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Dr. wants to extend tx!!!!! yikes!
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Dr. wants to extend tx!!!!! yikes!

2nd tx.  rvr at 4 wks this time.   Now at 41 wks.  still und.  Got a letter from my doc today that he recommends I extend tx 24 more wks past the 48!!!  Even with und at 4 wks????  he states that it is because I relapsed last time.  But last time I was und at 11 wks.  not 4.  I have had a hard time with tx, 3 blood tx.  anemia is awful.  so are the side effects from the neupogen...just to name a few.  I cannot stomach even thinking about an extra six months....what are your thoughts guys?
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162 Comments Post a Comment
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1491755_tn?1333204962
My heart goes out to you.  I wish I was a hepatologist and could offer you an educated opinion.
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Avatar_f_tn
i meant 3 blood transfusions, not 3 blood tx...

jean
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1477908_tn?1349571310
Ugh, I've been at that crossroad too.

Can I ask what your staging is? I read you had a Riba reduction a few months back...how long did that last and at what dose?
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Avatar_f_tn
That's my question as well.  Were your dosages reduced at all in your last treatment and for this treatment and if yes, at what weeks, for how long and by how much?  Thanks.
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Avatar_m_tn
NO WAY! Take your chances. With a 4 week RVR I would feel confident to stop at 48.  You have Telaprevir or Boceprevir to fall back on if you relapse. I just dont think another 24 weeks of the harsh drugs damaging the body is worth it.

If I did anything beyond 48 weeks it would be tapering off the interferon.

Something like 3/4 shot 49th week, 1/2 shot 50th, 1/4 shot 51st.

The tapering off gives your immune system time to start fighting on its own. Do data on this just personal experience and opinion.

Best of luck
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Avatar_f_tn
I am a 1b.  1/2 biopsy.  i had a riba reduction and it has not been increased, because of my weight loss and my anemia problems.  I started at 1000, and have been at 800 since the reduction.    I am so disillusioned right now.  My alt/ast is normal for the first time!  wasnt during last tx.  und at 4 wks.  11 wks last tx.    I am really torn up about this.

Jean
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Avatar_m_tn
Wow what a nice christmas gift from your doctor hey? Although it does seem to be the norm that doctors extend tx for relapsers even if und at week 12. how being rvr plays into that i don't know. If you do decide to extend tx try not to look at it as 6 more months, just play it one week at a time.

For all you have went through already you must be one tough cookie and determine to beat this, myself i would try and go as long as i could, just one week at a time.

Wishing you the very best,
cando
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Avatar_f_tn
i had the same riba reduction last tx.  I think it was around 20 wks.  It did not get increased.  because of my weight, and anemia.  no transfusions last time.  but it has been really rough with the anemia this time.

copyman,
I am inclined to agree with you.  I feel I will have svr. If not, I would rather do 6 mos with a pi thrown in.  plus, my body needs a break, as well as my mind.
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Avatar_f_tn
cando,

I feel being rvr has got to be a good thing.  Makes me wonder if good ole doc took that into consideration before writing his letter.  BTW, I was just in his office last Thursday....???
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Avatar_m_tn
" I would rather do 6 mos with a pi thrown in"

Would it only be 6 months if you were a 2 time relapser? Something you might want to ask.
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Avatar_m_tn
" Makes me wonder if good ole doc took that into consideration before writing his letter"

Good point there!
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Avatar_f_tn
cando

i just assumed it would be 6 mos.  but you may be right.  as a 1b relapser, it may be longer.  Just as I thought I may be getting my life back soon....but don't you think being a rvr is in my favor of stopping at 48?
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Avatar_f_tn
I would say ditto on can-do-man's comments, all of them.  I wouldn't be so quick to throw away 41 weeks of treatment and an RVR without digging deep and giving it just a little extra kick.  If I had already toughed my way through 41 weeks of treatment, I'd keep going and hope I'd never have to do this again.  Telaprevir and Boceprevir have yet to be approved and once they're approved, the insurance companies need to do their part and it's unknown what they're going to cost.  If you were waiting on treatment or still detectable at 12 weeks, that would be different.  But you've already made it to 41 weeks and toughed through this.  I sure wouldn't want to do this again if I didn't have to and Tela and Boce both require interferon and ribavirin.

I'd approach it also not as 6 months but one week at a time.  I'd get as far as I could tolerate and then stop.  That's my take on it.....not being actually IN your shoes.

It's your body .. and your experience however.  And a tough decision regardless so I wish you good luck in sorting out what's best for you.
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Avatar_f_tn
I would also agree...that as a two -time relapser, they may want you to go 48 weeks even with Telaprevir or Boceprevir.  I would give your current tx as much kick as you can muster up in you and hope it sticks.
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Avatar_f_tn
cando/trish

what do you think of copymans idea of tapering off the interferon?
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Avatar_m_tn
Sure do, being rvr has to be in your favor, not sure i recall anyone here ever being in this situation before, just the normal relapser doing 72 weeks their next tx if being a g1..... Being you have little liver damage might be a good way to look at it.......... Really sorry you have to be going through this.
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Avatar_f_tn
Can I ask what your ribavirin dosage has been throughout your treatment up until now?  That's the only dosage reduction you've had?  Thanks.
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Avatar_f_tn
thx cando.  really bummed.  but this tx has a way of doing that to us, doesn't it!

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Avatar_m_tn
Tapering to me would be just like dose reducing, myself it would be all or nothing. Just my opinon though.
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1477908_tn?1349571310
That's a tough call. If you were a 3-4, I'd say stay the course, especially since you've got so much invested into tx already. Is your 800 mg. Riba weight based for you?  With your bx and the serious anemia issues throughout, if I were in your shoes, I'd stick it out as long as I could, at least to 48 weeks and hope for the best. I went 72 but I didn't have the anemia issues you have and was crawling my way to the finish line.Teleprevir would be perhaps your best bet since Boceprevir has serious anemia issues. Like can-do said, there's no guarantee of the 6 month course with the PI's, so I wouldn't count on that. It's a hard call being so close to the new drugs and being so near the end of your second tx. My heart goes out to you.
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Avatar_f_tn
yes trish.  just riba reduction.  started at 1000. reduced to 800.  I cheated for awhile and stayed at 1000, but the anemia got so bad I had to reduce.  Doc wanted to go to 600, but I never did it.  Im a bad girl....
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Avatar_m_tn
"but this tx has a way of doing that to us, doesn't it!"

That it does, but we fight on. As a relapser that is now SVR it was worth it... Just keep smiling.

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Avatar_f_tn
I totally intend to finish out the 48.  Maybe kick in 52, if I can.  But I don't know if I can...the anemia is awful!!  Yes paen53, the riba is weight based.  I started out around 130 and am now at 104.  have been around 102-108 the last few months.  I guess so much of my dilemma is emotional.  If I had gone into this knowing I would be doing 72 would be one thing....but I didn't.  and with a 4 wk RVR, I just never even though I would be advised to extend...my bad.
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Avatar_f_tn
cando,

how many times did you tx?  and for how long?
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Avatar_f_tn
"Tapering to me would be just like dose reducing, myself it would be all or nothing. Just my opinon though. "

Ditto to can-do-man. Again.  I'd give it full guns if I was going to keep going.  Riba and interferon full, a week at a time to what you can tolerate.
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Avatar_m_tn
First tx i was a slow responder so i went 86 weeks and relapsed, then got in a boceprevir trial, did 48 weeks and now SVR.... But i was stage 4 so decisions was not as hard to make.
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Avatar_f_tn
cando

wow.  86 wks!  My hat is off to you...    what geno are you?  Congrats on your svr!!!!  
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Avatar_f_tn
"I guess so much of my dilemma is emotional.  If I had gone into this knowing I would be doing 72 would be one thing....but I didn't.  "

That's tough, particularly when it's unexpected.  Really...everyone has the potential to be facing an extension to 72 weeks going in.  Or...the opposite.  I had mine yanked on me at 34 weeks unexpectedly.  Didn't like that much either.  Treatment is really an expect the unexpected but it's hard to prepare for every eventuality.  Some things happen you weren't expecting and then you have to adjust.

If this is mostly mental....then take some time to adust your thinking and take it a week at a time.  I wouldn't necessarily see the need to go a full six more months but I can see some logic in going somewhere beyond 48 weeks.  
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1477908_tn?1349571310
Getting near the end of tx and then hearing you should extend IS an emotional issue - no doubt about it. I knew I had to extend, but was crushed (an understatement) when I had to stay at high doses. Once the shock wore off, I was able to re-focus and stay the course - and you may find  you get your mojo back too. One day at a time........
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Avatar_m_tn
This is a very personal decision that only you can make. My feeling is if you are going to relapse at this point you are going to even with 72 weeks or even a 100 weeks! If you relapse after 4 week unde then it dont matter how long you treat.  

