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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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979080 tn?1323437239
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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179856 tn?1333550962
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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96938 tn?1189803458
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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220090 tn?1379170787
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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979080 tn?1323437239
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 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 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" is subjective.
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179856 tn?1333550962
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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979080 tn?1323437239
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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238010 tn?1420409872
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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1477908 tn?1349571310
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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220090 tn?1379170787
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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1117750 tn?1307390169
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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179856 tn?1333550962
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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1117750 tn?1307390169
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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179856 tn?1333550962
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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220090 tn?1379170787
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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