Ready to Jump Ship

[Tracita]

Hi there,
My husband is on the Telaprevir trial. Started first four weeks with riba and interferon. Then the trial drug added. His intial load was 149,000 which seems pretty low. He was UND by the second week test. Two weeks before the third drug! He is know finishing week 12 -still UND. Fact is he hates being on treatment. He is very tired, cranky, joint pain, itchy and more. He is used to feeling great and being very active. We are hoping he is the the arm that gets to stop at 28 weeks. Otherwise, he may jump ship anyway. I suppose one of the reasons for the trial is to check on recurrance rates. But really -don't you think it is highly unlikely for the virus to return.? He can't imagine poisoning his body for another 24 weeks after 28 weeks. Any comments would be appreciated. How about the people that finished at week 28, -anyone get the virus again!! Please respond. Thanks!!!

[FlGuy]

Didn't he make some sort of commitment?

[portann]

What were his biopsy results before starting treatment?

[GreatBird]

One day at a time. No one likes being on treatment.

[Rockerforlife]

This tx is better than end stage liver disease or liver cancer or even a transplant....ny advice is not to jump inthe icy water too soon...when you do eventully leave the ship.,its better to jump on dry land.

[JTRiver]

hmmmmm he should stay on treatment just for the simple fact that he has a good chance of getting rid of it forever. He's luck he only has to treat for that one he could be like some of the poor G 1's around here 72 weeks ugh. Tell him to hang in there for your good and his. A lot of people on here experience sx so talk to some of them they can help you through it.

[copyman]

did you mean to say he was on the Boceprevir trial? I do not recall any Telaprevir arms with stopping at 28 weeks or a 4 week lead in.
Anyway keep telling him he has come to far to quit. It would be different if he was not responding and was not UNDE. If he quits now the drugs may not work next time, the virus could build up a resistance to these drugs. Good luck

[justme53]

Treatment is different for each of us, but with his RVR he's in a good position to beat this virus once and for all. I don't know how old your husband is or what stage his liver is, but the fact remains that many of the symptoms, to a certain degree, that he is experiencing on tx, the fatigue, joint pain, itchiness, etc. will come home to roost as his liver disease progresses. Here's hoping he can stick it out, clear it for good and get back to being active and.feeling great once again...Pam

[Tracita]

You are right-it's Boceprevir. He is geno 1. Has had Hep c for 20 years. No scar tissue. Just seems that treatment would work after 28 weeks for him. Yes, he made a commitment but has the right to withdraw at any time. I support him 100% in treatment but doubt he will go 48 weeks if still UND in test up to 28 weeks.

[Rockerforlife]

He must be in the Boceprevir (naive arm)...im in the (slow responder arm)..cut of for us is either @ week 36 or 48...im doing shot # 17 as i type

[thegypsy9164]

Hello,  All I can tell you is that it would be such a shame to end too early and relapse later on and have to go through treatment all over again.  You guys should seriously consider completing.  That seems to be the consencus here.  You know what they say....if one person tells you then....if two tell you then....if that third person tell you there may be something to it.  Good luck.
JJ

[portann]

You said he's a 1A with NO scarring and a starting viral load of 149,000, having cleared by week two, even before Boceprevir was introduced.

Do you have the hard copies of this? Is his biopsy result listed as Stage Zero, Grade Zero?

[copyman]

if everything is correct and you have seen the test results with your own eyes then I wouldn't treat longer then 28 weeks. I would withdraw consent at that point. best of luck

[jt57]

Tell him to hang tough.  This is really hard for all of us, but it sounds as though he could really kick this disease in the butt and be rid of it forever.  So just stick it out, and know that it IS NOT FOREVER......

We are talking about his life here..........not really many choices when you have hep c, except to give it all youve got..

good luck

Jean

[portann]

Your husband and you may want to read it through this very interesting thread that Jankar started, although I believe it only concerns SOC and not the added trial drug:

http://www.medhelp.org/posts/show/727547

Whatever you decide, he's done amazingly. For results like his, I'd gladly put myself through h-ell. He's got it in the bag, lucky guy.

