Prove 3 - 12 week checkup

[miked]

Sorry I haven't updated lately but my travel schedule has still been brutal.  I know some of you think I'm stupid for keeping up the business travel but I am the owner and guy with the function of business development.  It's travel or kill the business.  

Last Friday I went in for my 12 week Prove 3 checkup.  They exchanged all meds for new ones, took a bunch of blood draws and said that I will be called next week with my VL....is this true?

I'm not saying why (consent form thing again) ) but I am totally convinced that I am in Group D which is 12 weeks of VX950+INF+RBV followed by 12 weeks of SOC plus a VX950 placebo.  I also think this Group D is the optimum tx for Geno 1b's.  Now....I wait for the call about my VL.  No guarantees but I also believe that I've been UND early.  I stopped taking Celebrex which I've taken for neck "arthritis" for years which I no longer feel.

If you remember I was having issues with rashes on areas exposed to the sun.  I'm an outside guy and never wore sunblock.  Stupidly I lathered up in 50 sunblock, put on a pair of shorts and T-shirt and went about my lawn mowing, gardening, etc.  At first, everywhere exposed to the sun (except my face and neck?) especially my forearms and lower legs developed a rash that looked just like a bad case of poison oak.  Every 2 seconds I thought about, damn I itch!  My doc put me on antihisomines and Lidex cream that cleared it up in three days.

About a week later this rash from hell developed on my back from my shoulders to wasteline.  It looked different thatn the first rash and was MADDENING!  Again Lidex cream and antihistomines have it under control.  I asked my doc if itt was the Vertex rash and he just gave me a knowing look.

Last weekend my wife and kids were gone from Friday-Sunday; a rare thing.  I was looking forward to some quiet times, book reading movies,etc.  To date the Roche Pegasys hasn't been nearly as harsh as Peg-Intron but after Friday shot night I had a high fever, night sweats, nausea and felt like **** in general.  I've heard that the Roche Peg gets worse as time goes on.

I'm hoping Group D and 12 weeks to go of Placebo plus INF & RBV.  I'll let you know how the VL report comes back.

What's new with the rest of the Prove 1-2-3 community?  Any big news?

Mike

[VXman]

Thanks so much for all the support. It truly makes a difference having an extended support system with "people" that truly understand and are empathetic. I vicariously get enjoyment when I hear your success stories and likewise shed some tears when the news is not so good.  

[susan400]

I wish all of you a good report.  I know that you're feeling anxious right now, but with your good report at week 4, there's every reason to think that you'll have another good report!

Susan

[glucklich]

I have that anxiety as well.

Gawd I want this to work. Don't know what will happen inside my head if it fails.

three is no rational thought that helps today. I KNOW I am so lucky to be in the trial. I know I am so lucky that this biotechnology revolution is in progress. I know I am so lucky just to be able to walk around...

Hope for the best resul;ts for you and this thing ends well for all.

[APKhaos]

...and you are doing it!

[miked]

You did it!

[VXman]

It was strange for me having my Week 12 visit. Although I understood that I wouldn't have the results of the blood tests until Week 14, there was just a little extra level of anxiety knowing the milestone of this visit. I'll have my results next week (Week 14 visit) and wish you the very best and that you are in Group D too.

[glucklich]

I go for week 12 Thursday. I will see. If you had week 4 after 5/29 you are in the new criteria. I am there. The criteria is that you must remain UND if on Vx and 2 log if not on Vx. All of this is very reasonable and the change is to my limited mind a credit to Vertex.
Like everyone else I am hoping to be on D, but the disaster is right around the corner part of me would have B.

I am getting more and more of a reaction as time goes on. A coat of itch covers my body. But if there is a chance I am UND, then this is a breeze compared to the previous 48 weeks of hell. Just wish I had a mind about now...

[Electra56]

VX decided at some point along the way to change the criteria for VX-950-containing arms, so that they had to be UND at week 12.  But this only applies to particapants enrolled after a certain date.   If your progress is being "judged" by the "old criteria" and you were UND at week 4, but broke through somewhere along the way, and became detectable..but were still >2 logs- you would not be allowed to continue- I know because I asked this very question-(Great minds think alike!)  the other question that I did not ask...is what is the reference for comparing week 12 data, baseline or week 4?

