My vertex group.

Hello and merry christmas to all. Well, yesterday I became unblinded as to what group I am in, I will not get my VL untill the 27th, I am in the 24 week group (C) which means I have 3 more shots and then I am done. I did 12 weeks vx-950, and 12 weeks soc, I think I should be happy to be almost done but I am scared!!! I do know my predose VL was 205,000, I am stage 3.. I do not want vertex to lose my data as they will if I do not stop at 24 weeks.I am very greatful to vertex to allow me to have vx-950 as my DR ( Shiffman) told me today vx will not be out for 4 more years. He also told me I have a 90% cure rate, ( he uses the word cure alot)  PLEASE tell me some thoughts.

[sallyo]

Is Shiffman at U.M.?  I really hope your test is good and I will be watching for it.  Thanks for posting

[jmjm530]

Since there is no VX-950 SVR (cure) data yet, Shiffman must be basing your 90 per cent chance of "cure" on some of the shorter course studies that I believe found that cure rate in the sub-group of patients who had RVR (non-detectible at week 4) and a low pre-tx viral load (under 600,000 IU/ml). Since you're still blinded, he's making the assumption that you were non-detectible by week 4, which is reasonable since you're in the VX-950 Group. Curious, when are you to be unblinded as to your viral load?

As you say, if you continue on past 24 weeks, I assume Vertex will have to throw out your data from its trial database. I'm making the assumption that you would fully disclose your extension to Vertex because if you didn't it would throw off their SVR data to the detriment of those that will be using it to make treatment decisions.

No one can make this kind of decision for you but personally I would be happy I was in the 24-week group and in fact, given your pre-tx viral load -- and hypothetically being in the trial -- would have considered stopping at 24 weeks, had I found out I was in the 48 week arm. I say "considered" because of your (and mine) stage 3 status which gives us less room than say a stage 1 or 2. Still, I think I would have stopped, but that's me, not you and in my case it's all hypothetical.

All the best in whatever you decide but just keep in mind there are two factors going on here -- getting rid of the virus and minimizing damage due to the treatment drugs. IMO 24 weeks will potentially cause less damage to your body -- perhaps permanent damage, than 48 weeks, but again a lot of speculation here.

All the best,

-- Jim

[bobbyullc]

GOOD LUCK,
question,,,  what geno type are you?
mr dr thinks 2 years. hope mine is right?
did you do 12 weeks of vx alone or 12 weeks with peg and 12 weeks peg only?

[pln]

Jim"Curious, when are you to be unblinded as to your viral load?
I will have ALL VL dec 27th.. O'h yes I would tell my DR if I was going to keep going. In fact I start getting weekly blood test at week 25.    Bobby. I am 1a/1b. I did 12 vx-950 plus soc then 12 more weeks soc, I am at week 21.

[bobbyullc]

as you can imagine we are all pulling for your svr.

[jmjm530]

Recent related threads on shorter course treatments are "BlessedHeppers" thread about five thread down from here, PDS's thread below that and "AlaCarte's" below that
http://www.medhelp.org/forums/Hepatitis/messages/44218.html

Of course, these studies and reports are with peg and riba, not with VX-950.

-- Jim

[chcnme]

That is wonderful that you have only 3 more weeks and you are through with the 24 for VX.  Best of luck to you.  You had a great viral load going in.  If Shiffman has told you he thinks you have a 90% cure rate right now, well - if it were me, I think I'd stop at 24 (but then again, it's a very hard decision).  When do you have to make this decision?  

On the 4 yrs, I heard the same from the research coordinator at Duke (that it would be at least 3 or 4 years before it was approved, and she emphasized "if THAT"), and Duke is up there with the VX trials, and so - I think she might know what she is talking about  (and she said it very comfortably - no ifs ands or buts in what she said).  But ya know - even if Shiffman told you it's projected four years from now, I don't know how you factor that possibility into your decision unless it's because you are factoring a possible relapse on down the road if you DO stop at 24 and you wanted to treat again with VX .  Yeah - tough decision.  

Whatever you do decide, I know you feel a world of thanks to Vertex and your doc.  Keep us updated!  Happy for you!

[FlGuy]

What a ride, huh? Glad it's coming to an end for you, Pam. From my view, you were in the right group.  Given your upcoming vl disclosure, end of soc and any decision to continue must be in a pretty tight timeframe. I'm thinking you already hit the make and will have a whole new view of a new year.  Look forward to more news, soon.  Thanks for doing this stuff, Pam.

