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

[katla]

yeah, I plan on pursuing it. I can always change my mind at the last moment but at least it will be my choice.

I also thought about the possibility of dropping out if I don't get the RIba but really, that's not very ethical. I'm surprised they even have one arm with and one arm without Riba; I would think they'd use a placebo for the arm without, for this very reason.

Lastly, I'm not sure anyone really has a definitive answer regarding resistance, but clearly, they have a better idea than I do.

[UKgirl55]

Can't wait to hear what they tell you Jimee!

[UKgirl55]

Go for the screening Kat. You never know what they may come out with next. They know that there are a lot of people now that may back out. Hopefully they'll give us some info that will make it more appealing again.

[UKgirl55]

Looks like we all have the same question. I want the answer to the resistance factor. If that comes back good I'm going for it! Sick of feeling sick and ready to do something! If you don't get the Riba you can always back out of the trial. You have 28 days from the day of screening before you have to start the trial. I now have three weeks left. I'm sure they're going to take longer than that to find out the answer to the resistance question. We were all clamouring to get into this trial before this information. It's a tough decision.

[Jimeeboy]

Good question.  That's why I want to know if that does happen, can I go back on 7977 for a longer time.

[Cheesegrater]

From a previous post...
"3.   If you don't respond you can go on rescues drugs ( Peg, Riba ) for up to 48 weeks. That's a long time.   "

This shouldn't worry you as much as another alternative.... that you DO respond, you go UND all the way to week 12 after which they cut the dosing as per the plan.
Then 4 weeks later you rebound.  
What do they offer you in case this happens?  Is there anything in the protocol that covers what happens if you respond but after dosing the virus returns?

Cheese