What Would You Do??

Hey...just got a call from my Doc telling me the vertex trial is available for me if i want it...i am sceduled to start tx on the riba and peg...at least i wont be paying the big bucks and they say you clear the virus right away...i know,staying clear is the trick....the cons are i might end up taking the plecobo drugs....so what is the smartest thing to do...im a stage 2,,geno 1a...had virus for 20 years

[Fl_Gator]

...no brainer....get into the Vertex trial...

[Isobella]

Just saying....if you were to get the placebo arm at the very least you would end up getting 48 weeks of SOC for free.  

There is a bigger chance to be randomized into one of the 2 arms getting the telepravir-one for 8 weeks and one for 12 weeks.  And txing for 24 weeks

I am in the tx naive part of the trial and I will be  doing shot #4 tomorrow. I am geno 1a stage 1.

For me-I was going to treat this year anyway and I really wanted a chance to get the telepravir-but free SOC beats very expensive SOC any day in my book.

Just my opinion tho...we all know that this is a very personal decision and I wish you the best in deciding.


Isobella

[Rockerforlife]

Thanx....im lucky i cancelled my previous tx last month...i guess rash is the bad thing about vertex...but i got lots of coconut oil ready

[Rockerforlife]

anyone know the stats on the pervious vertex trials ..like what % got SVR?

[Isobella]

Well said Gator!!

Rocker-I am a believer--off to the health food store for my coconut oil in the morning.

The rash was a concern for me becasuse of my dry skin.  So far no troubles...but it is only the end of week 3.

[can-do-man]

Even if you get the placebo instead of the telaprevir you still get the real peg and riba, and you being a geno 1 relapser need a shot at one of the new drugs. Go for it.

cando

[jmjm530]

Maybe just hold back a wee bit on your nutritional philosophy until they sign on the dotted line :) Good luck with the trial if that's what you end up deciding!

-- Jim

[Rockerforlife]

Mke sure you get the DME virgin coconut oil...its the best and only one worth ingesting...i eat a table spoon morning and night

[Trinity4]

The only drawback I see is if you get the placebo and tx is only 48 wks, doesn't relapse mean automatically treat 72 wks on SOC?  Would your insurance pick up the extra six months because I'm not sure, but I don't think the trial will give you 72 wks?  
I could be totally wrong about tx duration for relapsers.  
Trin

[Fl_Gator]

....I was told that only 9% of patients get the rash....I haven't had any problem yet...I have two weeks and one day to go in the telaprevir/placebo part of the trial....then continue with SOC....

If you end up in the placebo group and don't respond, you may have first shot at the next trial.

[Isobella]

In the next trial, all arms get all 3 drugs.  

[jmjm530]

I don't know the trial specifics, but if there's a decent chance you will get the placebo, then I'd think about waiting until Telaprevir or something equally promising comes to market. Then, there will be no placebo plus more trial data to match with your stats. This will be your second treatment and you want to give it the very best chance.

-- Jim

[can-do-man]

The new trial for us relapsers is a 2-2-1 ratio, the third arm is a placebo arm. But wirh a 2-2-1 your odds are better.

cando

[can-do-man]

vertex trial dor relapsers.....

http://www.clinicaltrials.gov/ct2/show/NCT00703118?term=vertex+trial&rank=6

[Rockerforlife]

The trial i was in last time would not allow me to tx right away after my last shot....i had to wait 30 days for the final test results before i could continue on to 72 weeks...that means i would have a down time of a month with no tx drugs in my system...i dont think that would be ideal to do....what you think?....BTW....thax to you guys ...and gals...for your help...im gonna call tommorrow and get the low down on this vertex tria...BTW....i weigh now 200 lbs exactly...i lost 15 lbs ...ill get to 180 yet

[can-do-man]

I agree with jimbo, if i wasn't stage 4 i would wait till one of these 2 new drugs hit the market. Why risk it?

Also would like to know if their going to allow "rescue drugs" this time.

[Trinity4]

Is the protocol to go 72 wks for relaspsers?  I guess that was my question.  I feel pretty sure that if you get all 3 drugs you will be UND by 12 wks but if not do you have the option of 72 wks?  Would that be something you would consider?  
A month without drugs is not good.  These wonderful toxins have to stay in our system consistently or bad things can start to happen again.  I've read where relapse after 48 wks usually happens within the first six weeks?  
Trin

[Rockerforlife]

Whats the procedure with drug testing before starting in vertex trail...do they ban you from the trial if they find any drugs i your system...this is got me concerned now....i know if they find heavy drugs they wont accept you...like i said before, i smoke tiny amounts of pot ...

[Trinity4]

If that's the case drink lots and lots of water before testing.  Always worked for me.

[Rockerforlife]

ill check the details on the vertex procedures,,,did they ever let relapsers go the 72...?

id go fer that in a heart beat...another question.....do they use roche drugs or plough

i want roche this time...pegasus

[Isobella]

I'm getting Roche Pegasys.

