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.

[UKgirl55]

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!!

[curiouslady1]

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.    

[katla]

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.

[katla]

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.

[UKgirl55]

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.

[katla]

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.