Pulled from Tx

[sunshine585]

I am 40 wks into a clinical trial, with trial drug/pegasys 180 mcg/ riba 1000mg. Trial drug stopped some time ago on my arm, d/t complications. I was called in today for repeat bldwk., as apparently the CD4's on some of us have never recovered. Mine is 130, I have t be at 200 or I'm off. I said to my nurse, that I'm so close to the end, 8 wks to go. She said there was nothing they could do, it was beyond their control. I feel, I've been through so much, and I've been <15 vl. since before wk 18.

My question is this, do I have any batting power? I've never been on a study before. I'd like to finish.

[sunshine585]

Thankyou so much for your prayers. As I've looked in the archives, I've found that this is not uncommon with studies, unfortunately is seems they are much more restrictive of blood resultsthan SOC. So I guess I'll wait and see.

[stubby226]

I was really sorry to read about your situation.  I do not know the options available but I do know that without completing the 48 weeks does not mean the tx wasn't successful.  I was taken off my tx of interferon and ribavirin at 46 weeks instead of going 48 due to being so sick.  My Dr. assurred me that it would not affect the outcome.  What geno type do you know.?  I assume 1a or 1b.I tested neg all the way thru after 6 weeks until 5 months post tx.  I then tested positive.  So now I am on just a waiting game.  This tx was my 2nd time around so you may be able to see another physcian and go back on it.  I will add you to my list to pray for.  Hopefully you will be neg despite the situation.  Take Care.

[sunshine585]

My lymphocytes are .6 my ANC .5  haven't gotten back my rbc.s and my vl has stayed <15 I don't know why the rest of the bloodwk is taking so long, it never tkes this long.

[Trish77]

Sunshine, what is your ANC at?  Is that what you mean by neutrophils?  It's your Absolute Neutrophil Count that matters, the ANC.    What about your hgb, your hemoglobin?  Where is that at?  And your lymphocytes?  Are they measuring those and have they told you what those are at?

You mention Week 18 .. when were your PCR's after that?

Hang in there.

Trish

[sunshine585]

I still haven't heard what the results of my cd4 are yet. I was afraid to call them, just in case it was bad news then I would have to stop immediately. Since this origional post, I got 2 more inj. in., the last ones in my box. I called my clinic and they still haven't received the resultsof my cd4, however, I do have some wbc.s  1.6  same as prev.
                                                                           neutrophils .5  prev. wk.7
This is such an emotional mixed bag, just over a month ago, I didn't think I could do this anymore.Now, Im anxiously awaiting to find out if I get to finish tx.
The big thing that worries me is, I know it's most crucial for svr to maintain your maximum Rx dose the first few month of tx. The 1st few months, I had freg. dose reductions, and at one point was only on the RBV. I am und (<15) as of sometime between wk. 12 and wk 18. So, I wonder what this all means as far as my chances for svr. Especially, if I don't get the last 6 weeks. My nurse told me I had a 50% chance but that was before we found out, I may have to stop early.
Thankyou to everyone who responded previously.

[copyman]

did you give back the drugs yet? if not I would give some of them back and use some to taper off. I personally don't think those 8 weeks will make that much of a difference being in a study and were taking a PI with SOC. Best of luck

[sunshine585]

The Roche trial I am on is R04588661 protocol NV19865 The trial drug is a polymerase inhibitor. Thanks for the info on the helper meds. I was told no earlier on, but maybe I need to push harder.

[Trish77]

You might want to ask about the helper meds.  Sometimes you have to push for them.  I had to push for mine. They are sometimes allowed but they are very reluctant to use them.  They are allowed on my trial but I did have to advocate for them.  ARE you on the R1626 Roche trial, the polymerase inhibitor?

Good luck to you also, Sunshine!  please keep us posted.

Trish

[sunshine585]

I'm not sure exactly whichweek I became und. Week 12 I was <1000, by wk 18, I was <15. So somewhere in between there. I'm still on study protocol, so no helper meds. I haven't had the call yet, but I'm due for my next shot tomorrow, so I'll do that one early just in case I get pulled. Then I'll only be missing 7 shots. I've realized since doing this that research protocol is so much more restrictive than soc protocol. Where they would let my numbers drop a little lower, before reducing or discontinuing. Good and bad in that. Well Trish good luck to you and your cd4 tomorrow. I guess we're all on pins and needles with our bldwk.
Well, it's not over til the fat lady sings!  Thanks you guys, for your support, I'll keep you posted.

[mkp13]

You always have the option of moving into SOC, either with your current doctor or a new one.  Talk to your study doctor about it.  If he or she won't transition you over smoothly, find a new doc who will.  (Unless there's some reason why you should stop treatment whether you're in the study or not.  They should be discussing that with you.)

--mkp

[Trish77]

Are you in the Roche Phase IIb R1626 trial?  I forget what the longer string of numbers is that co-relates but your situation sounds alot like mine currently.  I can get pulled off the interferon entirely at any moment as well and I'm getting CD4 tests also.  Mine went down to 160 last time but apparently it's a combo of lymphocytes and CD4 and my lymphocytes were just enough to save the day.  And this time I don't think this is only trial protocol, it's treatment protocol.  I could be wrong about that but that's what I'm thinking and I will have to clarify.

The only pulling power I've used is to strongly request neupogen to bring up my white counts and I started finally yesterday.  I'm on mushrooms too. They've also got me on a prophylactic antibiotic to protect me from coming down with any infection.  Lots of fun.

If it's trial protocol then you can see if you can switch over to regular treatment if that's a choice you'd make at this point.   If it's treatment protocol then not much you can do about it.  

I go again tomorrow morning for CD4 testing.  It's not a happy situation.  Good luck to you.

Trish

[Marcia2202]

Beautiful sunshine! I don't know any answers, nor have any suggestions.

I just wanted to say that I am praying for you that you will reach SVR no matter what!

Lots of hugs, Marcia

[comeagain]

Your  a real diamond reaching out for me when your in worse trouble your self.

Do you know exactly which week you were UND ?
I don´t know if it has to make so much differens doing 40w or 48w we hope you have cleared.
Your in my prayers and thank you so much for your support it has really warmth my heart and still do.

ca

[fretboard]

That just sux, I'm starting a trial hopefully soon.  I'm starting to wonder if I should emplement a plan B, just in case?  Anyways, I hope you come up with something that helps you tx as you want.  God Bless

[sunshine585]

No placebo, the study was R04588661 I am und since before wk 18, I've been through difficultie, and I've gone this far, I would like to finish the  wks I've got left. As opposed to startingbon a notther 48 wks..

[HCA]

You don't have any pulling power 'cos if they let you continue it would contaminate the trial data.
You might have cleared anyway.
What is the trial drug?
Might you have been taking a placebo?

[sunshine585]

Thanks for answering so quickly. They told me if I became detectable again, they would offer me 48 wks soc, otherwise we watch and wait. I actually won't know til Tues or Wed if I'm pulled, but thought I should find out if I have any bargaining power.

[portann]

I just took my 22nd injection an hour ago and can't imagine how terrible it must feel to you to have done 40 shots, have invested so much and then be pulled. I am so sorry that you are faced with this.

I have very little experience but I believe I've read here that you may be able to 'roll over' your trial into an SOC with a regular hepatologist, if that is practically and financially possible to do quickly. Just ad libbing here, because I don't understand some of the issues you mentioned but hope some of the experienced people are still awake to help you.

Hugs.