Prove 3..Taking myself off the treatment

[mary55]

I had to change my name due to Forum changes. I have been lurking for some time now and have only posted a few times. Due to Vertex's strict rules, I thought I would refrain from posting. Believe me there have been times when I have wanted to jump in or ask for advice. I am in the C arm of the trial.....I can no longer take one more day!! I have treated 4 times and have dealt with the riba rash. But this rash is soo bad I hardly recognize myself. I'm covered from head to toe. I bath,shower 10 times a day, have tried every lotion, potion and perscription pill known to man. I lay in bed with up to six bags of ice at a time. I have never experienced so much pain  in all my life. It has now traveled to my face as well as other places too sensitive to discuss. I AM DONE! 12 weeks of torture. I will do double doses of Peg and Riba anytime.

My medical treatment was awsome and was I treated with dignity and respect throughout the 12 weeks. I was one of the very lucky ones that was chosen for this trial and and I am very grateful for the oportunity. Thanks Vertx. Can you now work on the rash issues?

I will never give up!

Geno 1a stage 4

[EarthMan]

Well, what can a person say except I'm very sorry it didn't work out?? This beast of a virus is a tough old brut!! Keep your attitude and fighting spirit and you will win the war yet!!!

[grammajen]

Starting in the 15th week of Pegetron, I started to get a rash that eventually covered me from head to toe.  Lots of raised red areas, spots, felt like I had 3rd degree burns.  For three weeks the rash kept increasing in area and intensity of pain.  I was panicking about what was going on.  The Hep Service nurse said it is common to have itch and rash so I kept on taking the treatment.   I finally couldn't take it any more so I stopped after taking with my family doctor and the Hep nurse.  After I stopped, I talked with a  dermatologist, and the Hep Specialist who said I was having an adverse reaction to the medication and it was a good thing that I stopped as it could have become life threatening.   It took about 10 days for the rash to clear but I still feel itchy at night.  Hopefully that will stop as well.  The side effects I was having until week 15 were not that bad to manage but the rash was too much.  Now I am waiting to see if the treatment cleared the virus.  The Hep specialist is doubtful but I am keeping up hope.

[FullOfHope77]

I'm very sorry that you were so lucky to get in and had a bad reaction to the VX-950. It was my understanding that they monitor that and know when you've reached a critcal point and provide the necessary meds to counter the rashes etc. but it sounds like you're saying you were on your own to decide that and that sounds a bit odd? I'm in the study too and feel so fortunate and haven't had any reactions to my knowledge and hope I'm getting the real deal but don't know of course as i could be in the control group getting a placebo. But good luck and hope you get over the rash problems and they learn what is needed to help others in that situation as well.

[web52-1]

sorry about the rash. are you going to continue the peg and riba? i just finished prove 1, 12 weeks triple tx and then peg  riba for a total of 48 weeks. had the rash and other sx (it was a very rough 12 weeks), but nowhere as bad as yours. i understand vertex is working on it.  

[dointime]

Mary, Is it possible for you to continue on just peg and riba, outside of the trial?  If you have done 12 weeks of VX then you may have an excellent chance for SVR, even at this stage.
One person in my Prove1 study discontinued all meds at week 10 because of a bad rash and she is still clear at her post 12 week PCR.  

You would need to get your own PCR quickly to see if you are UND.  I could well understand if you were just finished with all the meds now.  I got the VX rash as well, not as bad as you but damn well bad enough to freak me right out.  But if you are UND and you could stand to continue on peg and riba for more insurance then you really could have already done the work to beat this thing

Good luck whatever you choose.  That rash is real suffering,

dointime    

[dointime]

[dointime]

Here's a link to my post when I got the rash.  There's some excellent information there that great people on this forum gave me which helped.

http://www.medhelp.org/forums/hepatitis/messages/44630.html

dointime.  

[mary55]

Thank you all for your positive feedback. I haven't told my study nurse yet, I see her in the morning. We have  tried everything, even if I were to continue on soc, there is not a single white spot I could possibly inject. I was was told at week 8 that if I wanted to discontinue it would be up to me.. I  was following Nicks blog and was so delighted when he cleared only to be let down.....As I have said in an earlier post I have treated many times and have a rough go o f it but I can't function on this treatment. I can't go outside and I can't go to work. I'm pretty sure that I am clear but I haven't had my blood work. Now SVR is another subject. I knew before enrolling that Vertex was having rash issues in about 9%. I knew right away that I would be one of them. Lucky me!

