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1707536 tn?1334974077

PSI-7977 + BMS-790052

I was hoping for feedback from anyone on this trial; specifically gt 1A. I'm screening for the extension which is only 12 weeks, without interferon. One arm with and one arm without Ribavarin.

I realize it's tremendously competitive so although I appear to qualify I don't know if I'll get accepted.

Also, any suggestions of anything I can do during the screening process to improve my chances would be welcome.

Thanks.
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Avatar universal
You may want to check the archives for the following posters curiouslady1, gonnabhepcfree, attagrl.  We are all on the earlier version of the trial and finishing up.  Check my journals if you want more info.

Keep your BMI <= 35 if you want in this trial and your weight under 75kg if you want the lower dose of ribavirin.
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1707536 tn?1334974077
Thanks, I spent over an hour searching here before I posted, but I'll try searching those names...I'm having trouble finding things here.

BMI's not an issue, it's under 22.
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Avatar universal
I am also thinking about this same trial but the one thing that worries me is the resistance if I don't clear the virus.
In other words, should I wait and do this same thing with peg and riba in 3 years(both drugs are Phase3 ) or should I chance it w/o peg.

The medical knowledge on resistance to PI's if we don't clear is incomplete at this point
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1707536 tn?1334974077
I have the same dilemma but I think I've decided that if I have the opportunity to participate in this trial I will.

I could spend the rest of my days deliberating -  should I do it... should I do triple tx... should I wait for newer drugs...and I decided it's probably not in my best interest to wait too long.

They say it's better to make a bad decision than no decision at all - not sure that that applies to a life and death situations such as this but I felt I had to make a move. I've been burying my head in the sand long enough. I have no idea if I'm doing the right thing.
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Avatar universal
I hear ya! I was offered the same trial TWICE that CL is on (the 24 weeks). Now I wish I didn't hesitate, but maybe the 12 weeks will be as good (if not better) since it's a shorter duration (if it works) KWIM? So far, I'm still on board for going for it. I just hate all the blood draws on this trial though. Don't have great veins.
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1707536 tn?1334974077
In this trial, if the viral load increases at any point while taking the trial drugs they give you 'rescue drugs' i.e. peginterfon and Ribavarin for 48 wks for gt 1 and 24 wks for gt 2 ,3.

The same applies if VL doesn't decrease optimally - but I'm not sure how the criteria is defined.
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1707536 tn?1334974077
Hey UKgirl- what is KWIM???

I don't mind the blood draws but it sounds crazy - almost everyday...

If you now regret it could you get another opportunity. Here in the US, no one offered it to me. I did my own research and contacted them. Oh...what I wouldn't do for national health.....

I would have preferred 24 weeks since this seems very short and risky. Also I really hope I get accepted and REALLY hope I get into the arm with Ribavarin. I think it's randomly assigned 50/50.

I've been at my computer agonizing over this for 14 hours - knowing my luck I won't even get selected.
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Avatar universal
PSI 7977 has a high barrier to resistance unlike the PIs.  That is by itself.  If you pair it with BMS 790052 as in this trial, you are really stacking the deck in your favor.  

On PSI 7977 ALONE I had a greater than 4 log drop in VL within 72 hours (12 mill to 580).  By the end of Day 7 it was more than a 5 log drop.  They added BMS on Day 8 and sometime in the next 5 days I was UND.  I have stayed UND for the whole trial as has the other 5 people at my trial site, gonnabhepcfree and the others at her trial site and a lady on another forum.  I have not heard of one breakthrough nor has anyone I have been associated with.

None of us is on ribavirin.  I dont know if I was completely clear at 3 months but I would have felt fine with only 3 month dosing with 2 drugs.  

I have all this information in my journals.  There are almost 50 journal pages since I started my treatment.  If you click on my web page, you will see the journals section listed on the left hand side.  Go back to the earlier posts by clicking on the numbers at the top.    

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Avatar universal
I may be a UK girl, but that was only because I was born there :-) Came to the US when I was 18....I'm now a US girl really.So, the trial is here in the US. KWIM (know what I mean).

You're lucky you've only been agonizing over it for 14 hours...I've been agonizing over it for years...LOL. Look what happened to me...You snooze, you loose!

First things first...SCREEN!!
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Avatar universal
Are you sure about the rescue drugs for 48 weeks?

