UND at week 28, finally!

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

[Marcia2202]

Just wanted to say congrats to finally reaching UND.

I think that this new study is so promising!

I'm not knowledgeable enough to comment on this, but theoretically you should then be doing 88 weeks... or maybe going for 96 like some of our heroes did, would be the right thing to do.

Marcia

[Trinity4]

Smaug, are you saying that those who do no have UND by 24 wks should continue on and if so, how long?

[Deb_c430]

Awesome news! congrats!

[smaug48]

First, I am not a doctor and I do not to pretend to be any kind of hepatology expert.  I'm just another hepster trying to educate himself!! Each person has to discuss his/her situation with a qualified doctor/hepatologist to decide their own tx path.

My interpretation of the study is that the authors did not have enough statistically significant evidence to conclude that people who are und between weeks 25-48 should extend tx to >=60 weeks beyond.  More research needs to be done.

However, and this is a big however, I think the results that I posted above clearly show that people who are und between weeks 25-48 have decent shot at SVR if they treat >=60 weeks after becoming und.  

So for me, since I became und at week 28, add 60 weeks, I should do 88 weeks total of full tx (I hope to add 5 weeks beyond that to taper down the peg and riba).

But that's my assessment for my case.  I am going to thoroughly discuss this with my doctor next week and we will come to a joint decision.  I am "at least" stage 3 and feel I can't wait for the new drugs that will be coming out in a few years.

There is a risk in tx, and that risk increases with extending tx.  Each person has to weigh the risk/reward equation for their situation and make their decision in consultation with a qualified hepatologist/doctor.

Hope this helps!

smaug

[Proactive]

Congrats smaug!!!!! Good news indeed. Where is your riba dose now? 1400? 1600/day?
Pro

[Deb_c430]

More and more (thank goodness) more informed GIs are not sticking so much to standard SOCs.  Instead they are more and more treating each case as indvidualy.  

As much as I dislike txt,  I am glad you have a Doc willing to work with you and not give up.

Deb

[Trinity4]

I'm stage 3 also.  Was not UND at 12 wks - starting 1,300,000 - 12 wks 793 IU/ML.  I won't have another PCR until 24 wks and everyone has advised if I am UND at 24 to extend to 72.  I will probably clear sometime in the next few weeks or maybe already have as this is wk 17 but I was going to quit if not clear at 24.  As a matter of fact, doc won't treat further if I don't clear at 24 wks and like you said it's more of a decision based on individual situations and doctor recommedations.  Thanks for the info.  BTW, this is my LAST time with SOC -  I will wait for new meds also, with better percentages and less tx time.
Trin

[comeagain]

Congrats now you know your a responder.
It has been my strongbelieve for quite som time that if you respond, meaning get to UND shown by a enough sensitive test, you also should be able to clear on soc its just a question of strategi.

Doses but as I think most importent lengt of treatment ( the wart theori ) and the study posted by drofi very much confirme my believe.

Good luck on your ongoing tx, could that ND mean no differens.

ca

[Magnum]

Congratulations! May you remain that way forever...

Magnum

[smaug48]

Thanks for the good wishes!  Yes, I've been fortunate to work with a nurse practitioner and a doctor who are more foward-thinking.

Pro, I am still on 1400/day.  NP said she wanted to increase to 1600 but wanted to wait until the Procrit kicked in (haven't even taken Procrit yet, long story).  But now I am und, so not sure if we will still ncrease or not.  

How are you feeling?  More back to normal yet?

smaug

[Proactive]

Thanks for asking, actually I'm doing pretty well. As you might recall I was one of the ones who put a few pounds on during tx, and continued to add a bit of weight a few months post, finally topping out at 180lbs. Now 4 1/2 months post,back down to 170 (pre tx weight)...To be honest, I'd say all remanats of tx and sides are now gone now.
Hopefully I will get an official declaration of svr in Sept..and then it will be time to persue and battle my osteoarthritis!! (vbg).
I didn't get a chance to see Anne at my last visit with the hep doc..the woman is a peach.
Keep me posted, and best of luck....
hey, by the way, the pic in my profile is taken from here, looking in your direction-well maybe a bit toward Curtis' ribs...VBG
pro

[smaug48]

Great to hear that all remnants of tx are gone, but what a bummer about the osteoarthritis.  Sometimes a guy can't catch a break  :-(

BTW, after looking at your profile, I calculated my weight-based riba dose to be 20 mg/kg/day.

Thanks for pointing out the picture, great view.  I'm partial to Top of the Hill Grill :-)

smaug

[FloridaMouse]

Congratulation my friend!

