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218977 tn?1230697372

Prove 3 - Cleared Week 12

I just wanted to share the wonderful news that I just received a call from my clinical nurse that I have continued to be UND through Week 12 and will therefore continue with the Prove 3 Trial. Thanks to all of you for the encouragement and support. It was tough waiting this one out in anticipation.
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218977 tn?1230697372
I attempted a search for postings by “GoingForward” to review the comments that I briefly referenced above, and did not find a hit. I manually searched and found it:

Hepatitis Community/Living Forum - Title "effexor withdrawal" dated 07/29/07 and originated by Andiamo1. Comment in thread by "GoingForward" that I may reference but not at liberty to discuss.
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218977 tn?1230697372
There are so many stories and interpretations; we could start an urban legend! None of us truly know the full story and likely most of the trial investigators that we see, only know partial elements of the criteria. I have my Week 14 visit this week and will use my subtle interrogation techniques to flush out the information. I may have to resort to using sodium pentothal (truth serum)! There was post by: “GoingForward” made last week that leads me to believe that I am in Group D. My Week 4 was on 5/30 which required UND for Groups B or D. As “glucklich” appropriately points out, some of this is based on hopeful thinking. I am grateful that I have made it this far and feel the longer I remain enrolled in the trial - the greater are the chances that UND is realistic.

Also, “glucklich” pointed out on a different thread that that the list I compiled of Prove 3’ers doesn’t have anyone listed as a possible Group A patient. This is a valid point as it certainly doesn’t represent the 25% chance rule.
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233002 tn?1316027966
Vxman is being hopeful, as am I. While I find stories of people being reclassified odd, they have been reported here.
Until you know which arm you are in, you only know that you have a 2 log drop.; if, in fact,  you are in B or D  and you had your 4 week after 5/29 then you had to be UND to have continued. If you are in A you always had to have1 log for week 4 and 2 log week 12.
So time to relax and wait and see.
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80575 tn?1207132364
I don't know what to make of the information I'm receiving here, other sites and my clinic.

At Med-Help I've seen several posts about Week 4 & 12 criteria being changed to UND.  Also read something about May 29th as some knd of cut-off date????  

You and I are within two 2 of starting Prove 3 tx.

The reults from MY  12 week appointment were to
"Continue on; met the criteria".  When I asked the sudy nurse said 2-log drop or better for Week 12.

I shared the UND criteria change with my doc and he seemed unaware but also said he would look into.  

Because we started within 2 days of each other does yout data mean that I TOO was UND at Week 4 and at Week 12?  This is so important because of what I know about the benefits of RVR.

Is there any hard data by Vertex anywhere?

Thanks VXman.  


Helpful - 0
218977 tn?1230697372
Thanks for all the kind thoughts and encouragement. I feel that we're all in this together. I look forward to finding the relaxed time to visit the forum and to read and respond to comments. This is a healthy habit particularly since it focuses on "Hope'.

miked - as to the question of being told that I was UND: I had previously posted a description of how I was originally told that I had cleared the minimum Week 4 2-log drop during my Week 6 visit, only to then be told at my Week 8 visit that the criteria had changed to UND. Three patients in my clinic that had previously been told that they had met the original criteria, only to be told later that they were now disqualified due to the new criteria. I have my Week 14 review this coming week and I will be asking more specific questions, knowing that they may be restricted to what they may release. I have every reason to believe that I am in Group D, as I am regaining my energy levels and my taste buds are beginning to function again.
Helpful - 0
217229 tn?1192762404
Wooooooooooooooohoooooooooooooooo! This is a FANTASTIC NEWS week!

Meki
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80575 tn?1207132364
Congrats Prove 3 collegue!

We are only days away from each other so I'm watching your post carefully.

How do you know that you are UND?

Yesterday I too got the 12 week news that I'm to contunue.  

When I asked if that means I'm UND, the study nurse came back with that it means I had at least a 2-log drop and can continue.  I copied my doc on the email and he said he wanted to look into it.

I really do think that I'm in Group D which would mean that I'm now on the placebo & SOC for 12 more weeks.  Again my research indicates that this is the best protocol.

My rash from hell is under control and I'm staying out of the sun as told; at least until it is all gone.  If I'm on placebo (like maybe next week) I may spend an hour or two out in the sun.....if no rash.....

1st tx the RBV caused me no problems; spent a lot of time at the lake.

First tx I was on Schering's Peg-Intron which weekly kicked my axx.  This tx on Roche Pegasys the first 10 weeks I had very slight INF sides.  Going into 13 weeks it's intesifying.  Last night's shot wiped me out.

