Teleprevir feedback

[grshpr]

I'm a non responder treated 6 years ago with standard peg-riba therapy. Am returning to treatment now with hope that new drugs will clear this s**t.  Have viral load of 5million. CT scan today will know if damage has progessed since last imaging soon.

To those already in clinical tests with teleprevir+peg+ribavarin; Does it work?  I'll go through anything to get this monkey off my back once and for all.

[Andiamo1]

I treated 7 times with the standard drugs is various combinations.  Relapsed 7 times before I tried Telaprevir.  Now I am SVR.

[jacksonblue]

i have relapsed 3 times in past currently in week 15 been neg since week 2 you can google vertex give idea odds for non responders relapsers breakthrough null responders trials ongoing there our other drugs in trials that may turn out better for non responders i believe in small sample nonresponders about 40 percent there our stage 3 trials for naive and people whom failed treatment

[copyman]

It works. I know first hand :-)  

[dmhrdh]

Previous non-resonder now SRV with Telaprevir :-)

[comeagain]

You make me a bit curious here what exactly is it that you know first hand.

ca

[copyman]

sorry i forget that some may not have seen my few previous posts about this, although I did not talk about this much because I signed consent form not to talk about it on forums, etc. My first hand knowledge is I'm in the 13th week of the Telaprevir "open label" study. This study is where everyone gets the real drug for 12 weeks along with riba & peg then SOC for 12 or 36 additional weeks. NO placebo in this study so I know I got the real thing.  10 million starting VL, UNDE at 3 weeks (probably sooner), 8 & 12 weeks.
I guess this can be considered "first hand" knowledge. can't imagine anymore first hand then that :-)

[jacksonblue]

i assume you our done week 24 because evr home srtecth no worries good luck will let you now about hemo 9.9 went to clinic today hopefully up regardsteve

[Mary4now]

What are all your genotypes?

[copyman]

Jackson,
No, only in my 13th week. Just stopped the Telaprevir last week. Study will randomize at 24 weeks to either stop or continue on with SOC drugs to 48 weeks.

Mary,
My genotype is 1a. From what I understand Telaprevir study is for genotype 1a & 1b only.

[jacksonblue]

i new you were 13 week i just thought you were to stop at 24 weeks because of being neg at 3 weeks i was told i am done at 24 weeks i am a little concerned to stop at 24 i was neg week 2 i was told if neg by week 4 done at 24 regards steve

[comeagain]

The qustion was does it work for a nonresponders your not a non responder that have treated before are you?

But you know already doing treatment once ,you do want the best meds possible maybe telapravir is.
Boceprevir could be better specially that new stuff thats supose to be 10 times more potent then the earlier boceprevir .( rockerforlife has posted a link about that  twice before)

But  is there any studies not blinded on that, if not  when and if is it gonna be aproved.  Whats gsshprs liverdamage how much time does he got??

ca

[jacksonblue]

sorry missed question 1b did relapse 72 weeks

[Marcia2202]

it was the 518 he posted

[mnl1]

How do you know your results at 3, 8 and 12 weeks?

I am in the Telaprevir trail and I have been told I would not be able to get that info because of how it could affect someone in treatment, either stopping or continuing on based on the info.

[Tippyclubb]

Sounds like were in the same trial, but we will not know virus load until the end of the trial.  How did you get to know yours?  Maybe its different for genotype 1a and they give you vl ?  Or did you go to your private doctor to get this information?

[Debbie556]

My boyfriend is in the study for the telprivar and at 7 weeks we had his blood tested privately. He was at a 0. He had never tried any type of treatment before this and in a few weeks we will find out if he continues for another 24 weeks or stops at 24. He is 1a and has done the fibro scan for the liver as well as the biopsy. The fibro scan will be repeated in 4 months to see if there is any improvement to his liver..

[Tippyclubb]

I am considering doing the same.  Seeing as the test is expensive I can only do it once.  Which week is most important to know-- 4th, 8th, or 12th.  Or does it matter what week its done?

