nm283 trial

Rudy, Mike, Jane .... you are the three people I have seen on this board who are taking nm283.  I might go on the phase 3 trial.  I communicated to Divine who is on the Janus site and also on nm283, and she says it is a piece of cake compared to the old treatment.  Pegasys alone can knock one out, right?  I have my own marketing business that went down the tubes during my last two treatments and I'm now building it up again.  If this is going to put me in bed for another year I don't know .... I  think I can wait another year until this is on the market, and others are also being tested?  My doctor said it is my choice.  

I am confused.  Any advice?
Henry

[susan400]

I've heard that people who are previous non-responders will most likely have to combine the NM283 with Interferon and Riba.  The NM283 by itself in previous non-responders will probably not bring about SVR.

Susan

[miked]

Rudy,

How long do you have to stay on the NM283 + PEG?  Is 48-60 weeks the normal course and if so are there discussions of shortening tx time to something less?

Good luck with your tx and paving the way for the rest of us.

Mike

[rudy222]

I'm on the Phase IIb trial, in the low dose 283 arm.  I just got my 16 week labs and I'm still negative.  I say that quietly, not quite believing it yet.  "No HCV Detected" since week 10, <50 at week 8, 4 log drop at week 4.  No ribavirin.  I've been on reduced dose Peg, 135 mcg, since week 3.  Absolute Nuetraphils holding at .8.  i don't tolerate peg well, but hell, I'm undetected and 60 weeks of peg/riba didn't get me close.

My thoughts, Henry, is that you'll know by week 12 if you're responding in the trial.  Either you or the trial docs can decide then if you are to continue.  And after two bouts with peg/riba, I think you'll find this much easier to tolerate.  I really don't notice any sides from the 283, but it's hard to tell, sides are sides and Peg's a devious drug for me.  Lately I've been having my "bad days" just before the next shot.  For months it was the opposite in that it kicked my ass for two days after the shot.

I think it was a Woody Allen quote that said if you want ot make God laugh, tell him your plans.

Good luck.

Rudy

[Henry4]

Thank you for your thoughts.  I am losing sleep over this decision.  I am also feeling selfish about talking about my problems with anyone because of Katrina.  My health problems are now transcended by this catastrophe.

But 12 weeks does sound reasonable.  The trial, I believe, starts after the holiday season so I don't have to be gone for that.  But if I do respond I have to be committed to another 36 weeks?  There is the problem.    

Have you heard from Jane or Mike?

Henry

[rudy222]

Trial protocol allows either you or Idenix to discontinue your participation in the trial  whenever you want or whenever they want...12 days or 12 weeks.  My thought was that 12 weeks is a doable period.  If you're responding, another 36 weeks doesn't look so bad.  If you're not responding, wait for the next one.  

Phase IIb was originally scheduled for 24 weeks, then extended to 48 weeks.  I think it was done that way to allow data from Phase I and Phase IIa to be presented to the FDA to justify the extension...in other words, if the monkey is still alive, extend IIb for another 24 weeks.  I had to sign new consent forms to continue.  I have not read anything about the length of the Phase III trials.  There is just no data to discuss how long to treat or what happens when you stop.  Or what happens with dose reduction.  i was told Neupogen is not allowed in the trial.  I know Idenix will be presenting the preliminary data from Phase IIb this fall...and it's almost fall.

[hep62pj]

I was on virimadine/peg trial and dropped after 6 months because it was not working, very interested in this trial but I cant find out anything on it for phase III are they recruiting for that yet?

[irish00]

I am on the NM283 and my viral load has dropped from 1,222,000 to 4000 in 6 months. I also am on peg with it. This has been the only product that has worked for me so I am hoping for a 0 count sometime. I will keep you informed.

[rudy222]

Hey Irish

Hang in there, Irish, you got about 3 logs in the bank already.  Are you in the phase IIb trial for non-responders, or phase IIa?  I guess the question is were you a non-responder to peg/riba?

Good luck,

Rudy

[Henry4]

Thanks, everyone, for your response.  I am carefully mulling over this nm283, seeing if I am up to diving into the treatment game again.  It is scary.  Sounds like it worked for one of you already (Rudy), but it doesn't seem to be making any new headway for Irish.  Has there been any change over the past few months in your VL, Mike?

hep62bj -- Idenix is recruiting for phase 3, go to the www.idenix.com website and send them an email asking about a trial location near you.  I am in Chicago, there are many other sights around the country, like in New York and Florida, and others as well.  Good luck. (To us all.)

Henry

[poolcue]

Hi Irish00,
Good to see ya still hangin out here.  I'm in town to see Dr.G today.  
Hang in there, sounds like you may finely be on the right road to getting it whipped.
You and veryone else on the board is in my prayers.
Smiles,
diana