UND at week 28, finally!

[smaug48]

I just heard that my week 28 PCR was negative - YES!!!  What a relief.

I'd like to take this opportunity to thank everyone for being here - you guys are helping me keep my sanity while going through tx!

According to a new study posted by drofi (I'll call it the Arase study, the first author's name), these were the SVR %'s for super late virological responders, which was defined as achieving und between weeks 25-48.  The patients in the study were geno 1b.

Continuing tx for:
20-29 weeks after und - 18% (2 out of 11 people)
30-39 weeks after und - 20% (1/5)
40-49 weeks after und - 40% (4/10)
50-59 weeks after und - ND  (couldn't find in the study what this stands for)
>=60 weeks after und - 100% (2/2)

I wish people would stop saying that not getting to und by week 24 means a 2% chance of SVR!!!

Here is the link for the study
http://www.jstage.jst.go.jp/article/internalmedicine/47/14/1301/_pdf
or  http://tinyurl.com/5efhmy

I am geno 1a.  My understanding is that tx for g1a  and 1b is identical, so I can apply these results to my case.  Does anyone have a different opinion on that?

smaug

[merryBe]

congrats...its a long row to hoe......but at least you GET a row to hoe!!  Amen?

MB

[zazza]

The way I interpret "longer" is longer than 24 weeks. I think Shiffman is saying that if you are still detectable at week 24 it is no use to continue treating any longer than the weeks you have already done because you will never reach UND even if you treat the full 48 weeks. Just my take! Shiffman is too unclear for us to draw any conclusions.

[smaug48]

Thanks for the support!!!

smaug

[dperry10]

Congrats to you..  I knew you would reach it.. Keep on going..  You will keep that status..  I can just feel it.

Dana

[eureka254]

Most importantly:  Congratulations to you!!  My most sincerest wishes for SVR, whatever you do! :)
~eureka

[eureka254]

Understanding of this disease is still so very young, and I think both studies have validity, and both can be questioned -- and certainly lend themselves to much scientific debate!  I'd be very curious to know how much other data (besides drofi's original exciting post) has been collected on those who reached UND between 24-48 and continued treatment on (1) how long treatment continued after UND, and (2) how many were SVR vs how many relapsers.  

With all due respect, Schiffman makes an emphatic statement of (quoting above):
" THESE PATIENTS WILL NOT BECOME HCV RNA UNDECTABLE WITH LONGER TREATMENT... "(sic?) but he doesn't qualify or quantify "longer"... does he mean the 72 weeks? or 88 weeks?  Did he treat patients for as long as 96 weeks?  "Longer" can be subjective out of context ... maybe he only meant "longer" than the standard SOC of 48 weeks?  (btw, The same would questions exist in my mind whether referring to UND or SVR.)

And, certainly, the Arase study is limited in number... some 300-400 patients is certainly worth a hard look, but far from conclusive.  (More research, more research!)  But, I have to say I like to err on the side of hope myself.  For years, doctors said there was no cure for HCV... nowadays they're saying there's no cure if you're not UND by 24 weeks... what the dragon could morph into, who's to say?

From my standpoint, if you're facing Stage 4 with possible beginning decompensation and HCC as a result of geno 1 like my husband, even if it means treating for more than 72 weeks for just a 2% better chance at SVR, (presuming he can survive the treatment), it's a viable option to explore, especially if we could possibly increase the odds close to 100%  (if the Arase study is right).

And thanks to all for a most interesting thread.
Respectfully,
~eureka

[jmjm530]

Behave yourself or I'll make it disappear again :)

[Trinity4]

Ooops!!  Must be on my end - I must be the one having the senior moment!  It really wasn't there a minute ago.

[Trinity4]

Are you having another senior moment -  you name is showing 2 min ago but no post?  Where did it go to?

[jmjm530]

Smaug: Didn't you mean to say those who are still detectable at week 24?
--------------------------
Yes, thanks for the correction! And yes, have a good weekend !

[smaug48]

from Jim's post: ""I agree that Shiffman is clearly saying that they won't SVR." with "they" being those who are still detectible at week 12.""

Didn't you mean to say those who are still detectable at week 24?  In my post "they" are those who are still detectable at week 24.

Thanks for the good wishes, drofi!!

Just like it doesn't make sense to treat two people the same amount of time if one is UND at week 13 and one is UND at week 24, I think it doesn't make sense to say that someone who isn't UND at week 24 has no chance of getting to UND at all (which is what Shiffman is saying).

Each individual case should be considered. In my case, I had a 2-log drop at week 12, and a very clear downward trend to UND.  If I had listened to Shiffman, I would have given up by now, which I hope everyone would agree would have been the wrong thing to do, because I did make it to UND.

That is why I don't think it is right to say flatly that people who are not UND by week 24 have no or 2% chance of SVR - it's not that simple.

