What's up with Prove 1, 2 & 3 people?

I've been lurking from time to time but since being UND 12 post tx in the Prove 3 program (Arm with 12 weeks of VX950+RBV+INF followed by 12 weeks of placebo+RBV+INF).  Honestly I've not had HCV on the forefront of my mind and have been enjoying my kids, hobbies and work.

I can't find much data about the status of the people who participated in the Prove 1, Prove 2 and Prove 3 trials.  I know that Susan400 didn't get Ribivirin and it didn't work for her.  How about others?

Are there any published papers out about the status of UND or not for these studies?

I'd be interested to know if anyone has any data.

Thanks,

miked

[miked]

I received no information back on this question???

Did Vertex put the hammer down on information sharing?  Did all Prove people get SVR and are off doing other things?  Did all the Prove people die off????

Why am I not hearing about how other Prove people are doing?  My 12 weeks post tx PCR was UND and I'm hoping to hear similar results from other Prove lab rats.

miked

[willows]

Didn't get to participate in any of the trials, but I'd love to hear what the latest numbers are also.  Seems like a lot of new folks showed up with the new format and some of the lab rats aren't here too much any more?  I'll cross my fingers...

[miked]

Since UND 12 weeks post tx with VX950, I've visited this site less frequently.  You're right about the number of new people....it's just going to get bigger as people are diagnosed.

I can dig up Prove 1/Prove 2 data that a large percentage of people on triple therapy (VX950, INF, RBV) experience Rapid Viral logical Response (RVR) by being UND at Week 4 (I went UND between Week 1 and Week 2). Of those who got RVR a large percentage went on to still be UND at post treatment Week 12 (which I was UND).  In Prove1/Prove 2. 94%+ remain UND until post treatment Week 24; which is considered cured.

My post tx Week 12 PCR was still UND and I believe that I will still be UND at post tx Week 24; cured.

I'd like to hear from some of the other Prove 3 people on triple tx are doing.

Thanks Willows.  Nice to hear from you.

[willows]

Wow, wish you have gotten a bit more response, I'm sittin here pondering retreating and could use some good (or bad) numbers from all our Vertex trial folks.   I HATE feeling paranoid...but maybe our lab rats were constrained? by agreements from their trials.

Nothing would surprise me anymore...well, the addition of the new forum features was a bit of a surprise..adding photos of myself doesn't seem to be medically related.  Or even fun.

I gotta keep trying.  It's pretty important.

[willows]

Wow, you must have been typing your post as I was typing mine.  Yours was a hell of a lot more fun to read tho, congrats on the 12 week SVR and I'm gonna cross my fingers for your 24 weeks too.  I just have this gut feeling that adding telaprevir+UND at any time during first 12 weeks=SVR and I believe it will hold for you and anyone else in the same treatment.

I also believe that SVR+me=a lot less grumpy poster.   You gotta be hanging on the positive side of your whole experience....and keeping the faith.  Much good luck to you.

Willows

[Willy50]

Hey Mike, this is just my take on it but I think that no news may just be good news.

The Prove 1's; people who responded attained an SVR and may only be lurking now or have moved on.  I miss reading Mremeets posts and others but I have a feeling that they feel so well that they are unconsumed with HCV for once....and that they are enjoying it.

Ditto the Prove 2's

Now...... the Prove 3's are still in mid flight.  Those in a 12&12 are approaching the period of official SVR, but it's still a ways off.  Folks like Andiamo are....if memory serves me right at about week 45.  They then have to wait the about 6 months for the official SVR.  That means that Vertex could possibly wait another 7 months or so before releasing information on the trial results.  They may also do just that.

The reason is IF the results are strong enough they may ask the FDA to consider the Prove 3 as a registration trial.  Vertex has suggested that if the results are strong enough that as a treatment for treatment failures it could take a short cut (skipping a Phase 3) and be approved.  One of the factors in being able to use the trial as a registration trial is that the study must be flawless.  One way that a trial can be come "flawed" is thru unblinding.  For this reason Vertex has made clear that they will only release information about the trial results in manners which suit the FDA.  I think one might conclude that we may not end up hearing any EOT scores or "unofficial" SVR24's since they could diminish the blinding of the trial.  

Obviously If Vertex wants to guard that information they will also possibly not release it to participants.  No new information may equal no new posts.

No new information may not mean bad news; indeed it could end up bringing us good news by this years end when Vertex would release the data to the FDA and ask; approve Telaprevir for past treatment failures.

This is all talk and we'll see later if it ends up amounting to anything.  I hope that I reported it generally accurately.

I hope you are doing well.  If this comes to be your participation will have been in a very successful and significant trial arm.

Best,
Willy

[Xhrles]

Hi Willow, Vertex should have news on prove 3 sometime around June after end of treatment stage and then will have all the data by December. They will then decide on fileing for fda approval for non responder use on the strength of the results. That was what they said on the conference call so don't count it out yet. You might look for other trials for non responders in your area. Just heard about one for Debiopharm that is starting but not in the northwest. Drug looks promising and there will be others.  Congratulations Miked on clearing and staying clear. It's a real inspiration to me and I'm happy for you.Good luck

[lab-rat]

Hi Mike

I'm still lurking and post occasionally, however I'm only from the control group of Prove 1.  I relapsed after 48 weeks of treatment (11 weeks post)...But I am in the rollover trial and am currently in week 7 of triple-therapy.  I became UND sometime during week 1 so the outlook is positive...only time will tell.

