Really need Info

[pln]

Let me recap real quick, my study dose not alowe rescuse meds untill we stop vx at the end of week 12, Sunday is the end for me. Monday I go to study nurse for blood and more meds, I know I am not in group D which stops all meds at week 12, so I either have 12 more weeks of meds or 24 more weeks. My riba started at 1200mg cut in half at week 3 for low hbg, so I think I should start procrit so I can go back up on my riba for my remaining time. Who knows I may be on placebo!! and vx has no track record let! I need to do what is best for me and my health. Now my problem my DR will not give me procrit, told me I do not need it my hbg is 9.5, but I feel o.k. I showed Jim a paper (study) my DR wrote that said after you become und lowering riba will not hurt chances for svr, I hope you remember that paper Jim. Shoud I demaned procrit?? or should I just keep going like I am?? I KNOW vertex and all of our study nurse's read this site , My nurse, PDS nurse and MRE, Dr all got a letter about this site and the vx lab rats that post, I have been a good patinet, But should I put my foot down now?? I tried to get a pcr at week 4, was told no, so I had one done at week 11, I know that will not tell me placebo or soc BUT I did not want to go to week 20 and not know,sorry jen,  I will find out my pcr today. What would you do. Thanks Pam

[Mister beagle bailey]

Sorry hear that they won't allow procrit but I think you really have no choice as you probably signed a paper agreeing to the trial on their terms.  I know how you feel as I needed procrit durning tx too but I was not in a trial so I was able to get it.  This trial your in probably which is funded by the drug companies probably said no procrit on this trial and if the DRs give it they would probably lose funding on future trials.  It's like a catch 22, but I know how you are feeling and maybe someone else know's of a way around this for you.  Let us know how you make out.

Beagle

[NYgirl]

Part of being in a study is following very stringent guidelines so that everyones treatment is the same so they can get the result data.  I don't think it will do anything for you to "insist" as you are not on a regular treatment with a regular doctor.

As for this statement:  showed Jim a paper (study) my DR wrote that said after you become und lowering riba will not hurt chances for svr


It is patently UNTRUE.  The biggest doctors in the world (study docs)have determined that lowering the riba DOES indeed lower the chance of SVR.  Of course you surely CAN but it greatly DOES hurt your chance.

If your doctor is one of the like Big 3 then I would be interested to read it and see why they are contradicting what they have already posted data on.

PS MOst of us don't get Procrit until we are under 10 - that is a common thing anyway so if you are higher than that you wouldn't probably get it anyway.  

I hope you feel better PLN.

[prettydamscared]

Hi there,

She finishes the study officially on Sunday the 22nd.  She's not trying to get Procrit early.  The study absolutely allows rescue drugs after 12 weeks.  The problem is her study doctor DOESN'T BELIEVE IN PROCRIT AT ALL.  So, even after the study, he will not prescribe it for her, even thogh it's being paid for by her OWN insurance company and she is continuing on SOC for at least another 12 to 36 weeks.

Has anybody else experienced this?  I'm encouraging her to see another doc if her doctor absolutely refuses to prescribe even though her hemoglobin is at 9.5.  This makes no sense to me.  What do you all think?

[FlGuy]

You

[NYgirl]

OH h3LL yeah I would go to another doctor - right away.  Get a hemo or a hept or GI or anybody.  What kind of doctor would make somebody suffer when their hemo is that low - it's NOT tolerable...and maybe because he's never had it happen to him he doesn't understand that.

To him...it's JUST a number.

RUN PLN RUN as soon as you can get another doctor and don't give up until you DO get the meds!!!!!!!!!!!!!!!!!!

We completely misunderstood what you meant! I am so glad PDS posted!

[jmjm530]

Hi Pam,

Sorry you have to go through all this in addition to the normal rigors of treatment. And gosh, you're in a picklish situation so excuse any ramblings on this as nothing is clear cut.