[Debbie556]

his Dr told him that the earlier you test clear the better you are for cure.. I wish we would have done it sooner that the 7 weeks but at least we know he was clear at the 7 wk time.They will let us know at the end of his treatment exactly when he was clean but it was nice to know that everything he was going through was at least worth it.. Good Luck

[copyman]

Jackson: From how I read the consent form and from what the trial nurse told me even if you are unde at 4,12 & 24 weeks you could still be randomized to 48 weeks. From what I understand the FDA asked Vertex to add this 2nd part of the phase 3 trial on to compare 24 vs 48 week TX. So this is why it is my understanding that even some RVR's will do 48 weeks, to see how much, if any difference between SVR's.


Tippy: I did my own PCR's privitely :-) I would think the 4 week would be the most important PCR test if you had to pick one. Many treatment decisions can be made off this very important test. I did my own PCR's so I can make my own decisions at 24 weeks. Best of luck

[Tippyclubb]

Ok  thanks.  Do I have the Pcr done on the day of the fourth shot, or wait a week because then the meds are in my system for a month on the fifth shot.  Hope you can follow that.

[jacksonblue]

hi copyman you our in phase 3 trial i am in rollover trial from prove 3 i already did 48 weeks finished in may had placebo i have signed 4 different consent forms that is why my results our not blinded

[Tippyclubb]

Is PCR the same thing as a viral load test?  I need to know what to tell my doctor I need.  All I need is the vl.  I don't need anything else tested because they are doing that.

How expensive is the test?.  I had one long ago and it seems my 20% deduct was a few hundred dollars.  If necessary, I can do it more than once but prefer not to spend the money if I don't have to.

[copyman]

do the 4 week test on the day of 5th shot if possible, make sure to have test done BEFORE you take the 5th shot.

PCR is same as a Viral load test.

Cost is around $300 plus or minus depending on lab. If you can afford to get one more test beside the 4 week get the 12 week PCR. Again this test would be done on the day of 13th shot BEFORE the shot NOT after.

[jacksonblue]

svr 12 week post 24 weeks treatment nonresponders 41 percent
breakthrough 44 percent
relapsers 73 percent trials ongoing these numbers may increase when extend treatment out to 48 weeks or decrease at 6 months post maybe 12 weeks triple 48 weeks soc is the ticket these numbers do look better then boceprevir for 48 weeks time will tell if you have the time it may be better to wait if you our truly a nonresponder see what true stats our

[grshpr]

Thanks all, good to see an active response, keep it coming. I'll update with any news as things happen for me. Have been contacted by University of Gainsville, Fl. to enter trial there. In process of retrieving med records from liver Dr. to send them for review to see if I qualify. It's a 4 hr. drive but I'm tired of a wait and see approach. I'm going for it if I get accepted.
I'm in pretty good physical shape now, 6'4" 195 lbs age 52 very active. We'll see what shape my liver is in when the CT scan results come back and the study requires a biopsy also I think. Last biopsy Mar '02 Moderate activity (Grade 3) with Portal, Perioportal and Septal fibrosis (Stage 3) Mild Iron Deposition.

I tolerated the treatment then fairly well and when the doc told me I'm non responder, won't get any better might as well stop I begged him to up the dose and keep going.

I Quit drinking, smoking, drugs of any kind once and for all 8 yrs ago so have that going for me too hopefully.

Current labs from Quest; (Only the stuff that's out of normal range)

HCV RNA, QUANTITATIVE   4,960,000 H  <50 IU/mL  (Viral Load)
HCV RNA, QUANTITATIVE   6.70         H  <1.70 Log IU/mL

BILIRUBIN, TOTAL                1.7          H    0.2-1.2  mg/dl
MCH                                    34.6        H    27.0-33.0
ABSOLUTE EOSINOPHILS    8            L    15-500