BMS791325 clinical trial

The doctor was very pleasant, he looked me in the eye, when he spoke to me and took all the time in the world to explain my questions. re: rescue drugs. One of my biggest questions is this. he said if viral loan is not completly undetectable @ 12 weeks . then the SOC would be stopped as well is this standard? I asked about procrit for anemia. since his gal said he never orders it.  He said  studies look down on its use. and they dont pay for it , but I knew that they did'nt pay for it' He did say procrit is not the only way to help a anemia problem. he said I could do a blood tranfussion. Any body ever done that? has anybodies insurance company ever paid for a transfussion or procrit? I told him I would not want to quit treatment due to a anemia problem, and I dont. He will prescribe drugs for depression. uck dont want any. this is a phase lla study. only 39? people will get in, at various locations. I have a 1/3 chance of 75mg 2X daily or 1/3 ch of 150 mg 2Xdly or 1/3 placebo all with SOC.  I asked him if he gets to choose what studies he takes and if he believes in this new drug he said , yes and yes, although no garantees.  Anybody got any feedback, advice, opinions which I value. Thank You with kindest reguards I am Me

[nygirl7]

Trials are trials for a reason and they do have risks involved with them.

While it sounds like someone informed you that the insurance companies would not pay for tela when it is approved, Honestly I have never heard this before.  Considering how many doctors are looking to this drug to immediately start it in the regimen - I cannot see how insurance could refuse to pay for it as the odds will be so much better and the time of treatment even hopefully shorter.

Of course that goes without saying insurance can do whatever they want - in this case it would be extremely cost efficient for them to approve it.

As a stage 0 I would certainly think about waiting a little while - transfusions are certainly not the way to manage anemia and basically I've only seen them used when people have dropped so low that they needed the trans to bump them up to a level where they are then able to use procrit (it takes a few weeks to kick in) or something like that. Procrit is VERY expensive and you are not going to want to pay for it yourself.  At $6,000 for a box of only ten (which only lasted me 5 weeks) you can see it would be better to get into a program where they would allow it and pay for it.

There are lots of things that are up in the air right now and a little bit of patience might be a virtue (and believe me I believe in treating extremely aggressively and as soon as possible in most cases...but at stage 0 you certainly do have time to investiage all avenues).

[girrrl]

Big decision - Do you know the name of the drug that you would be getting if you get the real thing? and did you say it is a phase 2 of the clinical trial? Sounds like you're asking some good questions about insurance.I have good insurance and the other day my doctor told me that they may not cover telaprevir -- so, im just starting my research.... Thanks and good luck to you

[nutpea]

Wow , everyone on this forum who is waiting patiently for this drug telaprevir. Needs to know that insurance companies might not cover it....I think they should as it is probally cheaper than a liver transplant. But then again weights and measures. How many in desperate need for a transplant get it vs. How many people want telaprevir $$$. And the drug is called BMS791325. They have not given it a name yet. Telaprevir use to be a number too. Bms stands for Bristol myers and squidd. Did you ever make up with honey??? I took a looksie @ your post... Hope your doing well. I will probally be going thru tx alone. But I have my pets and my peace of mind. My new guy would rather be drinking. So sooo long. Sometimes people are miserable when they quit drinking, and probally smoking too. I try to quit smoking and fail. But if I get after it and do quit no man will probally wnt to be around me. hehe.

[nutpea]

I asked new study doctor what he would advise me to do if I were just one of his regular patients and not trying to get into study. He said he feels Sooner is better than later. He said my stats are good stage 0 grade2. low vL in 230k no fibro or cerossies. So he thinks it will be easier to SRV than if CerRossies.

[spectda]

Studies that are at the phase where they are being done to determine treatment protocol and svr rates will generally allow the use of helper drugs like procrit and neupogen. I am very surprised if your doctor indeed told you this is not so and suggested that a transfusion would be better then taking procrit for anemia.

Transfusions are not long term solutions. They are for emergency situations where they blood level has to improve immediately because of the risk to the patient. In regards to hep c treatment,  Procrit should be administered when a person has hgb around or below 10 g with the purpose of keeping them at the proper dose of ribavirin and keeping the  patient from getting to the emergency stage.

