Telaprivir works

I haven't posted in a very long time but I just wanted to share news with those of you who may be following the trial drugs  

I just received my 48-week post treatment test results and I'm negative !!!!!!!!!

I was in the control group (placebo) of the Prove 1 trial for vx-950 and treated for 48 weeks with standard treatment.  I responded well in the beginning but 11 weeks post treatment I relapsed.  So I joined a roll-over trial and treated for a total of 24 weeks - the first 12 with telaprivir - the real thing not the placebo.   I went negative at week 1 and remained that way until the end...and now.  Just wanted to let everyone know that Telaprivir works!

[Larry57]

Thanks Lab Rat!

I am in a Telaprevir trial where we all get 12 weeks of the candy, and then continue SOC for another 12 or 36 weeks, depending if we were RVR or not, and if we were, then you have a 50/50 randomization to either stop at 24 or go to 48.  I just found out yesterday that I am going to 48, which is fine by me.

Started week 22 today, and headin' for the half way point :-)

Larry

[newleaf09]

Wow!  Congratulations!  This is really a good news week.

[lab-rat]

Good luck Larry.

From what I've heard, you're best bet is to do the whole 48 weeks anyhow.  My doc from the original trial cautioned me about doing the 24 week rollover trial after relapsing as I did.  

Best of luck to you! - Soon this may all be a distant memory!

[Isobella]

Congratulations!  Sorry to hear you had to do it twice, but happy the telaprevir did it for you on the second go round.

I'm 45/48 of the one with a placebo arm...guessing I got the placebo since I'm still txing.

Thanks for updating us!

All the best,

Isobella

[copyman]

Hey great news. I agree that Telaprevir works. I also was in the same trial as Larry. NO placebo study where everyone got the real drug for 12 weeks. I was randomized to the 48 week group after 24 weeks but decided to stop after 33 weeks. I did my own PCR's and was UNDE from 3 weeks on. The studies show that there is not much difference between 24 or 48 weeks TX if you are unde 4 weeks or sooner with Telaprevir & SOC drugs.

[Tippyclubb]

Good for you and thanks for letting us know.  Am in the Vertex trial and was RVR by week 4 and randomized into the six month group.  Its reassuring to know you SVR with doing 6 months of tx.

[orleans]

long time, congrats, jerry

[zazza]

Hi, Lab-Rat! So you are SVR now?! Great news! Remember me, you encouraged me to go the full 72, and I too am SVR now!

[lapis]

Great news!  I'm another VTX lab rat.  Finished 24 wks in tx-naive trial, now 8 wks post EOT.  UND at 4 wks post, will have 12 wk post PCR in July.  Just holding my breath a bit till then.  After that I think I'll feel home-free.

So happy for you, SVR!!!  Lapis

[newleaf09]

Boceprivir had a roll-over, too.  People who received the placebo and did not clear by a certain time were allowed to add it later.  That's why I went for a PI trial myself.  Seemed like you couldn't lose if you'd be given a crack at the drug later.  That also struck me as a very humane thing for the pharmaceutical companies; to go beyond data gathering and offer a potential cure to the placebo lab rats.  I'll be interested to see the success rates for the rollover patients.

[Rockerforlife]

YOU SAID

The studies show that there is not much difference between 24 or 48 weeks TX if you are unde 4 weeks or sooner with Telaprevir & SOC drugs.


I THINK tere is a 10% diff,AT LEAST IVE SOMETHINg LIKE THIS IN THE BOC trials

[thegypsy9164]

Well,

I'm on a Telepravir study too.  I did shot #21 yesterday and will not be allowed to find out when I went UND until at or after week 24, which is coming up soon.  I'm excited to know and hopeful.  It sounds like a lot of us on this forum are clearing.  I wonder if it has to do with a positive attitude of participation and education about our disease as well as the new drugs.  No way to measure that right now though eh?

Joey

[copyman]

even if it is a10% which many studies say otherwise. The difference vs the permanent damage that an extra 6 months of peg and riba can do to you is not woth it. For me anyway, others may feel different.

