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HCV-796 trial - (update)
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HCV-796 trial - (update)

Hi everyone.  I got a call today from my research coordinator on the HCV 796 trial (phase II,  now recruiting).  She told me the trial does allow rescue drugs, Procrit and Neupogen, to be used during the trial to treat anemia and neutropenia (she said there had been a recent amendment to the protocol in this regard). So, I was glad to hear that (this question had been up in the air for many months - I had just been waiting for "the final word".)  

I thought I would also pass this info along (what I was told about the rescue drugs and this particular trial)  if anyone else here might be interested in HCV 796 trial but, like me, had concerns about rescue drugs.  I have an appointment with the research coordinator next Wednesday.  She said I would get all the written information on the trial then (the protocol, consent, etc).  I'll know more after next Wednesday.  

My doc (back in August, or shortly after I did not get in the VX trial) told me about HCV 796 and said it looked like a very promising PI (polymerase inhibitor by Wyeth.)  He said I would be getting regular SOC (PegIntron by Schering and Riba, I believe) for 48 weeks with the HCV 796 for the duration.  I guess I'll just have to wait and see exactly what it will be.

Is there anyone out there who is enrolled yet in this trial, or anyone out there considering it?  Or ... anyone out there with any words of wisdom / encouragement :) ?  

Thanks. Best to all.  
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Avatar_m_tn
Only recommendation is to research out the trial as thoroughly as you are able.

That might including getting hold of previous trial results (Phase I), comparing those results to SOC as well as other contenders (Telaprevir, for example), and getting hold of the disclosure document that details exactly how the trial will be run, including what tests will be administered and when, etc.  Understandably, doctors get attached (emotionally and financially) to the studies they are involved with and often with quotas to fill are often not as objective as we would like.

All the best,

-- Jim
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Avatar_f_tn
I'm so happy to hear you got in the clinical trial. That's wonderful. I'm so happy for you. And I'm glad you get to use rescue meds if necessary.

God bless,
GrandmaA

  
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Avatar_f_tn
Thanks so much, Jim and Elaine.   Jim thanks for the pointers.  I'm printing your note off.   Elaine - I have missed you too!  hehe -seems we fly by the seat of our pants around here and run into each other when we can.  Good to see you, as always.

While I was glad to get the phone call and glad to know they do allow rescue drugs,  getting the call was... well it was like getting a call after I had already made my mind up many months ago that I was not going to participate in it  (for many reasons - VX one, and the other - I was told over CHristmas they would NOT allow rescue drugs).  And now - I'm told they will, and .... she really wants me up there Wednesday for the interview.   I'm uh.... (how to say this?)  This will be a terribly terribly difficult decision -- one I will lose some sleep over, no doubt.  I'm just not sure I want to do this yet, but I'm also not sure I can afford to wait.   A second hepatologist I saw in March (to get his opinion)  was not too keen on this trial  because he thinks I will need rescue drugs.  He thinks I'm fine OK  (still stage 2, he thinks).   Another reason I'm not keen on it is  - well, the data just doesn't look all THAT great to me, and this trial center is 3 hours away (long hectic drive.)  I just don't know if I'm up to it for SOC and 796.   If it was VX, ???  different story.

hmmm... I guess I better not say too much, eh?   After watching some folks from VX, I feel like there might be "eyes" watching :)  

Thanks.  
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86075_tn?1238118691
hey, good job! If you wanna go, go! If you can up the odds a little, why not? Course, this stuff is so multi-factoral, but once you've really studied what is going to go on, I wish you all the best...in fact, I might be up for that trial too, if I'm not ex-nayed by a couple of issues I have...keep us posted!
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Avatar_n_tn
im a slow responder (first round 1a cirrhotic)at week 19 presently, so ill have to wait and see what happens.  i assume that you have to have a vl of more than 50 iu at week 24 to be a  "non responder". do yu know the specifics of their "non responder" criteria?  im still waiting on their return email . do you have a phone number for them? i m also trying for the 950 trial. youve been through multiple rounds eh? is there a rason why 796  instead of 950 for you
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Avatar_f_tn
I've inquired, just a little bit, about this trial in my efforts to try to get into the VX-950 trial.  I've got my records out in two different places that are doing trials, so who knows what will come up with it all.  I'm just exhausted with trying to run around getting records from these different places and sometimes I get a huge stack of records of which 3/4 of them, are not helpful to what they need.  I've got gobs of records on the Infergen and not enough records of when I was on the PEG drugs.  I've got gobs and gobs of records for things other than the Hep C.  So, I'm having to pick though these huge stacks of records, make copies, sent stuff to them by overnighting, or faxing it(I don't own a fax machine) and I've been running all over the county to get this accomplished.  I'd just sign a release and let them get the records, but it's not that simple.  One of my old doctors left the area and the other one retired.  My current one has only treated me w/Infergen.  I'm supposed to pick up another stack of them on Thurs. morning.  Pray that there's something in there that will help me get into a trial, if that's what I'm supposed to do!
Susan
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Avatar_m_tn
Susan; good luck.   You'll possibly need the records sooner or later.  Even if you miss out on Prove 3 there is always Phase 3 TVR which may be better yet.

