Prove 3 Trial Status - Forum Users

[VXman]

I hope you guys don't mind. As I have been using the forum since the first part of May, I have been keeping a little spreadsheet to track the progress of each of us Prove 3'ers. I am very impressed what I have comprised thus far. There is nothing scientific about this list: however, there is much to be celebrated. If you want me to: eliminate you from this list, add you to this list or make a correction to the list, let me know. I certainly find it interesting if nothing else. Congratulations to those of you continuing in the trial and a word of optimism to those that had to drop out. Susan400 has got to be encouraged!

Username        Status           ARM       Est. Start
josiejo        Unknown             C         04/18/07
andiamo        Cleared Week 12         B or D      04/18/07
dmhrdh        Cleared Week 12         B or D      04/27/07
Electra56        Cleared Week 12         B or D      04/27/07
miked        Cleared Week 12         B or D      05/04/07
VXman        Cleared Week 12         B or D      05/02/07
w.c. missy        Pending Week 12        B or D      05/06/07
Cheesegrater    Pending Week 12        B or D      05/06/07
glucklich        Pending Week 12        B or D      05/10/07
susan400        Non-response Week 4     C         05/29/07
kita1953        Unknown             C         06/08/07
FullOfHope77   Pending Week 12         B or D      06/08/07

[susan400]

Thanks, VXMan.    I have days where I'm really depressed, but overall, I'm doing pretty good.  Sure, I wish that the VX was the answer for me.  It still might be at a later date.  But, if I do it again, it will be at a time where I can pick which type of interferon to put with it (not Pegasys) and also with the Riba.  (Maybe even with a Polymerase inhibitor to boot!)    I still have time to work with since I'm still only at Stage 2 Grade 3.     So, I'm hoping for everybody else to have a good result.  Also, I think that Mary 55 was treating w/the VX, but I can't remember if she said it was Prove 1, 2 or 3.  She responded to my earlier post when I asked if ANYBODY else had been taken off the VX.  She's had a lot of rash problems.

Susan

[susan400]

Mary55 was in Prove 3.    I looked back on that old post and she responded to me that she had been in the Prove 3, but had been taken off because of the rash.   Then, she posted later on about some sort of call that she got back from the clinic?

Susan

[VXman]

You have a great attitude. With your young age of 46 and being at stage 2, you have alot going for you. The progress being made is incredible. I agree with you that there will be a cocktail of protease and polymerase inhibitors in the not to distant future that will likely eradicate the virus in short order without much fanfare relating to side effects. I understand your bouts with depression. Keep your boxing gloves on though, because there will be another round in the ring for you.

[glucklich]

Hate to make the observation but none of us seems to believe we are in A, probably bucking the odds on that.

I hope we non C ers- are all in B or D.

[glucklich]

Hate to make the observation but none of us seems to believe we are in A, probably bucking the odds on that.

I hope we non C ers- are all in B or D.

[meki]

Oh wow - you guys - that's simply amazing.

Susan - hugs lady --- I know something will work --- somehow...

Meki

[mary55]

Remember I am Josiejo and Mary55. Yes I did complete 12 weeks of VX and Pegasys but was taken off due to severe rash issues. I had my 12 week blood draw and was told to come back for another draw in two weeks, then got a call last week to come back this week for another. So I'm not understanding what is going on and neither does my NP. I was under the assumption that you had to be clear in order to have more blood draws. I wonder if this means there could be a slight chance that I may be clear. Wouldnt that be nice.....but I'm not holding my breath. But at least I will have more info in October once the trial is unbinded. Then I can go into the next treatment armed with a lot more info and hopefully kill these little suckers. Being G1a stage 4 it could be tough.

[dointime]

One person in my Prove2 group dropped out of the trial at week 10 due to rash.  All meds were discontinued (VX+peg+riba).  She's now coming up for 22 weeks post tx and she's still clear.

Let us know how you get on.  I'm keeping my fingers crossed for you.  Seems to me that anybody who suffered that rash damn well deserves their SVR!

[FullOfHope77]

I don't mind at all and helps me to know who's where... I'm in week 9 currently and totally confident that I'm clear and RVR'ed in 2-3 weeks... I can't prove that yet but I think I will be able to in the future. Part of my confidence is in your research and logical conclusions but feel certain that this is the the ticket for me. I am only concerned about one thing and that is the fact that I'm stage 4 and am curious if I should continue to tx after I finish the Prove 3 testing with success just to be sure that I SVR. During SOC I cleared at 28 weeks and was clear until about 15 weeks after ending tx. I have felt that I would have SVR'ed if I continued for 72 weeks; so I'm really curious about going further on my own especially if I'm in D and possibly also if I'm in B to 72 just to make sure. Any opinions on that or am I just paranoid?