Believe me I have done more research on the Telaprevir 24 vs 48 subject then probably anyone. I have read studies where the 24 week arm actually had a better SVR rate then the 48 week arm.

Bottom line is I did my own private PCR's and was UNDE at 21 days, probably sooner. I did the PCR's every 4 weeks throughout with the most sensitive test available at 24 weeks, the Labcorp NGI UltraQual which measures down to 2 virons.
I elected to do the Telaprevir study over Boceprevir because of the chance of doing only 24 weeks. I knew I had a 50% chance of being randomized to 48 week arm so I did my own PCR's so I could make a decision at 24 weeks.Glad I did. I tx'd an extra 9 weeks to help my chances.
I still have some praying to do to remain SVR

[Rockerforlife]

you said

I have read studies where the 24 week arm actually had a better SVR rate then the 48 week arm.

you got me thinking...maybe in some cases too much TX may detirmental...too much of a good thing i mean

[Tippyclubb]

gypsy they will not tell you when you went UND, only that you are by week 24.  The major criteria for getting into the 6 months group is being RVR.  If you are, you have a 50% chance of getting 6 months.  If not, RVR your percentage is very small of making 6 months group.   Two days after my 20th shot they told me what group I was in.  Seems I found out earlier than most?

[Rockerforlife]

In the BOC trials,63% get a RVR by week 4 after taking the BOC,,and of that 63%.82% to 92% go on to SVR

[newleaf09]

I completely agree with you. I randomized out of the boceprevir naive study at 28 wks. and it was a tremendous relief not to worry about more possible damage from long-term interferon.  Though I've never met them, I like my spleen, I like my thyroid.  I want to keep them.

[nanaviking]

Hi,
  I was just wondering what Geno type you had before starting the Telaprevir.    I am 1a and have been resistant to traditional treatment due to the high risks of long term negative effects with a low rate of sucess with genotype 1a.  I'm hoping for a treatment with a better sucess rate and lower risks. Thanks

[copyman]

all the new drugs close to approval are targeted to genotype 1's

[lab-rat]

Thanks for the kind words everyone!

isobella - How do you know you're in the placebo arm?  Aren't you blinded in your study?  I know when I was in the control group I pretty much guessed it right away - but I always held out hope that I was getting the real thing.

copyman - obviously they're still trying to tweak the treatment times to come up with the optimal...I feel I got lucky.  I'm betting that 33 weeks is sufficient since you went und at week 3.  Best of luck to you!

zazaa - congratulations!!! We made it!!! - I'm so happy for you.

lapis - good luck with your 12 week pcr next month - that was one I  really sweated over since that's where I relapsed the first time.

nanaviking - I'm genotype 1a.

Good luck to all of you.  This forum has been a great resource in helping me get through.  Thanks!

[Magnum]

Wonderful, wonderful news! As a 4-time non-responder, this is building my hopes sky high for next year... good for you!

Magnum

[annieCinMD]

I going into your camp with newleaf. After the most miserable weekend I've had in a long time, I've made a decision to go off at week 28 at most no matter what. 10 more weeks. I just crossed over to the PI arm of the Sch 900518 trial, after so-so results on SOC. Still not UND at week 16. I'm willing to give the PI the full run, but the sides from SOC are too much for me. I, too am concerned about sides that will never go away, and permanent damage. I talked to my friend that I speak of frequently earlier tonight. She found out a couple weeks ago that the virus returned, after many years of remission. She hasn't called her liver doc yet, but said she needs to deal with it. She told me I should quit the meds. It messed up her  eyesight and it never came back. I'm Grade 1 Stage 1 as of Jan '07, so I have time, and was always healthy.  My mother thinks I should quit, too. As a single parent I have to work, and I start Grad school in the fall. Quitting at week 28 will give me a few weeks to start feeling better before classes start in September.