But anyway, I really liked the last line of drofi's first post - let's enjoy the weekend!!!

:-)

smaug

[drofi]

btw, there is a new publication from Berg, published some days ago:

Tailored Treatment for Hepatitis C
Thomas Berg MD , a,  
aMedical Department Hepatology and Gastroenterology, Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Berlin, Germany

Available online 12 July 2008.

Considering the high number of global cases of hepatitis C virus (HCV) infection (around 175 million), effective, individualized, tailored treatment approaches are imperative. In this respect, defining patients according to their initial response profiles was shown to have great impact on choosing the optimal treatment duration. The application of new more sensitive HCV RNA tests may further help to improve treatment individualization. In spite of the many relevant studies conducted in the past and at present, however, this problem is far from being resolved. Generally, it can be said that the presence of a rapid virologic response is a significant predictor of favorable outcome and permits an abbreviated treatment period. In contrast, patients who have a slow response have a high risk for relapse but seem to profit from extending treatment duration. This viral kinetically driven approach to tailor treatment is generally applicable to all genotypes.
Article Outline
Principles of tailored treatment in hepatitis C virus type 1
Importance of the sensitivity of the hepatitis C virus RNA test
Experiences with shortening treatment duration in hepatitis C virus type 1 infection
Definition of a new hepatitis C virus RNA cutoff to predict sustained virologic response
Experiences with extending treatment duration in hepatitis C virus type 1
Predicting relapse according to the hepatitis C virus RNA-negative interval during treatment?
Summary of the current concepts of tailoring treatment duration in patients who have hepatitis C virus type 1
Principles of tailored treatment in hepatitis C virus type 2 and 3 infection
Experiences with shortening treatment duration in hepatitis C virus type 2 and 3 infection
Extending treatment duration in those who are slow to respond
Summary: tailored treatment for hepatitis C virus type 2 and 3
References

[drofi]

Smaug, great news! This is the next milestone for you.
I have done shot 82 today and hope to do 88 or better 90. My sides do not increase in a linear way, week 80 was not worse than week 60, even better. IFN and riba are strong drugs and each decision is an indiviual decision of course. What is possible for me might not be possible for another person.
Some weeks ago I met Berg myself and he supports my decision to continue. The problem with all the studies about 48 or 72 weeks is simple: these studies looked at 48 or 72 only, nothing else. There is no rationale at all to treat two persons for the same length of time, if person A was UND at week 13 and person B was UND at week 23 or even 24. The old studies jused low riba concentrations and there are several other drawbacks of the studies. I probably have all the publications here, unfortuantely some good reviews are written in German, eg http://www.kup.at/kup/pdf/6497.pdf
Sure, there is no guarantee. But I myself would feel much better with a relapse after week 88 than after week 72.
All the best for you and all other heppis around :-)
Have a nice weekend and don't forget there is more to do at a weekend than thinking about a virus.
drofi

[jmjm530]

I really don't know what more I can say. Shiffman's paper is relevant because he clearly states that one should stop at week 24 if still detectible. "Smaug" appears to agree that this is what Shiffman is saying  (see Smaug's last post) when he says "I agree that Shiffman is clearly saying that they won't SVR." with "they" being those who are still detectible at week 12. This doesn't mean he agrees with Shiffman, just agrees that is what Shiffman is saying. For those interested, hopefully they will read the entire thread as well as the Shiffman paper and come to their own conclusions as to relevancy. Better that for me to keep repeating myself because I have nothing more to add.

[Proactive]

Does anyone have access to this article? I hit on "96 weeks", but can't view the article TIA.
"Treatment of relapsers after combination therapy for chronic hepatitis C .  Gastroenterology Clinics of North America , Volume 33 , Issue 3 , Pages 513 - 526 F . Ahmed , I . Jacobson"
http://linkinghub.elsevier.com/retrieve/pii/S0889855304000548

[zazza]

Too bad you will not read my post.

What I meant was that there is no reason for me to try to understand your contradicting interpretations when I can read what Schiffman says himself. I do not find this Schiffman paper relevant at all in the discussion of extended tx for super late responders. I cannot see that he even touches this subject.

But I have read every word you have written in this thread. Too bad you will not do that for me.

[jmjm530]

Zazza: I actually will not waste my time trying to understand your interpretations.
-------------------------
Then I will not waste my time reading the rest of your post :) Have a nice weekend.

[zazza]

Just so you know, I have read every post in this thread, but one of your posts and Smaug's last post were written when I was writing mine, so I did not see them until afterwards.

"Are you suggesting that Shiffman is saying that if you aren't UND by week 24 that you will never be UND? I think he's clearly talking about sustaining an UND status to SVR."

I cannot see how this statement fits with your later posts. That is why I am asking if you changed your mind. I actually will not waste my time trying to understand your interpretations.