Chcnme;  I was looking through clinical trials but was really uncertain which trial it was.  If you have a link it would be helpful.  I came up with 4 trials but they all seemed to be old or too new.  It would be good to see the parameters of the trial and the trial locations.

By the way.....good luck.

Willy
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86075_tn?1238118691
Susan, best of luck with this, anybody needs to catch a break with this it's you...youre do for a good ending...

Willy: thanks for all your help, really like reading your posts...
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Avatar_f_tn
Thanks GrandMa!  I haven't gotten in yet, but considering what my doc and I have discussed before about VX and this trial (gosh - for the past 2 years now -time flies when you've got Hep C) it sure seems this is the trial he has wanted me in (perhaps all along)  and that it was just a matter of waiting for them to launch it.  

Thanks Foresee!  I hope you will get those issues worked out.  I'll be wishin you the best too.  While I was waiting for her to call back this afternoon,  I was reading more on Albuferon  (and this little voice said "maybe you should ask them what they think of this trial")   and then another little voice shouted NO WAY - stick to the topic of HCV 796 !!  :)  

Hi Cruel world.  Nice to meet you.  Are you saying you are on week 19 of treatment now?   If so, best of luck.  Best of luck, also, on getting in the VX-950.    This HCV 796 Phase II trial is for both treatment naive and nonresponders (they are enrolling from both groups)  BUT their definitions (or parameters) for treatment naive and nonresponder differ from VX-950 in that "treatment naive" does not necessarily mean that someone who's had two weeks or even 10 weeks of treatment can't be defined as "treatment naive" and get in the trial.   I'm not sure what I'll be classified as, but I'm assuming "treatment naive".  I had two weeks of treatment in 2003, and so no -  I have not been close to being through multiple rounds. And the reason HCV 795 over VX is -- VX would not let me in with those two previous weeks (or so that was the reason I was told, but I have my suspcions it was for other reasons, too, such as red flags, i.e. infection, low ANC, anemia, no rescue drugs - they didn't want me because I would not make it without the rescue drugs is my suspicion, which is a good enough reason.  I can't blame them - lol.   I wouldn't want me in a trial that was banking on great results, either :)

Here's the link to Viro-Pharma re:  796 and where you can also find contact info and press releases on 796.

http://www.viropharma.com/therapeutic/hcv796.asp

The trial on clinicaltrials.gov
http://www.clinicaltrials.gov/ct/show/NCT00367887?order=2


Susan I feel for you.   I can't imagine the angst you're feeling with this kind of pressure to treat and trying to get in VX trial and putting feelers out on two trials.  It is an exhausting process even when you have just a few records to send or when you're dealing with just one trial center.   I have picked through records like that before, making copies, stacking em, mailing em, and wanted to hurl em all across the room  (when I was filing for disability).   Records and paper work everywhere. It finally paid off  (if one can call getting SSDI anything close to "paying off").   I hope your hard work will get you some satisfaction on one of these trials, and I'm sure it will!   I read in an earlier note about your doc not having the records on your first treatment,  and -- well, that is just an awful shame that your pharmacy records would not do.  So sorry.  When I got my records up to Duke before that first appointment, I didn't have a copier or fax, either, and it was the pits,  but at least my records were only from 3 docs and those visits had been within the last two years, and so - it was just driving around to all these places and signing stuff and getting copies and mailing them (and wishin I had a copy machine and a fax! )

Keep your chin and spirits up, Susan.  Something will come through for you.  I would venture to say  (and this is based solely on what I went through trying to get in VX versus 796 and just my personal opinion on criteria and leniency versus strict -- that the 796 might be easier to get in - possibly).   BUT, don't give up on the VX!   Best of luck to you.  