[VXman]

I admire the fact that you would be willing to extend the SOC to 72 weeks. It's an example of how determined many of us are in eradicating this nasty virus. The fact that you'd be willing to do that, is a testament of how much you value your life.

[dointime]

I suggest that you continue tx until we get more data from Vertex.  Data is due in September and we should get quite a bit from the Prove1 and Prove2 studies at AASLD in November. (See Vertex July press release).

You can then make a more informed decision based on the reported efficacy of the 24 week duration and hopefully also the 48 week duration (the Prove1 people will have completed 48 weeks plus 12 weeks post I think).

My personal opinion is that the VX goes very deep and is very thorough.  If you RVR'ed then after that it becomes a case of SOC knocking off any resistant variants which might have escaped and are persisting at undetectable levels.  

Vertex already posted a 10% relapse rate on the 6 month duration but omitted to tell us the sample size, so I'm not relying on that.  I am currently treating with SOC the VX-resistant variants I was left with from doing the Prove2 no-riba arm.  I want to get the figures on the relapse rate for the 48 weekers before deciding if I need to go longer into 72 weeks.          
    
dointime

  

[glucklich]

Hi dointime,

Is there a reference for
Vertex already posted a 10% relapse rate on the 6 month duration

I have seen most of the Prove 1 and Prove 2 data releases.
I agree with your belief that Vertex goes very deep and is very thorough. I always have felt that they have not only a good scientific team but a very fine development team.

I would not be surprised if the analysis they are doing now is far deeper that the efficacy of Vx but rather how it is effective and for whom - with strong predictors - is it effective. This is just wild thought on my part and has no basis in fact.

[FullOfHope77]

That sounds to be wise advise and helps me think i'm not paranoid for sure. I feel that the VX-950 has knocked it out so fast that I'm blown away and If i go for 48 on arm B then by then it will be well into next year and will know much more than now and able to make better decisions. I do want so badly for it to work this time and know I won't get another shot at VX for possibly years and now is my chance. I hope I get B and go for 24 on the VX and another 24 on the the regular for a stage 4 person seems like it might be about right. But the 72 is a real option I think and will pursue that if I have any doubt that i may relapse. That is the worst feeling in the world when you thought you beat it and relapse, but I didn't know then what I know now thanks to this board. I appreciate greatly the input from you guys and keep my prayers and thoughts with all you guys as you battle forward!

[dointime]

I agree with you that in time many factors of the VX action will be studied and the treatment finessed.  The data from the studies is trickling through at a frustratingly slow rate though.  Especially for those who have already been involved in the trials and are coming to the point where they need to make an informed decision about stopping tx rather than just a stab in the dark.        

Anyway, here's the ref for the 10% relapse rate:-
http://www.vrtx.com/Pressreleases2007/pr072407.html

"Relapse rate data from PROVE 1
Vertex announced today that it received preliminary data from a planned interim analysis of arm C of the PROVE 1 trial, which evaluated treatment-naïve genotype 1 HCV patients treated with telaprevir plus pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, followed by 12 weeks of treatment with peg-IFN and RBV alone. The interim analysis included end-of-treatment data as well as 12-week post-treatment data from all patients who completed the 24-week course of therapy. Among the patients who completed 24 weeks of therapy and had undetectable HCV RNA (less than 10 IU/mL) at the end of treatment, fewer than 10 percent had relapsed by the end of 12 weeks post-treatment follow-up. Results obtained to date in PROVE 1 suggest that 12 weeks of telaprevir-based treatment followed by 12 weeks of peg-IFN and RBV could be a promising treatment regimen and duration."

[w.c. missy]

fyi... i got the green light to continue tx at 12 week point.  hope this is good news...
w.c. missy

[VXman]

I am thrilled to note your status change from "pending" to "cleared." This is wonderful news!  Enjoy the success......

[Jesser]

This is my first time entering this forum so I don't really know how to do it.
I'm going to try to send this little bit before I type a bunch and botch it.
Jesser

[Jesser]

I started the PROVE 3 May 3, 2007.At week 4 I was called and congratulated that
I met the protocol (I think at this time it was a 1 log drop) to continue.  At week 7 1/2
I was called and told to stop all TX "the protocol was changed to - must be undetectable
at 4 weeks". Since then I have also like a female above have been called back not
twice but three times for blood draws.  Maybe between weeks 4 and 7 1/2 could have
dropped to undectable???not going to have any answers until 6 months which for me
is Nov 3rd. then will know alittle bit of what is going on and will share.  I am a 4 time
TX nonresponder -grade 2-3 (1a).
Question - did others in the PROVE 3 have 4 weeks as the undetectable mark or 12 weeks?
Thanks for everyones support,
Jesser

[VXman]

I started the Prove 3 trial on May 2 and was told at Week 6 that my Week 4 had met the minimum 2-log drop. At Week 8, I was told that the protocol had changed and that I was actually UND and would remain in the trial. I have since met the UND at Week 12 and will begin my Week 16 tomorrow. Were you receiving triple therapy or in Group C which did not include ribavirin?