What weeks did you get the PCR done during this treatment?

Being an EVR (early responder) first tx & RVR this tx I would stop at 48 weeks or taper  off like I said in my last post.

I think what damage can be done with that extra 24 weeks and it just doesn't make sense.  I don't think the odds or risk makes it worth it.

But enough of that negative talk. You are going to SVR this time :)
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Avatar_m_tn
I was a geno 1b and crazy, now i'm just crazy.....:)
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Avatar_f_tn
copyman

I had PCR done at 4wks, 12 wks, 24 wks and 36wks.  Did the ultra sensitive test  which test down to 2.  (not 43 like the dr used last time).  with these tests, my normal enzymes, my RVR, just the one riba reduction, which made sense due to my weight, even though I cheated for a little while,  I truly feel like I would have svr...

cando

I am 1b also.  tough ones, arent we!
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Avatar_f_tn
The logic to me would be to go , as a 1b, 48 wks of tx once you are und.  Since I was und at 4 wks (and maybe before, just did not test until then), I would think that 52 wks could do the trick.  Is my thinkng askewed?
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87972_tn?1322664839
As a genotype 1 patient, I treated the first time with Pegasys; I didn’t achieve a 2 log drop at 12 weeks, so we increased riba to 1800 mg/day and because I didn’t become fully undetectable until between week 16 and 20, we extended treatment to 56 weeks. I relapsed at 30 days post.

Second go around, we changed to Pegintron, and increased riba to 2000 mg/day. I became undetectable for virus between weeks 4 and 8 this time. My doctor agreed to allow me to extend to 96 weeks based on liver damage (stage 3-4), previous relapse, and also because I tolerated therapy so well. I never really became anemic or neutropenic, and other than some fatigue, I found it very tolerable. I was successful the last time, and have now been SVR since August, 2008.

The landscape has changed since then; some form of three way cocktail appears inevitable, and of course, I wasn’t dealing with the side effects you are, Jean. I won’t try to interject with any opinion, I just wanted to share my experience with you, and wish you the best. You can draw whatever you want to from this.

Good luck and I hope everything works out for you this time, regardless of the path you choose.

Take care—

--Bill




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Avatar_f_tn
Thank you Bill.  So glad you achieved svr after so much hard work.  I don't know what to do.  Scared to extend, scared not to.....

Jean
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29837_tn?1314410659
A few months from now when you're completele Hep free, all this won't matter. I say go for it with careful monitpring by your doctor...

Magnum
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29837_tn?1314410659
Make that "monitoring" by your doctor...

Magnum
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Avatar_f_tn
Well jt, I put 72 straight weeks into it and it's not easy.  Long term exposure to interferon and possible post tx side effects shouldn't be an issue because you've already been exposed, nothing you can do about that now.  Just for the record, I didn't ever have any problems with that,

You upped the odds of SVR with an RVR but you didn't guarantee anything just like extending ups the odds but no guarantee.  However, extending doesn't increase the odds by very much but RVR does.  I like numbers and I'm not sure if my math is accurate but the way I see it and factoring in previous relapse you've got about a 70 percent chance of beating this by extending out to 72 weeks.  If you stop at 48 weeks and relapse you go another 48 weeks with a PI and a 75 percent chance versus six more months with SOC with 70 percent chance.  If it were me, I'd go for extending SOC.

I've never thought tapering interferon was beneficial.  Seen several who have followed that concept but it didn't work to their advantage.  Hit the virus with all you got right to the very end under the watchful eye of your doctor of course.

Trinity

  
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Avatar_f_tn
"Long term exposure to interferon and possible post tx side effects shouldn't be an issue because you've already been exposed, nothing you can do about that now.  Just for the record, I didn't ever have any problems with that, "

I wouldn't say that's exactly true.  Continuing to pump interferon and ribavirin into a body can do interesting things over time and it simply needs to be monitored.  I don't think any of us who DID come out with post tx side effects were able to predict that we would and it doesn't seem to have much to do with how short or how long one was on the treatment.  It simply impacts people in different ways.  You can take a slew of people who were all on treatment for the same length of time even and they will go through treatment AND come out of it differently. That's where the careful monitoring comes in.  And that doesn't necessarily prevent something such as thyroid issues, it does catch them though so that you can deal with them and manage what comes along. That's all you can do.  Take it a step at a time and deal with what comes.  So I wouldn't want to hold out false hope that you're at no risk of additional side effects or post side effects.  The fact is...we simply don't know and we take our chances with this stuff and we go along under the careful (hopefully) supervision of our doctors and we keep an eye on our own labs and do the best we can.  

Good luck with your decision, jt57.

Trish


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1183884_tn?1356358153
Of all the people to have to extend treatment, I can just imagine how difficult it is to get this news when you were thinking it was almost time to wrap it up.

You've been through a really tough battle, but of course there is no way to know for sure what is the best course of action. If you hadn't suffered sever side effects (especially anemia) during tx then the generally prescribed method seems to be to extend.

I suppose there is always consideration of how extended tx will risk one's body. It seems only you can make that decision. Obviously you can stop anytime if you choose to extend.

I am sorry you are facing this now, I know how much I am counting on tx being over, and I haven't been through nearly what you have been through.

Good Luck - Dave
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Avatar_m_tn
I agree with the others who have said that this is very emotional for you because of the shock of finding out that you should go another 24 weeks when you thought you were finishing soon.  But you still have 7 weeks to make that decision.  I would concentrate on the goal of 48 weeks first.  Then you could decide to continue for a few weeks more as long as you can stand it.

Vik
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Avatar_f_tn
(2) 48 week tx = 96 wks SOC

(1) 48 week tx + (1) 72 wk = 120 wks SOC

(2) 48 week tx + (1) 48 wk triple  = 144 wks

(1) 48 week tx + (1) 72 wk + (1) 48 wk triple = 168 wks

The math indicates long term exposure to interferon with all the scenarios.  
96 wks - 120 wks - 144 wks - 168 wks.... all long term exposure.  Jt's case in particular, the point is if she does experience post tx side what duration time was responsible?  The least amount of exposure to interferon will be 96 weeks and that's a long time.  That bell has rung, can't take that back.  That's not false hope, those are facts.

Trinity
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Avatar_f_tn
I am the type of person that has to have a goal in sight....can change the goal along the way if I have too, don't always like it, but.....

I am definately going to go 52 wks.  instead of 48.  If my body will allow.  I feel i can definately add 4 more wks to the mix.  But will have to wait and see about more.  My concern is the anemia, phsically, and my emotional state.  The drs have played with my procrit this entire tx, which has caused me to end up in the hospital, 3 transfusions.  My  hema is wanting to dump the procrit and just do regular transfusions, but I don't agree.  I hate the transfusions and the procrit will work if they just give me what I need!!!    Emotionally I am not good.  All my relationships are suffering.  I really need to weigh out LIFE.   To go on another six months is a hard pill for me to swallow.  And Im not sure my family can take it.  I'm pretty mean these days   and I cry very easily, which they are not used to.  We have all been marking the days off the calendar. Now the wind has been knocked out of all our sails..I have tried to be strong, I have tried to hang in there.  But there come a time when I am going to have ro recognize my own limitations.  I placed a call to the dr after I got his NICE LETTER, but have not heard from him yet.  Hopefully I will today.  Throwing 4 more wks into the mix cant hurt.  I will have to wait and see if I can do more.  In my heart, I feel I am cured...But as we all know with this disease, there is no guarantee.

I so appreciate all the feedback.  BUT IM HANGING ONTO THE FACT THAT I AM A RVR THIS TX, EVR LAST TX.   Had high iron and ferritin issues with last tx.  did not start with those issues this tx.  Hit it hard with riba, even after the reduced me.  cheated until I couldnt because of the anemia.  OH, what is a girl to do.....
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979080_tn?1323437239
not that it changes anything , but i find it strange that you get extention news @wk41
what has changed since wk4 other that you stayed UND all this time ?

Also I would want to know how much exactly your doctor thinks the extension will
increase your odds ? There is never a 100% as we all know.
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Avatar_m_tn
The key here is that there is no hard data stating 72 weeks will increase your odds of SVR, "that much", if any. However there is data showing RVR increases the odds a lot so that is why 48 weeks would be enough for "me".

As for the tapering off the drugs. This concept was something I have seen others do with success and my doctor also (Hepatologist) went along with it. It worked for me but I also did Telaprevir so who knows.
I didn't taper off thinking it would guarantee SVR. I just liked the concept, it made sense to me and figured it couldn't hurt. I had the extra drugs so why not.
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Avatar_f_tn
good point Bali05      I think the fact that I have remained und is his validation that I should just keep on keeping on.  But Im like you.  why extention news now?   Wish I had known months ago...
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96938_tn?1189803458
If you relapse after 52 weeks it's 100 wasted weeks.  There is no carry-over benefit to a 3rd tx.
How sensitive was that 4 week pcr and are you sure it was 4 weeks?  It's not unreasonable to re-check basic information when making a weighty decisions.