Thanks everyone.  
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Hi WIllie -- (you came in while I was writing everyone.)  I shot a link to Cruel world  (two, I think).  Hope they'll give you some infor.  Thanks, my friend!  
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Avatar_f_tn
I did my 796 first appointment last Monday (16th). They called me at the last minute and said, we have decided not to have you come in to try to screen because your platelets are so low. So frustrating, as I was stressing about whether I wanted to do this or not and waiting for appointments and calls, you know how it goes..wasn't planning on treating right now and wanting to wait for VX etc. Well, her cancelling the appointment, changed my mind real fast, I wanted in!

So I insisted she explain what was up. She got a hold of the doctor in his taxi, coming home from Barcelona and they had me come in! I went through and signed my consent forms with trial nurse and NP. Did bloodwork, ekg, physical/mental exam. Same deal, rescue drugs = yes, unblinded = yes (including results, I was surprised to find out) and you are not forced to continue if you do not respond by week 20. Or is it 12. Whatever the normal time you give up would be (read it here a million times, but I am fried/no memory).

My platelets actually went up, so that was fine, but my INR was too low. I went back on Friday, gave em some more blood and had chest x-rays. If the INR passes the muster, then I have to go to have my eyes checked. There is an 18-day window from first appointment to beginning treatment so I would start next week. My clinic makes you start by Wednesday, because you have to go back in on day 3 (Friday). Lots of ekg's during the first two appointments.

FYI, you have to fast for every test day, so schedule early! I didn't have any food in me until almost 5 in the afternoon last Monday. But I had about a pot of coffee (which was ok as long as it was black) and had the shakes pretty good.

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Foofighter, you're so funny. Really wanted in the test in the worst way once you got turned down, huh? Good luck, hope everything goes smoothly.You'll start next wed? How come all the ekg's?
Chcnme: Funny, two people two responses. Really made up your mind months ago to pass and now...
Good luck,
hugs to all and svr!
Bug
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146021_tn?1237208487
ChcKnme? You have really gone to the birds! Hawks, ducks, and now chicks!:)
How are the thighs? Hope you are doing well. Shot 21 Thursday, right? Hang in there!
Bug
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146021_tn?1237208487
That's very good news. I had a friend who txed for hep B in 92 and it was daily interferon shots. I hope that hepc tx will eventually go in that direction.
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Avatar_f_tn
Super congratulations FOO!   That's funny (that when they cancelled, you wanted in fast!)  I hope your INR will be OK and that you get in!!    So - if you do get the clearance you will be start soon, huh?  Gosh.  Thank you so much for responding here and giving me the scoop and pointers and such.  Fasting labs eh?   Like after midnight?   (hmm got me singing  "after midnight, we gonna cut the snackies out - after midnight, after midnight.  After midnight, ain't gonna chugalug or shout")  :)

On  the stopping treatment part,  I would assume it's at week 12 weeks ??   I think that's what it typically is  (week 12) that you are stopped if not you're not responding.    

If you don't mind me asking, how "low" was low on your platelets when they scratched you?  Last time mine were 130.  That was in October.  Mine got low at one time right before my first attempt at treatment in 2003  (they were OK for biopsy, though - INR was OK, too.)   I think they were 120 something when I started treatment in 2003, and then on treatment they bottomed out, and I was pulled almost immediately, and the infection was there, and they were saying "risk of bleed and sepsis" blah blah blah (scared the H out of me).  Labs came up quick, though, once they stopped treatment, they were able to do the invasive procedure safely, I did fine, no hemorrhage, no infection, etc., and I've been better than they expected in that department since (peridontal).   I've spent a lot of money since 2003 keeping this stuff at bay (just on "maintenance" therapy).  Teeth and gums have been fine, though.  No worsening pockets since initial "dig out". Lotta home care but worth every took I have invested in.  Doc told me last year (when he was shooting for the VX trial)  that IF my teeth/gums began bleeding or showed any sign of infection, they would pull me from the trial  (and then - I didn't even get in the trial).  