I vaguely remember you mentioning or posting about something similar, but I thought the gist was that full-dose riba was less important after week 12 -- possibly after being non-dectectible -- not I don't remember saying that lowering riba wouldn't hurt your chances of SVR.  Why don't you post the link to the paper again, or if you don't have it, insist that your doctor and nurse provide it to you since they are the ones using it to make treatment decisions. Also, what date were you non-detectible and when did they reduce the riba, as those two factors seem germane to the paper.

Paper aside, my understanding has always been that full-dose riba is important for SVR especially during the first 12 weeks of treatment. There's also something called the 80-80-80 rule, but since you're on half-dose riba that doesn't seem to apply.

The way I look at it is that you have lived up to your end of the bargain. You followed their "no rescue drug" protocol for 12 weeks. Instead of giving you Procrit, they lowered your riba by one half. Now they're telling you that the lowered dose isn't going to hurt because of some paper that perhaps you haven't seen and none here seem to be aware of. So...if it were me -- yes, I'd want to see the "paper" right away but would also probably start doctor shopping today as a backup. Like I said, you lived up to your end and now it appears they are letting you down. At the same time, you could as others suggest 'insist' on Procrit now since you're at the 12 week mark and see what happens.

So cover your bases, get the Procrit now and start adding riba in whatever dose the protocol is. Then, once you become unblinded, when you became non-detecible, know what drugs you're really on and the duration, etc. -- you and whatever doctor you have at that point can make some more intelligent decisions on how to proceed. Keep in mind that in Europe they are trialing VX without riba. Do you want in a sense to put yourself in that trial? That's a toughie question and premature to answer at this point since you don't even know you're on Vx-950.

Good luck and let's cross our fingers that it all works out.

-- Jim

[jmjm530]

Just another thought. Now that you're approaching week 12, is it possible to remain in the trial but switch trial doctors? If so, this might be the quickest and least expensive route but I'd definitely "quiz" the new doc regrarding his philosophy on Procrit administration prior to making the move.

-- Jim

[Kalio1]

pln

After the 22nd he won't administer Procrit? At 9.5? You do have to think of your own health, I'd push for it with him, show him some of the info/studies that show it is necessary below 10.0 and if he still refuses, and it was me, I'd get my doctor or some doctor to help me get some. I've read a zillion studies and people DO get Procrit on studies all the time. He sounds like he is just bull headed and has a need to be in control rather than to help you when you need it! You are courageous to still be hanging in there with Hgb at 9.5. Mine is usually around 10 or 11 and it just about does me in some days! I hope you get Procrit soon.



PDS

I hope the rash has subsided and you are feeling ok. You are very strong to have gone through all of that and still hang in there in the study. I hope it is smooth sailing from here on out.

[prettydamscared]

Pam just had to run and go do her "meals on wheels" that she does every Fri.  I completely agree with you about this though.  I frankly think it's a little unheard of for a doctor to unequivocally state that he doesn't believe in procrit and won't prescribe it.  

By the way, her doc, as you probably know, is Dr. Shiffman.  We actually just left a message for him on his recorder and by we, I mean I did.  It's kinda scary to do that on someone else's behalf but she's so easy going that her study doc and nurse seem to discount her questions and opinions.  She doesn't get listened to.  Anyway, I said I was Pam and that I very much wanted to be prescribed procrit at the completion of the study and that I understood my insurance was paying for it.  I asked him, with all due respect, would he absolutely not prescribe this kind of rescue drug and if that were the case, we need to have a conversation about it because unless there's some medical reason that I'm (she's) unaware of, I'm going to insist on being prescribed a rescue drug and raising ribavirin accordingly.  

Damn, I hope I did the right thing.  I guess we'll see what he says when he returns the call.  Probably just really ticked him off but I was respectful and professional, just very firm.  Almost can't believe I did it but it's what she wanted to say - she's just too nice and maybe a little in awe of Dr Shiffman.

[Kalio1]

Just wanted to add that my doctor also is very hesitant to use Procrit, he feels it "brings it's own problems" with it.
However, in spite of that, he WILL prescribe it if the patient's Hgb falls below 10 and the patient is feeling awful.