[VXman]

Est. Start User Name       Status       ARM
04/18/07 Mary55/josiejo  Left due to rash          C
04/18/07 andiamo        Cleared Week 12      A,B or D
04/27/07 dmhrdh        Cleared Week 12      A,B or D
04/27/07 Electra56        Cleared Week 12      A,B or D
05/04/07 miked        Cleared Week 12      A,B or D
05/03/07 Jesser        Not UND Week 4      A,B,C or D
05/02/07 VXman        Cleared Week 12      A,B or D
05/06/07 w.c. missy        Cleared Week 12      A,B or D
05/06/07 Cheesegrater    Pending Week 12     A,B or D
05/10/07 glucklich        Cleared Week 12      A,B or D
05/29/07 susan400        Nonresponder Wk 4     C
06/08/07 kita1953        Unknown          C
06/08/07 FullOfHope77    Pending Week 12      A,B or D

[Jesser]

I was on triple therapy. So if the first protocol was a 2 log drop...I did meet that
requirment...just not UND at week 4.  They call me every other week to come
down for a repeat PCR...which makes me wonder if maybe I went UND between
weeks 4 and when I actually stopped the triple therapy at 7 1/2 weeks???
When they stop you... they have to unblind you at 6 months (physician thinks)
so Nov. 3rd I will have some answers. Great to see so many cleared at week 12
on your chart...actually they were all UND at week 4! Nice to have this forum as
a sharing place.  I will share what I find out in Nov. and follow up to see how others
are doing.
Jesser  

[Andiamo1]

I have many side effects that I never experienced in any other of my previous 7 times on tx, so I believe that I am not in a placebo arm.  I am in week 18 now. so 8 more weeks and I will know the details!

Many thanks to all here for providing so much detail.

[Jesser]

If you are in week 18 now...then you had to be undectable at week 4 (that was their new protocol
change) so you are on your way to a healthier life...congratulations! Jesser

[Andiamo1]

I passed week 4 under the old rules and there is some debate about the new rules being retroactive.  The medical center I am treating with says they are not retroactive, but who knows!

Thanks for the encouragement though.  I am hopeful.

[Cheesegrater]

Fellow vx'ers,
I will leave any further input on info on my stats,  until I am unblinded.  I would appreciate it if you leave me as pending until week 26.
I am thankful for my chance to be in this study and think it fair to keep certain info in the spirit of a truely blinded study.
I hope everyone in the study has a safe ride.

Cheese.

[nelson958]

How do you get into this trial?

[geterdone]

Ya know, I would be really pissed if my name were to show up on a message board in a condensed list of prove 3 study groups. Did YOU ALL not sign a contract of confidentiality before starting the study groups. I would not want to be yanked from the study group and have my health issues severely compromised because someone decided to publish a list of group participants without a letter from the study group sponsors saying it was ok to do so. Gezzz

geterdone

[Andiamo1]

The consent form we signed was not a confidentiality contract.  It did contain a request to not discuss the trial in detail, so that the trial data would not be compromised.

Saying that you are participating does not provide data that could compromise the trial IMHO.  Entering a discussion that tries to identify the placebo would compromise the trial and might even cause the FDA to stop the trial.

We do have freedom of speech here, at least we did until recently.  I think that means we must use some judgment to decide what to discuss and what not to discuss.  It does not mean, IMHO, that we can't say a word about the trial.

nelson:  The way to get into the next trial, this one is closed, is to become a patient at  a medical center that participates in the trial.  Each medical center gets slots in the trial and selects the participants, subject to the pharmaceutical companies approval.

[APKhaos]

FWIW, the confidentiality vs freedom to post issue came up in spades during Prove1. There were some P1 subjects who posted that their study coordinators had obvious knowledge of the fact that they were posting here, and that they were warned that this could compromise their trial status.

I'm not aware of anyone who was actually pulled, but there were reports of warnings being given. This was around the time that people were posting theories of how to detect VX950 vs placebo, and discussions of people who found that they were in the 48 week arm [12 weeks VX + SOC, 36 weeks SOC] dropping out after 24 weeks [12 + 12]. Its fair to say that some of the discussions got a little paranoid and a little heated.

All this just FYI from one of the first batch of VX lab rats [ with a 30 weeks post-tx SVR from the P1 trial, thank you very much] :-).

