My trial has been cancelled.

[susan400]

I just got called by the study nurse.  The trial I was in was cancelled because 3 patients had elevated bilirubins.  For now, the plan is for me to stay on SOC until my follow-up appt. next Wed.  Dr. mentioned that he'd like for me to consider rolling over onto Boceprevir if I can find a way to get it paid for, since I've already been on the SOC for 9 wks.  I will be unblinded on my viral loads and will find out if I was getting the placebo or the study drug; but that information wasn't available when she just called.  My brain is feeling confused and honestly, I don't even know where to start.  I have insurance, but these drugs aren't on their formulary and it's a sh*tty insurance because it's Medicare Advantage.  So, I'm not sure if the drug company will enable me to have any patient assistance.  My husband started a new job and was adding me to his insurance, but he doesn't have any paperwork or card on that yet and I don't have any idea whether it's in effect, or if it will even cover such expensive drugs right out of the shoot.  Part of me feels like giving up and saying that's it, I've had it, no more I quit.  Because I'm just so tired of trying to get SVR.  But, the other fighter part of me, says, what do I have to lose by trying?  I don't have any desire to wait another 5 yrs for all oral treatments, so that's not even on my radar screen.  I've been doing treatments on and off since 1997 and I am wanting to get on with my life.  I just wanted to let my friends here know what I found out.  Susan400

[lynda607]

http://www.natap.org/2010/AASLD/AASLD_66.htm

http://www.hivandhepatitis.com/2010_conference/aasld/docs/1123_a.html

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2011.01449.x/abstract

http://www.natap.org/2010/EASL/EASL_07.htm

[pommes]

I agree with the last post.    Trust your doctor, wait for a better treatment.

The research Lynda605 points to strongly suggests that resistance is not an issue for re-treatment with some protease inhibitors.    Even so, why do it?   It is after all just RESEARCH thus far, and as dointim points out, even if the resistant variants have declined, re-treatment with the protease inhibitor may or may not be effective.   And why treat with something that may have serious even if unlikely resistance issues (the paper from Lynda607 mentions limitations to detection of resistant variants, and dire consequences of misestimating) when there are better options coming down the line?

After all these horrific treatment experiences, you must be emotionally and physically exhausted.    Your liver is still relatively healthy---no need to rush to sign up to be lab rat yet again.    Rest and wait for the Right Stuff.

But do push on that IL28b testing (no excuse for your doctor's office to delay on that).

Take care,
renata

p.s.  Lynda607 I do thank you for pointing us to that set of slides.    Definite eye-opener, and good wake-up call for me to realize how easily I can be duped into swallowing conventional wisdom (like the "obvious" cross-resistance issues of PTIs).   And whoa big relief to see public acknowledgment of worries about what will happen when all these new drug treatments land in the lap of our Happy Hepatologists.

[dointime]

lynda607 - the study that you posted does not say at all that resistance should not be an issue after 3 years.  I really don't know where you get that from.  

susan400 - on the basis that you may still have resistant mutations which would make the boc ineffective, and that SOC alone will not do it for you, I'm with your doc on this one.  Even if the boc would work, what would be your realistic chances based on your ifn response?  If I were you I'd trust your doc and not what you hear on this board.  The guy knows what he is doing and he'll get you there.  You have the liver time, you just need the patience.      

dointime
------------------------------  
http://www.natap.org/2011/EASL/EASL_54.htm

"This is a controversial issue & was at this just completed EASL. Where a number of researchers said flatly 'we will be able to re-use HCV protease inhibitors after patients develop resistance if we wait 2 years for the mutations to disappear & this was pretty much said with regards to telaprevir following the oral presentation by Sullivan of Vertex reporting that mutations mostly disappear after 1.5 years following stopping telaprevir therapy'. This may end up being true but right now this is just a theory without any evidence, no data to support this supposition, it cannot be considered true until a study or real clinical evidence supports this. Until we have data on this question one cannot say flatly patients will be able to re-use a HCV protease after resistance and receive viral load reductions from the drug. Will such a study ever be done, I don't know. There are many other classes of HCV drugs in development so in the future patients ought to be able to switch to a regimen of 2-4 oral drugs with or without peg/rbv without a protease, so the question may be moot. Still I think we need to clarify this. One issue is that the Sullivan study did not use ultra-deep sequencing, which in this study below shows mutations missed by clonal sequencing are picked up by UDS. At baseline before therapy mutations pre-exist, so 2 years later you would expect these same pre-existing mutations to be present but HCV multi-drug therapy suppresses these mutations and SVR still has been achieved evidenced by the studies with telaprevir & boceprevir, but the question is will these mutations be further enriched after failing therapy, will mutations accumulate to a significant degree if a patient remains on failing therapy, will compensatory mutations accumulate, and will these situations persist & affect re-treatment with a PI, I don't know the answer to these questions and I don't think anyone does. Perhaps the prediction that this will not be a problem is correct but we don't know & we have not studied this adequately.

[susan400]

I don't know how to argue this point with a top of the line highly educationed hepatologist Professor Dr.  I barely graduated from H.S. with a H.S. diploma.  I do well do have fairly intelligent conversations with most doctor's concerning my disease, but to question his opinion, I'm not sure that I could hold my own in that argument.  All I did so far was beg for him to right the script and I was told NO, he would not do it, because he said it was not in my best interest.

Susan400

[willbb]

http://hepatitiscnewdrugs.blogspot.com/search/label/protease%20inhibitor-%20%28NS3%2F4A%29%20Drug%20Resistance%20Test

[lynda607]

http://www.informedhorizons.com/resistance2011/pdf/Wyles.pdf

http://www.natap.org/2011/EASL/EASL_54.htm


Labcorp offers this test but I do not know if it is used to determine resistance profile for those previously treated with a DAA.

Hepatitis C Virus (HCV), Quantitative, RNA PCR (Graphical) With Reflex to Hepatitis C Virus (HCV) GenoSure® NS3/4A.  Test #550066

If you access the Labcorp test menu and find that particular test you can also click on the link they provide "Related Documents: Hepatitis C Virus (HCV) Resistance Testing: Applying the Model of HIV Drug Resistance Monitoring" which gives additional info.