If you are in the vicinity of 100-120 pounds I'd think about extending (maybe not a full 24 but some middle ground) with 600 mg riba.

You don't want to do this a thrid time.
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Avatar_f_tn
FLGUY

the 4 week pcr was to 43,  the rest of the tests have been measured down to 2.  And yes, it was 4 weeks to the day.  all of my tests have been, this tx.  what are the odds that 72 weeks is better for me that 48, or 52?  I feel that if I give up more of my life for this tx, which I have really fought hard to hang in there and slay this dragon, it might be better spent when the pi's are available.  when my body is stronger.    I am really scratching and clawing to make it 48, but Im determined to do so.  and feel I can squeeze in 52.  but not sure about more.
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96938_tn?1189803458
From what you write you most significant problems (anemia, procrit, transfusions) seem to stem from the riba.  I saw your post about your current weight and 800, 1000 riba.  Your body seem to respond to the riba (unlike some people).  At about 102 pounds, 600 is about the right weight dose and you seem to have positively responded to less riba whe you reduced it in the past.

Toleration of treatment, in many respects, is a key to continuing.  Maybe if you drop the riba a bit (as the doc suggests, by the way) maybe the intolerable treatment can be a tiny bit more tolerable even if it's not the full 24 the doc suggests.

It's generally a good idea for the patient to survive treratment.
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179856_tn?1333550962
To be honest I did 72 and it wasn't that easy. However it worked. so it's hard for me not to suggest going with your docs opinion since you have relapsed once already. It's not just getting to UND it's training your body to use it's own immune system that is clutch to success. If it doesn't do it........that's where the relapse happens.

I dont know any studies to suggest that 52 would do anymore than 48, if I was you I would go as long as I could just taking it one week at a time.

You really don't want to have to do this again, PI or not. FLGs suggestion of dropping the riba down (at this point it is your body weight anyway and you are far out in tx) and continuing the interferon to get that immune system trainned makes the most sense to me.

I am curious why the doc did not bring this up earlier. In my case I had to fight for it and it wasn't approved until week 46 but at least I knew I had done everything I could at that point and what would happen would happen.

Good luck Jean either way!
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1183884_tn?1356358153
Hi Jean-
I don't want to make this anymore difficult for you, but in case you haven't already read this information perhaps it will be useful. It doesn't seem to differentiate between und at 4 weeks and 12 weeks in relapsers from what I am understanding.
Good luck,
Dave

http://www.hivandhepatitis.com/hep_c/news/2010/010510_a.html
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2009.01218.x/abstract

Management of Non-responders and Relapsers Treated with Pegylated Interferon plus Ribavirin for Chronic Hepatitis C


SUMMARY: Management of patients who do not achieve sustained response to an initial course of interferon-based combination therapy for chronic hepatitis C virus (HCV) infection remains a challenge, according to a review article in the December 2009 Journal of Viral Hepatitis. Fewer than 10% of non-responders benefit from re-treatment, but the odds improve with extended duration of pegylated interferon plus ribavirin, and directly targeted anti-HCV agents offer hope for the future.


By Liz Highleyman

Fewer than half of patients with hard-to-treat HCV genotype 1 achieve sustained virological response (SVR) -- or a cure -- with their first attempt at treatment with pegylated interferon plus ribavirin.

"The probability of a previously treated patient responding to re-treatment depends on the nature of the previous regimen, the magnitude of the response to previous treatment, and the patient's characteristics," wrote Douglas Dieterich from Mount Sinai School of Medicine and colleagues.

In particular, relapsers (those who achieved undetectable HCV RNA during treatment but experienced a rise in viral load after completing therapy) have higher re-treatment SVR rates, as do people who experienced partial response (reduction but not clearance of HCV RNA) compared with complete non-responders.

Re-treatment of non-responders using a standard 48-week regimen of pegylated interferon alfa plus ribavirin resulted in sustained response rates of about 6% in the EPIC-3 program and about 8% in the REPEAT trial. In REPEAT, however, the SVR rate was twice as high -- 16% -- in those re-treated for 72 weeks (P = 0.0006). "Based on available data," Dieterich and colleagues wrote, "extended treatment is the best option for these individuals."

Undetectable HCV RNA at week 12 was an important predictor of successful re-treatment in the REPEAT and EPIC studies, as it is for initial therapy.

Based on disappointing results from trials such as HALT-C, the review authors noted that, "Maintenance therapy with pegylated interferon is generally ineffective in non-responders and cannot be recommended."

Directly acting antiviral agents, such as the experimental HCV protease inhibitors telaprevir and boceprevir, may increase sustained response rates in prior non-responders and relapsers. However, these drugs have mostly been studied in combination with interferon plus ribavirin -- therefore adding to the burden of adverse events -- and "will not be available for some years."

In conclusion, Dieterich and colleagues wrote, "after careful evaluation of an individual's benefit-risk ratio, a 72-week regimen is the preferred strategy for optimizing sustained response rates in patients who have not responded to the standard of care, provided that viral RNA is undetectable at week 12 of re-treatment."

Mount Sinai School of Medicine, New York, NY; Division of Gastro-Hepatology, Ospedale S. Giovanni Battista (Molinette), Torino, Italy; Department of Gastroenterology, Hepatology, and Endocrinology, Medical School Hannover, Hannover, Germany.

1/05/10

Reference
DT Dieterich, M Rizzetto, and MP Manns. Management of chronic hepatitis C patients who have relapsed or not responded to pegylated interferon alfa plus ribavirin. Journal of Viral Hepatitis 16(12): 833-843 (Abstract). December 2009.
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1113735_tn?1273178030
Hello Congretulations for SVR. I am apsolutely with Trish , when it comes to extending tx to 72 weeks. Specially because you are geno 1b. Do your best to endure untill the end.I have a same problem. I am geno 1 and went through therapy. I was undetect.at week 12, (dont know before that, because they did my PCR only at begining , and at week 12, and ofcourse the end of therapy). At the end (48 weeks) detectable again.I also had a lot of problems with anemia, because he reduced me Riba.to 800 ( and I am not a little , and small girl, eventhough I lost by then about 10 kg).I am sure that reducing therapy, is strongly associated and connected to the final  results.I never took any of medications for raising blood plateletes (since my Government Funds dont pay for that). IT was October 2008, when I finished. Now is two years since then , and I am thinking about repeating it again. My Doc. told me that is up to me, so I will have to make decision, since I will have to finance therapy this time on my own. Waiting for a new Tele or Boce+Peg.and Riba., might take a while, specialy in the country where  I am from (east Europe).If I decide, which I think I will do, if I face anemia again, I will go for Eritropoetin, or so ( in your country is Procrit, Neupogen, etc....)its the same thing I guess, (if someone is more familliar with that can give me a clue).I know that is far from easy, but keep on untill 72 weeks! Good,good luck!
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96938_tn?1189803458
These things are not questions to you but me wondering out loud...

Based on what I read, your second treatment is the same as your first treatment with the exception that you responded earlier the second time (11 vs 4) and you seemed to hit the wall earlier too.

The thing that gnaws at me is the concept that if you do the same thing the second time that you did the first time that one would expect the same result.  The wild card in all this is the 4 vs 11 and wondering what the difference  is between TX 1 and TX 2, which is preplexing.

We often read here that there is x% chance or y% of patients that clear or don't clear.  I'm not sure if you can get anything significant about a population when you have exhibited such different personal results in two treatments.  Sometimes we get a little clouded by the numbers, probablilites and data.  In the end, it's much more simple - either you clear or you don't.  It's easy to get caught in the mumbo jumbo and sometimes you need to just give what you can, do your best, sprint the last few hundred yards and then hope for the best as you roll the dice.

I've used my limit of metaphors for the day.

Good luck in your decision.
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Like copyman said, there is no hard data to indicate longer tx will make a difference, especially if you are stage 1/2.  And to bali's point, what is making your doctor make this recommendation at week 41?  Your doctor's recommendation is baffling.

I did 88 weeks of tx and a 4 week taper and relapsed. But I don't regret it because I am stage 3/4 - your position is quite different.  I do certainly understand your wanting tx to end.

I feel for you being in this situation.  I would certainly grill my doctor about his/her reasoning for the recommendation if I were you.

Regarding the riba, did you see the recent study about riba/anemia and SVR?  
http://www.medhelp.org/posts/Hepatitis-C/Study-Anemia-in-treated-HCV-patients-bodes-well-for-sustained-virologic-response/show/1410985

BTW, I did the taper because I thought it might be beneficial in reducing long-term sx, not because it would affect my SVR chances.  I don't know for sure if tapering did anything because I have no basis for comparison.  But tapering makes sense to me and I plan to do it again next go round.

