Are you in the "Procrit" trial study?

[positude]

I got the call from my nurse this morning that an addendum has been added to my study. She read it to me out loud and it went like this; "For all study participants who have been UND since week 8 and UND at every subsequent visit, treatment is to be stopped at week 28 with follow ups to 44 weeks." That's me.

I happen to be on week 28 right now and have been told that my treatment stops as of Monday morning. I was told that those who have been UND since week 8 but are past week 28 of treatment, will have to complete the full 48 weeks.

Just wondering if anyone else is in this boat with me?
She said that if at my 3 month post treatment I am still UND, then the chances that I am "cured" are 99%.

Praying for that.

I cannot thank all of you enough for your insights and encouragement. You are the experts and such a blessing to all newly diagnosed. Many nights I have sat at my computer, unable to sleep, and been touched by the compassion and concern that many of you share with complete strangers. Thank you for your wisdom, and for your willingness to share it.

I will still be around for a while. :) God Bless.

~Pos.

[spectda]

Don't paint your house blue, they just changed the color to yellow and red, would that work?
- Dave

[dabink]

Congrats on all that great news. I just watched the online symposium from AALSD and everything says that this Response Guided Therapy is THE way to go. Glad that you qualified for early discharge. I am hoping my husband gets the same. Out of curiosity, did they consider just your week 8 RVR, or did they consider other factors? I am wondering if they are looking at the elusive IL28b allele markers, too...

Just reported to my DH that you are already feeling better after stopping the meds. I'm sure you know, but 6 months to clear all that Riba out of your cells and then you will be feeling great (I'm certain!).

This is wonderful news for all involved.

[positude]

Hi Lynda,

I am feeling a bit better each day, thank you for asking. I may be pushing myself a little more than I should, and part of it may just be wishful thinking, and part of it may be that my body was just finally starting to get used to the meds, but whatever the reason, I have been able to function somewhat better and get more done in the last couple of days. I know I need to be patient, and my husband is always cautioning me to "take it easy", but it's hard to do. My appetite is already coming back and of course the nausea is almost completely gone. I still have a dry cough at night, and some itching, but the sides that I still attribute to tx are not as intense as they were even a week ago. Except the anemia, I still get tired and out of breath pretty easily.

Yes, there have been adequate studies done that have proven that those who RVR and remain that way, AND have been on one of the PI's (Telaprevir or Boceprevir) in conjunction with the SOC meds, have a very good chance of SVR when stopping tx at week 28. My beginning viral load was 12 million, and I WAS genotype 1a. :) Undetected at week 8, I remained that way at every consecutive visit without any deviation. I have faith and confidence that the virus is gone. And I am very grateful for that.

Don't worry about it too much Lynda, if your team doesn't feel like you are a candidate for early discharge, then they won't let you. And the IMB/IRB at each site are the ones who have to approve early discharge of any of patient, with stipulations on patient to meet specific criteria.

Hope you are doing well and staying "postive". :) Thanks again for asking about me. I went to the beauty shop two days ago and had my hair done, (didn't take long, there isn't much hair left, lol) which made me feel much better!! Take care and keep in touch. I am praying for us all.

~Pos.

[mountainair]

Hey Pos, how are you feeling?  Noticed any improvement in sx yet?  Did your doc show you any data that indicates that 28 wks is as good as 48 for svr?  That's my big concern with them changing the protocol.  I have 20 wks in and I'm really feeling ambivalent about the risks/benefits of stopping tx at 28 wks.

[dabink]

Hi Dave,
Our Clinical Coordinator did not answer my questions about the rumor of shorter treatment - but we are due for a visit this Thursday - we'll see what they say...At least you will be able to continue to fight the disease - if you figure the cost of those nasty blue pills are at least $3500 per month, Rebetol at $2000 - $3000 per month, PegIntron at $3000 per month, it's like you have won a small lottery - you just have to feel like crap in order to get the reward!!

[positude]

HAHAHAHA! Inside and out right? :) That is hilarious Dave. Thanks for the laugh!

Pos.

[spectda]

Congrats in then end if those Freaking pills pos. I think you should paint your house that blue color - Dave

[positude]

Thanks Gee. I will definately let you know how long my "recovery" takes. I can't tell you how very happy and blessed I feel to be able to stop early. I know there are "nay sayers" out there that would have something negative to say about it, but since I did RVR at week eight, and because I had the Boceprevir in the mix, I feel confident that I have won this battle. What great encouragement to those who are waiting for the PI's to hit the market in a few months!! I wish you all the best my friend, and will keep you and all of us in my prayers.

Dave, you are so strong and I know you will make it and announce SVR when this ordeal has past. When I heard that they were thinking of reducing treatment time for those who were UND at week eight, I told myself that I wasn't going to get my hopes up and just mentally settled in for the full forty-eight. And I barely made it! If the decision hadn't been made until next week, I would have been past the stop week and would have had to go on anyway. Treatment will be over before you know it my friend. This site has been a source of strength and support for me as well, and I am thankful to everyone also.