I also have a heart valve condition (MVP) diagnosed and followed by a cardiologist for about 20 years now.  It's stable.  Doing fine as far as I know.  I've been on a betablocker (Toprol)  to keep my heart rate from soaring so high and to stop eratic beats.  Been on it for decades.  The MVP ties into my periodontal disease because of the risk of endocarditis or.... whatever they call that heart infection one can get with dental work if they have MVP, and so I always have to go on prophylactic antibiotics for dental work, which is fine.  I do OK.  Did OK yesterday.  Stomach isn't feeling all too spiffy after eating all that amoxicillin, but - I'm here :)   I have been told by both hep docs that if / when I attempt treatment again, I will have to be cleared first by my peridontontist  (brought up to "optimum",  which is where I"ve been since this stuff began - no worsening and improved pockets).   The peridontist and dentist, likewise, have told me they will not touch me (not even regular cleaning) if I go on Hep C treatment UNLESS I get clearance from the my hep doc that my ANC and platelets are OK.   All these "conditions my condition is in"  is one reason I refuse to try treatment without rescue drugs.  When I found out VX didn't allow them   (which was here on this board and long after I had been told I had not been chosen, I was shocked to learn that trials normally didn't allow rescue drugs, and I was actually relieved I had not been accepted for that trial.  I learned a lot here about rescue drugs and their importance, and for me - I am convinced it would be insanity to attempt treatment without them.  My second hep doc thinks the same.   I was adamant (when Duke offered me the HCV 796)  that if the trial didn't allow rescue drugs I would not do it.  I was very surprised when the research coordinator (or PA)  called me yesterday and told me they DID allow rescue drugs .  She had told me before (many months ago)  they would NOT allow them (my doc had told me to wait and see).  Since I had not heard a word from them, I had begun to think they had scratched me off entirely, or that I had fallen through the cracks.  But - I guess I was wrong.  

What's all this stuff with the  EKG's one after the next?   I guess precautions.   I guess they do that for all of these trials??   I had to wear a holter monitor in 2005 shortly after I went to Duke for weird heart beats.  EKG was OK,  Holter was OK, and I passed a treadmill stress test then.   Now?  I have no clue what they might be.  I guess I will find out if I proceed with this.  

And a "mental health" test, huh?   Well, I know I am totally FINE in that department - LOL.  Yeah right.  I have  been in an ongoing trial called "Uncertainty and Watchful Waiting in CHC" .   The trial nurse called and did another interview last month - which is just a bunch of questions on depression / self worth / self esteem, etc)  that they are getting ready to present data on the cognitive component of HCV and the depression scale.  I can't do AntiD's .  Not that I'm not depressed,  but they make me more depressed ... or just make me feel very weird and detached.  I've been on Valium since 2003 and take 5 - 10 mg every 3- 4 days or... sometimes I can go a week without any.  I don't take them if I can do without  (scared of addiction).  

FOO - did you or anyone else happen to see the posters Viro-Pharma presented at the EASL on the data from their Phase Ib.  I tried to read some from it last night  (it was late; I wasn't absorbing it; I am brain fried on reading stuff, too.  It's going into the eyes but not sticking in the brain).  I saw their AE's (adverse events) at 1000 mg  cohorts  (the highest dosing).  One AE was pneumonia at day 15;  one was seizure at day  (forget), and one was rhombdylo something at day (forget)  all at 1000 mg dosing  (cohorts were discontinued due to those AE's).  

Gosh - sorry this was so long.

Thanks everyone -- OH!  :)  Good to see you.  Ladybug!  :):)  Jboyhk :)  (got your name right this time :)    OH - I see you are hanging in there!  That's wonderful.  I am so glad you got under the care of another doc when you did and got that Neupogen!  I remember when your platelets were taking a dive - or your ANC was, or both were.   Whew - you have been a fighter and a trooper. All of you are troopers.  Hey - are your platelets doing better?   Did you find anything to make them go up?  Besides rescue drugs?  

Gotta go.  I guess I'm going to try to print some data off on HCV 796 and the trial info and maybe call my second hepatologist and let him know I've been called and see what he thinks about the whole ordeal.   Gosh - they pulled a "quickie" on me.  Been sitting here thinking they had forgotten about me, and .... they suddenly call and say "get up here next WEEK!"   We'll have to see.   I haven't decided anything yet.  I gotta digest some things.  

