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956931 tn?1271639769

Are you in the "Procrit" trial study?

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.
18 Responses
1363928 tn?1285085263
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.  
956931 tn?1271639769
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.
1363928 tn?1285085263
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
956931 tn?1271639769
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.
Avatar universal
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......
956931 tn?1271639769
http://blogs.consumerreports.org/safety/2010/02/unsafe-by-definition-voluntary-recall-.html
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