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524608 tn?1244418161

Vertex participants....what do you know?

I've heard that Vertex has unblinded the  Phase III Advance study....I haven't gotten my results yet but some have...If you were a trial participant and have your results, would you post them here please?

Do they give you VL info?

I started the trial on Friday June 13, 2008
with a VL of 14 ml
officially ending treatment 24 weeks later on Thanksgiving Day
I'll post info when I have it....
38 Responses
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Avatar universal
I also only was able to take 600 mg(?) of ribavarin. I did not have to reduce my interferon.did you reduce any drugs?
Helpful - 0
264121 tn?1313029456
Yes, I finished about six months of tx and then my bone marrow completely shut down.  At about the same time, I got a consult with UAB hepatology and they ok'd six months of SOC tx since I was an acute patient.  Actually, they felt I would have been ok with three months of tx.  I wish I'd gone to them sooner.  My anemia was like clockwork, I was taking 40,000 units of epogen 2x week and still, every 7 - 10 days my hgb would get down to somewhere between 6 - 8 (dependent upon how fast they admitted me and got me transfused) and I'd get two or three units of blood.  I had pre-existing chronic anemia though, but it was a different type of anemia than the type caused by the tx meds.  At any rate, I've been SVR since April 2008.  I haven't rebounded from tx quite as well as you though, I don't think.  But still, happy to be SVR.
Helpful - 0
Avatar universal
I would love to know when I became undet. Hopefully vertex will let us know soon. My anemia never got better the whole tx,so I wondered if I really got the telaprevir. I wasn't too surprised to find out I was in the placebo group. I taught high school special ed and some days it was challenging. Thank goodness for my team mate who helped me.I was hospitalized once when my hem went to 6. I went to ER and knew what I needed( transf) ,but I had to wait 5 hours and then have them ask a million questions before my transf. It was so late at that point they admitted me while they found my blood! And the high school staff only thought I had anemia. They still do not know,but after 38 years of teaching,I retired.it was quite a year,but I do think the dragon is gone. Did you finish tx?
Barb
Helpful - 0
264121 tn?1313029456
Hi Jacks, I was really interested to see that you also had anemia to the point that you received transfusions.  I wasn't in a trial, I received SOC for about six months.  I had 14 transfusions (about 40 units or so of blood total).  So far, you are one of the only other people I've seen that experienced the type of severe anemia I did.  I can't imagine continuing to work through that.  I was pretty well bedridden and/or in the hospital most of my treatment.

I'm really surprised and glad for you that they let you stay in the study with anemia that severe and supported you through with the transfusions.  Sometimes it seems like they hardly even let people take epo to boost their blood if they're in a study.  Even though I wasn't in a study, sometimes I talk them into keeping me on treatment.  Anyway, all of that is kind of off-topic.

What I was wondering is, when is it that you are thinking that you became undetected?  Surely it was before 24 weeks?  I'm just thinking that with your anemia hitting so hard and fast that early in tx that possibly you were UND at an earlier point.  But at any rate, it's the SVR that counts in the end, so congrats on that!
Helpful - 0
412873 tn?1329174455
Ditto...I'd check again.  My study nurse said it would be a while, but they were for sure going to release all our data.

Good to see ya, Pilgrim =)
Helpful - 0
524608 tn?1244418161
your study nurse could be mistaken....they gave me my info...kinda late but I got it. Ask her to send a specific request for it.

Gator
Helpful - 0
619930 tn?1260374254
Hey all you Vertex people!  I haven't been around much, but have kept an eye on this thread for obvious reasons.  I found out a while ago that I was in the placebo arm...just call me Placebo Pete!  Yesterday I called up my study coordinator to follow-up on my VL labs to see when I first cleared and she said that Vertex isn't going to release that information.  I know it doesn't matter as long as I have SVR'd, but I still was very curious to find out.  Oh well.

Have a great summer everyone.

Pilgrim
Helpful - 0
412873 tn?1329174455
Yay!!!!  So glad you finally got the info.  

Isn't it funny how we could kinda tell anyway tho???  I, for one, will never forget the Telaprevir "sensation", lol!!!

Congrats, Gator!

Isobella
Helpful - 0
524608 tn?1244418161
Tks for the Congrats! MerryBe...yes Isobella and I both SVR'd.

I got confirmation...as I thought...12 week arm.

Helpful - 0
233616 tn?1312787196
I have taken a couple extended breaks from this board, and you must have SVR'd while I was away...congrats so much on that, both of you!!!
The more I hear about the PI's the better the news gets...I'm so happy for you!!
Helpful - 0
524608 tn?1244418161
Finally!!

got some of my info,

My Viral load had spiked to almost 18 ml according to the blood work drawn the day I started. By the end of week 1 it was 73...just 73...not 73 thousand or 73 hundred...just 73.

I was undetectable by the end of week 2.

I still don't know what arm I was in, it wasn't included in the info that I rec'd today but I sent an email to the study nurse so maybe tomorrow I'll have that info...or next week if she's out for a long weekend...I'm guessing 12 week arm only because of the way I felt after the end of the first 12 weeks....could be the placebo effect though.

