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

[flcyclist]

Susan, you certainly haven't gone over the top considering your situation.  And have done a good job of explaining exactly where you're at.  Wish you the best at your trial visit and choosing the next step.  

[susan400]

No worries.  Thanks for all of your support everybody.  Now I just will do my visit to trial site tomorrow and whatever happens, I'll go from there.  I appreciate all of you letting me rale, and rant and rave, and b*tch.  I know I've gone over the top.  I am TRYING to pull positive up out of my gut.  Susan400

[pommes]

I apologize too!    It's so easy for other people to spout off about what to do, and especially to tell you what not to do.    I haven't even treated, so how can I possibly appreciate the enormity of what you're dealing with.

I didn't want you to get the wrong impression that your doctor is behind-the-times, or that there was an obviously good route for you to take.    You've had it so tough and it's not clear how things are going to get better right way.

Sounds like you are living a total nightmare, despite doing everything you possibly could do.    You got every reason to be sick and tired.

Kudos to you, warrior woman.

renata  

[lynda607]

It is your body and mind Susan and you must do what you must to heal.  Life goes on, whether we're living with or without HCV.

I apologize if my posts upset you, I was trying to point out that there is no concrete data showing re-treatment with a PI after a certain amount of time is off the table but because you feel the way you do it is a moot point so no sense beating a dead horse.

Good luck and I agree, at some point we have to stop the HCV madness.  Please don't be too hard on yourself for past mistakes, we eventually get to where we want to be because of where we've been before.    

[susan400]

Once again, Boceprevir/Victrelis is off the table, as I said above, so this part of the conversation is a moot point.  As far as letting my body rest and waiting..., I'm sick and tired of waiting. I had to wait 3 yrs for this darn treatment to materialize.  Waiting is all I've been doing and I'm tired of it.  I want to forget about the dumb disease and just pretend like I don't have it.  Walking around with having this in my body just reminds reminds me of my past, which I want to forget and want to be able to move forward with my life.  Kind of hard to do when I have to keep on hearing about coming in for the liver labs and sono's and blah, blah, blah.  Every time I hear about it, it brings up all of the horrible mistakes that I made in my past, and how I got this to begin with.  I want this nasty disease to be gone.  And waiting for the perfect treatment and/or the right combination of drugs, is a laugh as well.  That may never happen for me since I have Prot.Resist.  There are no guarantees w/TX in my body, with this disease.  At this point, as far as I'm concerned they are all a slim chance.  Now the Hep C vaccine, that's an interesting thing that being worked on.  If it would actually cure an active chronic Hep C, that would be something worthwhile.  They came out with a vaccine for melanoma, I heard, or maybe it's still in trials?  And that was supposed to actually cure some forms of melanoma.  

Susan400

[lynda607]

I am not saying resistant variants are not an issue for everyone or do not exist after 3 years, but there is data showing a definite decrease over time.  Susan had very little exposure to Telaprevir which is also a plus.

http://pi.vrtx.com/files/uspi_telaprevir.pdf

Persistence of Resistance-Associated Substitutions
Persistence of telaprevir-resistant NS3 amino acid substitutions has been observed following treatment failure. Of a combined 255 treatment-naïve and
previously treated subjects from Studies 108, 111, and C216 in whom telaprevir-resistant variants had emerged during treatment, 103 (40%) had detectable
resistant variants by population sequencing at end of study (follow-up range 2-70 weeks, median 45 weeks) and results for loss of variants were similar
across the three studies. In the combined studies, 46% of the telaprevir-resistant substitutions in subtype 1a and 16% of the substitutions in subtype 1b were
still detected by the end of study: 29% of V36, 16% of T54, 38% of R155, 14% of A156, and 44% of V36M+R155K variants were detected at the end of
study.
In a 3-year follow-up study of 56 treatment-naïve and prior treatment-failure subjects who did not achieve SVR with a telaprevir regimen in a Phase 2 study
and had telaprevir-resistant variants after treatment failure, variants were detected by population sequencing in 11% (6/56) of subjects (median follow-up of
25 months). Telaprevir-resistant variants V36L/M, T54S, and R155K were detectable (present at greater than 25% of the viral population) in some subjects
at 24 months. By 36 months, V36M, T54A/S, and A156N/S/T variants had fallen below the level of detection by population sequencing in all subjects. At
36 months, 3% of the subject isolates that had the R155K variant still had detectable R155K variants by population sequencing.
The lack of detection of a substitution based on a population-based assay does not necessarily indicate the substitution has declined to the pre-treatment
level. The long-term clinical impact of the emergence or persistence of detectable INCIVEK resistance-associated substitutions is unknown. No data are
available regarding INCIVEK efficacy among patients who were previously exposed to INCIVEK, or who previously failed treatment with an INCIVEKcontaining
regimen.