With an RVR, you are looking pretty good.  Crossing my fingers for your SVR.
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I wouldn't be afraid to stop at 52 weeks. I think you'll clear despite your previous relapse. Undetectable at week 4 is a very very strong predictor of SVR.
You cleared at week 4, your histology is decent, your anemia is a good sign and, aside from your relapse, I see no compelling reason to extend to 72 weeks. Does it increase your chances? Probably - but minimally so in my opinion.

I'm not competent to advise you how to proceed. I can only say that I would not be scared to stop at week 52 but, if you feel well enough, it certainly cannot hurt your chances to extend.

Good luck,
Mike
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"I'm not competent to advise you how to proceed. I can only say that I would not be scared to stop at week 52 but, if you feel well enough, it certainly cannot hurt your chances to extend. "

I would come in somewhere around there in that go as far as you can, simply.  And I'm not competent, nor any of us, frankly to advise you how to proceed.  It's only our own opinions.  Tough, very tough to have to make a call like this.  In the end, you do the best you can with what you know and the rest is left up to "what will be will be".  

When my treatment got yanked at 34 weeks, I had the option to go off the trial and continue with a different medical team .. or simply stop.  It was agonizing to decide.  Agonizing.  Lots of opinions and very good ones.  However, in the end, it was all on my own shoulders and I had to make the final call, as do you.  I know what a tough spot that is to be in and my heart goes out to you.  Every situation has it's variables.

I would like to *suggest*...and only my own unlearned opinion....that you get to your 52 weeks and then simply continue to take it a step at a time.  You don't need to decide past that point and nor should you, because you will have to see how you're doing.  Something could change between now and then.  I understand goals.  It gives me the motivation to keep going to the next goalpoint.  And then set another one.  And so on.  I think you have a very good plan to aim for 52 weeks.  And then you can assess your situation as you approach that point.  I see no reason why you have to decide NOW to do 72 weeks.  

Even at that....things may come up between now and then that may change things yet again .. and you'll deal with them if they do.  If anything is constant when it comes to treatment....it's change.

Heart goes out to you ... however you have full support here for whatever you decide is best for YOU.  

Trish
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thanks Trish.  I will be so glad when we have the drugs to eradicate this awful disease.  I wish this on no one.

Not even my sister in law.....
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I am not treating exactly the same as last time.  High iron and ferritin last time.  I was told I should not have treated without getting it under control.  I did that and then started tx again.  It has since gone back up during tx, but I started in a different place.  could be why I was an rvr
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LOL!!!!  You still have your sense of humour. That's a *great* sign. You're awesome...and you'll do fine.  
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but trish, my ex husband may be a different story....
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"...what are your thoughts..."

Your doctor is covering his @$$ without much thought of what the consequences to you are.
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I wouldn't be afraid to stop at 52 weeks. I think you'll clear despite your previous relapse. Undetectable at week 4 is a very very strong predictor of SVR.
________________________________________________________________________
I agree totally!  I would quit at 52 weeks, period.   Doctors are a trip!  All they know is what they see most of the time, in other words they have no idea what it feels like to go thru tx at all.  good luck!!
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And to bali's point, what is making your doctor make this recommendation at week 41? "

Maybe the doctor had just read what Spectda posted and it weighed on him heavily or something. I would certainly ask him what his logic is and what study information suggests that 52 will do anything more than 48 - certainly the code of conduct around here has always been Berg and S. Tapias but the latter is not applicable here in this case.

But I do agree that the interferon is already on board and adding a few more weeks isn't going to really do a darn thing at this point. I think those of us who developed autoimmune problems developed them way earlier than the 40s......

Can high iron vs. low iron really be the entire difference here in tx results?

It will be interesting to see how this works out.

QUESTION - did you have an earlier PCR last time other than the 11 week test?
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nygirl

yes  i started at 5 mill  4 wk was 3k 8 wk was 187  11 wk was neg  

and the dr did not suggest 52 wks  i did  he suggested additional 24!
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Part of the problem really is that there is no guideline or study that has been done to support anything except extending to week 72.  When I had to extend (remember I had a great response but was stuck at 400 until somewhere after week 12 and before week 24 so not the same) I only wanted to do 60 but none of the doctors would agree to it because there was no protocol to support that going to 60 would do anything.

I am guessing your doc figures that since had to lower your riba and you are a relapser that the 72 gives you a better chance.  If you were not RVR it would not matter it would be automatic 72 but I guess there is just nothing to support anything else (and I did go to Dr. Ira Jacobson and that is what he told me, in my case, that I had to do the 48 or 72 there was nothing in between).

I really dont think doing 52 makes any difference from 48 but then again I'm not a doctor and only am basing it on the facts of what I just told you.  Maybe it has something to do with insurance approval too.

I am curious to know why he wants you to extend though as an RVR which we all wish we could have been but have not had that luck :(
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i would think rvr would carry some weight......i tend to agree that considering my rvr, this letter was probably an *** covering letter.  I know drs have to follow protocol.  But if he truly felt I needed the extention, I believe he would have called me in his office to TALK me into it.  Instead I simply got documentation for the proverbial paper trail.

wish he would call!!!

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HE CALLED!!!

I pointed out my rvr. the study showing severe anemia was a predicator for svr.  The fact that this tx is tough for me.  I even corrected him on what week of tx I am in.  He thought I was further along.   I am convinced, he had not really paid any attention to my file and my stats.  I told him I would go as long as I could.  But I truly did not think i would make 24 more weeks.  He had a change of heart.  He said looking at my rvr, and the other records, he feels I should stop at 48,  I told him no.  I wanted to ride it out, but he said all indicators were good and if I did relapse, we would wait a year and revisit it.  He also said that in his 30 years of practice he had never had a relapser to become rvr the next tx.  geez,  I am worn out..
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He said looking at my rvr, and the other records, he feels I should stop at 48,"

Yes this what we all have said there is nothing else to ride out at week 48 you are done. There is no reason to do anything more than that, it's just overkill.

Glad you got your answer!
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I guess that puts it in perspective.  The scripts stop after you complete the 48 weeks.  Unless you have something rock solid, I mean down right compelling to justify extending I'd say leave it as it is.  Less drama that way.
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something I would do is run a Qualitative TMA test.
I am currently treating with the same doctor Nygirl treated with.
He believes in the TMA Qual as being the best for sensitivity.
Not TMA Quant (it gives too many false positives according to him)
TMA is a different amplification method and it can happen
that people are PCR negative but TMA positive after 48wks.
If TMA positive and PCR neg. you are more likely to relapse.
http://www.natap.org/2006/HCV/080106_03.htm

Also two TMA positives while PCR negative is not a good sign.

My Hep likes to run <43 Real Time PCR Quant  +  TMA Qual together same draw.

Since the TMA Qual has a detection limit of <10 , I still prefer the NGI QuantaSure
<2 but there is no direct comparison available , so I say just run them all.


After all what`s another VL test these days to make sure?

just a thought ......
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Isn't it frustrating that we have to tell the drs what is going on?    THANK YOU ALL FOR TALKING ME THRU THIS!!!!  this board is more helpful than any dr!!!  I may relapse, but I don't think so.  If I do, I will tackle it with a pi, and when I am stronger.  at a weight in the low 100's, hgb hovering in the 7 and 8's.  neupogen kicking my butt every week.  an emotional wreck (not to mention my family).  It is time to get strong and have faith that i have it kicked.  I want to live like I am dying, not live like I am dead.  I have fought the good fight.  got 7 wks to go.  plz pray for me guys.]

and again.  thanks everyone for all your support.

Jean
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"so I say just run them all."  What a revelation!  There is a thing called limited financial resources or insurance company approvals and denials.  Perhaps you've heard of that?

Trinity
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I have been running the quantisure <2 throughout my tx, except the 4 wk  that was <43.  That is the TMA Qual?
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Yeah.  I can run them all, but it would have to be at different times.  BCBS don't play that.

Jean
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I meant What is the TMA Qual?
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FYI the tests you have been running (QuantSure) is the most expensive around approx $730 if you had to pay for it.
TMA Qualitative is done by Quest labs.
If Quest is covered by your insurance they will run the <43 PCR Quant together
with the TMA Qualitative <10 if your doctor gives you a lab requistion for it .

I have one of the lousiest insurances there is and if they will pick up the tab
I am sure BCBS will too.

It`s pretty easy to find out

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I dont want the <43 Quant .  I want the Quantisure..
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Me too , and in this case we both are negative using the QuantaSure.
As I said earlier running a different amplification method "TMA"could give
you extra reassurance.
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Oh.  I understand.  I will ask for it.  Thanks!
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Someone who wears a well-fitting belt (I had PCR done at 4wks, 12 wks, 24 wks and 36wks.  Did the ultra sensitive test  which test down to 2.)   does not need suspenders (I want the Quantisure) to hold up her pants.
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Very good point FLGuy!  Thanks!
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" I told him I would go as long as I could. "
-----
I think that's a good thought to hold on to ... once you get to the 48, anything after that is just 'icing on the cake' so to speak.  As long as YOU'RE satisfied in the end that you're done, you can be accepting of whatever the outcome.  Wishing you the best. ~eureka
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I would keep going for so many of the reasons already laid out very well by Trish, cando and others.  