[copyman]

are you going to do 12 weeks of the PI ? Not sure if that would be enough TX. what concerns me is you still being detectable at 16 wks. You may want to look into this before you make that decision. Since you are a stage 1 you might be better off waiting a few years for the new drugs to come and doing 24 weeks then. The PI data out for non-responders & relapsers is really good, over 70%.
Best of luck

[annieCinMD]

Yes, I thought I would give the PI a chance. I will get my first results next week. I'm curious as I'm sure they are, too, if it works being introduced part way in. It is pretty obvious that they work pretty well if started at offset. If it comes back UND, I will definitely try to stick out the duration. They used week 4 and 12 as critical points, just as in SOC. I think I will be offered out if I show up UND by week 4. I am honestly hoping for UND at week 2. After that conversation with my friend it turns out she still was UND at 6 months. I don't think that had the stats they do now about clearing by week 12 or off. I'm just glad it bought her as many years as it did. I'm pretty sure the VL tests weren't as accurate as they are now, either. As I only get 12 weeks of the PI, and I think the majority of my problems stem from the Peg and Riba, I want those 2 out of my system. If it works, it works. I know to expect the worst at this point.

[newleaf09]

Will the trial allow you to roll-over at 24 weeks?  That was the boceprevir protocol for people who still were detectable at 24 wks.  Lab-rat had a good experience.  I think you will know how it's going to go within a month of starting the teleprevir, just by the PCR.  You would still be on only 48 wks of TX and it may make all the misery up to this point worthwhile.

[annieCinMD]

Since I started the PI at week 16, due to waiting on results, and because I think my study coordinator forgot to bring me in earlier, probably week 14, 12 weeks of the PI will put me at 28 weeks. So, I think I am already rolled over. I agree that I will know how it's going pretty soon (next week). She just sent me an email telling me my neutrophils are low, and to cut back on my Peg on Friday. Have to look up what that causes because I was miserable over the weekend and still don't feel very good.

[mremeet]

Hey there labrat, great news! Congrats, but I guess we knew by 24 weeks post UND you would make it. Anyway, we probably won't be speaking to one another again. I'm fading off into post SVR-land, sounds like you are too. It's been a long strange trip. Hope you enjoy the rest of your hep c free life, I know I sure will.  Best regards and best of luck to you - meet

[lab-rat]

Hey mremeet - good to hear from you!  UR right about fading into post-svr land - it's all becoming a distant memory.  Actually I didn't really know at week 24 - but I certainly did hope.  Take care of yourself and have a great life!!

[thegypsy9164]

Wow you guys,

It is midnight here and I am having one of my can't sleep nights.  I've been sitting and laying here just looking at my 2 1/2 year old baby girl thinking about what a blessing from God that she is.  I just wanted to thank you all for your hopeful input on the vertex and bocepravir trials.  I'll do shot 22 tomorrow.  My hemo is back down at 8.7 and I've felt pretty sh- - tty.  Nurse called today to say to reduce riba to 600.  I argued for giving me some blood so I can keep up a more therapeutic riba dose since such a reduction scares me that virus could come back with a only a half daily dose.  Missed a day of work this week (unpaid) but hanging in there.  Sleep tight, don't let the side effects bite.
Joey

[Ozzie62]

gr8 news for you labrat... are you still clear?

[susan400]

Telaprevir works only if you take it with the full SOC.  I had the real deal of Telaprevir in Prove 3/Group C.  However, Group C was the Non-Riba group.  Though I had a big drop in my viral load, I did not clear w/o having the Riba in the mix.  Pegasys & Telaprevir alone will not clear the virus in most people.

Susan400

[newleaf09]

There was a phase 2 (I think it was a 2) trial with low dose riba, standard IFN and boceprevir, too.  It was also a failure.  

[thegypsy9164]

FAR OUT MAN!
Joey

[deb121260]

im going to start all this in a month whats are side effects

[JAY0914]

Het Deb this is an old post...you might want to post yourself to get responses....i.m 12 weeks in with Telap   not fun but doable...beats ESLD