Have you read my post?! I am saying f!ck the Schiffman paper and let's concentrate on discussing the studies that actually are looking at extended tx for super late responders.

I am not at all disregarding stopping at week 24 if detectable. This has always been my recommendation (knowing very well I am a layman) to all detectable at this time. But I find this new study interesting. Maybe there is something such as a group of super late responders who would benefit from extending tx beyond 72 weeks. In my mind this is worth looking at. And of course I am being as critical as always when looking at a study, as you ought to have noticed if you read my post above.

Smaug had already decided to go 72 weeks before he saw the Arase study. I understand that he tolerates tx well. So why should he not indulge in this study, talk to Dr Dietrich, find out all he can and figure out if what he finds has any impact on how long he wants to tx.

My own experience is that tx was tolerable all through my 72 weeks. The worst part was between week 5 and 16, so a long tx does not scare me. I am now 4 months post, and completely back to normal. I know all are not as blessed in this way as I, but this is my reality. I hope Smaug will be as lucky as me in this regard.

[jmjm530]

Please read "Smaug's" last post as well as some of the interim ones.  

He and I are in *agreement* on what Schiffman says. And no, I did not change my mind during the thread.

The fact that Smaug (or anyone) may not agree with Schiffman's conclusions is a different matter. I suggested a remedy in my last post, i.e. contact Shiffman.

You are also skipping over the advice that many here have been given -- NYGirl from Dr. J. as one example -- re stopping at week 24 if not UND.

Things change in the HCV research landscape and we can only report what we know at a given time, and perhaps this new study will offer some an alternative approach to consider -- but that doesn't mean we should just accept it at face value any more than we should reject it based on previous guidelines.

-- Jim

[zazza]

I so disagree with you on your interpretation of Schiffman's words. (At least your first interpretation, I am not sure if you changed your mind in your last post.) You are reading things into his statements which are not there. I totally agree with Comeagain's and Smaug's interpretation of the quote. People who never become UND during tx obviously can not SVR.

I think we should leave Schiffman's paper behind, and concentrate on studies that actually look at extended tx for super late responders. Just like Smaug I am unaware of any studies other than the Arase study which have actually looked at extended tx for super late responders. As long as noone can actually show us such a study, I think we should refrain from trying to find excerpts here and there that we interpret to prove our own point. Sorry Jim, if I seem harsh here.

I am kind of surprised though that super late responders means all who become UND between week 24 and 48. This is a very long time period, and usually tx has to be extended exponentially in relation to how long it took to become UND. Maybe one can contribute this to the research of extended tx for super late responders being so new.

I think the Arase study brings hope to people like Smaug who just barely missed UND at week 24 and have the motivation to continue treating right now. People who become UND later should be careful since the study sample is so small.

Also, I can not see how Smaug's borderline detectables can be discounted as false positives. They may be discounted because of being so close to UND, but not as false positives, since Smaug got 2 in a row with 2 weeks apart. I know on my borderline detectable test result it said "repeatable borderline value", so at least in Sweden they recheck these.

By the way, the link worked now when I typed it in manually. :)

[jmjm530]

Perhaps write/email Shiffman and ask what he's basing that statement on and maybe also refer to the newer study posted? That's what I'd do if in your situation. Also perhaps things have changed since he wrote that. The more info we collect the better.

[smaug48]

I agree that Shiffman is clearly saying that they won't SVR.  

But I am making a distinction between a person who reaches UND after week 24, and a person who never reaches UND after week 24.  In what you posted, it seems that we agree that Shiffman is saying that someone who has not reached UND by week 24 will NEVER reach UND and therefore cannot SVR.

I guess I'm saying I disagree with Shiffman's statement, because I'm talking about someone who actually reaches UND after week 24 (like myself).  I have not seen any research saying that people who became UND after week 24 and then treated 72 weeks had an extremely low chance of SVR.

smaug

[jmjm530]

I know that wasn't your inference, but I was getting frustrated not being able to find the wording I had read previously. As to the Shiffman article, I think if you re-read it carefully, you'll see he definitely is talking about SVR.

He says with parens mine:

Since these
patients (those still detectible at week 12) are not HCV RNA undetectable they cannot achieve a SVR..."  Then he goes on to say that these patients will not become undetectable WITH LONGER TREATMENT (caps mine).

So..l. if they can't become undectable with longer treatment, then it stands to reason they won't SVR

------
Yes, be intereresting to see what Dieterich says, but like I mentioned earlier, I think he will discount your very borderline detectibles and assume you were UND by week 24. In other words my guess is he will tell you to extend treatment.

-----------

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[jmjm530]

The link works for me, maybe try again. If not, maybe "tinyurl's" aren't welcome in Sweden :) If that's the case, let me know and I'll get you the original link somewhere -- just don't want to screw up the formatting since that link is three lines long.

http://tinyurl.com/6j466y