Prove 3 results

[3txsofar]

Seeking a recap.  Admittedly this will be anecdotal, not scientific, but how many on this board have reported a Prove 3 SVR 24, or being clear at EOT?  And how many did not clear or relapsed?  

Thanks in advance

[miked]

I participated in Prove 3 in the arm that received VX950+INF+RBV for 12 weeks followed by 12 weeks of Placebo +INF+RBV.

My VL went UND between Week 1 and Week 2 and has stayed UND since.  January 3rd I had my 12 week post tx PCR that came back also UND.....so my future looks bright.

Andiamo1 above mentioned a 6% relapse rate for geno 1's who get a RVR and still undetectable at 12 weeks.  The data I read is that 100% of people who get a RVR and are still UND at 12 weeks post tx are still UND at week 24 post tx.

I haven't bounced back as quickly after this tx.  Maybe it's because I'm older (50) or the VX 950 has some after effects that will be known over time.  I still feel fatigued, not motivated and haven't gained muscle mass back as quickly.

Right or wrong I do consider myself cured of HCV at this point though.

miked

[Aquila]

My sympathies to you for being one of the PROVE3 un-success stories.

How were your sides?  Did you get the rash?

I remember the feelings of despair when relapsing on SOC and the sick feeling that there were no further options.  I can only imagine what it would be like to fail with the long-awaited Telaprevir.

Vertex is already developing VX500 to follow Telaprevir and they expect to initiate Phase 2 trials of it in 2008. They say their goal is to create treatment that consists of 2nd Generation Protease Inhibitors + Polymerase Inhibitors + Novel Interferons - getting rid of Ribavirin.

Maybe VX500 is your next step.  Or Boceprevir.  Or R1626 - the polymerase inhibitor.  Things seem to be moving along quickly - or quicker than they have been.

Best of luck to you.

Aquila

[glucklich]

24+24 was not enough for me.I went UND but came back to 29 then UND and back to 29. Now I detest leap years.

will see in a coupe of weeks where my VL ended up when I go for the follow up.

got the sense that the study will be able to classify those who are unlikely to benefit from Telaprevir

[Bill200]

Andiamo, Ok, I guess we could tell war stories.  I've been in two phase 3s in the 1990s.  The first was ultra-high-dose interferon.  I think they called it "infusion."  Actually not as bad as it sounds.  The first time I did the interferon it wasn't fine by any means but I was still able to exercise and get along ok.  Then did the first phase 3 riba trials.  That was rougher and slowly ground me down.  I don't if it was because it wasn't working or because of the riba.  But I made it until it was clear I wasn't going to clear.  The last time a couple of years ago I did the SOC with peg.  Very rough.  

My doctor is running the phase 3 trials and at my last appt last summer the PA said this is it this is what we've been waiting for.  Well results don't seem that positive now.  Anyway I've got an appt in a month so I'll see what's shakin'.    regards, David

[Aquila]

Okay, I thought it was 12+36.  Wow 24+24 - that really does seem like overkill.  But as you say, it's too early to tell.

They're looking at having an 8+16 arm in Phase 3.  That sounds great.  Hope it works.

A friend of mine saw her specialist in Melbourne today, down here in Australia.  He said that they are expecting a phase 3 trial of Telaprevir for previous non-responders to start in the next few months.  I find it hard to believe .... but you never know.  Maybe they'll launch phase 3 when the early SVR data from the PROVE3 12+12 people come in.  That will be in March/April.

Argh!  All this speculation is taxing.

Aquila

[Andiamo1]

I don't know the RVR rates for SOC; perhaps Jim can comment on that.

I am in the 24 + 24 group: 24 weeks of triple therapy and 24 weeks of SOC. That is probably more Telaprevir than anyone needs. but we won't know for sure until the results are in.

Eric

[macna]

I am in the Prove 3 Rollover
I am UND after week 3. I have had some fluctuation in viral load in my 3 weeks (I am on week 4 now). I was in the control group A. They did add the control groups from Prove 1 & 2, maybe they will add others later.
Recap:
Week 0: 30 Million
Week 1: 83 Each
Week 2: 253 Each (the virus strikes back)
Week 3: UND
This VX-950 seems to work well. I was in the control group a and I hardly had a drop and was released after 4 weeks.
macna

[Aquila]

Do you know what the percentages are for RVR with SOC?  I was undetected to under 50 at 5 weeks and again at 15 weeks, did my whole 48 but with a riba dose reduction, and relapsed.  

