When your in a trail tx., do they give rescue drugs?

[HappyDeb]

I was wondering if you go on trial tx. like Teleprivir combo, will they give you rescue drugs or do they feel that since you excepted to be thier guiena pig, that you have to go through tx. with no rescue drugs to see reactions? I am thinking of trying to go on the 3rd trial of Teleprivir with intfn. @ riba, I was a slow responder @ my Dr. took me off tx. After 12 wks. due to only a 2.5 log drop and the infamous RASH !!! Now that I know that I will probably get it again, I could at least take the drugs prescribed after the fact.

What's your spin on this question ? PLEASE anyone or everyone jump in .  


                                              DEBBIE :)

[merryBe]

I think it's **** to trail and be left in the dark.

A little legal info, you are not required to complete a trial, and have a right to know how sick you are if there are other options out there.

before I went through a trial, I read the legals. At the appropriate point I requested my records.
they did not want to disclose them until the study was closed

BUT legally they have to give them to you, so you can inform your doctors and seek better or life saving treatment.

All they were going to tell me is :you no longer meet the criteria to remain in the study".

But they are legally required to give them. Ask them if they are...(they know it) and will cave.
I got all my labs etc. found out which sides were the prob,
because of this I got the right drug, saved my life.

[susan400]

I was taken out of trial for the breakthrough virus at the 5 week point (based on my 4 wk blood draw), but by that point, I'd had the really bad rash and a significant drop in my white blood cells.  I was not in the Ribavirin group and know that it was not Ribavirin that caused this horrific rash.  Since I didn't get Riba, I never had any problem with the red blood cells, or with anemia.  I'm still having a problem w/the white blood cell and with the neut's.  It's now been 13 weeks since the meds were stopped.  I have a sore that I cannot get it to heal and I'm almost sure it's because of this white blood cell issue.  I really don't want to have to go to the doctor about a dumb sore, but if it doesn't start healing soon, I may have to.    Susan

[Xhrles]

For future reference,what was the powder that your doctor gave you for the rash? Thanks and good luck with your treatment

[HappyDeb]

WHAT HAPPENS TO GENO1 ERS LIKE US WHO HAD TO GO OFF TX. FOR ONE REASON OR ANOTHER ? DO THEY FOR GET ABOUT US AND SAY YOU CAN'T PARTICIPATE IN OUR TX. OR IS THERE ANOTHER ALTERNATIVE FOR US TO GET TO SVR ?????????????????????/Did you have to retrive from tx. because of a rash also ? and if so what was your outcome with finding out what you had come down with , and thier tx. for you ???

[susan400]

The rash issue for me, along with the lack of rescue drugs is significant enough for me to opt out of doing the Teleprevir again.  If the trial is modified to include us Group C'ers in a rollover-the only way I'll consider it is if A: rescue drugs are allowed and B: if there's something more that they can do about the rash.  I just can't take going through that again.  Also, as I've said before, I almost got kicked off the trial for the white cells alone-even before I was kicked off from the viral brreakthrough.  I'm happy for all the others who are able to clear on the Telaprevir....   Susan

[HappyDeb]

My Dr. felt that if I was undetected at wk. 12, that we would use meds. to control the rash. I honestly think that he and the derm. Dr. did not know what to do. I went to the Derm. Dr. and she did not even look at my rash closely and had no idea about my symptoms so the best thing to do when you don;t know is to eliminate. I am still itchy and breack out in dry patches and little bumps that wind up opening from scratching. My reg. Dr. gave me this powder to drink for it and guess what, he hit the nail on the head, this hepled me more then the pregnosone and steroid cream the Derm. Dr. gave me. Personnaly, I don't think she had no clue and my G.I ? Hep. Dr. either. I am so frustrated at the health system. I asked the question about resue drugs, because I would like to keep on the Med. my reg. Dr. gave me while going back on tx. , so maybe I don't get a reacurrence of the rash.


THANK YOU ALL FOR YOUR INPUT.   Happy Deb :) ( FRUSTRATED TOO : ( )

[Andiamo1]

I am in the prove 3 trial and rescue drugs are not allowed.  I had to reduce my riba dose instead.

The first proposed phase 3 trial planned by Vertex will not include people that have treated before.  I am sure they will start another one for non responders and relapsers, but I have not seen that announced as yet.

Good luck with your treatment.

Eric

[Terrylee8]

I'm in the Scherring-Plough trial.  They weren't going to allow rescue drugs but so many people headed toward anemia that they changed the protocol and they sprung for Procrit.  They won't pay for it with the SOC control group people of which I am one.  So far I'm holding Hg @12.

[wyntre9]

You're handling the disappointment a whole lot bertter than I could.

I can't imagine (although of course there's a 50-50 chance of relapsing after 43 weeks of tx.

I'm on for 72 as well.

wyntreI,

[indyjo]

Not sure about Prove 3 but I was in the IDEAL study and had meds reduced rather than use rescue drugs. Guess they want to see outcomes that are not tainted by addition of other drugs. I had breakthrough between week 24 and 48 (I am a little bitter about 24 worthless weeks of treatment). Back in the saddle again. Week 26/72.

[susan400]

I was in the VX Trail  :)   oops, I think I meant, Trial...., the prove 3.  They do not give you rescue drugs in the VX trials at this point in time.  Who knows what they will do in future trials.  There is always the possibility that in latter trial that they would allow rescue drugs--if it seems that too many people were to end up being taken out of the trial due to anemia and low white cells.  But, as it stands right now, no rescue drugs allowed.  If your red blood cells or white cells drop, the treatment is modified, like the Pegasys dose might be lowered, or the Riba cut back, if that doesn't fix the problem, they you're taken out of the trial.

Susan

[FlGuy]

Depends on the design of the trial protocol.  I thinks it's been reported here by the VX'ers that rescue drugs are not in the protocol.  Several have had doses reduced instead of introducing Procrit, for example.

[wyntre9]

In a TRAIL TX they give you Trail Mix.  *LOL*

Seriously, I don't know about trials.  But why did your Dr. pull you off previous go-round when you had a 2.5 drop?  I thought that was supposed to be ok for continuing?

Was it more coz of the rash?

wyntre