[can-do-man]

First, who's to say he won't be in the 28 week arm? he still has 16 weeks before that comes into play. Not to sure at this point i would worry about that yet.

Second, Isn't there a 20% chance he could be in the placebo arm? If he is would you want to risk stoping at 28 weeks with just SOC? And yes i know the low viral load, and yes he had an early RVR. I'm also a geno one who relapsed. Trust me you only want to do this once if possible.......... Best to both of you.

[comeagain]

If he`s UND at week 2  with a sensitive test and not stage four with that low baseline vl I don´t think he benefits on doing more than 24 weeks anyhow.

If hes getting the boceprevir which he doesn´t seem to need i dont know if its not good to stop at w 24 ask a doc and check that up with studies.

Always check everything up whats said on the net and also double check what docs are saying!!

Looking real good for your hubby congrats!!

ca

[Max60]

Treatment is difficult. I thought we all knew that before we started.

Of all the bad outcomes I can imagine, the very worst would be someone stopping prior to competing the regimen and having the virus come back.

He may well be ok with stopping early. . . does he really want to take the chance?

sincere best wishes,

Max

[fretboard]

If he really feels that he can't tx for the 48wks. then he should at least stick it out for 28wks. and then decide.  He's one lucky person and he may not do as well if he chooses to tx later.  Besides if he quits, he won't be able to get into another PI study again, as far as I know.  Take it from someone who had to walk away from the boceprevir trial, tough it out and stay the distance.  One other thing, they don't want ppl leaving their trial and you can't blame them as they have a vested interest even if he did UND before the trial drug.  Boceprevir in the system, will not allow a relapse.  good luck  

[Magnum]

Saw my Gastro today who said that even after a liver transplant, you will still have the Hep C virus and will have to still be treated for it. So... do everything and anything to not let your liver get to the point of needing a transplant... in other words, suffer through treatment and consider it a blessing and a gift that there is something that can potentially kill the virus!

Magnum

[CMcH]

I had a low starting VL 1a and was UND per sensitivity of the test unfortunately it was >480. I am on 41/48 and have had a very bumpy ride. Including bumps all over my body that itch like crazy, anemia, blurred vision, Headaches, joint pain etc.. I long to stop poisoning my body and would have a good chance at SVR but I would be beyond depression if I did not achieve SVR. I just don't know how I would reconcile myself?
I can't imagine doing this TX again and going through this for not. I do think that soon people will be going shorter. The trials are working towards that. So your husband might have a good chance of clearing but what if???? I think the second time you TX it is stronger and longer. Tough call. I wish him well.
Connie

[Rockerforlife]

http://www.youtube.com/watch?v=QudbMsi1kds

[Rockerforlife]

The days grow shorter and the nights are getting long
Feels like we're running out of time
Every day it seems much harder tellin' right from wrong
You got to read between the lines

Don't get discouraged, don't be afraid, we can
Make it through another day
Make it worth the price we pay

The Good Book says it's better to give than to receive
I do my best to do my part
Nothin' in my pockets I got nothin' up my sleeve
I keep my magic in my heart

Keep up your spirit, keep up your faith, baby
I am counting on you
You know what you've got to do

CHORUS:
Fight the good fight every moment
Every minute every day
Fight the good fight every moment
It's your only way

All your life you've been waiting for your chance
Where you'll fit into the plan
But you're the master of your own destiny
So give and take the best that you can

You think a little more money will buy your soul some rest
You'd better think of something else instead
You're so afraid of being honest with yourself
You'd better take a look inside your head

Nothing is easy, nothing good is free
But I can tell you where to start
Take a look inside your heart
There's an answer in your heart

[Tracita]

Wow!!! What a great board with all these responses. My dear hubby will have time to read them all tomorrow. Yes, we have hard copies of all the test results. It is very difficult as our daughter cried tonight when he did not have the energy to go ice skating.  She understands but it is heart breaking.

[copyman]

I know how you & hubby feel. I have been fortunate to be able to do most things with my daughter but the few I have not been able to do hurt.