I went 84 weeks. For me it was too depressing to think about the long-term goal. I just tried to go a week at a time and I was able to keep going. Your odds of success look very good with the 4 week RVR. Just think about being hep free in the end and how great it will be to put this whole thing behind you for good!

You only have to do one week at a time. you can do this.

Brent
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I agree these doctors are a trip. sometimes they need to be put back in line. it was easy for him to tell you to do 72 weeks. If only he would have looked at your records and saw RVR if would have saved you a lot of grief.

well back to square one. If considering doing the extra 4 weeks maybe taper off the interferon. this will be the icing on the cake.
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the tapering makes sense to me, copyman.  what research have you done on this?

Jean
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thinking of tapering also , read the HR posts in the archives

problem is how do you get the extra INF  ?  It is expensive and even if your doctor
plays a long with a rx your insurance still needs to ok it
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To each his own but I think tapering is pointless.  There is no peer reviewed clinical data to back it up.  When your done, your done.
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I agree 100% with Trinity.  

I also think people should not give medical advice about length of treatment choices.  We are all lay people here.  We might know more than some doctors about some things, but in the end, we are amateurs and have no business recommending treatment options. It is one thing to say here are the options, make an informed choice.  It is quite another to say, I think you should do x.
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I am always open to new approaches and share them with my experienced hepatologist
before I put anything into action.
Making "suggestions" like copyman did in reference to tapering for example helps keeping my mind open. I still need to discuss it with my Hep but if it were not
for other people helping to come up with ideas , they would most likely never
be on the table.
I discussed  predosing Riba and induction double dosing INF with my Hep and I
will discuss tapering as well. For that purpose I appreciate any additional
information anyone possibly has and I think Jt57 is interested in discussing it
as well.
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"He also said that in his 30 years of practice he had never had a relapser to become rvr the next tx."
=============================
That's fascinating........ I wasn't aware that they had been treating HCV for that many years.  They were actually only to test for and differentiate it just before 1990.

You also have to wonder..... in the "30 years" he has been treating HCV patients how far back he did 4 week PCRs?  My sense is that testing for RVR is a fairly recent protocol.

My comment is that I just had a friend complete a 48 week TX.  They had prior relapsed from a past from a 48 and 72 week treatment.  This time they RVR'ed and the 4 week EOT PCR said clear.  We will see what the 12 & 24  week PCR is, but I wanted you to understand that your case isn't one for the books.

I also wanted you to know that the "books" probably don't go back 30 years and that the 4 week PCR tests may be a rather recent phenomena.

Doctors professional opinion; good.

When they actually read your records and correctly interpret; priceless.

best,
Willy
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I can tell you from personal experience that 30 years ago, no one knew what HCV was.  I was diagnosed in 1987 with Non A Non B hepatitis.  HCV was discovered in teh early 90s, but there were no PCR tests.  By the mid 90s, there were PCR tests, but no Riba until 1996 but withour pegylated interferon.  Finally Pegylated interferon and weight based Riba came along and presto, many prior relapsers became SVR.  Then, response based treatment was put in practice and again -- better results including prior relapsers.

So far, I have not seen a single study or even a valid theory that says tapering Interferon produces better results.   I am an amateur and I don't read as much as I used to now that I am SVR.  It is possible that I missed a paper on tapering Interferon, but it has never been presented at any of the major conferences.  If anyone has a study they think makes a valid case for tapering, I would greatly appreciate a link to it.
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Very good points about hep c testing time frame.  I was (needle) stuck in a hospital setting 1994 and had to insist on a 6 months HIV - my hep couldn't believe that they didn't test me for Hep C.  Guess what, even as an RN CEN, I didn't know about Hep C at that time or you could bet I'd made them test.
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The latest studies posted by vertex show that prior relapsers that do a course of Telaprevir plus SOC for 12 weeks followed by an additional 36 weeks of SOC have an 83 - 90% chance of SVR.
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Woohoo!   Tick...tick....tick
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Wow now those is some great big fat marvelous numbers arent they?

BEAUTY!
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I think my doc was referring to the fact that he had been practicing for 30 yrs.  Maybe i did not communicate it correctly.  I did not say my case was one for the books, nor did he.  He stated that he personally had never had a patient respond the way I have.  

I think all of us are aware of when Hep c was actually acknowledged as a disease and testing began, hence treating.  We all have hep c, right?   And I don't think the people on this forum are giving medical advice....they are giving medical opinions, which I appreciate.  Most of them follow up that opinion with a disclaimer...

I do my own research before making my decisions.  I would like to know more about the tapering off because it makes logical sense to me.Any info anyone has on it I would appreciate.

Jean
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You can find a lot of discussion about tapering in the archives.
Here is something I just dug up , originally posted by Orleans in 2009

Hepatology. 1996 Jul;24(1):21-6.

Improved sustained response following treatment of chronic hepatitis C by gradual
reduction in the interferon dose.

Shiffman ML, Hofmann CM, Luketic VA, Sanyal AJ, Contos MJ, Mills AS.

Hepatology Section, Medical College of Virginia, Richmond, Va 23298, USA.

Interferon (IFN) treatment of chronic hepatitis C virus (HCV) is associated with
a high rate of relapse. IFN is thought to exert its effect against HCV via direct
viral inhibition and immune stimulation. We have hypothesized that relapse
following termination of therapy results from the sudden withdrawal of this
immune modulatory effect and that gradual reduction in the IFN dose may decrease
the incidence of relapse. One hundred six patients with chronic HCV were enrolled
into this 24-month controlled, randomized prospective trial. All were treated
with 5 mU of interferon-alpha-2b three times a week for 6 months. Patients who
achieved biochemical response were randomized to either stop or taper IFN
gradually at monthly intervals as follows; 3 mu, 2 mU, 1 mU, and 0.5 mU (all
three times a week). 0.5 mU twice weekly and then once weekly. Liver histology
was assessed by Knodell index and HCV RNA was measured by a quantitative
polymerase chain reaction (PCR) assay. Of the 92 patients who completed the
initial 6 months of IFN treatment, 47 (51%) achieved biochemical response.
Twenty-one of these patients were randomized to stop IFN treatment and 25 to
taper (1 drop-out). At randomization patients were well matched with respect to
age, sex, race, serum alanine transaminase (ALT), and liver histology.
Biochemical relapse was observed in 19 of 21 (91%) patients who stopped IFN
treatment compared with only 60% who tapered IFN (P= .04).

Virological relapse
occurred in 90% of patients who stopped and only 48% of persons who tapered IFN
therapy.

At completion of the 24-month study patients who achieved long-term
sustained biochemical response had a significantly lower mean Knodell score (3.5
vs. 6.5) and a significantly greater number were HCV RNA negative in serum (85%
vs. 18%) compared with relapsers.

We conclude that gradual reduction in IFN dose
is associated with a  SIGNIFICANT HIGHER RATE OF SUSTAINED RESPONSE and clearance
of HCV RNA from serum compared with abruptly stopping treatment. This in turn is
associated with a significant improvement in hepatic histology supporting the
premise that response to IFN therapy can prevent progression to cirrhosis.




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thanks!  Do you know how gradually this was done?  Over 4 wks, 8 wks, ?

Jean
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Most of that info is very very old and as far as I remember we all sort of disregarded it as being necessary or anything a long while back.

If the job of interferon is so that when it's stopped your bodies immune system is 'kick started' into working it sort of seems opposite to me....tapering it slowly wouldn't give you that kick start.  At this point in almost 2011 they would know if it really was viable and most top docs would be doing it but I dont know of any that are.

As for someone (me) who had either a false neg at my EOT week 4 of 63 or something but since then has maintainned SVR - I will always believe that it was the fact that it took my immune system a little while to kick start in after treatment but that it did. But that is typical of my course since I had two strains and couldn't get to UND to save my life (except when it finally was necessary I've always been stubborn). ;)

Just my opinion though but I dont think anybody really practices this any longer.  
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Sorry if I was snarky about the doctoring.  IMHO your doctor originally seemed to be undervaluing the RVR.

As of late that seems to be about the very best predictor of SVR.

Here are a few links. There is talk about an RVR being used to determine if a 24 week TX is sufficient. for geno 1's

Yes.... you relapsed and no one wants that to happen again, but for instance...... in the Telaprevir trials the most likely person to succeed isn't a TX naive, it is a past RESPONDER that relapsed.  It isn't such a stretch that you RVR'ed.

http://www.hivandhepatitis.com/hep_c/news/2008/101408_b.html

http://www.hivandhepatitis.com/hep_c/news/2010/0903_2010_a.html

There are other links on the subject, papers at AASLD or EASL.