It's good to hear that someone else in the Prove 3 trial continues with a work week and more.  For the past three weeks I had senior people from my client in Europe over for US customer visits.  We've been to 7-8 cities and 20+  customer meetings.  I'm done in.

VXMAN....again, my big question is how do you know that you are UND?

Also has anyone heard how MissyWC is doing; she was 1-2 days from me in Prove 3.

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149918 tn?1208128744
pln
Congratulations!... I do know how you feel, and I am sure it will stay UND!
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Avatar universal
Tha't's GREAT news. Congratulations! Thanks for sharing it with us. I'm so happy for you. You are leading the way for many of us.
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208764 tn?1249429657
I'm only a few weeks behind you and feel certain that I also cleared before 4 weeks and am still clear. I also assume I'm in B or D and the meds that get replaced at 12 weeks will either be the placebo or more vx-950. i'm sort of leaning toward B since I'm stage 4 just to go longer etc. but feel i will likely be in D as that is what I originally wanted :)

Anyway, good luck and i will know in 3 weeks the same thing you know and will switch to placebo or continue... does it taste the same? :) Either way what do you think about going 48 weeks no matter what? I feel like I could and almost should just to know that I've fully cleared but will let the 'powers that be' determine that for me. Congrats!!!
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86075 tn?1238115091
I don't know what others are thinking, but this stuff seems to be better and better, cheers to you!
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164592 tn?1222906774
Congratulations!!!  It's so great to see the relapsers and non-resonders get some good news for a change!
It's funny that you mentioned the lack of liver pain.  I mentioned that to my nurse yesterday.  I don't think I've had even a twinge in 2 mos...
Again, congratulations!!!!!!
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229344 tn?1189755837
How fantastic is that! Your a trooper boy.
Good Luck To You

Thanks
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Avatar universal
That is great news.I just wanted to say congradulations and thank you for giving those of us that are waitng for this drug to be approved hope.  Just wondering if the 2009 time table from what you know is still a possibility for approval.God bless
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Avatar universal
Congratulations!...
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173975 tn?1216257775
Congrats on the great news!

It must be sooooo encouraging to you!  

I am a slow responder and didn't reach UND until week 16 or so but when i saw that little <10 on my lab report beside HCV Quantitation it made it a little easier to tolerate SX.

wyntre
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218977 tn?1230697372
It's no bother at all asking me questions. As a matter of fact, you may be sorry that you asked!  The most difficult part regarding side effects has been the fatigue. Despite a nurturing and understanding family, sometimes it is difficult for them to understand that I have limitations as a result of being on therapy. In the past 13 weeks, I have been to: my daughter's college graduation, Disneyland, Graduation Party at home (100+ people), 1-week vacation in Molokai (miles of hiking in rain forest), 1-week vacation in Lake Tahoe (jet ski boating and bicycling), 40+ hours of work per week (when not on vacation), attended All Star Game and Home Run Derby, 8+ Giant's games, Mother's Day (Cable Car to Fisherman's Wharf), Father's Day Social Event, and in process of remodeling 2nd home (rental). My brother called me the other day and asked me to play tennis with him. I told him that I just didn't have the energy. He said, “great - all the better, let's put some money on it!"  

Each of the scheduled events noted above, were pre-planned months in advance of me being accepted in the trial. Part of the problem is that I don't look different to anyone, despite feeling quite different. The other part of the problem is that I would push myself a little extra because I didn't want to let others down.

My vacation days are all used up and I am happy to get back into normal routines with work and home life. After re-reading what I wrote above, I think I may take a cat nap!

There have been many occasions where I get unbearably itchy and have become more successful with time to ignore it so that I don't create a self inflicted rash. It is tough but is working. Right now I'm thrilled because I can reasonably assume that I am either in Group B or D and that I'm well on the way to beating the monster that invaded my liver some 35-years ago. The abdominal pain that I felt in my right side consistently over the past several years, is almost a fading memory. The last thing that needs to be said - "Thank You Vertex."
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Avatar universal
yes!!
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229344 tn?1189755837
One more question ..were your sides tolerable or not?
I have tx at end of year and getting a little nervous the past few days....
Ok i wont bother you again.....keep on with those spins!!
take care and congrats!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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Avatar universal
Congratulations on clearing the virus and leading the way for the rest of us! Goodluck
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229344 tn?1189755837
Keep on spinning. You deserve it!
Hopefully one day I will get the chance to spin as well.(I PRAY)
BEST OF LUCK!!!!
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218977 tn?1230697372
GT-1b  I'm getting dizzy with all the spinning!
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Avatar universal
Way to go mr vxman...you're on your way, congrats!
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229344 tn?1189755837
Congratulations! You must be doing spins!!  May I ask what genotype you are.
The very best to you.
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