That seems like a great trial!
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1707536 tn?1334974077
Yeah, I think so; I read the consent form. 48 wks for gt 1, 24 for 2 & 3.
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1707536 tn?1334974077
I see you're in MD; they're recruiting at John Hopkins and Mercy Medical Center (Baltimore). Here are contact numbers:

http://clinicaltrials.gov/ct2/show/NCT01359644?term=7977+bms&rank=1

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Avatar universal
I finally got my call from U of M and she has approved my medical records and was forwarding on to the person in charge of the next step for review over this weekend. She said I should be getting a call this coming week if approved in this next step and a "meet and greet" appointment will be set up for further screening and to explain what would be expected of me and how the trials work, etc.  I'm just wondering if anyone brought a friend with them to this meeting to help remember and decipher everything or if that's not a good idea.  Also, since you've been there, approximately how long should I expect this meeting to last?  
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Avatar universal
I dont know if I was completely clear at 3 months but I would have felt fine with only 3 month dosing with 2 drugs.  


You were clear way before three months.  Didn't quite understand this sentence.

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Avatar universal
Thank You very much  Katla. It looks as though its for treatment naive so
I don't qualify for this study as I failed Peg/Riba in 2004.The odds are that this treatment will cure you. Wishing you success!
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Avatar universal
I was told by my study coordinator a few weeks before the end of my trial that after the 12 week if I goes as they think it will there are plans for another  but only 4 weeks.  It's a little early obviously but I waited till my Dr and biopsy results said I had to treat rather than go through SOC. The next time the criteria might be different.
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Avatar universal
I recall that meeting.  I think I was there with another patient or two.  One man brought his son.  I felt uncomfortable with this for privacy reasons.  So no, out of respect for the other patients, it wouldn't be good to bring anyone else but yourself.  I think it lasted about an hour maybe less.  Bring a notebook.  I did.  I have been told that I knew much more than the other patients and even some of the staff.  The people on the forum can help you with stuff you don't get.  They just tell you about the set up, appts., blood draws, etc.  
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Avatar universal
I dont know if I was completely clear at 3 months but I would have felt fine with only 3 month dosing with 2 drugs.  


You were clear way before three months.  Didn't quite understand this sentence.

*****
I was undetectable way before 3 months as were you.  That does not mean the virus was completely gone.  In fact, it most likely was NOT gone for some time afterward.  For some people it may still not be gone.  That is why this next 1 to 3 months without the drug is so critical.  It could be lurking beneath detectable limits.  Please God I hope it isn't.  
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Avatar universal
If you had had the triple for your past treatment, you would have qualified for the trial.  Two arms are for those who failed the triple.  You cannot go by what is posted now because the study is different than the one that gonnabhepcfree and myself are on.  It is an extension.  It is not the same.  Part of it is for naive GT 1a and part of it is for treatment experienced GT 1a. (maybe 1 b too, not sure).
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Avatar universal
I think you mentioned something about the rescue treatment for Gt 1 and GT 2/3 being different on the consent form.  This is true because of the resistance patterns.  However, they may be using portions of the same consent form they used for my trial.  This trial extension is not open to GT 2 and 3 as far as what my trial coordinator has told me and based on availabe info descriptions.  It IS open to treatment experienced as long as they took the triple and failed it.  I think it is only open to GT 1a.  
Here is the handiest info I have on the subject
http://www.dailymarkets.com/stock/2011/11/04/new-12-week-interferon-free-treatment-arms-added-to-all-oral-combination-study-of-psi-7977-and-daclatasvir-bms-790052-for-hcv-genotype-1/
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Avatar universal
Thanks for your reply.  I hadn't thought of the privacy issue and it being a group setting.
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Avatar universal
I have brought in several people to screen (3 actually) and my Dr not my study coordinator had a problem with it.  Why would they?  Its your privacy that's at issue and if you don't care why would they.  Many times people want support and an extra set of ears.  
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Avatar universal
(correction) nor my study (not not)Lol!!
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Avatar universal
I hope I am not misunderstood here.  It is me who had the problem with someone else's significant other being in the room with me, not the doctor.  If you are alone with the doc, you can bring anyone in you want to.  If you are meeting in a group with other study participants, as I know to be the case here (since it is my site) it is not appropriate to bring non participant others.  
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