Sounds like she meets tht criteria with Hgb at 9.5 and having trouble walking up an down stairs.
It was very supportive and kind of you to call for her and advocate for her! How nice to have a friend like that when she is feeling so tired and weak. I think you did the right thing.


PLN
I coordinated a meals on wheels program for many years and people like you, the people that take the time to deliver the meals each day/week are some of the best, most generous loving people in the world. Thank you so much for doing that, I know how very important tat is to the recipients.
A study was done about this and it showed that the people lived longer and had a better QOL due to the person delivering the meals bringing that slice of joy into their lives each day. The impact of the volunteer bringing the meal was even more valuable than the meal itself. And to be doing that in spite of your low Hgb, you are a true hero.

[jmjm530]

You're a good friend with good intentions. I doubt the doctor listens to his own messages anyway. You certainly were clear to the point and hopefully that will prompt a direct response.

I personally know nothing about Shiffman other than he appears to have a good reputation. Based on the paper below, I doubt if he is against Procrit per say, so maybe there is something else going on. Has PLN talked directly to Shiffman or is everything coming through the study nurse?

Anyway, here's something on Shiffman and dose reduction.


"Data presented by Mitch Shiffman from the HALT-C study, which Afdhal referred to in this oral talk at DDW, showed dose reductions in ribavirin had a more negative effect than a dose reduction in Pegasys on end-of-treatment response and sustained viral response in the HALT-C study. Shiffman reported that sustained viral response was 23% (n=118, no dose reductions) and when there was a dose reduction only in Pegasys the SVR was still 23% (n=70). But when only ribavirin dose was reduced (n=36) the sustained viral response (SVR) was 11% (23% vs 11%, p<0.008). When there were dose reductions for both Pegasys and ribavirin the SVR was 8%."
http://www.natap.org/2003/DDW/day18.htm

And here's another:

"...he use of epoetin (EPO) [Procrit] has been proven to reduce anemia and the need for RBV dose reductions. Study results presented at the 56th AASLD by Shiffman and colleagues show that the use of EPO also increases sustained virological..."

http://www.hivandhepatitis.com/2005icr/aasld/docs/112305_a.html

[FlGuy]

I didn't realize that it was Shiffman and now really surprised at the procrit psoition.  I'm glad Jim cam up with those excerpts because that's what I thought Shiffman's (and most other to hep docs was) to use rescue drugs judiciously to avoid dose reductions.  Maybe it is interference being run by another doc or nurse.  It's much easier to say no than to explore possibilities and remedies.  It's nice that you intervend and hopefully the Doc will respond accordingly.

[prettydamscared]

Thanks for that.  Pam is going to be delighted that you found those references.  She actually has met directly with him about this and, according to her, he flat out told her that he doesn't believe it's necessary to raise the ribavirin once a person has become undedected.  According to protocol of the study, that makes no sense because he shouldn't know if she is undedected.  Only the third party administrator, Dr. Andrew Muir, at Duke University should be privy to that information.

Dr. Shiffman, as well as her study nurse have been telling Pam all along that she would be unblinded at 12 weeks, which is incorrect information.  The study only unblinds one group at 12 weeks, the 12 week group.  The rest of us have to wait until 20 weeks.   They were so insistant about that point that I speculated that perhaps Dr. Shiffman knew which group she was in.  I thought perhaps he had requested an early unblinding before he dropped her riba at week 3.  I thought the reason he was dead set against procrit is that he knew perhaps she was in the 12 week group and was coming off of all study drugs at week 12, therefore he didn't want to bother with all of the pre-authorization business that goes on to get Procrit through private insurance.  None of this makes much sense and as it turns out, none of the speculations are true.  They were just giving her misinformation as to the unblinding period and I have no idea why Dr. Shiffman won't prescribe Procrit.  Pam puts me on the phone quite often when she calls her study nurse and I frankly am a little appalled by the unprofessionalism and misinformation that is being dispensed.  And, I do know the correct info because I'm in the study, as well as others throughout the country.  The whole thing is very odd, imo.