I've always wondered why - probably the dose reduction, but with RVR I think I had like a 90% chance of SVR.  Makes me feel pretty special.  lol.

That Motley Fool article is suggesting that if they get at least a 30% SVR rate in PROVE3 that is compelling enough to drive it forward very quickly.  From what we see here 30% sounds conservative.

Must be tough to continue to the end of the 48 weeks.  You'd have to think the 12 weeks of triple wiped all the critters out of your system.  48 seems like overkill.

I'd jump at triple therapy in a heartbeat too, Willows.  But no way I'd touch SOC again.  I just couldn't face it.  I'm coping quite well these days with my hep.  Fatigue is under control and I kind of like my simple toned down lifestyle.  Learning to be gentle with myself has really helped.

Aquila

[Andiamo1]

Each time I treated with a different protocol.  I participated in all the phase 3 trials since 1989.  SOC has changed considerably over time: The interferon dose was increased dramatically; Ribaviron was added; Pegalyated interferon was introduced and weight base Riba was added.

eric

[Andiamo1]

There are many people here that responded.  Almost everyone on triple therapy did.  In fact, I only know of one person on triple therapy that did not respond.  Vertex says that if you are RVR and still undetectable at 12 weeks, you have a 94% of SVR.  They actually worded it as a 6% failure rate, but I like the positive approach.  This from their last webcast on their website.

Eric

[willows]

I read the same article and had heard hints of the same news from a few other posters, here and on a Yahoo board.   I thought I understood all that Vertex was doing, but it was all a surprise to me....a very good surprise.   My doc gave me odds of only 10% and asked me NOT tx again for a few more years, but it doesn't sit really well with me.  So I guess the idea is......we've already tried the one approved method of tx and it didn't work, so we get to use telaprevir first?  If I was treatment naive, I might cop an attitude, with only a 50% (at best) chance from SOC, I sure would want to add a PI first try!  I gotta tell you, NOTHING the FDA does makes sense to me.  Except for this latest development...I'll try the triple combo in a heartbeat.

I'm pretty tired of waiting.....tired of being tired.  So your news is most welcome and I will be watching with sharper eyes now.  Wonder if CCO has any info about this new idea?  Good place to start looking.....

Willow

[Aquila]

So if there's no rollover for Group C, Missy must have been in the control arm.  That's quite a bummer, that they're offering Telaprevir to the people who didn't get it before but not the people who failed because of no riba.  As you say, maybe down the track they will.

Judging from the responses here, Eric you are the only PROVE3er who is actually responding.  Surely not.

I just saw a Motley Fool article today speculating that Vertex might get approval for Telaprevir for treatment experienced patients sooner than treatment naives, depending on SVR data from PROVE3.  Interesting.  He suggests that there are no other drugs that have gotten good results for previous relapsers and non-responders and SOC is only effective in about 16% of that group - a figure higher than I expected.

Of course this is stock market driven speculation again but it's a different angle that I think is interesting.

http://www.fool.com/investing/high-growth/2008/01/28/vertex-has-a-lot-to-prove.aspx

[Bill200]

Whoa! Treated 7 times.  Wow!  Did you ever figure on the 4 or 5th time that maybe it wasn't going to work and wasn't worth it?  After 3 times I'm kinda at that point - got to have something new.  I never cleared though.

[Andiamo1]

I will be sure to post the results of the post 12 week PCR.  Thanks for your support.

Eric

[susan400]

At this time, there's no rollover for the people who were in the Group C (no Riba) group on the Prove 3 trial.  This is not to say that at some point in the future that this might be changed/modified.  

Susan

[Aquila]

Missy, do you know which arm of PROVE3 you were in?  Maybe the no-riba arm and that's why you had viral rebound like Susan?  Or maybe the control arm.  In your previous treatment were you a relapser or a non-responder?

