New Vertex Trial

[Upbeat]

Here is the clinical trail info. I sure would try the combo vx-950 and vx222 without SOC if They were running it in Az.
The short duration is nice.

http://clinicaltrials.gov/ct2/show/NCT01080222?term=hepatitis&cond=%22Hepatitis+C%2C+Chronic%22&lead=vertex&phase=1&rank=2

[Bali05]

when you did peg/rib how quickly did those sx show up ?

[dointime]

I'm very hopeful about these combos that don't include peg/riba but I wouldn't want to be first to try it.  I was in the telaprevir no-riba trial too and now have resistance.        

I hope that without the peg/riba the sides might be minimal.  If it came to it I would take the pills for the rest of my life to save my liver, providing that I could feel ok on them.  

I'm pretty scared to take ifn/riba again, the ifn because it scrambled my brain really bad and the riba because of the constant rash.  I'm lucky I didn't get any permanent damage from tx like what happened to a friend of mine and to some folks here, and I don't think I want to roll the dice again.  

So I hope I have the liver time to wait for a peg/riba-less combo.  That's a lot of hoping, I know,

dointime    

[Upbeat]

I take it you were in the original vx950 trials. I always wondered why the trial was so short after the RVR. I know about the resistence but I can't help wonder what would be the out come if a person stayed on monothearpy for an extended period of time. Because the FDA requires SOC as part of the mix it makes wonder if research wasn't stopped to early.

[Bali05]

thanks for the support , i sure can use it  right now

i started with alinia mono last year (after my own research)

and my vl dropped fromm 99k to 46k.

was offered trial with r7128 but than they excluded me because of previous alinia

exposure , so i got the first taste of the trial world. the minute you step foot one way

you get limited options in another way, makes you want to do nothing at all.

[susan400]

I think that your plan with starting off with SOC is a good one, most especially if you have doctor supporting it.  I always add that because I don't want to be accused of giving unauthorized medical advice.  If I can say it enough, I will say it that you need to go into these clinical trials with the mindset that they are still experimental.  I wish I had thought more about that before being exposed to Telaprevir prematurely.

Susan400

[Bali05]

to orleans : I care to

to susan400:

You are absolutely right, The new PIs are direct antivirals and therefore will create

resistant mutations. One shot deal !

I can only see 2 scenarios where I would try this:

1) One is a non previous non responder/relapser and just can not wait any longer
2) Wait for the phase 3 results and follow that protocol when Tele comes out
    first to second quater 2011.

I am still naive/geno 4  and about to embark on my first attempt.

Have been thinking long and hard about waiting for Tele in 2011 since it has

shown stronger antiviral activity in a small trial (Tibotec C210) for geno 4 .However

not as strong as geno 1 or 2 and it it is still under investigation for geno4.

Seems like everything is under permanent investigation with geno4.

What if you do VX950 + VX222 for the shorter run and turn out to relapse , OOOps !

should have done it with Peg/Riba ? To late now since you now have Tele resistant

virus.

Since I am still naive/geno4  I think I will go for Alinia+SOC and keep Telaprevir or

other PIs as a plan B option in case I turn out nonresp./relaps. even if it comes out

next year. Theses new drug launches always come with a lot of hype to , with

Tele I do not think 24wks are not garanteed only with quick response , also it is

a third drug with more sx.

I was on a UK forum and read that Pegasys changed their guidelines recently for

geno 1 to 24 wks for early responders only. Still need to investigate this.

What I dread right now is to do SOC with a negative outcome and than seeing

trials coming up in the future that are INF free but have no previous INF exposure as

a requirement. And than again I might be "cured" by than.

[susan400]

Yes, Willy, I most certainly do remember the Telaprevir no Riba arms as I was one of those arms.  I, for one, will choose to reserve judgement on this trial until, "THE PROOF IS IN THE PUDDING", so to speak.  I'd hate to jump the gun and be exposed to Telaprevir plus the new Polymerase inhibitor, of they come to find out in a year, that oops, they needed to have the Riba included, or oops, they needed to have the full SOC included.  I don't wish to get screwed again!  Susan400

[Willy50]

I am particularly watching this and other stat-c trials.  This one is very small; 25 people per arm.

Should it turn out that the short duration is..... not quite enough we may see break through or rebounds (remember the Telaprevir no riba arms?) and possible resultant resistant issues.

I think that this is the wave of the future but personally don't want to be the first one through the gate.  I do believe that they will have some success with 12 weeks of TX; no question in my mind, but one form of TX is likely to be more effective.  That is the key question.  
I think we may see the results of the Inform 1 at EASL this year.  That should provide some data on which to make projections about this trial.  Vertex also claims that they will provide data on this trial in the second half of this year.

best,
Willy

[WriteItDown]

I agree. I think impressive SVR rates AND a shorter duration is extremely desirable. Some people just have such a hard time staying on the meds, a shorter tx that worked would be a great thing.

NYGirl, you may think you're a baby but you're obviously a very tough cookie, and for those folks who end up having to stop tx, maybe they could manage a shorter time period.  Not everyone can do 72 or even 48 weeks.

[orleans]

I care.

[nygirl7]

The short duration is not as nearly important as the spectacular results that they are achieving.  Who cares if you treat for a month but aren't cured or 48 weeks and are?  It's about being cured at the end of the day and the little perk of being shorter is just a bonus.

Really. To think otherwise just confuses the issue. It's about LIVING in the end - who cares what that takes. :)