I would look at this way:  No ice skating for 16 more weeks or possible liver cirrhosis, cancer or transplant if he stops now.
Then he would have trouble walking yet alone skating!
Hope he ***** it up for at least your daughter so he has many more years of skating with her.
Best of luck

[JennyPenny]

Your daughter willl cry harder if he can't give her away at her wedding. Hang tough. He's doing great!

[comeagain]

We have a very skilled dr to ask here at the expert forum (Dr Dieterish) he has had the virus him self treated twice now cured.

Post him a question see what he thinks doesn´t cost much!!!!!

[sandbash]

Hang in there if you can...it is well worth it to ensure SVR.  I am in the telaprevir Naive geno 1 trial.  I know you have to make decisions based on your situation, but any dropouts are considered a failure in the study, even if they clear the virus.  

[orleans]

Someone that unds at 2 weeks is called an "ultra" rvr. only 4% do so (I too cleared by 2 wks) If his liver is stage 1 or 2, ALL of the data says 24 weeks is just as effective as 48. I have read 10s of studies, dozens of abstracts, all show rvr w/ low baseline VL can stop at 24. Many European countries have already changed thier protocols to this. Don't take my word, give Google a good work out. jerry

[portann]

In additon, Tracita's husband, who is an Ultra RVR, may have Stage Zero, as well as 149,000 starting viral load.

What a lucky guy.  

[jmjm530]

It's unclear to me if a PI assisted 2 week UND has the same meaning as a 2 week UND on SOC. The studies mentioned above by Jerry were all for SOC who were RVR and low-pre tx viral load.

So what you really want to do is compare Apples and Apples. Do some digging and find out what the Telaprevir trial results were for previous 24-week arms with the same dosing, etc.  assuming you can find matching data. If its convincing, then there's your answer.

My guess is that 24 weeks is all he needs but it's only a guess and I personally wouldn't make any decisions without looking  at previous trial data.

-- Jim

[portann]

Note Tracita's husband was ultra RVR at two weeks on SOC. He hasn't begun the boceprevir yet. (He's not in the telaprevir trial.)

[orleans]

she made a mistake, they are not vx-950ers, but boce, which does not lead in but comes at 4 weeks. he was already und. to bad for me, as your point does apply to my situation as I led in w/ alinia. we totally agree, they need to do more looking in order to make an informed decide jerry

[jmjm530]

PA,

Thanks for the heads up! Didn't realize they were pre-dosing SOC with Telaprevir now.

Anyway, assuming they're using a very sensitive test -- and I assume they do in the trial -- then, yes, wow, Super SVR as we used to call it. Pare that with a very low pre-treatment viral load and my guess is that her husband will SVR in 12 weeks with theTelaprevir added and 24 weeks without Telaprevir. Not a recommendation mind you, just a guess. Personally, and given the some of the short-course trial data, I would seriously consider stopping at 24.
----------
.

[orleans]

opps, been away

[jmjm530]

Our posts crossed and now I'm confused. What drug? What was the sequence? When were the viral load tests done? What were the results and how sensitive were the tests? This is important stuff and another reason why I hope no one ever makes a tx decision based solely on what they read here without going over the whole shebang with their doctor. It's not uncommon for people to inadvertently post incorrect information. If the information is incorrect, then the opinions/advice can't really be correct.

-- Jim

[GreatBird]

The incorrect information is in the first post. He is NOT doing teleprevir. He is doing boceprevir. It was clarified later.

[jmjm530]

If the only difference is that he pre-dosed Boce and not Teleprevir, then my opinion really doesn't change. It's a genuine non-PI aided RVR and combined with a low pre-tx viral load the chances of SVR are excellent with or without a PI even with a shortened course

[jmjm530]

What I meant to say was that if the only diffference was that Boce was used instead of Teleprevir, then my opinion is the same.