I still haven't heard of anyone who got Telaprevir + SOC who didn't clear.   Not that I remember anyway and I've been watching pretty closely.  Come to think of it I don't recall seeing anyone from PROVE1 or 2 who got triple therapy and didn't respond or relapsed either.  I'm more interested in the treatment experienced people though since I'm a relapser myself.

Eric, I put a note in my calendar with your EOT date.  I'm one of the many people on here who want with all my heart for you to get SVR.

Susan, I so feel for you drawing the short straw in the trial.  Is there a roll-over trial for you too?

What other PROVE3 people do we have on here?

Aquila

[w.c. missy]

i was in prove 3 last june - november... had required log drops at required testing dates, however at 24 weeks did not clear.  i will be starting the roll-over trial very soon, and hopefully, good results as well~
w.c. missy

[susan400]

I was in Prove 3 last Spring through early July.  I was only able to stay in for 5 weeks.  I had a good response in the first 1-2 weeks with a huge viral load drop, but since I was in the no Riba group, I had a viral load rebound.  I had to be undetected by week 4 and w/the rebound, I didn't make it.  I was called at week 5 and told to stop treatment.  I was encouraged once I got my unblinding reports and saw what a huge drop I'd had in my viral load.  It was a hard TX for me to take even w/o the Riba as I had the rash pretty significantly from about day 10 forward.   If you ever take Telaprevir, a word of caution -stay out of the sun when you're on it.

Susan

[Andiamo1]

I forgot to add, I believe I am in the 24 + 24 week arm.  I base this on how sick I felt the first 24 weeks, the enormous improvement in viral load response and how much better I felt at week 25!

[Andiamo1]

I treated 7 prior times and did not respond for the first 5.  Then riba came along and pegylated interferon.  I had a two log drop by week 12 and undetectable by week 24.  I relapsed two weeks after EOT.

I started Prove 3 in April and became undetectable at week 2.  I am still undetectable at week 41.  SEVEN WEEKS TO GO!!!!!!!!!!!!
Eric

[Aquila]

Thanks for asking the question.  I would like to hear from all the PROVE3 people too, just to see how they're all doing.  Not for the share price but to see what kind of results Telaprevir is getting in previous non-responders and relapsers.  

I'm using Andiamo's date of March 17 for his end of 48 weeks of treatment to give me a feel for where people are at.  If everyone started at roughly the same time then that means that the people in the 12+12 arm are about 17 weeks post tx.  

I seem to recall someone else recently posting that they got their 12 week post results and they were undetected.  

I'd like to see a thread with all the PROVE3ers checking in.  Status update.  It would be very helpful too to say if you previously relapsed or were a non-responder too.

My impression is that PROVE3 is getting very good results except for the no-riba arm so maybe Vertex could use the good publicity.

Roll call!

[geterdone]

Congrats on the trades, sounds like you’re in the right seat for trading. It’s been awhile since I have traded any stock but have been following this one for some time and think it’s the right time to get in. My timing is not that good at the moment to trade on a regular basis but loved it when I did I guess it is an adrenalin thing. Yeah, with trades like you’re doing I would not speculate on the bio’s either but by being challenged as I am I can only screw up on one at a time and think that vrtx will start to open up their data from prior Prove trials, just a hunch. Keep them trades a trading.
jasper

[Proactive]

Best of luck,,should be a trading opp somewhere along the line..As I've said before, I've traded it in the past, but really have no desire to trade anything in the hepc field...to close to home and as we know, emotions and investing are not a good mix...Besides, there are plenty of trading opps around, heck I grabbed some Mr.Softy at 31.15 in the premarket last week, and sold it in the aftermarket the night they reported earnings @ 34.65..Also picked up some dow diamonds (DIA) the same morning premarket at 115.50 sold them above 124..traded nicely in a couple banks and the xlf...all these guys moved more than 10%..who needs to take on extra speculation in the biotechs when you have big dogs making 10% moves (up or down, I like volatility)...fun week though, think I turned a total of 14 roundtrip trades....stimulated the mind a bit,and that was good thing..

[geterdone]

don't be telling me that after I just bought 225 @19.07. I think all the bad press is over with for the moment at least with Vertex as I am sure others in this arena will fall to a similar fate in the coming weeks.

jasper