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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.
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.
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 :)
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 :)
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
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
I am happy and excited for you AND I admire your patience.
Good luck on this being the perfect treatment for you.
Good luck on this being the perfect treatment for you.
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.
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.
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.
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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