It is a tough call but there is some evidence that suggests you have done enough at 48 weeks.  The evidence may get sketchy trying to find proof that adding 24 weeks will change the outcome.  There are people who do become injured through exposure to SOC. See the black box warnings that accompany the drugs.  One would think that greater/ longer exposure might equal greater risk.

best,
Willy
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maybe copyman knows more , looks like he was part of a lot of those discussions back than , also merrybe is very knowledgable about the old HR posts..
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Tapering did not work to merrybe or smaug's advantage.
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Copy succeeded after relapse (thank GOD finally) with boce and merry is a relapser herself....these drugs are hard core and personally if you dont need to extend I cannot see why staying on them just for the heck of it.  Look at all the folks who did extend and yet did not succeed? I agree with Willy that RVR seems to trump everything these days as a predictor.
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My recollection of the tapering, without reffering back to previous posts, was that the subsequent tapering was AFTER the full course of treatment and not replacing the later SOC weeks with less Peg.
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Thanks for the clarification.

As far as advice is concerned, anyone that reads the forum for awhile will see that some people have strong opinions and others present the data and let people decide for them self.  On the other side, some people believe what they want to hear, so for example, saying that it's ok to stop treating might cause someone to take the advice if they were having a hard time and wanted to stop.  Many of the opinions are truly well informed and in many cases more so than most doctors.  Some others are not well formed opinions.

This is true for both doctors and people on this forum.  It is nice to think that the licensing and education required for doctors would make them all perfect, but we all know that is not true.  I do think that the licensing and education requirements make it more likely that doctors are better qualified to give advice than most people on this forum.  

Differentiating between medical advice and opinions is splitting hairs in my opinion.  The biggest danger in taking forum advice or opinions is that we on the forum do not get to see the patient or all the data and (jokingly) we are idiot savants medically: we know a lot about a little (HCV).  The doctor gets to see the entire patient and has training on how to evaluate all the data.  Not just HCV statistics.

Using myself for example, during the Telaprevir trail, I was undetectable by the end of week 2.  I wanted to stop at 24 weeks, but Dr Dieterich said I should go the entire 48 weeks.  I believe that discussion here would have produced many opinions telling me to stop at 24.  Dr D said that because of my age, 67 at the time, he felt that my immune system was weaker than the average trial person and that I stood a very high chance of SVR if I went 48 weeks.  I took that advice and I am SVR.  Of course, no one knows what would have happened if I stopped, but looking at the trial results now that they are published, I increased the odds of SVR by staying on for 48 weeks.  I bet that once the data are refined, age will be a determining factor in lengthening treatment.

Eric
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Copyman stated earlier in this thread he believed in it and that he knew others
who had success with it.
Would be interesting to know what kind of tapering schedule was done after EOT.

The only reason I am entertaining the idea is that I have no reason to believe
it will harm but could maybe help. If it is not for relapse maybe with post
side effect issues arising from INF withdrawl (withdrawal) so to speak.
Of course it is all a guess...but I appreciate the open discussion and everybody`s
viewpoint and experience
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If interferon withdrawl (withdrawal) was real then everyone would experience it without expection and they don't.  I didn't after 72 weeks of the stuff and many many other haven't either.

Trinity

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flguy is correct, the taper was in addition to the full course, i did it, did it help? who knows, i had the inf, so why not
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I guess the word "withdrawl (withdrawal)" is subjective.
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I believe that discussion here would have produced many opinions telling me to stop at 24."

HA you know which camp I would have been in............I am glad you stayed on the full 48, just in case it did matter ;) cause now you never have to worry about it again!!!!!!!!!!!!!!!!   :)

And yes of course the idea of tapering is in addition to the full SOC that was a very good point for FLG to point out. Personally I think it's overkill (and that coming from a 72 weeker) but sort of like if you taper down slowly to nothing isn't that sort of like not doing the interferon ever at all? Interferon doesn't kill the virus it trains our immune systems to do so - wouldn't it be like untrainning your immune system?.......it just doesn't make sense to me but then again that's just me.

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as to getting the extra interferon to taper off, you have to tell a little white lie. something like two syringes were broke during shipment, etc etc.

you get the idea.......
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man am i getting forgetful , i think i left it on the backseat of a NYC taxi cab a long
with the additional Riba....

just kidding.....

I discussed the issue of tapering before (different forum) and I am getting more
prepared now for my wk36 meeting with my Hep when I will put it on the table.

When I originally "signed up for tx" the PA confirmed that they would taper me of
if I wanted to , of course that guy is no longer there now.....
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Here is the thread where HR presented his ideas on tapering.  

http://tinyurl.com/98fstf

In that thread HR also posted the following (albeit a study from 1996, which makes one wonder why more follow-ups were not done):

Hepatology. 1996 Jul;24(1):21-6.

Improved sustained response following treatment of chronic hepatitis C by gradual
reduction in the interferon dose.

Shiffman ML, Hofmann CM, Luketic VA, Sanyal AJ, Contos MJ, Mills AS.

Hepatology Section, Medical College of Virginia, Richmond, Va 23298, USA.

Interferon (IFN) treatment of chronic hepatitis C virus (HCV) is associated with
a high rate of relapse. IFN is thought to exert its effect against HCV via direct
viral inhibition and immune stimulation. We have hypothesized that relapse
following termination of therapy results from the sudden withdrawal of this
immune modulatory effect and that gradual reduction in the IFN dose may decrease
the incidence of relapse. One hundred six patients with chronic HCV were enrolled
into this 24-month controlled, randomized prospective trial. All were treated
with 5 mU of interferon-alpha-2b three times a week for 6 months. Patients who
achieved biochemical response were randomized to either stop or taper IFN
gradually at monthly intervals as follows; 3 mu, 2 mU, 1 mU, and 0.5 mU (all
three times a week). 0.5 mU twice weekly and then once weekly. Liver histology
was assessed by Knodell index and HCV RNA was measured by a quantitative
polymerase chain reaction (PCR) assay. Of the 92 patients who completed the
initial 6 months of IFN treatment, 47 (51%) achieved biochemical response.
Twenty-one of these patients were randomized to stop IFN treatment and 25 to
taper (1 drop-out). At randomization patients were well matched with respect to
age, sex, race, serum alanine transaminase (ALT), and liver histology.
Biochemical relapse was observed in 19 of 21 (91%) patients who stopped IFN
treatment compared with only 60% who tapered IFN (P= .04).

Virological relapse
occurred in 90% of patients who stopped and only 48% of persons who tapered IFN
therapy.

At completion of the 24-month study patients who achieved long-term
sustained biochemical response had a significantly lower mean Knodell score (3.5
vs. 6.5) and a significantly greater number were HCV RNA negative in serum (85%
vs. 18%) compared with relapsers.

We conclude that gradual reduction in IFN dose
is associated with a  SIGNIFICANT HIGHER RATE OF SUSTAINED RESPONSE and clearance
of HCV RNA from serum compared with abruptly stopping treatment. This in turn is
associated with a significant improvement in hepatic histology supporting the
premise that response to IFN therapy can prevent progression to cirrhosis.  
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Withdrawals is a very big reason i think tapering makes sense.  When I stopped tx before, I definately had withdrawals.  They were awful.  I dont know if it was from the ribavirin, interferon, procrit......you get the idea.  I'm leaning toward the ribavirin, simply because it was a drug I took daily for 48 wks.  So yes, I would like to know more about tapering, not just for my immune system, but for the withdrawals.  On everyday rx, they usually state, "do not stop taking this drug abruptly".   Im thinking there is a reason.  But Im going with RVR.  My money is on it.  I do know there is no guarantee.  But Im going to take my chances.

Thanks to you all..

Jean
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Rooting for you and hoping for you, Jean.  

Trish
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Jean,

I had planned on tapering after my 72 weeks for the same reasons you gave. It just seemed right after being on these drugs for so long, that an abrupt stop could create problems. My Dr. did not agree, but I had enough stash to carry me for a couple weeks if I wanted.

But in the end, 72 weeks was more than enough for me and I didn't feel any the worse in the initial post tx time - energy soared quickly. Three months later things changed somewhat, but I didn't experience any immediate withdrawal issues, just the sweet thought of finally being DONE.
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Ribavirin has a very long half life and gradually leaves the body so your body basically tapers it all on it's own. Takes about 3-6 months.  I seriously doubt anyone would experience any adverse effects after stopping ribavirin.  As I said previously, the whole withdrawal thing is subjective anyway.  Pearlman wasn't on board with tapering and that was good enough for me.