[orleans]

boce is added 4 weeks after soc is started, soc is pre-dosed, if you will. he cleared after 2 weeks of soc which bodes VERY well for him indeed

[Willy50]

Good advice.  I think that I would suggest staying the course until week 28.  Don't jump ship early.  If you are in the arm that you want you will have complied to a "T".  You will also benefit from all the subsequent follow-up visits and get free PCR tests and any related medical treatment.  You will also be furthering an important study.

DO NOT....unless it is really important quit the trial prematurely before the 28 weeks.  You stand a very good chance at succeeding but you don't want to quit prematurely.  I didn't see anyone mention it but the PI that your hubby is taking may create resistance issues should he fail and have to treat again.  Re-treating with a PI may not be effective on the second try.  That is an important fact to consider.

By the time that the 28 weeks is up there may be data released which will aid you should you decide to quit at the 28 week mark.  I agree that his odds are quite good with or without the boceprevir.  But if you quit they probably won't tell you which arm he drew or share other data.  IF you stay to week 28 you will possibly know.  For the time being commit to the 28 weeks and worry about the rest after.....

Good luck.

Willy

[comeagain]

The issue here is if hes in an arm that says hes gonna tx for 48 weeks shall he jump the ship and quit at 28 weeks.

Quiting before 28 weeks has never been in his thought if i understand it correct.
I my self has been in a regular soc study for relapsers and i had the option to quit anytime i want and it was also written in the contract by doing so  it should not interfer with any treatments in the future.

ca

[Willy50]

Thanks, it wasn't totally clear to me that it meant at 28 weeks given the way that the hubby felt.  The discontinuation rate in the boceprevir trials...... I think was around 15-17% in the earlier trials and so we all must admit earlier withdrawal would be a possibility (either at the direction of the doctor or the patients choice).

I just felt that it might be worth mentioning the few principles like resistance and underline the need to get and stay clear once one is exposed to a PI.

IF they stay on to the 28 week mark there is a good chance that they will have complied and the study will continue to provide care and data.  It would be a shame to quit before they told you if you were in an SOC arm or a triple therapy arm.  I don't know when they are unblinding information in this trial and what info is getting unblinded.

I think you judged their intention better that I did.  I marvel at your ability to read and interpret a foreign language and interpret medical issues in this forum.  Hats off to you sir!!

I just wanted to impose a few arguments against stopping early and a few for continuing to at least the 28 week point.  

Thanks again and I agree with your assessment of their intent.

best,
Willy

[Rockerforlife]

YOU SAID:
I don't know when they are unblinding information in this trial and what info is getting unblinded.

If the trial is discontined at wek 28...then to me thats aotomatic "unblinded"...because you know you were not in are 1 and you know your not continuing to week 28 in arm 3.

[Willy50]

Yes but.....

In some earlier Vertex trials in an effort to keep them *super* blind they might tell people at the 24 week mark that due to the way they responded they would not do further treatment.

That could mean.....
1)  You broke through and therefore we are going to stop further dosing  (you failed TX)
2)  You succeeded with your response, maintained your clear status through 24 weeks therefore there is no need to treat further.  (you will almost certainly SVR)

Quite a difference eh?  

Before they started the phase 3 trial Vertex said that they were going to leave their trials blinded until the SOC arm completed 18 months (12 mo TX and 6 mo PCR).  I don't know if they continued doing that but it is one he!! of a long time to not know what arm you were in, if you cleared, etc.

I was just making the point that I do not know what and when they will reveal to the trial participants.  In the past the Boceprevir participants had more revealed to them (compared to TVR trial participants) but I am just not assuming; whatever it said in the trial agreement will probably reveal the answer.

I was vague about it cause I don't know what they will unblind.

best,
Willy

[Rockerforlife]

YOU SAID:

That could mean.....
1)  You broke through and therefore we are going to stop further dosing  (you failed TX)


i don think a breaktru would happen in a RVR`er...but anything is possible..

i know for sure they wont officially unblind the trial until its all over...like 6 months EOT...but ill bet the farm if i am cut off at wk 36...ill be in arm 2...but if i did breaktru.ya think they will keep that info from me?...it all comes down to end of the trial tho...we have to see written documents to really know what arms we were in...we can guess all we want

[Willy50]

In the trials I spoke about they left the RVR info blinded as well.  Yes; a breakthrough would be unlikely with an RVR (but not unheard of, I think) but the deal was that people were not told if they RVR'ed or not.