Mouse

[rita863]

Congrats on UND!!!

peace
rita

[charm27]

Wish you well. Thats great news UND. Best of luck. Hang in there.







CHARM

[smaug48]

Thanks so much for the good wishes - they mean alot.

Mouse, thanks for those undie vibes amigo, they worked!

smaug

[fretboard]

Glad to hear some great news!!  I'm a 1a myself, I'll be tx'ing soon.  later

[smaug48]

Best of luck to you, keep us posted on your progress.

From one Jimi fan to another.

smaug

[zazza]

Just want to check with you. Did you have any viral load tests done between the one at week 24 and the one at week 28? If not, you could actually have become UND at any time in between these two tests, right?

Za

[jmjm530]

Smaug: I wish people would stop saying that not getting to und by week 24 means a 2% chance of SVR!!!
------------
First, congrads on getting UND.

Yes, I've posted similar to above -- as have a number of us here. It was based on previous study(s) that suggested a very low chance of SVR for those detectible at week 24, even with 72 weeks of treatment. The question therefore is if there's almost no chance of SVR in that sub-group with 72 weeks of tx, then how all of a sudden do they have a great chance with 88 weeks?

I've tried to pull up the study in question but so far no luck, so all I have to go on is my memory. Hopefully I'll find it, or perhaps someone else will.

-- Jim

[Deb_c430]

The statistics may say that Jim, but each  person responds differently, the word almost is not all.  


If you are one of only 5 % is it it worth it?

[jmjm530]

Of course it's an individual decision, but don't you agree that we should have as much data/stats as possible before making that decision? When I give my opinion, it's just that, my opinion in terms of what I might do and why. Hopefully I make that clear and hopefully others do as well.

[Deb_c430]

yes i agree with that,     slow down jim, no one was attacking you or your opinion,  

Informed GIs are now treating each case indvidually, because of slow responders and the abilty to change SOC  for each person

[nygirl7]

CONGRATS ON FINALLY GETTING YOUR UND!!!!!!!!!!!!!!!!!!!!!!!

Trin,

Although GIs are indeed beginning to see the value in treating each patient individually - you can't throw the baby out with the bathwater.  The statistics of the older study are tried and true - as someone who did treat for 72 weeks and investigated this all WAY before it was the current "trend" I can't see how the older numbers can just be negated completely because I new study was done.

I would get a second opinion from one of the best hep docs in the world, no matter what the cost and what the travel problems.  Someone like Jacobson who understands the subtleties and differences of how this "new" study can possibly be correct if the old study is too.  Considering ALL of the latest studies say getting to UND at week 4 or as close as possible is CRUCIAL to success. It just can't be both things.

Unfortunately I can't see it making sense since both statements can't be correct.  I would ask someone much more knowledgable than us what the parameters of the study were before I would even THINK of doing treatment for that long.

Be sure be sure be sure - interferon is some nasty poison as you know.

[zazza]

I can't remember any study that looked at 72 weeks for super late responders.

[BWCABOB]

Conrats smaug!

I am also a 1a and was told I would need to stop treatmet because I wasn't <10 at 24 weeks.
I was 20 on the Lab Corp HCV Quantasure Plus PCR test.

After getting info from this forum I asked to be immediately retested and the test came back UNDETECTABLE!

I met with my doctor on Tuesday and will be able to continue tx but must go another 48 weeks. Good news ,bad news but at least I have more hope now.

Bob

[Texas714]

Good for You!

[smaug48]

I did do a viral check at week 26.

week 24 - "<10 but detected"
week 26 - "<10 but detected"
week 28  - "Negative (<10 IU)"

Quotes are from emails, haven't received actual copies of the PCR results yet.

smaug

[jmjm530]

While this doesn't say it explicitly, I believe it was stated either in the full-text version of same study ( Berg) or in another similar study. I'll try again to find it but hopefully someone else will beat me to it.

"...CONCLUSIONS: Extended treatment duration generally is not recommended in HCV type 1 infection and should be reserved only for patients with slow virologic response defined as HCV-RNA positive at week 12 but negative at week 24...:

From: http://tinyurl.com/559vow

[zazza]

I have the full text of Berg's study here, and he has not looked at any patients who became UND after week 24. In his study those detectable at week 24 stopped tx. Also the limit of detection was 50 IU/ml, while Smaug was detected at 10 IU/ml, so Smaug would actually pass Berg's definition of a slow responder in this study.

I think what Berg wants to say with the quote you posted, is that it is only slow responders not rapid or early responders who would benefit by extending tx.