Trinity
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You all make very good points.  Maybe I should just suck it up, be happy I am off the drugs and live again.  Please pray that I am svr this time.   If Im not, I will tackle again down the road.  with a stronger body and mind.  but I pray this rvr is an indicator that I am done..  Love you all.  and hoping for svr for all of us!

Jean
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and mabe my withdrawals are the irritability leaving my body....
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From Smaug's post:

"....One hundred six patients with chronic HCV were enrolled
into this 24-month controlled, randomized prospective trial. All were treated
with 5 mU of interferon-alpha-2b three times a week for 6 months. Patients who achieved biochemical response were randomized to either stop or taper IFN gradually at monthly intervals as follows; 3 mu, 2 mU, 1 mU, and 0.5 mU (all
three times a week). 0.5 mU twice weekly and then once weekly...."

"...Of the 92 patients who completed the
initial 6 months of IFN treatment, 47 (51%) achieved biochemical response.
Twenty-one of these patients were randomized to stop IFN treatment and 25 to
taper (1 drop-out). At randomization patients were well matched with respect to
age, sex, race, serum alanine transaminase (ALT), and liver histology.
Biochemical relapse was observed in 19 of 21 (91%) patients who stopped IFN
treatment compared with only 60% who tapered IFN (P= .04). "


Of those patients who achieved a biochemical response (undetectable viral load I assume) at 6 months - one group (control group) stopped treatment and one group (the taper group) continued treatment for at least 4 more months and it looks like a 6 month extension albeit with decreasing doses of interferon.

So, if that is right, one group treated for 6 months and one group treated for at least 10 months and probably l12 months.

That's not the type of tapering I thought we were talking about - a 6 month taper! That looks a lot more like extending treatment beyond 6 months than it does a taper. No wonder we see twice the relapse rate! I haven't revisited the HR thread but I wonder why HR thought this said anything about "tapering" as I have seen the concept discussed here.

HCV treatment was in it's infancy when this study was conducted and provides no relevant information, in my opinion, regarding the impact of tapering following a standard course of treatment.


Mike
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My life revolved around treatment for 72 weeks.  I had the physical and emotional side effects to deal with and it occupied my mind everyday whether I wanted it to or not.  My whole world involved adjusting, tweaking and rethinking all the things I had done in my life without much thought.  After stopping treatment I had to adjust my thinking and focus on recovery because it was no longer a core basis in my life. It was like a big chunk of my world disappeared and moving forward was more difficult to do than I had anticipated.  It took a little time but I realized I did not want to be consumed by a chapter in my life that was closed or an outcome I had no control over.  

Trinity

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Amen Trinity!  My experience has been he same.  Time to live.  We only get one shot at this and I have alot of work to do when tx ends.   Im sick of being consumed by my limitations.  Never done well with vulnerability, and I have been more vulnerable during tx than I feel I ever have.

Merry Christmas everyone!

Jean
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Best of luck to you and Merry Christmas.
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Mike - all good points and I concur. Not a comment for or against tapering, just in using this study as justification for it.  It would need a whole lot more data than this, I'm thinking.
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Merry Christmas to you, Jean....hope you get so much enjoyment out of the beauty of this season, my favourite holiday. :)

Trish
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i thought in the states you could just buy interferon?
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You mean like on the streets?  Oh hell no, but I suppose there's a black market for everything if you know where to look.  If I'm going to hit the streets for drugs it's not going to be interferon I'm looking for. :)
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LOL boy James you really think we live in the land of opportunity here dont you ;)  Us Americans out running around looking for cheap interferon LOL I agree with Trin if I have to go looking it aint interferon or riba I'll be looking for ;)
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bali said you could , thats why i asked , but can youi buy it if the doctor gives you a perscription? maybe thats what he meant
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Yes you could buy it with a prescription - although at the cost of $20,00 for 48 weeks who'd want to unless you HAD to?  I dont ever want to have to buy it again even with insurance that is for sure. Evil stuff LOL.
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"yes you would wonder"  

hahahaha
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Public domain once you post it on MH Bali!
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In that case you might want to also monitor 3/4 of the posts on the other existing threads.

Trinity
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jt57: congratulations on a very successful if difficult tx, W11 und was already respectable but pushing that back to w4 is really amazing! What strategy did you use to reduce ferritin and what was the change in your rbv mg/kg ? It never ceases to amaze me how one can make such dramatic changes in ifn-responsiveness by tweaking the right dials.

Andiamo/Trin: do you know whether vertx has released anything on REALIZE more recent than their Sept 7. press release? Agreed the numbers for relapsers look very good. Per Pockros' AASLD slides (which will likely become  defacto AASLD usage guidelines after getting cleaned up) on-label PI use will probably follow the trial protocols, so for relapsers 12+36 (and similarly for boce). An interesting detail is that the lead-in arm eked out a better (88%) response than the simultaneous start (83%).
http://investors.vrtx.com/releasedetail.cfm?releaseid=505239
I've been placing my bets on the assumption that if a 4w lead in helps, 24w can't hurt. But in any event starting a month before 1st PI seems a good idea.

all: how history repeat repeats itself!. That Shiffman'96 study was obsolete in '08 and has gotten a couple of years mustier in the interim. There may be good reasons to gradually reduce ifn dosage - but that study  does little more than confirm that in '96 they didn't yet know you can't treat G1s with 24w.  Tapering only makes sense if you believe there is a sizeable population of infected cells at eot - and whether the native immune response can control them determines whether relapse occurs. Mikesimon posted a very interesting recent paper about a month ago that provides uptodate evidence for gradual phasing out of the virus post-EOT, Unfortunately I've lost it and am too frazzled to dig it up at the moment - Anyone have the link?
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Was this it?

Sporadic Reappearance of Minute Amounts of HCV RNA after Successful Therapy Stimulates Cellular Immune Responses.


http://www.ncbi.nlm.nih.gov/pubmed/21040725
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One thing i'm confused about here is it seems  that relapsers will extend tx to 48 weeks when the new pi's come out even with an RVR, (12+36 instead of 12+12) at least thats how they seem to being heading with the trials. So why not with just SOC.? Maybe i'm missing something here but it seems that relapse trumps RVR.
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yes - thanks! I glanced at it at the time and then lost it. Very interesting stuff - looks like the final chapter of the occult/persistent vl saga. Basically both sides were right - yes there is post tx vl and yes it eventually fades.
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not sure I understood your question. Relapsers are a pretty homogenous group. Our ifn response passes the Goldilocks test - we're neither nulls nor partials nor super-responders, just stuck in the good, but not quite good enough box. Tx naives on the other hand are all over the map. It makes sense that the  PI protocol for relapsers (with acceptable but not great ifn response) would be 12+36 whereas for naives (many of whom will be super-responders) 12+12 will work fine among those who rvr. But maybe I completely misunderstood your point ...

Sorry to hear fatigue is still an issue BTW.  It sure is one of the sides I was hoping to leave behind.
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I was responding to some posts that feel a relapser should do the same exact thing over again for the same amount of time if one is RVR the second time around even though they was evr their first failed SOC.

To me doing the same thing for the same time could bring the same results, and it looks like even with the PI's they feel a relapser should tx longer.

BTW willing how is tx going for you?







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My husband repeated the same treatment for a second time. although with Pegintron instead of Pegasys. First time clear at 12 weeks, went 48, relapsed AFTER 4 weeks EOT ( 4 weeks post treatment was negative viral load ). 2nd treatment, Dr said 48 weeks was enough ( was clear at 4 weeks ), but I wanted him to do 72. My husband settled on 58 , from the beginning and stuck to it. Was SVR at 6 months post, and coming up for 12 months post. Feels great and liver function excellent.
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I have no additional data on SVR rates for relapsers.  Did you try the Vertex website?
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personally ive never heard of anyone who rvrd only to relapse later  thats not saying its not possible  but its one of the best positive predictors for treatment outcome    also i read the protocol for telaprevir with previous relapsers would most likely be 12 + 24
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suem37: congratulations! So another case of g1  rvr-on-retx. You wouldn't know it from this thread - but these are pretty rare events! Did your husband make other changes besides ifn2a-to-ifn2b? (eg increase rbv, reduce weight or IR?). Anyway - congrats on a great outcome.

cando: I see your point about not doing the same thing over and expecting different results, but I think an rvr is VERY different from a garden variety evr. In fact I suspect that had jt57 gone through with the Dr's letter she  might  have been the 1st rvr on the planet to do 72w.

Re tx,  I'd be lying if I didn't admit it's kicking my *** pretty hard. But hopefully I've  found a steady walking pace I can keep up. Rbv is at 1500 (18mg/Kg) and the Hgb seems to be holding in the low 11s, anc   0.9. Expecting  und by start of the year (about w8). Definitely no rvr but a good improvement over last attempt. Hope to add a PI in summer to cut relapse risk but even if that doesn't pan out,  odds seem fair.