I don't mean to mix this persons result in with past or other Vertex trials; they are separate and distinct trials.  

I only mean to convey that I don't know what will be unblinded and when in THIS trial.  The answer to that question should be in the boceprevir trial agreement.

best,
Willy

[comeagain]

I once posted a question if anybody know about someone who had not becomed SVR when UND at 2 weeks I sure never has, and apperently no one else on this forum has since nobody answered!! thank God for that LOL.

Both floridaguy and andiamo where UND week 2 they both cleared  , but its probaly to little 2 weeks tests done so far to make any valuable prediction.

Why I asked was because I´ve got the idea that those 10%  that didn´t clear although RVR  was UND in the fourth week but the rest 90% that indeed SVRed maybe was UND before week 4.

Anyway if there has been more frequent pcrs done in  earlier years particulary in the beginning of tx preferably week 1 , 2, 3 and 4 many more people would have reached SVR and many wouldn´t have to overtreat I both think and believe.

Glad it seems to go in that direction so you who hasn`t treated yet will get better ods than us poor pioneers.

[Rockerforlife]

I feel sorry for 10% of the RVR`ers who relapsed...im sure they are out there somewhere,that would be very depressing to have come so close to SVR and then to be told that..i dont know what i would do if i relapsed again...i just lost my job too...no job...no health insurance...nothing...no place to live..no food...even talks of funding for welfare running out....soory for the negative thoughts....but im holding my head up till the end.

[Rockerforlife]

I didnt mean to say i have no ffod or place ,im ok now...what im saying is....it could end up this way...things are looking really bad in this world right now...i hate to even turn onthe news...all you hear is no jobs here...wars there...starvation...murders drug wars...on it goes....if God says this time on this earth is a test....i thing God needs to give ua a break...LOL

[can-do-man]

I guess i'm the odd one because i was brought up if you come to an agreement with someone you do your best to live up to that. Not just when it benefits ones self.

Its easy to see why there are as many drop outs in these trials. And yes i know its in the papers one can drop out at any time, but to use that as a reason is silly, what are they suppose to say, we can force you to remain in the trial???

And yes i know there are plenty that have to drop out either due to work, or side effects, or other health problems. If i am able i will live up to my agreement, i've gotten their free drugs, including resuce drugs, all tests and labs have been paid for by them and i have been given good medical care.

Win or lose at least i will have the satisfaction of knowing i kept up my end of the bargin and can hope it will only help someone else down the line.

[can-do-man]

You got a raw deal, you gave them 20 years and they gave you the shaft, i would hate to be in your place or any body else looking for work these days. I know words don't help much, sure don't pay the bills but something tells me your the type if someone knocks you down you get right back up for more. I don't see you as a quitter. So my bets would be on you winning in the long run.........Best to you

[fretboard]

"Otherwise, he may jump ship anyway. I suppose one of the reasons for the trial is to check on recurrance rates. But really -don't you think it is highly unlikely for the virus to return".?

Most clinical trial patients don't just jump ship at 12wks of tx.  I was told that out of all clinical trials given that the dropout rate is 1-2%, but this is normally done prior to the first 30 days.  Unfortunately I had to stop tx, right around my 30day mark due to a major depressive episode and problems with severe anemia.  On patients who must cancel tx b/c of a medical condition, the relapse rates are extremely high.  When patients dropout after the 30day mark it's normally for a reason such as the patient needed heart surgery or something along those lines.  As far as patients who have tx'ed for 28wks, the results haven't even been determined yet.  Your husband was fortunate enough to get into a trial that may allow him to be one of the first pioneers who treats for only 28wks and successfully stays SVR.  Here's a link with some stories to read, there are only 4 or 5.  good luck to you and your husband and hang tough, you both are doing great

http://www.hepc-connection.org/Page/165.aspx