.
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Avatar universal
meant to say:

And in fact, even if someone with cirrhosis did RVR, not sure the shorter course would be in their best interest.
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Avatar universal
I don't think there's a big likihood of becoming UND in 4 wks with stage 4 and only treating someone with advanced liver disease for 3 months?  
---------------
Good point. My comments on the shorter-course were not specific to her case, just a general statement. And in fact, even if someone did RVR, not sure the shorter course would be in their best interest.
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Avatar universal
I don't think there's a big likihood of becoming UND in 4 wks with stage 4 and only treating someone with advanced liver disease for 3 months?  Unless they did not do a biopsy prior to treating.  Something very strange about this.
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Avatar universal
A fine point, but let me change the word "protocol" above, to "protocol and/or strategy" as some may argue slightly lower SVR rates per some studies while other studies show parity. But all appear to agree that it's a reasonable strategy in the context of signficant side effects. We've had at least six members here do either a 12 or 16 week shorter course and to my best recollection all of them are SVR. Weve also had at least a couple of members do the  24-week shorter course for Geno 1s. Again, by memory both were SVR. The common denominator of course is that all were RVR which is known being recognized as the prime predictor of SVR.
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Avatar universal
Yes, treating geno 2 and 3 populations for 12 weeks with weight-based ribavirin  is an accepted protocol in selected patient populations with the usual criteria being UND at week 4 and low pre-tx viral load. But as stated, what is not usual is being UND one year post treatment and then showing virus positive at a later date. Probably either some confusion or the possiblity of reinfection.
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388154 tn?1306361691
Hi christy welcome here to the forum I´m a geno 3 relapser first did  24w now I have done 48w weigtbased hopfully I will clear this time.

Here in Sweden they had a study in 2006 with geno 2and 3 only doing 12weeks of treatment.

Maybe you were in a simular study.

Anyway I will qoute jmjms comment by the letter get a doc who knows his business.

Can you tell us all the pcrs (viral load tests) you have done and the result from them both during and after treatment?
Also how sensitiv they were <615 ,<15, <10 <5iuml or whatever sensitivity the tests had?

Best wishes.

ca
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233616 tn?1312787196
treating for 3 months...why?  that's not enough time.  did you have to stop choose to??

this time pretreat with antidepressants, Riba and Alinia in doc will let you, and for gosh sakes stay on the whole course.  It's not easy, but stage 4 is last chance before you can't treat and go end stage....

I'm curious why only 4 3 months??

mb
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373023 tn?1318524578
Hi Christy...I agree your post it a bit confusing...

Did you get a 6 month PCR to see if the virus had gone..6 months after you finished treatment.?...Or is this year one the first since finishing..?...

Alot of geno 3s get a EOT PCR that shows they are clear, they then think they are and never go back for another test.....I think this causes lots of confusion......Hope you can clarify the situation soon.Pxx
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Avatar universal
I went through the Pegasus/co-peg tx in 2007 for 3mos. was clear for a year afer Now they want to treat me again for 6mos on a weight based dose
----------------------
Either you are misconstruing what you've been told, or your docs have told you something incorrect. Either that  or your case is quite rare because SVR is durable approaching 100% for anyone UND one year post treatment. My guess, based on both statistics and similar stories here which were later shown to be incorrect, is that somehow you have the information wrong.

Are you seeing a liver specialist (hepatologist) or a gastro? My suggestion, especially if you're stage 4 and have relapsed, is to see a hepatologist to go over your chart and point you in the correct direction. But the first step is to find out what happened the first time, and at first glance it appears there is some confusion there.

-- Jim
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Avatar universal
Since ýou were undertreated last time, treating only for 3 months and apparently not weight based, you might very well want to treat again. This time for at least 6 months and with weight based dosing.

Studies are now being made for geno 3 relapsers to see if 48 weeks or 36 weeks will increase their SVR odds. There are also doctors who recommend 48 weeks for all geno 3s with cirrhosis. This is something I would recommend you to talk to your doctor about.

Being you are a stage 4, I don't think you should wait for the new PI drugs.

Helpful - 0
748940 tn?1233337448
interesting, most people who are clear for a year never have the virus return. Perhaps it's in some way related to your cirrhotic liver?

What were your pre-tx biopsy results? What is your current viral load?

If you're stage 4 on the Metavir scale, waiting for the PI's may not be a good idea. Generally speaking, repeating a failed tx doesn't do the job.

People have gotten good results after relapsing by predosing the riba and sometimes interferon.

Many others here have great expertise regarding those options.

good luck,

Max
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