[mremeet]

If you can help it mary, DON'T QUIT!! Stop the VX and get some derm help ASAP, but DO NOT quit!! Believe me I know how you feel, I went  through what you're going through right now. It got so bad all I could do was lay around naked on a bed with a clean sheet on it covered in welts, itching, burning and half delirious like some wigged out leper. I was hanging by the thinnest of threads, but I managed to cling to that thread day after day. After stopping the VX (once we knew conclusively that's what was causing it) and getting on prednisone and then later solumedrol, I was able to slowly get better (with "better" being defined as experiencing SOC side effects alone). I still had significant skin issues, but I was able to continue on IFN + riba alone (I made it to week 41 before stopping). PDS here experienced a very similar rash scenario as well, and managed to hang on too  (with prednisone, steroidal lotions etc).

I know you haven't been unblinded, but if you're also getting ribavirin, the odds are overwhelmingly in your favor that you went UND very early on. On average most of us (in the riba group) went UND by week 2, and some much earlier than that (pln went UND by day 4!). So you have a very significant incentive to keep going if there's anyway you can. I had actually decided to drop out at my very lowest point with the rash, but I knew I would always be allergic to VX after that (which would preclude me from ever taking it again), so this would be my one and only chance at being an SVR "contenda" with VX950. Otherwise I'd have to wait years for some other PI-like drug to come along before treating again. So I decided to tough it out and get back on my "treatment feet" as miserable as it was to do so. I'm so glad I did now, so think carefully before giving up the ghost just yet. You have a unique and *very* significant window of opportunity to rid yourself of the virus once and for all right now - again, think carefully about whatever decision you make concerning discontinuance.

In the meantime, hope you're feeling better soon - and if you need detailed advice on how myself and PDS dealt with our horrible VX rash let us know and we'll do our best to help guide you out of the rash tunnel. Take care...

[nygirl7]

I agree with the other guys who said see if you can ditch the Vertex and keep on the peg and riba.  The first 12 weeks are the MOST important and you GOT the Vertex during them - maybe now you can just take the remainning time to make sure those buggers STAY wiped out for good and catch any stragglers or something?

I had the worst case of riba rash and know it's NOTHING like the rash you are going through.  You are ONE STRONG Chick - let me tell you that.  I have the feeling if not for the rash you could do ANYTHING.

Can you go to a different hep doc - explain that you want to stay on SOC but have to drop the Vertex because of the side effect (face it, everyone now knows this is a big big big problem with the drug!) and perhaps he can prescribe you something marvelous for it AND you can get rid of it and still keep going?

I'm SO sorry for your agony.  Hang in there - make an appointment right now if you can! Then you can kill two birds with one stone, get a good med for the rash AND continue to fight the fight!

MrEMeet knows what he's talking about he was the first one I knew of who had the rash bad like you do and knew it was from the Vertex and NOT just regular ribarash (which almost killed me as it was it drove me so crazy!)

He's been there.....talk to him if you are still online.  I see he posted so start up a good dialog with him. You'll be surprised at how much help it will be for you to just talk.

[mary55]

Thanks so much for your support. I stopped the vertex last friday as I could not bring myself to take one more pill. By Monday my eyes were close to being swollen shut. As soon as the nurse saw me she said your done, I didn't have to tell her that I had stopped all ready.

Even if I wanted to continue I couldn't because I live in Canada and was treating in the states, as you all know that our system works differently. My treatment has to be government approved as I don't have extended medical...too much of a time lapse. I knew in my heart a year ago that I would be one of the lucky ones to be choosen, and in the past treatments I have had problems with the rashes. So I'm in the lucky 9%. I surprised myself by sticking it out for 12 weeks. The 1st 5 weeks was a breeze. I just wish that with all the suffering that I could have had a little Ribaviron thrown in or good luck. At this time I have no feelings as to what the outcome will be. I'm being pumped up with loads of Prednisone.....now I'm going to bed. Thanks again

Not all is lost, there could be a miracle as I am still in the trial. I had a PCR yesterday and in 2 weeks I will have another. We will only know if I am clear. I will not get my numbers untill week 24.At this point we still aren't sure what the protocol is

[susan400]

I was on the Prove 3 Vertex trial, I had the bad rash that came out in me on week 2!  It was really bad on me and I did not have the Riba.  I only was on the VX and the Pegasys.  I had a breakthrough in my virus. In other words, I had started to respond, but the virus rebounded through it.  I was taken out of the trial after my 4 week blood work results were reported at week 5.  On the Prove 3 Group C, (no riba group), we aren't offered to roll over into the SOC drugs only group.  I don't know if I could get prescribed regular SOC tx drugs again, but I think in my case it would be a waste of time.  I've treated 7 other times already and didn't respond, this Prove 3 was my 8th try on it.  I wish you the best of luck with your lab work results.

Susan