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

[Jimeeboy]

But if your done with the 12 weeks and then you relapse then your on your own?  I did not hear anything yet. I'm sure next week I'll hear. I have many questions.

[katla]

yeah, I'm really worried about only 12 weeks without Riba.

Blondie and UKgirl- - can you please provide the links if you have them handy...thanks.

[blondie717]

  I was reading a link on another forum. Im confused. The way I interpeted one article was they tx for 12 wks, then 12 weeks later they test again. In the one I  was reading. only 4 of 11 were svr @ 12 wks after EOT. 10 of 10 were SVR @ 12 wks EOT when riba & or interferion was in the mix.  My question is what happened to six month's after EOT.  And isnt 12 wks risky? why not 24 or 48 wks ...? any thoughts

[UKgirl55]

Did you see the article about Vertex and their 12 week all oral trial? 7977 is the highest resistance drug out there. If you get all three drugs, it sounds like a good chance as any of doing well on this trial. Nine out of 11 patients cleared with a non-nuc, a protease and Riba. That made me feel a bit better about what I'm deciding to do.

[UKgirl55]

Haven't been back on since this morning...Not trying to ignore you :-)

I see what you're saying now. No matter what, I don't think I'll take the IFN, so I'm not even going to worry about that one. I couldn't imagine taking all four drugs...Ugh, I'd be under the table!!!

[UKgirl55]

They do have rescue meds. Their rescue meds on this trial is SOC

[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!

[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

[Jimeeboy]

I have the same concerns about resistance.  I won't hear back until the end of the week if I am accepted so in the meantime I will try to find answers to all these questions.  Take care.

[katla]

I assume we're talking about the same location since I only know of one site in NYC. I'm tx naive but share some of your concerns. I'm really reluctant to do it without Riba.

I would really like to know if these drugs will create a resistance issue with the Abbott drugs that are getting such an amazing response. If you hear anything about that please send me a note and I will do the same :-)

[Jimeeboy]

I was screened on Friday for that trial in NYC. 7977 plu the BMS drug and maybe riba.   I am a null responder ( Incivek, Peg, riba ) GT 1a.  I've had Hep C for probably 35 yrs.  Biopsy in 2002, stage 2, level 2.

The things I don't like about it so far are:

1.   It's only 12 weeks.
2.   50%  of people will not have riba, and  we don't know who will get it.
3.   If you don't respond you can go on rescues drugs ( Peg, Riba ) for up to 48 weeks. That's a long time.  

I do like that there is no Peg but if the odds are that I will not achieve SRV with just the 12 weeks tx, and then I would have to go on the Peg to continnue tx, I might wait a while.

[katla]

If you were implying that my mind was already made up and I was just posting to waste everyone's time, I assure you, that isn't the case.

I'm sorry to have bothered you if I did.

[katla]

I thought I decided and when the I read about the failed trial I was getting second thoughts. In any case, I decided to pursue it and see if I get accepted. I can always decide then to decline.

[willbb]

In your first post you asked for advice on helping with a desicion on treating

"Any assistance/advice in making this decision would be appreciated thing to do;"


Then you post and say:

It's tremendously competitive here in NY. I know a lot of people applied and there are six slots.

I wish you luck and I wish me luck...kat

Sounds like you have already decided ??

Best of luck...whichever you decide...
Will