More Info On VX-950 For Non-Responders

[Magnum]

Just spoke to Cedars-Sinai regarding my soon to enter clinical trial of VX-950 for non-responders. They said they are still battling with the FDA as to the start date but predict it will be in September. I WILL have to drive from Las Vegas to L.A. once a week for the first month, then it will be less frequent, but still 12 times in one year. Unfortunately, I will lose my job, but health first, work again in the future...

There WILL be a 3 arm treatment but not for everyone as I stated before. 33% will get the placebo and that is per Vertex's protocol. None of the testing or screenings can be done in Las Vegas according to their rules and orders. Orders must be obeyed at all times.

Although they are helpful, they are very clinical in their approach and answers, as one tech actually said his hands were tied by Vertex. This coming Wednesday, a 4-way Cat scan with Barium will be performed, then a liver biopsy will be performed right after it. The new protocol now is a 45 minute wait after the biopsy to monitor possible internal bleeding. It used to be three hours.

So, there it is. I will keep everyone informed as to the ever changing rules and time lines as per the non-responder Telepravir treatment. Otherwise, good luck to everyone in clearing. We will all be victorious if we keep fighting, and no matter how hard these treatments will be, think of our brave soldiers lying in bunkers and hand dug trenches who are wondering if they will see the sun rise again. In perspective, I think we have nothing to really b**** about...

Magnum

[Magnum]

Riba, Interferon, VX-950 and placebo will be given with the A & B trials. You will get the placebo in only the C trial without VX-950 but still given the Riba & Interferon...

Magnum

[kespr]

Do you mean Cinical trial B Is with ribavirin or without

[Magnum]

- If I get into Clinical Trial A, I would be given VX-950 (along with Ribavirin & Interferon) for 12 weeks. Then, 4 weeks of the placebo.
- If I get into Clinical Trial B, I would be given the placebo for the first 4 weeks, then the VX-950 for 12 weeks.
- If I get into Clinical Trial C, I would be given the placebo.

Magnum

[Bill200]

What will be the other two arms?  Will both get teleprevir but in different dosing levels?

[Magnum]

Point well taken. however the biopsy will be done here in Las Vegas, 8 miles from my home and a friend will drive me home. I've been fortunate to not have any complications in the previous two biopsies and the chance of internal bleeding will be rare, but???

I want to also pass on that I was told 5 days before the biopsy, no aspirin, Coumadin, Ibuprofen, or any blood thinners.

It's all so confusing at times. You feel great, but the doctor said that it is no indication of what may be going on internally. Internally, I felt lousy under treatment only. Hmmm...

Magnum

[dointime]

I suppose this won't be your first biopsy so you will already know how it goes.  But if it were me I'd book a room really close to the hospital and have a taxi ready to take me there when the biopsy is over.  Park your car and leave your stuff in the room so you won't have to carry much when you leave the hospital and  - oh yes - make sure they have room service. :))

Good luck
dointime

[frijole]

Please keep us posted on this.  The clinicaltrials website now shows this trial to only be in Ireland - they have taken all the US sites off the website (on July 3, I think).  I am looking for this trial too in Dallas  as well as candoman in Indiana.  

The Boceprevir trial for relapsers is also going to start soon, but the odds appear to be better on the Telaprevir than Boceprevir and I certainly would like to have the best odds.

BTY, I believe the ratio in the3 arms is 2-2-1 with the 1 being the placebo, so there is a 20% chance for the placebo

seriously magnum -- pm me if you hear anything because I don't read here everyday and I really want to stay in the loop on this one.
frijole