PSI-7977 + BMS-790052

[katla]

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.

[Michigan57]

Thanks for your reply.  I hadn't thought of the privacy issue and it being a group setting.

[curiouslady1]

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/

[curiouslady1]

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).

[curiouslady1]

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.  

[curiouslady1]

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.  

[gonnabhepcfree]

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.