Andiamo: thanks.  I looked at their press releases but have found nothing more recent than the Sept. 7 one linked above. Wonder whether the full FDA filing will become publicly accessible at some point.

bostoncream: Please post where you read that - it would be interesting to compare. REALIZE was vertex's phase III previously-treated trial and all arms did 48w. Study design is in the press release above and at
http://www.vrtx.com/assets/pdfs/VRTXRealizeFactsheet.pdf
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Hi, I don't know the answer but I believe that the approval will bring us response guided TX, yes even for past TX failures

Here's why;
1) shortening the treatment time one one of the primary goals for a new compound.

#2 There was a level of success with Prove 3 on the shorter TX arms for RVR's;  I don't think they had a lot of difference between the 24 and 48 week TX arms in Prove 3.
==================================
http://www.hivandhepatitis.com/hep_c/news/2008/061308_c.html
"• 73% of prior relapsers achieved SVR12 with 24-week telaprevir-based treatment.

• 41% of prior non-responders achieved SVR12 with 24-week telaprevir-based regimen."
==================================

#3; Quite right about the TX times in Realize, but I'm not sure that it means that they are wed to the concept.
I think they are exploring the longer TX time for 2 reasons;
     a) They were lacking a "12 and 36" arm in Prove 3
     b)  Boceprevir had a longer TX arm that showed a very high success rate; I think Vertex decided to try it as well.  The problem....if you want to call it that, is that telaprevir worked so well that in Prove 3 if memory serves there was not a lot of difference between 24 week total and 48 week total SVR rates, at least not so much in the RVR's.  it is the slower responder that longer treatment times will probably help.

I don't claim to know the correct answer.
But a 24 week TX is one he1l of a sell for a past TX failure. I'd guess that it may be an option for RVR's.
Time will tell.

PS....I'd guess that there were exclusion factors in the trials.  Anyone who treated for ONLY 24 weeks was probably a RVR at 4 through 12 weeks.  I don't even think they are doing 12 week PCR's anymore after a RVR.  IF the didn't attain RVR they surely didn't stop at 24 weeks.

Currently there is also a mitsubishi (telaprevir) trial for past tx failures w/ a 24 week total TX time; 12 & 12.

I'm not sure you'll find it in print yet but I expect there to be 24 week potential TX  with a RVR for past TX failures.  My opinion.

I hope that this isn't too disjointed; if it is I'm posting it anyway.  : 0
Too late to be typing.

best,
Willy
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"cando: I see your point about not doing the same thing over and expecting different results, but I think an rvr is VERY different from a garden variety evr. In fact I suspect that had jt57 gone through with the Dr's letter she  might  have been the 1st rvr on the planet to do 72w. "

jt57 - jean - is already a rarer bird.  She was a complete eVR who relapsed.  A smaller percentage of those, around 32%.  So perhaps not your everyday RVR.

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Eric & willing;
"Andiamo: thanks.  I looked at their press releases but have found nothing more recent than the Sept. 7 one linked above. Wonder whether the full FDA filing will become publicly accessible at some point.
=======================================
This is from Vertex in their November 26 bulletin that they applied for the NDA.  Note the last sentence;

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=532555

"In REALIZE, people received 48 weeks of total therapy, which included 12 weeks of telaprevir combined with pegylated-interferon and ribavirin. One of the telaprevir treatment arms was designed to evaluate, for the first time, whether viral cure rates could be further improved by starting pegylated-interferon and ribavirin alone for the first four weeks of treatment (delayed start) compared to a simultaneous start of telaprevir in combination with these medicines. There was no clinical benefit observed with the telaprevir delayed-start treatment arm in any of the subgroups of patients compared to the simultaneous-start arm. Final results from REALIZE, including safety and efficacy data, will be presented at an upcoming medical meeting.
=============================

Vertex has indicted they were very happy with the way the Phase 3 trials went; they were better in all aspects than the phase 2 trials.  We may find out by EASL.

willy
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Trish: yes - but no all cevrs are equal. The overall average is around 70% and since for RVRs  it's well above that  for those who clear close to the dealine it's got to be quite a bit lower. Look  at the difference within the blue and yellow teams on the SVR prediction algorithm on my journal between those below the limit of quantitation (BLQ) or above. Also , in Figure 2 from
http://www.ncbi.nlm.nih.gov/pubmed/19091819
how the predictive power of the low-sensitivity test (the CAM) drops off in the w9-12 range.

Any shred of vl remaining by w12 nukes your svr odds on 48w.  The odds for an und11 aren't going to be 70%...

Some of this hits close to home. If I und by w8 and can't add a PI I'll stop at 48 - otherwise I'll hunt around for plan B.

Willy: no argument that there will be many more dials to twist and adjust after PI approval and that  response-guided tx always make more sense than a  cookie -cutter approach. However part of FDA approval is agreeing on the package insert and what it says about dosing and duration. The point from Pockros' slides, which seems reasonable, is that those usage guidelines will  be written using the available evidence - and for tela re-tx that's primarily the REALIZE data with a 12+36 protocol.  

Thanks also for that footnote. Yes, it sounds like they're keeping that for EASL . A bit strange that they couldn't put it in AASLD but maybe their marketing  needs something to keep the drum roll going. Also interesting to see the statement that
"There was no clinical benefit observed with the telaprevir delayed-start treatment arm in any of the subgroups of patients compared to the simultaneous-start arm"
whereas their Sept, 7 release states
"the SVR rates for the telaprevir simultaneous start arm, delayed start arm and control arm, respectively, were 83%, 88% and 24% in relapsers (p<0.0001)"
I guess the 83 vs 88 difference didn't reach stat. sig.
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Yes, my husband also pre dosed ribivarin 1200, for 4 weeks. other than that, everything else was the same. His Hgb was low for most of the treatment, down to 9 at times but epo didn't seem to help.
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Thanks for your comments.
===============================================
(you wrote)
"the SVR rates for the telaprevir simultaneous start arm, delayed start arm and control arm, respectively, were 83%, 88% and 24% in relapsers (p<0.0001)"
I guess the 83 vs 88 difference didn't reach stat. sig."
==============================================
I agree that 5% as it gets closer and closer to 100% is a large deal.  It is also a big deal for those who end up failing and having to wait for something better or for the resistant virii to re-convert to wild type.

We need to remember that these were done virtually without rescue drugs (I thinkone  Ph 3 one trial had a 1% usage, others NO usage).  We may be able to see improvement yet post approval when doctors may add these anemia helpers.

I used to think that the 4 week lead in would bring the SVR rate up; I'm sure that it must improve that initial response rate.  The bad news is that it may also increase the drop out rate due to anemia or rash.  Even so, the anemia can be treated.  

I'm sure that you are right; they need to have some instructions for treating.  I really don't follow the need for a past responder/relapser to have to do 48 weeks of TX when.....as a group...... they may have a higher SVR rate than the treatment naive aggregate.  That would defy logic for me.  
          If I recall there was once a time that there was discussion about whether the FDA could approve telaprevir ONLY for past tx failures (in order to get an earlier partial approval for past TX failures).  I thought that I understood (and I may have gotten it wrong) that Prove 3 had all the components needed for a registration NDA for TX failures only.  Therefore, it may follow that the success of the 12 and 12 for RVR  through 12 weeks may be sufficient guide for doctors followed by the 12 & 36 for slower responders.  

Time will tell and yes, I think that some of it has to do with marketing, but some of it has to do with defining the very best way to treat the hardest to treat.  That is probably harder than determining the no brainer 12 and 12 for much easier to treat groups.

Based on viral kinetics I would bet that they have a handle on how the 1 and 2 week responders would fare for TX times.  I don't know if anyone remembers that (was it prove 1?) there was a small group who treated triple therapy and were allowed to quit at 12 weeks; they still netted about a 40% SVR rate.  I'd venture that those viral kinetics could be used to assert various treatment times for various response rates.  These new more powerful drugs are going to make the concept of RVR *so* 2006.

Segue into the newer DDA trials..... The (preliminary) results of the Vertex TVR-VX-222 trials will be out in the first quarter.  It's unknown whether they will be released in time for EASL but particularly in the 4 drug trials there should be some insane viral declines.  I think they are going to have to start looking at a new acronym for the 1 week or 2 week clearance.  I also don't know if anyone remembers but in Prove 1 PLN was clear in something like 2 days.  It would seem that there is a need for the ability to predict SVR rates using the viral response/decline rates.

best,
Willy
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suem37: thanks - it's interesting that both your husband and jt57 seem to have paid for those rvrs with heavy anemia!

Willy50: yes I recall the approval-for-re-tx-only rumors ; looks like Vertex decided to go for across the board approval instead. Relapsers are still the group with the clearest overall benefit. It's hard to see any reason for the FDA to stall,  but even if they do I would hope they'd consider approval for sub-classes of pts. For null responders, whether a 30% shot at SVR is worth the risk of strengthening resistant mutations seems less clear cut.
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