Have a great one, everyone.
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Avatar_f_tn
chcmne,,,,I wish you the very best!!!! I pray you breeze thru tx.Glad to hear things seem to be working out. Just sent up a prayer for you.

susan, you're always in my prayers. God will honor your perserverence and also give you back the years the locust ate when you do become SVR ,,,,,and you will become Svr, I believe that. To hear you are no longer 2 geno types is proof HE is at work, but I know you know that.
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163305_tn?1333672171
I am happy and excited for you AND I admire your patience.
        Good luck on this being the perfect treatment for you.
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Avatar_m_tn
forseegood, thank you for the great compliment.  This is a very good forum and I've enjoyed lurking here but it's also fun to participate too.  I've learned a lot here from the many folks that post here.

Chcnme, thanks, I found the link.  I was a bit confused since that trial seemed (or so it said) that the trial opened ot listing started in....was it September 2006? (at the very bottom of the page).

The results look very good on this drug.  It's a longer treatment but that may very well spell out a higher clear rate.   It seems as though it is pretty effective in bringing down the viral load fast.  I wonder what will happen when they combine the polymerase with the protease inhibitors?  

This is an exciting time.  So many new and potentially great therapies coming almost at once.

Willy
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163305_tn?1333672171
I like chcknher !  I also like the way I misread things, its very funny.
     I was walking through the wildflowers and looked down to see this cute round red bug. When I went to count her spots she flew away. COME BACK !
     I'm in denial at the moment, we won't speak about my thighs or hair :)
  
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Avatar_f_tn
Chmne,  How great is this.  I am so happy for you.  Sounds perfect.  Isn't it funny how things just line up sometimes.

Susan,
   Hang in there lady.  I will say an extra prayer for you.  You will get a trial I can feel it.
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Avatar_n_tn
HepB current treatment doesn't even involve inteferon so much anymore. It is pure antiviral therapy.

That may be the ultimate treatment for Hepc. A cocktail of antivirals and maybe if the viral load gets low enough the body can eventually get rid of it.

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LMAO... chknher ...hahaha!  Hey - I was reading from the SSDI thread yesterday and got real excited to see you talking about possibly having orioles -lol, and having spotted a western tanager, and before I knew it - I was writing to you (on that thread)  about how cool that was, and I was telling you about our Baltimore orioles having just left (they winter here)  and about having spotted the summer tanagers (pair)  the other day,  and.... I figured I'd better not do that on that particular thread, and I erased my ...bird intrusion - haha!  But  - do you have orioles?  What kind do you have out there?  Orchard?  I am a bird geek freak!  I swear I could watch em all day (and I DO!)  My little wrens who nested right outside my door in the gourds are feeding their chickies right now (and raising he** at my fata** cat who is plopped down on the cool cement pad and couldn't nab a bird if she even wanted to try, but - I got her fata** back inside so they could tend to their babes in peace.  OK.. I just had to ... to talk about birds for a while!  See ya :)  
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Thanks Pdilly!  I'm sitting here stressing, and my head is spinning.  I swear - never in 100 years did I think they would allow rescue drugs.  Never did I think I'd even hear back to be honest.   And now?  Now I am faced with... with ..... with ....  

I'm going back outside now and think some more.   I'm psyching myself up :)    Thanks for the good wishes!  
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Avatar_f_tn
Thanks Myown !   and oh..... thanks for the prayers going up.  I need some prayers!  (This is one of those times I think I am trying to "come to believe!"   hahaha! )   Hope you're doing good!   Are you still on treatment?   I'll see ya around, hun!  
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163305_tn?1333672171
I didn't see the other thread. My slow dial-up limits me.
   I looked at a book in the library and I think they are bullock's orioles.I'd only seen orioles in Arizona.  I like watching the birds too. We've had lots of bluebirds and meadow larks. There are  tons of turkeys. And the various hawks and ever present turkey vultures. I just bought a fuschia for the hummingbird who keeps checking us out.
  I got two ducklings for my birthday. They are such messy, fun creatures.Give them water to splash in, and they are in heaven.   Happy birding.
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