Peg, Ribavirin, and Telprevir

[gregchicago]

I was offered to participate in a blind study using those three drugs.  However, only 2/3 of the study particpants actually get the Teleprevir, the other 1/3 gets a placebo.  And the study can continue from 52 weeks until 72 max.  Non of the particpants will even know their viral lode until everyone is complete with the study.

I'm feeling reluctant to participate given I'm Geno 1 and if I don't get the Teleprevir that success rate is not that good.  Also becasue I wont' know any reults for a year of more.  My hunch is to wait until T is approved, or go for tratment without the Teleprevir.  Lastly, a biopsy is required to begin the study and as you all know there are significant risks with that.

Any opinions out there?

[sandbash]

Yes, I agree that in the study you get better than average care.  They are going to send us to the dermatoligist if we get a rash....they want to bx it.  I was also told that they manage side effects....I asked about depression and nausea meds and they said that they treat if it happens.

[Fl_Gator]

you can't loose in this study....you either get SOC or Triple therapy and the biopsy is a breeze, Ive had two since being diagnosed two years ago. Not to mention that it's really good to know where you stand.

[fretboard]

Yes you are right, I was thinking of someone on here who was on the telaprevir an Peg only arm no Riba, and they don't do that anymore.  Thanks for catching that, you can't beat an offer like a telaprevir trial, it's free and with the telaprevir in the mix it increases your chances towards SVR.  Hell even in the no telaprevir I think your chances still could be better cause you get better than average care.  Are they giving rescue drugs or not, I heard they were adding a dermatologist and other things on one persons post awhile back.  later

[meNtoby]

Yes, that is what I thought,- that either way you are going to get SOC, so why wouldn't you want to be in it...unless you were hoping NOT to be the teleprivir guinea pig, and just wanted the free tx.  

[sandbash]

Im not sure which study you were offered.  I'm just in the screening phase of the Vertex Phase 3 geno 1 naive tx study.  
The very least I will receive is the current SOC...and will have a 66% chance of receiving telapravir if Im in one of the other arms.
They will let me know if i'm responding by week 12....and week 24 there might be a chance that tx will be over (or continue through week 48).
I'm going for it ....my liver bx was stage 2, grade 2.
If for some reason that I fail the screening phase...I will go on SOC anyway.
Good luck!

[meNtoby]

Wow, I am treatment naive, and study naive, I better recheck the one I was looking into!
c.

[meNtoby]

I was under the impression that the other 1/3 still get the Peg Riba but just not the Teleprivir...I could be wrong,
c.

[fretboard]

That's not how the telaprevir study I was waiting to get into worked.  If you don't have a 2log. drop by week 12 you are dropped that's how the tx naive one worked in my case.  I don't know I guess all trial protocol can be different, but for tx naive it would all seem to work the same, however I am hardly an expert in these matters.  Take a look at one of Magnum's post as he tells how his will work, of course his is for non-responders but the way his works is closer to the one I was going to be in.  I wasn't accepted b/c of meds I am on, but telaprevir has had excellent results with a very high percentage of geno 1's clearing.  Of course the placebo arm would be a terrible situation.  About a biopsy, it really ain't nothing to worry about, I've had two and the only problem that I've ever had was that it took a long time, meaning 6:30am till 5pm., the whole day.  later