[VXman]

I agree with you that it would make no sense whatsoever to digress from a requirement of UND at Week 4 and then allow for a breakthrough that resulted in a >2-log drop at Week 12. Statistically, this would be considered a relapse. This is not the type of data that Vertex is looking for and certainly would not justify a continuation in the trial. In reality, there's no way that they will settle for anything less than what was required at the time of your Week 4.  

[APKhaos]

Just got results back from Prove 1 week 28 post-tx. UND again, which I'm now calling SVR. Not bad for a 1b and a starting VL of 26,480,000 after just 24 weeks of tx. My arm was the golden 12 + 12.

FWIW, the unblinding in Prove 1 happened AFTER the results for the last blinded week were available. In my case, week 20 was the last blinded week, and the VL results came in during week 22. I received a summary of every single PCR taken by the trial - from teh two initial screening visits right through to the week 20 draw. It was quite something to finally be able to see the response. Turns out I went clear around day 15, and have stayed clear since.

Keep the faith folks. Its frustrating during the blinded period, but that's just part of the trial protocol. Best to relax and concentrate on killing the dragon rather than trying to second guess the universe. The results will come soon enough, and I'm sure you will be in for a very nice surprise when they do.

[Andiamo1]

I did complete the week 12 and was told I passed, but no details.  The coordinator thinks Vertex left the criteria for week 12 at two log drop.  That makes no sense to me, if the new criteria for 4 weeks is undetectable.

A few days into week 13 I decided I had switched to a placebo, but now I am not sure.  I also feel worse now, so who knows.  As MikeD says, this is an area we should not discuss.

[Electra56]

I completed my week 12 and got my "ok to continue" fax a week later.  They are not saying anything about the actual VL data- and for those of us who started before the change in criteria- the 12 week continuation is dependent on at least a  2 log drop- not UND, unfortunately.  Everyone had all of their meds changed at 12 weeks- so as not to compromise the "blinding".  I too had thought (hoped) I was in D...but now I'm not sure, as at week 14- I still feel that same and actually maybe worse!  For me the fatgue is a killer...I too continue to work, travel and do all of the inside and outside work...but wow, I'm ready for bed at 8 o'clock- I didn't feel this bad after 52 wks of PEG-IFN and Riba- I exercised the entire time. Not this time.  But Miked- reading your stories- you're an inspiration!  So what if you get cranky every now and then- who wouldn't?...I too have to travel for work- not as much as you, and those 4 am wake-up calls are tough!...But as often has been remarked on this site- I feel lucky to have this opportunity- so whatever it takes!

Good luck to everyone...I'm glad that I found this site...it's great to be able to connect with other people and share experiences...

Electra

[miked]

I hope both of our 12 week reports are UND...will they really tell us our VL?  If UND, will they say when we went UND?

I haven't read about Addiamo1's good news!  Great!

Missy....have you heard anything?  We are a couple of days apart also.

[VXman]

Glad to hear that you are doing well and that the rash is under control. As an added benefit to the lesser amount of treatment in Arm D vs. Arm B, you may perceive less itching too. Based on previous postings, I believe that you and I are within just a couple of days of starting treatment. I just had my Week 12 visit last week as well, and hope for a continuation of the good news relating to UND. Andiamo1 received great news regarding his Week 12 results and is hoping for Group D as well, particularly since Vertex released information just recently that the Group D is likely going to be the new SOC based on recent releases from Prove 1 & 2 trials. I believe Andiamo1 has just completed his 15th Week. I'm working 44 to 50 hours per week and find that it actually keeps me energized. I'll share one interesting observation that each of us on treatment should be aware of. I recently had a week's vacation that took me from my normal sea-level suburbia home to that of the Sierra Mountains where the elevation was >8,000 ft. Well, you know how you can get a little of breadth in your normal environment. There were times that I was like a panting dog just playing Ping Pong! The thinner air (less available oxygen) in the mountains never affected me that way before.

Two other posters: josiejo and dmhrdh should have received their Week 12 results: however, I have not seen any recent postings from them.

Best Wishes on your test results! Please share when available and I will do the same.