I'm curious as to how the others are doing also, they seem to have disappeared.  I'm interested in any relapse rate from those who treated with triple-therapy.  Congratulations on your very good news!!!

[Lady Lauri]

My post tx Week 12 PCR was still UND and I believe that I will still be UND at post tx Week 24; cured...................

GOOD to here, good for you!
And glad you are 'living life' again, more now.

And...it would be good if those in trials would post a bit on their outcome, to help those still looking, as you are.

LL

[Lady Lauri]

Willy...Just read your post. Probably the case, reason for not many follow ups here yet.
In a dense moment (S) here..... does that mean even those tx'd are not told their results until a certain time? In my trial, we were not told until week 12, etc.

Miked....were you/Susan told not to disclose your results, wait ?

Lab rat....how are you handling the triple therapy?
Allowed to say? (not real up on rules, etc. in these trials.)

LL

[Lady Lauri]

"does that mean even those tx'd are not told their results until a certain time?".....

That meaning even after tx, told if SVR or not?

LL

[lab-rat]

I'm handling triple therapy pretty well...thanks for asking.  I have a minor rash that I didn't experience on SOC - it started around week 3 on my back, and its since spread to my chest, stomach and arms.  But it's not unbearable so hopefully I'll be able to tough it out for a few more weeks.  

Other than that the only other difference I've noticed is that I seem to get chills more often...I don't remember having that at all during SOC (past the first shot).  I was lucky the first time around with sides - I didn't experience any big problems - just some minor annoyances (extra cavities, dry eyes & skin).  

Congratulations on your good news.  That's very encouraging!

[willows]

Howdi from the wet Willamette Valley.  For some reason, OHSU and the U of Washington can never seem to get it together enough to actually put trials together.  They are both listed as potentials but are still not recruiting.  Same experience on Prove 2, I tried and my doc from U of W tried.  Ah well....just gotta flex my patience muscles longer.

I love to read the posts like the ones here, they ARE encouraging.  Perhaps this lull is just the calm before some storm....seems like a whole lot of rock and rollin ought to be going on near the end of 2009/beginning of 2010 when it comes to triple therapy.  Take care til then.

Willow

[Willy50]

Hey, I assume that they will honor whatever disclosures to people that they said that they would but my guess is that they will otherwise be keeping their cards close to their chest.  That means that they probably won't come out with interim results, incomplete results, data that might drive stock prices etc.  IF they can get the FDA to accept Prove 3 as a registration trial they will have a several year head start on the competition.

When they do release information to trial participants they may ask them not to share it.

On a different topic the stock price has lowered significantly because they also mentioned that during the Phase 3 trials (which may start in March) for those same reasons they might not share data until it is all in; that means about a year and a half from start to finish.  Maybe I didn't hear that right.  Wall Street may not want to have money tied up without getting progress reports.  In the midwest parlance that would be like buying a "pig in a poke" (translation: buying a pig in a gunny sack unseen).

That's quite a stretch from hi tech to very low tech but it still conveys the idea.  : )

Willy

[FullOfHope77]

I have 10 weeks left on ARM B (I presume) of Prove 3 Phase 2 and been clear since week 2-3. I hope that it's a good time to buy the stock as it's at 17.80 and thinking about loading up as something in the next year will have to push it back up in the mid upper 20's. But I'm still believing that it will work for me and others that are in similar situations. I think the triple therapy is near perfect as best as I can tell. I've heard no relapse stories of those doing triple therapy for 24 weeks and SOC for 24; have you?

[susan400]

I'm still here, post Prove 3 (almost 8 mon.).    As you said above, I didn't clear-which you know, since I was in Group C No Riba group.   I'll be keeping my options open for any future developments for retreating at some point in the future.  Don't have a lot of choice in that because of having the bridging fibrosis already.  So, it's either try to stay at this level, or it gets progressed to cirrhosis, or I do something to treat further and some day get SVR.

Susan

[miked]

Thanks for your comments.  It's good to hear from some of the old timers on this board.

Lab-Rat and FullOfHope - Both of you guys are on triple therapy, experienced RVR and are still UND....your chances are very, very good.  It does seem that 3x therapy with RVR is the ticket.

I'm starting to feel like my old self again.  About a month after stopping tx I pretty much emptied my medicine cabinet, with the exception of Maximum Milk Thistle which I will have shipped to me every 90 days until I'm dead.  Getting off the AD earlier than my doc wanted caused some crankiness for my family but I was just so tired of taking this pill to stay up and this pill to go to sleep....

BTW, the Vertex consent form says not to disclose non-public data....but so much came out from AASDL.  My concern isn't their stock price but not slowing down the progress for everyone to be rid of this bug.

I hope Prove 3 results are the same as Prove1 and 2.  I'd like to be cured.

miked

[dmhrdh]

I did shot 44 this past Sat. and am crawling to the finish line.....
I'm feeling stronger as they have stopped trying to increase my Riba and decided to keep me at 600 where I have been since Dec.1....and still clear thank God!
I find posting, emails, phone calls very difficult right now.  
It's great to hear you're feeling like your old self again!

[miked]

Let us know your outcome.  I assume that you are UND?