Berg does say however that to have the best chance by extending tx, you should not have more than 6000 IU/ml at week 12. Smaug was below this. My personal belief is that Smaug will have a good chance by extending tx, especially if he extends past 72 weeks. If I were him, I would consider doing 96 full weeks like Bill did. But that's me.

[zazza]

So it did really take you more than a week after being detectable at 10 IU/ml to get to UND. Interesting.

When is your next PCR? You are getting some more PCR's throughout your tx, right?

I am very happy to see that you decided to go the full 88. I was worried for a while, as you know, that you would taper off before the full 72. I fully support you in your decision.

I think one should consider very carefully if one should continue tx if detectable at week 24, and I know you and drofi have done this. You were both so close to UND at week 24 so it makes sense to continue. For others, at least if they have a choice having a good enough liver stage and grade, it is probably better to wait for the new tx drugs.

88 weeks is a long time, but so is 72. Just do it! It will be in the past before you know.

[jmjm530]

I did see it somewhere, so I guessed it was the full-text Berg, but appears I'm wrong on the source. What I did recall reading was that if you weren't UND by week 24, then even 72 weeks wouldn't help. It was that specific, and I know NYGirl remembers same, as it was discussed quite a lot back when she and I were treating and she saw Dr. J. who recommended she extend. If/when I find it, I'll be sure to post. The other point -- a somewhat separate one -- has to do with whether one's personal risk/reward equation warrants extending to say 90 weeks without significant liver damage. My risk/reward equation would say it's not worth that length of drug exposure even if the odds were decent. YMMV.

[Trinity4]

YMMV?  = You made me vomit?  Oh, I get it -  Your mileage may vary?

[nygirl7]

Jim,

Yes I remember it extremely distinctly because my entire course of treatment depended on it and my regular GI would NOT allow me a PCR between 12 and 24 saying "it doesn't matter". If I had cleared at 16 I would still do 72 weeks and if I did not I would still stop because the odds were almost impossible after 24 that the interferon would have time to do it's job trainning my immune system.  Its not that staying on it longer "kills" all of the virus' inside it's that it needed the proper reactions chemically in the body. That is how it was explainned to me although I cannot do the doctors words justice. They were admant and Jacobson was the lead investigator of Berg so I'd imagine he literally knows better than anyone.  THIS is why I advised taking this new study and asking his opinion.  I know recently that someone on here emailed him and DID get a response. He is a brilliant man who would respond to this question for certain.

I'm sorry but I agree with Jim on this one.  Coming from my experience (and how difficult it was to deal with the interferon later in treatment (ie: autoimmune thyrodic problems...skin diseases etc) it's a HUGE gamble to continue if there are such low odds of achieving SVR.  

My plan was to stop at 24, wait, and then hit the Infergen (at the time the tele was just coming out with no data behind it then).  But using something that had a less than 2% chance just makes no sense when there ARE other options available.

Just my two cents but Jim is 100% correct about the information.  I no longer keep my notebooks here or I would dig out exactly what Dr. J had to say about it.......I spent an hour asking him questions and he answered every single one for me.

You should contact  him and ask him his expert opinion.  In the end of the day - what do we know about this study except someone did it, we don't know much more than that compared to the viability of Berg.

[jmjm530]

Yes, I remember those days of decision when you were treating.

As to the current study, it wasn't available at the time -- and don't believe anyone previously collected data on treatment more than 72 weeks -- so I won't go as far to say that this study is wrong.

My only question was that if 72 weeks gave so little chance of SVR to null-responders, how do we all of a sudden get such great results with 90 weeks? I don't have the answer.

-- Jim

[smaug48]

Can you tell me how to contact Dr. J?  Or at least where to start looking for his contact info?

PM me if you prefer, thanks.

smaug

[jmjm530]

This may not be his office, but if you call the number at the bottom, they should be able to direct you: http://www.hepccenter.org/jacobson.php

[jmjm530]

http://www.hepccenter.org/contactus.php

[nygirl7]

I KNOW he had just responded to someone. I wish I had his email but I was so desperate to figure out what to do I spent the money and went to him. It was worth every single penny - he doesn't mess around, he's SO nice but he'll tell you flat out exactly what his opinion is and I think regarding this you need one of the biggies.

Since he's the only one I know who responds.........

Dr. Ira Jacobson, MD  
Hospital: NewYork-Presbyterian Hospital - New York Weill Cornell Medical Center;
Address: 450 E 69th St, New York, NY 10021-5016; Phone: [phone];
Board Cert: Internal Medicine 1982;
Med School: Columbia P&S 1979;
Resid: Internal Medicine, UCSF Med Ctr 1982;
Fac Appt: Prof Med, Cornell Univ-Weill Med Coll

[smaug48]

Thanks for the info!  I'll keep everyone posted.

smaug

[nygirl7]

I liked what they put in his comments section so I thought I'd stick it in there.