THANK YOU VERTEX!!!!!!!
Helpful - 0
Avatar universal
Hey fellow vertexers,
I just recieved my info that I was on the placebo. My doc was sure I was on it for 8 weeks because of my rash. Guess is was the riba. Haven't gotten the viral load but am thankful everyday to have had the cure. Stay strong. Love to all.
Barb
p.s Izzy i'm thinkin bout u.
Helpful - 0
412873 tn?1329174455
AAARRRGGGGGGGG!!!!!!!!!!!!!  That stinks.  
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524608 tn?1244418161
Still waiting for trial info :( GGGGGGGGRRRRRRRRRRRR!!!!!!!!!!!!!!!!!!!
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412873 tn?1329174455
Yay!!!! Confirmation is good =).  Congrats on getting the info and the drug!!

Helpful - 0
683664 tn?1330966324
Just got the call from trial coordinator.  As I thought, I was in the 8-week Telaprevir group.  

Soon I will receive a letter from the trial center, detailing my tx (SOC + Telaprevir for 8 wks, then SOC for 16 wks).  I asked about VL results, when did I clear?  She said she hasn't gotten that information yet, but will receive it soon.  They aren't allowed to copy the data sheet from VTX, but she said they may put the info on a flow sheet and include it with my letter.

That's it for now.  Confirmation is good : )
Helpful - 0
683664 tn?1330966324
OMG I got a star!  This is the first post I've made since the star thing.  I thought I wouldn't have any stars.  How does this work?
Helpful - 0
683664 tn?1330966324
Thanks for starting this thread!  I called my study site this week.  My trial coord called back at a time when I couldn't answer the phone!  She said she'd be out on Monday, so I guess I have to wait till Tuesday to find out something.

I will be shocked (almost as much as you, Izzy!) if I wasn't in the group that got Telaprevir for 8 weeks.  I started tx Oct 2008 and finished April 2009.  Starting VL of 3.6 million.  UND in all follow-up tests, the last one March 2010.  

Wah hoo!  Thank you Vertex!  And thanks to all of you here who helped me make it through tx.  

I'll post when I find out something.  I think I'll also do the email thing from the link you posted, Gator.

Lapis
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Avatar universal
I agree . We will  be married 38 years! Yikes...He was a real trooper through out this. I too am totally impatient and should have gone and had a PCR early. My anemia tanked at about week 3-4 and another month later, I was having transfusions..W/out them, I would have not been able to complete the trial. I also lost around 18  lbs. My nurse said had I lost it in the beginning, they might have taken me off the trial....I have gained some back which I wanted to do, as I looked quite gaunt with skinny face, and hair that was becoming quite thin. I remember you saying you still colored your hair and I laughed. I never missed my color or hair apt. Did it every month. Hey, at least I wanted to have something I wasn't upset about. My hairdresser did get me a gigantic bottle of Nexi??? and my hair is fuller and in wonderful shape now. It did get depressing looking at my computer at times and seeing hair all over it. I was never bald, just thinning out. I cut it very short and that was that. At one point one my para pros ( a dumb one at that), said in front of the entire class" Are you losing weight- and what is going on with your hair?" My main alibi was that I was anemic and that was what I told everyone. No-one blinked an eye. I probably told about 8 friends and my family. I felt it was no-one's business . I didn't want the studen'ts or their parents to know as some of the parent's were not much brighter than the special need students that I taught. I did love the kids, but after 38 years of teaching special ed, I decided it was time to enjoy what other things life has to offer!
I will tell you something funny-guess I am telling the world, but who cares. I had a pap test during treatment. I was so incredibly dry, my gynecologist could barely examine me. I told her to look carefully-she might find some cactus growing!  Have a good weekend.
b
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412873 tn?1329174455
My nurse only had the info on which arm I was in, but said she will request more comprehensive data.  That will probably take a while, but I still want it.

I did get private PCRs.  I started with a VL of 919,000 and at day 6 it was 616.  I did another one at the 21 day mark (yeah, I'm a little impatient) and was surprised to see that is was 8.  I was a bit worried at the time that it wasn't UND to <5, but figured that by trial standards it was because they only test to <10.  That's what made me think I was on the placebo....now I see that my virus was just being stubborn.  I thank God I did get the Telaprevir, otherwise I may not have cleared at all.  

Oh, yeah....my husband put up with alot during tx.  I'm pleasantly surprised we survived that 48 weeks. Celebrating 25 years together next weekend,despite tx, lol!!

Ask your nurse to request the additional data.  It'll be worth the wait.

All the best,

Isobella
Helpful - 0
717272 tn?1277590780
I'll be darned.  Finding out you had the drug after thinking you were on placebo is incredible.  Let us know when the twilight zone feeling fades away (ooo-weee-ooooo).  As long as you ended up at the right point.
Helpful - 0
Avatar universal
I am curious, Izzy
My trial nurse only received information regarding the arm I was in-still do not know at what week I became undetected. I am curious as I did not get a private PCR. I wish I had now, but it's done! Did you find out that information? I thought I was told I would receive all that  and maybe I still will.
I also have to tell you all that my husband was wonderful  during my treatment . He patiently listened to me b.....ch  and kept cheering for me.
  thanks,
b
    
Helpful - 0
Avatar universal
i meant too say  
"if you ever met met me in real life"..in above statement
Helpful - 0
Avatar universal
Life is better than good izzy its a wonderful life my dear,i actually love all you gals and guys from the bottom of my beating heart and soul,i mean that too,if yu ever mmey=t me in real life you would see i have great personality to boot

WHO LOVES ya?
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