PSI-7977 + BMS-790052 trial - need advice

[katla]

I'm in the processing of applying to a clinical trial with PSI-7977,  BMS-790052, one arm with and one without Ribavarin. It's only 12 weeks.

I passed the initial screening and I'm going back for another one. I was far more enthusiastic before the news broke that null-responders all relapsed in the 7977/Riba trial.

I'm stage 2, grade 2. GT 1A, CT. (In a perfect world I would like to do this  for 24 weeks with RIba). I'm concerned about 12 weeks and seriously hope I get the Ribavarin.

Any assistance/advice in making this decision would be appreciated. I hope it's OK that I started my own thread, I am just desperate for help in figuring out what I should do.

Also, anyone else who is in the process or has completed this trial, particularly 1A, I would love to  hear from you.

Thanks you all so much in advance.

Kat

[blondie717]

  I cant make your decision for you.  But I can tell you I choose my trial simply because it offered old SOC with it. I also read up on the people relapsing after just 12 wks of trial. Those were the one's w/o interferion/riba. Sounds scarry to me. I wish you all the best in what ever you choose. Ginger

[Jimeeboy]

How can they expect people to sign up it they won't provide rescue drugs after the tx is over?  So if I rebound 2 days after tx is over I'm on my own?  I don't like the sound of that. I guess there needs to be a cut off but if  they are going to monitor you for 12 months after tx, shouldn't it be part of it?  Your still in the trial if your giving blood every month.  Is this SOP?

[katla]

Good morning-

Maybe I wasn't clear. I meant if I fail the trial - ie vl goes from UND to detectable or rises during trial the 'rescue' would be both trials drugs TOGETHER with riba and IFN.

[UKgirl55]

Without the IFN in the mix you shouldn't need rescue drugs. The Riba is much more tolerated without the IFN. He should have explained all this to you, to put your mind at ease. The hope is that the resistance issue won't be an issue. If I go on this trial and fail, I'm going to wait to re-treat on 7977. He didn't sound very informed. I know you can't give false hope, but there's probably more he could have told you.

[katla]

I had a screening today and spoke to the trial doctor. This is what I understood:

If you rebound after trial's over you're on your own, i.e. not their problem.

If during the 12 weeks you go from UND to detectable or your VL rises after dropping the rescue is ALL FOUR  drugs (trial drugs + SOC) for a period to be determined by trial doctor in concert w/BMS up to 48 weeks.

Trial doc seemed to think resistance wouldn't be a problem with Incivek, Victrelis or 7977 in the future but acknowledged that that was really unknown and it's obviously in his interest to say that. I asked about the possibility of resistance w/the Abbott drugs currently in trials that seem so promising and he didn't seem to know anything about them.

I asked if I went on rescue therapy and needed other drugs (for anemia or whatever) whether they're providing them. The answer was negative. I'm concerned that my health insurance won't cover them either (Procrit being VERY expensive I think) because this is a trial. He downplayed the possibility of me needing them but that could potentially present  a huge financial problem.

The coordinator acknowledged that I was called because people pulled out after null-responder news. He downplayed that as well. I hope he's not reading this.

[UKgirl55]

Well, that's good of you to worry about things not being ethical, but I look at it as, this is my life we're dealing with here. If I absolutely didn't feel comfortable about doing the trial without Riba, then I'd have no qualms about walking out the door and leaving the drugs on the table.

The trouble is right now they don't have any difinitive ideas about resistance. They're going to be frantically working on the answer to that question, but apparently it's a complicated process and takes time.

If the answer to that question is a positive one I'll be jumping in!