Physician: Ira Jacobson, MD
Type of physician: Hepatologist
Address: The Center for the Study of Hepatitis C

1230 York Ave
New York, NY 10021


Phone: [phone] or 866.672.HepC (4372)
Comments: Devoted to his patients needs.
Highly respected in the HCV field.

[zazza]

The way I understand virus, is that if you make the environment unpleasant enough long enough for a virus it will eventually die out since it needs to replicate. This is true of viruses such as hep C which cannot exist if they cannot replicate. Viruses like HIV do not have that need.

Unfortunately when we make the environment in our body unpleasant for the hep C virus by taking interferon and ribavirin we also make it unpleasant to ourselves, thus the sx.

I guess I will have to support Comeagain and his wart theory. Who hasn't had kids who have struggled with warts? If you fail the first time, you just have to go at it, deeper, harder and for a longer time. If you give up early, the virus wins. You have to continue long enough.

I don't think it is about teaching your immune system how to beat the virus. Interferon boosts your immune system to a certain degree and then it is about being more persistent and stubborn than the virus.

[zazza]

Of course if you never reach UND, it does not matter how stubborn you are or how long you treat. But people like Smaug and drofi who just missed UND at week 24 by a cat's whisker, I cannot believe that persistence won't help.

[smaug48]

Dr. J has very good guards.  "He's hardly in his office, only takes patients Mondays and Fridays, etc etc"  I didn't get to talk with him, and his next available appointment is October.

I did get to talk to Mary in the research center.  I explained my situation, and she said I didn't fit in the super late responder category. She said would recommend that I extend to 72 weeks if I am tolerating tx well, and that would reduce my relapse rate chance by 15%.  

She wasn't familiar with the Arase study and didn't really shed any light on the 2% issue.

I'd still prefer to get Dr.J's take.  If anybody has his email address, could you PM it to me?

I guess I'll see what Dr. D thinks.

smaug

[can-do-man]

zazza.........The way I understand virus, is that if you make the environment unpleasant enough long enough for a virus it will eventually die out since it needs to replicate. This is true of viruses such as hep C which cannot exist if they cannot replicate
------------------------
Not quite sure what your saying here, since i was und at or before week 24 and tx for 86 weeks, that would be at LEAST 62 weeks of tx after being und. How much longer should i have tx sense i relapsed after ending tx? I'm really not sure how much longer i could have tx and now wish i would have ended much sooner.

BTW congrats on your svr

Cando

[zazza]

I know, there are no guarantees with this virus, right? It is a cunning enemy. Unfortunately stubborness and persistence does not always work in our battle with the virus. But there are those for which it works. Extending tx is always a risk though, you cannot be sure you will be rewarded with SVR.

What I mean is that SOC suppresses the virus and viral replication, and I have read that the hep C virus needs to replicate. A virus like HIV can rest under bad conditions and wait til better conditions to replicate in a greater number, but the hep C virus might finally perish if its replication is suppressed long enough.

I am so sorry for your relapse. I know you treated long and hard. I believe though that those of us who are relapsers are very likely to SVR with telaprevir. I wish you luck next time around.

Za

[smaug48]

May I ask what the sensitivity of your PCR tests were? Just curious.

smaug

[jmjm530]

This paper by the well-respected hepatologist, Mitchel Shiffman, supports what NYGirl and myself have both heard and read, although not the exact paper I remember reading, which perhaps was in his supporting papers.

As mentioned, this does not mean that the more recent study posted is wrong, but it did bring up some reasonable questions, at least to me.

BTW I did see your question to Dr. D, and it will be interesting to see his response. Based on some of his previous posts, my guess is that he will view those last couple of very, very low detectibles as false positives and urge you to continue on. And because you state you are somewhere between stage 3 and stage 4, I certainly couldn't disagree and wish you all the best luck whatever course you decide to take. Dieterich, btw is known as a very agressive treater and I assume a very *realistic* treater -- so if he gives you the green light, I'd I'd say go for it! Now, if you said you were stage 2, I'd probably say don't go for it, but that's just me, which you probably know by now.