Congratulations on the weight loss!!

[lpw]

is vertex any good?  I am a non responder 2 times - both tx's - Interferon/Riba ; Peg/Cope with procrit and neupogen.  I have been fihting this sinse 2000 and it has just about done me in.  I suffer extreme bouts with encephalopathy - used to be every other month, and now it is weekly.  I am taking a boat load of meds and continue to have horrid labs.  My ammonia levels stay in the 300+ levels...  I am certainly open minded about anything out there that can help before I lose it from brain damage which I am expierencing daily bouts of.

[Trish77]

Ask under what conditions they will reduce your drugs.  I didn't know to pay enough attention to this one on the trial I'm on and now dealing with the implications of dosage reductions at blood count levels higher than if one were on straight SOC. For example, my interferon gets reduced if my ANC drops below 1.5, which is not even close to a level that INF would get reduced at on SOC.  You should be aware of this and consider the implications for yourself, particularly if it comes to this in the first 12 weeks of your treatment, which are the most critical.

Ask about the rescue drugs and under what circumstances they'll give them to you, what the conditions need to be if they do allow them. You might not want to get too pushy about this before the trial, just ask the question.  You can advocate later on IF necessary. Also ask if they cover the cost of the rescue drugs. Likely not and, if not, you need to realize that, because you're in Canada, the cost will be borne by you until the Trillium application goes through and that takes about 4-8 weeks.

I say these things to you because I dealt with them on the fly during my trial and it added some stress to the situation.  Even at that, things will come up you don't expect, regardless of how well prepared you try to be.  All you can do is make the best decision at the time and hope for the best.

If you were in the U.S., I'd say if there's a chance you'd get a placebo, weigh it out vs a high-powered beginning phase of SOC with Alinia thrown in that gives you the option of extending if you need to ... or wait for the other drugs.  

However....having said that .. I know we're not that progressive on treatment options in Canada, we're lagging behind except *maybe* in the larger treatment centres and it's not easy to find a doc who will treat aggressively such as double dose the INF to start with and likely not with Alinia...considering that, this trial may be a good option in Canada - although I do know of a doc that has suggested to a non-responder I know that his next round of treatment will be done with higher starting dosages.  Now that was interesting.

Can I ask what centre you're getting treated out of in Canada that's doing a Vertex trial for non-responders?   If I have it right that you're a non-responder.

Good luck to you with your decision....and hope I haven't confused the issue more!!

Trish

[Rockerforlife]

My little rubber duckies are all ready to blast away...ive got Trilium setup...be set up for a while now...my work place will cover the rescue potions if needed...the center is in Toronto...Mout Siani Hospital...ask for Dr Finnemans office....hes well known...its called THE LIVER STUDY

[Marcia2202]

First, great you are able to get into the study. A lot of stuff to weigh out. I myself I think would go for it. Whatever you decide, I am rooting for you, big time!

Marcia

And yes, I drink my riba with a tablespoonful of VCO. Those little capsules glide down so well with it.

[kitkat14]

I'm also treating at Mount Sinai in Toronto.  Small world!

I am geno 1b treating with the standard pegasys and riba.  The doctor has not hesitated to prescribe additional drugs when needed.  I am also taking folio acid for my red blood cells, symbicort to help with my breathing, and clobetasol for my rash.  I was told I could have the rescue drugs if needed (not so far).

k

[Trish77]

kitkat, you are in a trial at Mount Sinai as well or regular SOC?

Rocker, is this a Vertex trial for non-responders?  Sounds like you've decided to go for it.  I would ask what their approach is on dosage reduction.  They'll have to follow trial guidelines and I'd suggest you at least make yourself aware of what they are and what the implications to you are.  I wish you good luck with this and here's hoping you get a telaprevir arm.  Rock on!  :)

Trish

[Isobella]

In the tx naive part of the trial-they do not allow rescue drugs.  They do dose reductions based on SOC guidelines.  

It is my understanding that after we are done with the telepravir/placebo portion of the tx, we can have rescue drugs-our cost.  

We are not given the opportunity to extend tx,  If you are getting the real deal and UND at 12 weeks, you treat for 24 weeks.  Not an option to continue 48 weeks.  

Good luck with your decision, Rock!

Izzy

[kitkat14]

I'm treating with regular SOC.  By the way, I finally got the results of my 4 week test.  I'm down to a viral load of 24 from 9,450,000  so I'm well on my way to getting rid of this thing.  I've completed 12 weeks and I am now waiting for those results (which should take another 3 weeks to get -give or take.)

k

[Fl_Gator]

....I wonder what trial you are looking into. If you are talking about the same trial that I am in, I thought this one was for tx naive? please look into it...let us know.

[Isobella]

I know my center is doing both (vertex)  a tx naive and another for what my NP says is a "certain type" of hcv patient--read non responder.