Have you come across any other geno 1a's that have been on the same trial as you? I've heard quite a bit about 2's and 3's. Some at my clinic have already finished the trial. I believe only one was a geno 1 (not sure if it was a or b) and the rest were either 2's or 3's.
Yep. That sounds about right if it is supposed to mirror the study I was on. None of us needed that nor did anyone at gonnab's site or the site of the lady on the other forum. I have to check and see how she is doing.
update:
Apparently the rescue drugs for 1A are the two trials drugs TOGETHER with pegInterferon and Ribaviarin for up to 48 weeks (at the discretion of the doctor). They are given if one at any time during the 12 weeks goes from UND to detected or if at any time the VL increases by one log. (that's my understanding).
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.
(correction) nor my study (not not)Lol!!
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.
Thanks for your reply. I hadn't thought of the privacy issue and it being a group setting.
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/
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).
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.
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.
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.
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!
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 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?
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
Yeah, I think so; I read the consent form. 48 wks for gt 1, 24 for 2 & 3.
Are you sure about the rescue drugs for 48 weeks?
That seems like a great trial!
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!!
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.
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.
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.
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.
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.