[VXman]

With all due respect to your request for confidentiality, I must point out that the consolidation of data that I previously listed, represents information that was previously posted by you and other forum users. It was at that point that it became public information. There was never any ill intent of the list. Many folks have welcomed it as a way of easily seeing how "Joe" is doing and hpoefully allow for some congratulations and some consoling to each other as appropriate. Your tracking information has been pulled from the following list;

Est. Start User Name ARM Status
04/18/07 Mary55/josiejo C Left due to rash
04/18/07 andiamo                 A,B or D Cleared Week 12
04/27/07 dmhrdh                 A,B or D Cleared Week 12
04/27/07 Electra56                 A,B or D Cleared Week 12
05/04/07 miked                 A,B or D Cleared Week 12
05/03/07 Jesser                 A,B or D Not UND Week 4
05/02/07 VXman                 A,B or D Cleared Week 12
05/06/07 w.c. missy                 A,B or D Cleared Week 12
05/10/07 glucklich                 A,B or D Cleared Week 12
05/29/07 susan400                 C Non-response Week 4
06/08/07 kita1953                 C Unknown
06/08/07 FullOfHope77 A,B or D Pending Week 12

[Cheesegrater]

Thank you VXman.
I appreciate your action.

I realise that any info posted here is in the public domain.  
Because of this fact, I cannot complain  somebody wants to make a compiled list of the infos they can imply from anybody's past postings.
I have not asked for confidentiality and there is nothing I regret posting.
What I have chosen to do, (from the very start of prove3 if you read those messages again) is to limit any info
I post because of certain reasons I feel strongly.

Without malice, and in the spirit of free speech,

Cheese

[w.c. missy]

hey vx -
i was just thinking... even though i was told i could continue to stay on tx after my 12 weeks, i was never told i was cleared... i know there is a lot of info on the net, but out of respect to the double blinded study, i'm not comfortable with it being posted that i'm "cleared" (by the way, did you intend it to mean cleared to stay on tx, which i assumed was the case, or cleared from the virus - beacause that has absoutly not been confirmed to me).  i'm fine with my status being "still on tx", but now thinking that i'm not so comfortable with the word "cleared".  i just don't want to jeopordize anything regarding the study... thanks for your consideration.
w.c. missy

[macna]

Hi,
One more to add. I started the first or second week of may. I did not clear by week four. I was in group A,B or D. However, I have good reason to believe I was in group A.

[VXman]

w.c.missy - I understand your concern regarding the term "cleared". This should be less ambiguous.

macna - Thanks for sharing your information. I hope that you were in Group A too, because that would open the door for you to enter the rollover protocol during Week 26. I'm sure that you are anxious to find out. Even though it may seem like it is along way off, October will be here before you know it!

Est. Start User Name   Status   ARM
04/18/07 Mary55/josiejo   Left due to rash   C
04/18/07 andiamo   Week 12 Criteria Responder   A,B or D
04/27/07 dmhrdh   Week 12 Criteria Responder   A,B or D
04/27/07 Electra56   Week 12 Criteria Responder   A,B or D
05/04/07 miked   Week 12 Criteria Responder   A,B or D
05/03/07 Jesser   Week 4 Criteria Non-responder   A,B or D
05/02/07 VXman   Week 12 Criteria Responder   A,B or D
05/06/07 w.c. missy   Week 12 Criteria Responder   A,B or D
05/07/07 macna   Week 4 Criteria Non-responder   A,B or D
05/10/07 glucklich   Week 12 Criteria Responder   A,B or D
05/29/07 susan400   Week 4 Criteria Non-responder   C
06/08/07 kita1953   Unknown   C
06/08/07 FullOfHope77   Pending Week 12   A,B or D

[Jesser]

I just want to say "kudos' for all your hard work and efforts.
Jesser

[w.c. missy]

thank you so much for changing the status to "responder"... i do think it is in everyone's best interest to stay away from words like "cleared", and am grateful that you agree.  i think your new status post is great, helpful, and hopeful!
peace,
w.c. missy

[macna]

Agreed, Oct is a long way off! According to the taste test, I had the placebo. Do you know if the Control group will get the longest treatment available?

[VXman]

This is a great question! There has been virtually no discussion about the specific protocol rollover plans for this group. I'm streching just a little, but I think that Vertex will likely offer the Group D 12/12 plan without the extra unnecessary last 12-weeks of placebo. Andiamo has been quite vocal about the recent public announcements by Vertex about how confident they are in securing the 12/12 formula as the new SOC. With that being said, it would only make sense that they would offer this to the Control Group A patients.  

[Andiamo1]

I don't have access to my consent form, but somewhere I read that Arm A failures would be offered 24 weeks of telepravir+inf+riba.  That might now be changed, but I think it can't be changed without FDA approval.  

The medical center I am treating with had been approved for this protocol.  It has a FDA designation and I apologize - I am on the road and don't have high speed net access, so I am not providing the links.  Hopefully, one of you with high speed access can google this protocol and find out what has been filed with the FDA.

I certainly agree that 12/12 makes the most sense, but sense is not the issue when the government is involved!