[jmjm530]

Found the paper from the link PLN posted on 10/2.

http://www.ccjm.org/PDFFILES/hepadshiffman.pdf

Page 3, reads in part:

DOSE REDUCTION: Reducing the dose of ribavirn especially during the first 12 to 24 weeks of tx impairs the abiity of patients with HCV genotype 1 to achieve SVR...In contrast, patients in whom the dowe of either of these meds was reduced after week 12 had a smaller decline in SVR rates.....In contrast, reducing the dose of ribavirin after HCV RNA levels already have become undetectible appears to have little effect on SVR rates.
--------------------------------------
So there it is, the last sentence. Assuming he's still referring to the first 12 weeks of treatment, I'd have a couple of questions. First, how does he know that PLN was non-detectible when the riba was reduced since this is a blinded study? And second, what exacttly is "appears" based on. Unlike many of his other statements, I could find no footnotes for this. Personally, I'd like to see study data supporting the statement and then see how the study data profile pares up to the PLN's profile.

It's quite obvious at this point that Shiffman is no neophyte in terms of riba/epo/SVR, etc, but for me more answers/explanations would be needed. Also, consider a quick second consult with someone else at his level like a Dieterich, Afdhal or Jacbosen.

Wish I could be more helpful.

-- Jim

[friole]

Of course the doctors are right that Procrit carries its own risks.  All drugs do.  The most important thing (to me) if Procrit is prescribed is weekly CBCs (I posted mine below on the thread started by pds, I think, a few below this one).  

They don't want the hemoglobin to rise more than 2 points in a week.  It could endanger the heart.  Thickens the blood.  I would have to read the insert with the rx to really discuss this intelligently and I don't have it here.

Still, under the proper care, it is the best thing round to allow us on full dose medications to increase our chance at SVR.

[jmjm530]

Yes, it does get odder and odder. Like you say, how do we know she is non-detected or even in the VX-950 group? The other thing, Shiffman's point of view -- which we haven't seen the source -- wasn't based on being non-detectible with VX-950 -- so this could cloud the picture as well.

If it were me, I'd first try and find out how Shiffman knows that I was non-detectible as the study is supposedly blinded-- second, ask for the study that backs up his position (plus querry him on the VX950 angle above)-- and, third, get on a plane or train and bounce the whole thing off someone else in his league like the doctors previously mentioned. Alternatively, she could do what most folks do and that is simply listen to their doctors and cross their fingers. A lot easier, but not a path chosen by all here :)

-- Jim

[mremeet]

Wow what a headache. I mean as if all this hoo ha we've all had to go through isn't enough, you gotta put up with this nonsense. The criteria as spelled out to me prior to enrolling in the trial is simply that (1) rescue drugs are precluded for the first 12 weeks only and (2) they ARE available after that as needed - PERIOD! They are definitely NOT absolutely precluded in the trial protocol guidelines. And there's no way they have a "moving standard" from study group to study group either. The standard and rules are the same for all groups, obviously. I'm sure Dr Schiffman, as all of the study doctors, have their own powers of discretion concerning the individualized management of the care of their patients based on each paitent's specific criteria. And of course that's appropriate and even necessary. But I absolutely do NOT believe he can flatly dictate to you that you cannot have procrit which effectively enforces an ongoing half dosing of riba. The only way he could do that is if there was some outstanding condition that indicated the procrit would be a danger to your health or was in some way contraindicated. But that's not the case, right?? You don't have any special health concerns that preclude the use of procrit, right? He hasn't stated that right? If not, then I would simply sit down with Dr Schiffman, tell him you are going to get the procrit outside of the study and that you wish to increase your riba once the hemo elevates. You want him to work with you on your decision and ensure he's onboard with it and that he isn't going to attempt to have you dropped from the study for doing so. Legally and ethically he cannot drop you from the study for doing so. That would be in violation of the agreed upon contract, so I'm sure he'll understand and concede to your wishes if push comes to shove. Just because we are enrolled in this study we are not precluded from seeking medical care elsewhere, that's just a simple fact. And you receiving the procrit after the initial 12 weeks is NOT in violation of the study protocol. Therefore, he cannot terminate you from the study for doing so, end of story.