May we all reach SVR, may we feel better everyday, and may we all continue to encourage others.

Tonight at 9 P.M. I will take my last hand full of pills!!! Peace. :)

~Pos.

[spectda]

I absolutely want the full 48, especially since I.did not rvr. It's my.best chance. I hope we all make it and can continue our lives without this virus.  I appreciate the many good people I have found through the blue bomber club. I think we have supported each other with intelligence and kindness. Thanks to all of you.- Dave.

[Gee704]

You know we are all rooting for you Pos!
Good luck and let us know how quickly your sx's go away.
Lucky lady to get to stop early.

Gee

[positude]

Hi Dave,

Sorry you don't get to stop at 28 weeks my friend. I will let you know what my results are at 3 months for sure, and I fully expect to be SVR very soon. :)

Pos.

[spectda]

I didn't rvr so full 48 for me. Good luck to all of you. I hope to see an svr a few months from now pos. - Dave.

[positude]

http://blogs.consumerreports.org/safety/2010/02/unsafe-by-definition-voluntary-recall-.html

[dabink]

Wow - my DH is in this trial in NYC - and at about the same 28 week mark. Just sent a message to the Clinical Coordinator to see what they say about both the Procrit and the shortening of treatment. On one hand it is a wonderful thought to think he could be over the drugs - on the other hand it is scary to think that 28 weeks of meds might not be enough to slay the dragon......

[positude]

Hello again Lynda,

"Unsafe by definition: Voluntary recall
What it is: Most recalls of defective products are characterized as "voluntary," a confusing term that can lead consumers to believe that the recall is optional. But voluntary recall is just government-speak for a deal that a manufacturer or retailer of a hazardous product has negotiated with the federal agency in charge of overseeing the safety of that product category. Voluntary recall would also seem to indicate that there are “mandatory recalls” that can be issued by the government should manufacturers or retailers refuse to cooperate, but nearly all the recalls announced last year were voluntary."

source:


I was in the Procrit arm of the study, but because my anemia continued to be a problem, they also dose reduced my Boc, and Riba. My Peg was never reduced.

Were you also UND at week 8?

I hope you start feeling better very soon. Yes, this tx has been tough, but the support and encouragement that I have received from family, friends, and the people here have helped greatly. :) Let me know what you find out from your Dr. if you think about it.

Pos.

[mountainair]

Hi Pos,

When I heard about the recall, I wondered about this study!!  What the heck is a "voluntary recall" anyway?  I was randomized into the Dose Reduction Arm - so no procrit allowed for me.  I have had a really tough time with the anemia and I have even been considering dropping out of the Study so I could take something to help w/ the anemia.  I am no longer responding with any improvement in my hgb despite both riba and multiple PEG dose reductions.  I am at Study Center #1 - Cedars Sinai - Los Angeles.  My doc had been going thru appeals to try to get my insurance to cover the neupogen he ordered 3 wks ago, but this week he just dropped it - whereas before this week they told me I "should just pay for it out of pocket".  Maybe he thinks it's OK to risk it if tx will be ending soon?

Anyway,  I heartily agree - Best of luck to you us all!!  The tx has been tough, but I know this will fade to a distant memory if I can get SVR!!

Lynda

[positude]

Yes, that is exactly the trial study I am in! I heard a rumor a few weeks back that the ILB was talking it. And not only is Merck under pressure to have the 24 week treatment with Boceprevir approved ASAP, they must also be concerned with the costs of keeping the study participants on all these expensive drugs when they have a rapid viral response and may no longer need them.

I also wonder if the Procrit recall was the icing on the cake for the ILB to reach approval of this addendum. All of the Procrit I have in my refrigerator is on the voluntary recall list, and because this trial study is specific to Procrit vs. dose reduction, it may at least have played a small part in their decision.

Let me know what you find out about your individual study. And the best of luck to us all!!!

~Pos.

[mountainair]

Hi Pos -
I am in the Bocep "anemia" trial - is that the one you're in?  I heard something similar from my treatment coordinator last week.  She said the Clinincal Trial might terminate tx at 24 wks for those w/ RVR (as you described).  She said they still had to receive approval from the ILB at each Study Center (an ILB governs clinical trials at each study site).  Each Study Center is legally obligated to ensure ethical treatment of human research participants.  Merck is under a lot of pressure to get a 24 wk TX program approved so they can compete with telaprevir.  Interestingly - I asked her if it was 28 wks (24 wks of bocep +4 wk lead-in) or a total of 24 wks and she said the latter.  It appears that your info indicates the 28 wks.  I am in wk 19, so I expect I won't hear from them for another week or so.  I made an appt to talk to my regular hepatologist about whether to continue SOC or stop per the revised trial addendum.