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

[willing]

>Did Susansf also have a history of having tx'ed already with a PI?

no, so there's definitely more risk for Susan400, but from all indications if her VL dropped fast enough during the past 9w that risk is  small:

- as several have pointed out there's plenty of data suggesting the PI-resistant variants selected by 5w of tela 4 years ago have largely been replaced by  PI-sensitive wild type

- the combination of a strong ifn response and triple tx is better than homegrown tomatoes: from available data for relapsers and naives,  SVR odds are in the high 80s/90s.

- in particular, a strong ifn response will trump even high baseline incidence of native PI-resistant variants, as shown in a recent post from frijole's

Still not a guarantee, but if Susan400s VL drop from lead in was strong enough (eg RVR or close it as was the case for Susansf)  the prospects looks good.

[meakea]

Susan, I wish you the best today!!   I'm sooo sorry about all the crapola you have been through over the years...I truly am.  Sitting here shaking my head.  There has to be a turn around for you one of these days and I'm hoping today is that day...with all GREAT news.  Keep us posted.  I truly admire you, by the way!

[paen53]

Good luck today, Susan. Hope you'll get the answers you need and deserve and some options for the future should you decide to move in that direction again.

Pam

[dointime]

"Susansf as I understand it, was in your same trial, also SOC only, and was able to continue onto boce with confidence because of her known very good VL drop before the PI. You should have the same option, if you choose to go that route."

Did Susansf also have a history of having tx'ed already with a PI?

dointime

[willing]

good luck tomorrow. It seems a great time to bring up that if they are genuinely sorry the trial didn't work out they will  make your VL drop over the past 9w quickly  available so you can evaluate alternatives.  Susansf as I understand it, was in your same trial, also SOC only, and was able to continue onto boce with confidence because of her known very good VL drop before the PI. You should have the same option, if you choose to go that route.

[elpasolady]

Good luck tomorrow, Susan.  You, indeed, have my sympathies, to say the least.  I will pray for you!!
I just want to add this......With the exception of maybe the first year that I learned I had HCV in 1996...( I know i contracted this 33 years ago in 1978)  I have pretty much lived my life in denial of having this disease. I know we are all made up differently, but as long as I went in to get my blood work checked from time to time, and the results were good, I did not worry. There was a period that I did not get checked for 3 years...it was that far from my mind.  I am not saying I was wise, but that's just how it was for me.  The only reason I am treating now, is because of the new drugs and because we now have health insurance, which may not be the case in the very near future. If it were not for the health insurance issue, I may still have waited.  I have not been sick a day from HCV thus far.  I don't know your history, or your levels  but If you are a stage 1-2, I would tell you to just put this on the back shelf, live your life as if you don't have this, (of course, be careful and take care of yourself) Your diet and exercise can do much to keep this at bay. You seem to do so much  meaningful work when you are not consumed with your TX.  Keep that focus, and in a few years when they really come up with a better treatment and cure for Hep C, you can try again.  Without the horrible side effects they are trying so hard to do away with, you will have nothing to lose to try again in the future.  
Don't forget...you are NOT your HCV.  You are so much more than this!!!  Don't let it consume your thoughts.  It is a part of you, that for now, may just need to die, in your mind, at least.
I  just wanted to try to give you a different perspective, for what it's worth!  You are not a failure, it is just not  your time.
Please keep in touch and I want to give you a BIG HUG!  
Debbie