Pam, be assertive and firm. Communicate to him what you want to do, and get his assurance he will work with you on your decision. Get him to openly commit to you that he will not attempt to discontinue you for doing so. If he refuses and/or implies he will attempt to discontinue...well, that's when the next level has to be taken. No need to discuss that option unless it comes to that, which I seriously doubt it would. Good luck, hang in there it'll all work out.

[jmjm530]

I think adding "Shiffman" changes the equation somewhat. The problem doesn't seem to be the protocol's but Shiffman's own take on Epo intervention as discussed earlier. It sounds like PLN will either have have to get Shiffman to re-evaluate his opinion based on things previously discussed; accede to patients wishes regardless of his opinion; or switch doctors. What Shiffman appears to be saying is that full-dose riba isn't necessary after someone is non-detectible and for some reason he's assuming that PLN is/was non-detectible even though the study is blinded.

[l-horn]

" If your doctor is one of the like Big 3 then I would be interested to read it and see why they are contradicting what they have already posted data on. "

And just who is 'the big three' and who designated them that ?

[prettydamscared]

Thanks for all your input.  Pam's going to have a lot to digest when she returns from Meals on Wheels today.  lol

Kalio, I just wanted to thank you for all of your continued support and well wishes.  I don't really feel like I deserve it though.  Like someone said yesterday, the real heroes are the people that treat 54, 72 weeks and time and time again without giving up and continue to come to this and other boards and share their experience and knowledge.  In spite of differences of opinion, I admire so much the fact that many here continue to help each other even after they're finished with tx.  This thread is a perfect example.  I didn't know where to find those references and really appreciate that Jim and others did.

[MissMiss]

http://www.procrit.com/

Here you can get the full prescribing booklet.  Maybe this will help.

I gotta add that without Procrit I could not have finished tx.

Also, I am left with some heart problems I never had before.  They may have been there and tx just brought them out, from hgb being so low for so long, from tx itself or other drugs I had to take.  I just don't know yet.  Only that I have heart issues I have to deal with now.  I will post more after I have a better picture of what's happening.

Being in a trial may complicate things but living with hgb too low MAY complicate things later.  Your health is most important here, there are others in the trial who can make up the statistics.  Please let us all know how it works out.

miss

[prettydamscared]

Thanks for your input and the link.  I'm going to read through it very carefully and you're right, my health is important too.  I don't want to end up with ongoing problems from hg being too low for too long and it is different for everyone so I'm definitely taking that into consideration.

Char

[mremeet]

Re Shiffman's "knowledge" that pam was undetecable: Pam started with a low VL (~200,000) and her LFT's plummeted very rapidly after starting treatment. She went from like 118 to 23 within 2 weeks and even showed a significant drop within 4 days. It may be that he's simply inferring from that information that she's very likely to be on the VX and consequently went undetectable early on. Not that he's justified in concluding that with any certainty, but it might explain where he's coming up with that notion. Obviously only he knows for sure though. The question should be posed directly to him to see where he's coming up with that most definitive and consequential assertion.

[jmjm530]

Probably that's it but like you say, the question must be asked. Also, as well respected and knowledgeable Shiffman is, others equally respected docs may disagree with his theory that you don't need full-dose riba after being non-detectible. I know my NP felt similar at one point in my tx, while my doctor (at Shiffman's level) disagreed with the NP.

Add to that the fact that in Europe they're testing VX-950 without ribavirin -- cause they think it may not be needed -- add all things together and you have anything but a neat little package to make a decision on. For some reason always seems that way with Hep C treatment :)

Be well.

-- Jim