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1707536 tn?1334974077

PSI-7977 + BMS-790052 trial - need advice


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
27 Responses
Avatar universal
Hi Kat,

I screened for this same trial on 16th of this month. What was the initial screening? I just went for the one and am now waiting to hear my blood work results. I'm a 1a, high viral load and tx naive. I don't know what my biopsy results would be right now. My last bx was in 2008 and showed mild inflammation. Hoping the fibrosure doesn't scare me to death!

I was a lot more enthusiastic also until I heard the results of the nulls, but looking at the fact that they tried 7977+Riba for 12 weeks for nulls was really stretching it! My gut feeling is that the combo of 7977 and the BMS drug would be better. I wish we knew what the resistance factor is. That's my biggest concern. I still feel on track to go for it, but it would be nice to know that if 12 weeks failed you hadn't built up a resistance to the 7977.
1707536 tn?1334974077
nope, sorry, forgot to ad I'm tx naive.
1707536 tn?1334974077
Hey UKgirl-

I guess it was actually a pre-screening (?). I spoke to the trial doctor for an hour and a half and took a drug test (urine). I showed the doctor my biopsy report and previous blood tests. Next appointment they do an EKG and take blood.

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
Avatar universal
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
1707536 tn?1334974077
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.
1707536 tn?1334974077
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.
2035311 tn?1332679977
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.
1707536 tn?1334974077
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 :-)
2035311 tn?1332679977
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.
Avatar universal
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
2035311 tn?1332679977
Good question.  That's why I want to know if that does happen, can I go back on 7977 for a longer time.
Avatar universal
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.
Avatar universal
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.
Avatar universal
Can't wait to hear what they tell you Jimee!
1707536 tn?1334974077
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.
Avatar universal
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!
1707536 tn?1334974077
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.
Avatar universal
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.
1707536 tn?1334974077
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.
2035311 tn?1332679977
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?
1420486 tn?1384793153
  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
Avatar universal
They do have rescue meds. Their rescue meds on this trial is SOC
Avatar universal
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!!!
Avatar universal
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.
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