[APKhaos]

Welcome to the magical Arm C. Like Jim, I was very happy to find that I was in C, and now with just two shots to go.

You might want to wait until you see your VL data before deciding on the 48 weeks. Seem to remember answering you a week or so ago on this 'whats next' question.

FWIW, my Geno 1B load pre-dosing was 28,400,000.
After 4 days that went to 514IU/ml, and to UND somewhere after 15 days at 29IU/ml and 22 days at UND. Been UND since. Loving life right now. It has definitely been worth the risk so far.

[pln]

Jim, I have been thinking the same thing, how about the people that did 28 days of vx. PLEASE Vertex post some svx data....

[jmjm530]

Shouldn't the 12 week group be having their 3 month post treatment viral load tests pretty soon?

[pln]

FL ,thanks,From the start I wantedC,then when I was told I am in group C I started to cry, both joy and scared. I just wish we had some svr data on vx. APK, I am going to wait until I get my VL unblinding before I decide on any thing.I have mixed feelings right now! I could wake up tomorrow and start jumping for joy, it is just so new right now. Pam

[lab-rat]

Congratulations...I would be thrilled if I were in your shoes!  Of course you have to think about yourself first. Clearing the virus is the most important goal.  But If I were you, I would be more than happy to stop at week 24 and see what gives.  I'm only on week 15 so I've been very interested in watching the unblinding news from those ahead of me in the trial.  Thanks for posting your information, and best of luck no matter what you decide!

[jmjm530]

I would imagine the first to know after the unblinding (other than the patients) would be the doctors and study nurses. I'd give them a call soon after and see what info you can get.

-- Jim

[pln]

Thank you,I think I will stop! I have to have faith in the meds and my DR. Lab, I am thrilled, I have all but one of the criteria of short coarse any-way, and that is low damage, the big one I guess, But the 24 weeks studys never had vx in them, so we can not really go by any studys. good luck to you as well. Jim. my study group had no group D (12 week). I gusee we will see soon.The more I think about this and read people's reply the better I feel about this. I will post my VL as soon as I get them.Pam

[chcnme]

oooooo good gracious!!!  hehehe!  I would be so relieved too!!
(I amaze myself at how excited I feel for someone on VX :) !!  I just get THRILLED myself and can't imagine how you feel!

Best of luck, and do keep us updated.  I have a hard time keeping up over here with threads (there is so many!) but I keep my eyes peeled for the VX :)

[SixtiesSage]

I really don't think it will take 4 more years to release 950.

Testing is toward the end of phase 2 and the results look extremely good so far. Don't forget that the FDA really wants this drug because of the medical need and financial burden it places on society. How do I know? The drug is FAST TRACKED by the FDA. I'd say less that 2 years. Actually by June 2008 as a good guess. Otherwise it would not be Fast Tracked.

HAPPY HOLIDAYS!!!!

[APKhaos]

As sixties said, the first phase 2 trial [Prove 1] is maybe three or four months away from the entire cohort being through the first 24 weeks. The subjects who started dosing at the very start of the trial are being unblinded now, but it will take some time to get the entire cohort unblinded.

There are two more Phase 2 trials are in progress. Prove 2 for naive geno 1 in Europe is starting to dose soon. Prove 3 for non-responder geno 1 [and a few subjects who had a viral breakthrough during Prove 1] should start dosing something like mid 2007.

As I understand it [which is not that well] if the results of all these Phase 2 tests are strong enough for efficacy and safety, FDA's fast track allows the drug to proceed no or limited Phase 3 testing. If that is right, then sometime in 2008 sounds like a reasonable estimate. Anything goes wrong in the Phase 2 trials and all this changes, of course.

I can tell you that I'm more than grateful for being lucky enough to make the Prove 1 trial. To go from a 28,400,000 VL pre tx to UND in two weeks in impressive, and to see the relief on my family's faces when we got those results was something I'll never forget.

Just one more shot and 48 weeks of clinical follow-up to go!

[pln]

Thanks that is very good news, when my DR said 4 years I was a little skeptical, Sometimes I wonder if my DR know's who I am when we talk on the phone. APK, WE ARE ALMOST THERE!!!!! I will post my vl tomorrow, can't wait. Pam