Polymerase Inhibitor question

[susan400]

Can anybody tell me if you know when they will start doing trials for the polymerase inhibitors..., for non-responders??  A trial that would actually consider taking a Telaprevir failure patient?

I am so tired of even trying to find a trial because I've been turned down so many times for be a Telaprevir failure.  I guess all the protease inhibitor trials are going to definitely be a no go for me.

This whole thing is so unfair!  I'm very angry about being kicked to the curb!!!   I really don't want to be a whiner, but hey, you know, I think that I've earned the right to whine a little since I've done these awful treatments 10 times with never being given the pleasure, even once, of being told, 'you are undetected'.

I really just need some drug company out there, to read this and to give me a chance, cut me some slack and allow me to participate in your trial!!!   Can anybody hear me?????   Does it even matter to you- research companies, research doctors, clinical trial coordinators???  Do any of you even read this site?

For the record...., there are people out there who have been exposed to Telaprevir and did not clear and now they are being written off!    Basically, I feel like they are just telling me to 'go away and leave them alone' ..., that sort of attitude.

I write this as I've just been turned down yet again, today, for another clinical trial, due to being a Telaprevir failure.

Waiting for the new drugs to be FDA approved is not a solution either.., as both of them are protease inhibitors - one of which I've already got resistance issues to (Telaprevir).  My insurance will never pay for them when and if they are ever approved because I have the Medicare Advantage HMO and it will not cover any drugs that are not Tier 1 or Tier 2 drugs... and will not cover non-generic drugs.

So, basically, I feel like I am scr*wed!

O Lord, please just heal me now, so that I can be done with this already!

Susan400

[Proactive]

Hi Susan, spotted this news..something different
http://us.rd.yahoo.com/finance/external/reuters/SIG=118cks9u6/*http%3A//www.reuters.com/legacyArticle?duid=mtfh43719_2009-12-03_20-31-05_n03103326_newsml&rpc=44&type=marketsNews

[susan400]

I totally understand what you're saying however..., I've been treatment free, no trials, no drugs, etc., etc., for 17 mon. now so, that's not the problem here that I'm up against.  Totally cleared out of all the TX drugs.  They only issue I'm having is the fact that I am a non-responder (not a relapser..., even though I do get a partial response, I've never cleared so, they do not term me a relapser) AND that I am a "Telaprevir Failure"..., how I HATE that term, but it's what they term me.  I don't have cirrhosis, so I don't know that I'll qualify for compassionate use either.  Basically, it's like I'm between a rock and a hard place.  I can't get compassionate care until I get worse, WHICH HELLO..., It's not what I want is to get worse!   and I'm going to be too unable to afford the new drugs whenever they finally arrive.  So, I NEED a trial.    In the past, I was on traditional Medicare and my husband had insurance for my secondary..., through his employer, so, I had better coverage for meds.  However, since that time, he's lost his health care coverage since the company went bankrupt and not only does he not have any health care coverage, I lost the supplemental as well.  Which was why I had to go to Medicare Advantage coverage which su*ks.  You have a huge gap before catastrophic coverage will pick up and until that time you only get generic drugs covered and they will only cover Tier 1 and Tier 2 on their drug list, which excludes interferon, Riba and anything else non-generic.  From what I'm hearing Obama-care is supposed to further rip through the Medicare Advantage programs so...  I'm not trying to get into anything political here, that's not what this is about.  I'm just trying to make a point that I'm tired of dealing with this stuff.  I want to get on with my life and quit having to address Hep C.  I'm bored with the whole thing!

Susan400

[newleaf09]

Susan, the language for exclusion from some of the trials is this:
# Treatment with any investigational drug within 30 days of the screening visit in this trial.
# Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.

For trials aimed at naives, there's also exclusion for prior TX of any kind.  It seems logical that you may be eligible for a polymerase inhibitor trial.  Keep watching for them.  Hoping for you.

[KniteWolf]

Susan    im on week  5  of Protease Inhibitor BI 201335   trial   ill ask my nurse  next time we speak..she's a great lady and may have some insight
good luck

[rexx73]

can someone explain me whats the different between a protease and a polymerase inhibitor.

[WriteItDown]

Susan, I'm very sorry the TMC435 trial turned you down. I recently read a paper about TMC435 that discussed the resistance profile of Telaprevir and Boceprevir vs. TMC435, and there was some overlap, so I guess that explains it.  

I think R7128's treatment-naive trial started recently, so perhaps the trial for treatment-experienced people will be coming soon.  I hope it does and that you can get in on it.  

Kristina, what is your Canadian friend's handle on here?  My husband is indeed on the same trial for treatment-naive, he's doing well.  Hope your friend has a good ride and gets SVR.

[Willy50]

I wonder if there will be a "commitment to care" type program installed at vertex for those who cannot afford to TX?

I also wonder that if post approval a compassionate care provision may be made for you.

If they determine that resistance can easily be overturned you will not be turned away.  I hope that understanding comes soon.

best,
Willy

[susan400]

A post approval trial will be the ONLY way that I'll be able to afford the new drugs.  My insurance will never pay for them!  They won't even pay for Inteferon and Riba, do you really think that they'd pay for a brand new drug?  NOT!  Thanks anyway.  I'll be looking out for those post approval trials that you speak of.

Susan400

[susan400]

Thanks but, the TMC435 trial was the one that just turned me down yesterday, due to being a 'Telaprevir Failure'.

Susan400

[Willy50]

Mr Liver dug this up.  I think you'd be interested in reading it.

http://www.medhelp.org/posts/Hepatitis-C/Protease-resistance-explained-/show/1111476

Susan, should be able to get the PI's once they are approved.  There may also be post approval trials in which the very area of your interest could be in trial.

I think that time will also be an important factor in treating.  As time goes on this will be better understood.  A trial may be cheap but to some extent the trials are designed, not to cure EVERYBODY, but to differentiate groups (with different drug combos, doses, etc).  That could mean another similar failure in the randomized lottery.

best,
Willy

[Kristina538]

Hi Susan,
A Canadian lady I met on this site is starting this week on a trial for  "TMC435" .  I don't know anything about it (actually 'writeitdown's' husband is on it and the only other person I know of).

So, not sure if it's a protease inhibitor, but this lady has been search for a trial - she's stage 4 and was a non-responder to SOC last year.

This may not be any assistance to you Susan, but if they're doing non-resonders in Canada with it, I couldn't bypass mentioning it to you.   Hugs..

[WriteItDown]

Gee, Susan, sorry, I am having a "stupid" night here... Duh, the title of your post says "polymerase" and I mis-read it.

[WriteItDown]

Susan, I am sorry about your predicament!  It does truly s*ck.  

But what about the polymerase inhibitors?  I think some people on this site have been in trials with R7128, which I believe is having very good results.