Anway, to further the discussion re the studies, and to show that neither myself or NYGirl pulled anything out of thing air  -- and btw I never posted a "2%" figure -- here are some exerpts from Schiffman:

Complete copy here: http://tinyurl.com/6j466y

"...The duration of HCV therapy should therefore be adjusted based upon when the patient
becomes HCV RNA undetectable. This appears to be independent of genotype.
a. Patients who become HCV RNA undetectable by treatment week 4 (RVR) – treat or
24 weeks
b. Patients who become HCV RNA undetectable between treatment week 4 and 12 –
treat for 48 weeks.
c. Patients who become HCV RNA undetectable between treatment weeks 12-24 –
treat for 72 weeks...

These patients have a greater than 2 log decline in HCV RNA within the first 12
weeks of treatment but remain HCV RNA positive at treatment week 24. THESE PATIENTS WILL NOT BECOME HCV RNA UNDECTABLE WITH LONGER TREATMENT (CAPITAL LETTERS MINE). Since these
patients are not HCV RNA undetectable they cannot achieve a SVR. Treatment
should therefore be discontinued in these patients at treatment week 24..."

[comeagain]

Will not become HCV RNA UND.
It seems to me he is talking about nonresponders here that never will become UND.
UND he says not SVR .
And that has nothing to do with smaugs situation since he has become UND.

Cando I´m also curios what test thay have used also curios of your liverstatus (fibrosis stage) and BMI
when you were treating.

ca

[jmjm530]

Agree with his statments or not, Shiffman clearly says: "...Since these
patients are not HCV RNA undetectable they cannot achieve a SVR..."  
--------
"they" refers to where Gauf was at week 24 "...These patients have a greater than 2 log decline in HCV RNA within the first 12
weeks of treatment but remain HCV RNA positive at treatment week 24"

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.

[can-do-man]

To answer your question i think it was <10. That is without digging it out.

Man what a tough spot your in, i do know that at week 24 had i not been und my hepo would have stoped tx as he said the odds would have been very low to ever reach svr.

Even at my stage 4 i would not tx again with just soc but am looking at getting into a trial for relapsers. My doctor did say if i ever did tx again with just soc that we would tx for at least 2 years. Curious though, if you stop now or continue and do relapse how you would be listed, as a non-responder sense not being und at week 24 or as a relapser.

Whatever you decide i wish you the very best of luck, sometimes we have to do what we feel is the right thing for us.

cando

[can-do-man]

Test was at <10, stage 4, strated tx about slighty over weight but lost that and much more in the first 30 days of tx.

Had over a 3 log drop by week 12 but hepo told me that i must be clear at week 24 or my already low odds would be close to zero if still dectected at week 24.

I must say i agree with what jim is saying and what Doctor Shiffman is referring to is that you can become und even after 24 weeks but the odds of sustaining it and becoming svr afte tx are very very low. At least that how my hepo sees it.

cando

[comeagain]

Ty for info can-do.
jim I think theres a little to little info when did this people got to UND how many where they
And how many (maby all) was stage 4 which we know doesn´t fall under the same categori as those better of.

I know that doctors signature is impossible to interpret but that UND has sustained in it thats even harder to figure out..
If you have the link please post otherwise i look in hectors posts he is always refering to him.

ca

[zazza]

Your link is not working. Please check it.

[smaug48]

Jim, thanks for the post and your added comment.  Your and nygirl's posts started making me think that I that I didn't have all the info I needed to make an informed decision.  It will be interesting to see what Dr. D says.

I didn't mean to imply that you and nygirl pulled anything out of the air.  But every study I've looked at just excluded people who were UND at week 24, which was frustrating to me because as time went on it was looking like I would be a super late responder. As far as I knew there were absolutely no studies on people who went UND after week 24 and treated for 72 weeks until this Arase study.

I don't doubt that you and nygirl are sure that not getting to UND by week 24 means an extremely low chance of SVR, and I respect your opinions.

With regard to the Shiffman paper that you posted above, though, I have to agree with comeagain.  WILL NOT BECOME HCV RNA UNDECTABLE  says just that, will not become undetectable.  Not "will not relapse."  I don't know if Shiffman had a different meaning, but what he wrote says that the person's PCR will never show "undetected" and therefore cannot attain SVR.

Za, I had no problem with Jim's link...

smaug

[smaug48]

correction:  I meant to say

But every study I've looked at just excluded people who were not UND at week 24

[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

[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.

-----------

--------

[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]

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.

[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]

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]

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]

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]

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.

[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

[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.

[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

[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

[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

[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 !

[Trinity4]

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

[Trinity4]

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

[jmjm530]

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

[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

[eureka254]

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

[dperry10]

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

Dana

[smaug48]

Thanks for the support!!!

smaug

[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.

[merryBe]

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

MB