If you are stage 0 a good hepatologist with your best interest in mind would tell you that you have plenty of time to wait for the right drugs and to make a wise decision about treatment. The disease progresses over many many years and at stage 0 (no liver damage) you are not in danger any time in the near future of having serious hcv complications.

Good luck- Dave

[nygirl7]

Trials are trials for a reason and they do have risks involved with them.

While it sounds like someone informed you that the insurance companies would not pay for tela when it is approved, Honestly I have never heard this before.  Considering how many doctors are looking to this drug to immediately start it in the regimen - I cannot see how insurance could refuse to pay for it as the odds will be so much better and the time of treatment even hopefully shorter.

Of course that goes without saying insurance can do whatever they want - in this case it would be extremely cost efficient for them to approve it.

As a stage 0 I would certainly think about waiting a little while - transfusions are certainly not the way to manage anemia and basically I've only seen them used when people have dropped so low that they needed the trans to bump them up to a level where they are then able to use procrit (it takes a few weeks to kick in) or something like that. Procrit is VERY expensive and you are not going to want to pay for it yourself.  At $6,000 for a box of only ten (which only lasted me 5 weeks) you can see it would be better to get into a program where they would allow it and pay for it.

There are lots of things that are up in the air right now and a little bit of patience might be a virtue (and believe me I believe in treating extremely aggressively and as soon as possible in most cases...but at stage 0 you certainly do have time to investiage all avenues).

[spectda]

I am not positive, but I am pretty sure that most of the trials more "recently" that allow procrit and neupogen expect the patient to pay for these helper drugs or use their insurance. the exception would generally be if the drug is being used as planned part of the study.

If you are in a really early phase trial that is not designed to determine protocol and svr rates, but is really about the safety of the drug for humans and how quickly viral load drops (usually very short term trials) then very likely these drugs would not be allowed either.

Others of course may have had a different experience in trials they have participated in or inquired about.

[nutpea]

Thank you for your opinions, advice and wisdom with tx this diease.    Ok nygirl7 I am assuming you had reg SOC. did your insurance co pay for your procrit with SOC. I really appreciate the advice about waiting. This was the second GI, I have seen.  I dont think we have a hepatoligist in my area, infact I drove 150 miles just to see this doctor. He thinks the sooner I treat this the easier it will be to tx or maybe clear. He said my odds go up with no damage. my hbg is on the high side @ 15.8 so hopefully that will help with the effects of Rabivarin. I read on a post on this forum about a doctor telling a hepper that insurance companies will not want to pay for the tela when it arives on the market.  Which i also find hard to believe if it will save them money. I will try and find that post and put it up on this forum. Spectra.. Thank you for your information. I too was wondering if a transfussion would just be a temporary fix for a problem. plus subject my to the possibility of more dieases. Although I understand they screen blood or plasma better after 1989, I still believe there is room for human error and laxadazical or poor work ethics in all areas of the work force. My own mother donated her plasma as often as she could for a half gallon of vodka. there was never a day she went without alcohol. I guess she must of went in there one time very drunk. because they tested her blood on that ocassion and called her back and told her never to donate blood again. She died of the final stages of liver failure. On the death certificate it reads accute ethanolism, high blood presure, and final stages of liver failure. The plasma event took place aprox 1997. I dont know how they ever accepted her blood as she always reeked of alcohol. She once went to the dmv to get her licence. When they informed her they couldnt let her take a drivers exam because she was drunk. She demanded her right to take the driving test. They finally agreed, but told her she would be arrested for DUI as soon as she put the key in the ignition.  To all. as it stands today I have no medical problem with diabeties (which runs on the male side of my dad) no heart problems or blood presure problems or any problems that come on with age.. That is another reason im looking to kick this hep in the butt. As fifty is just around the corner. I dont want to wait too long and have other age related problem hindering my tx. Also my health insurance will be gone by may 2011. So I need to do something. Thanks Nutpea

[nutpea]

I forgot to put your names in the To Box

[nutpea]

i dont like this best awnser because they were both the best.

[spectda]

"i dont like this best awnser because they were both the best."

Choose by alphabetical order then, her name is deb, mine is dave. LOL

A lot of us ignore the best answer, what's important is that we share information and experience and expand our knowledge.

[nygirl7]

LOL none of us like the best answer feature either so don't worry about it (but yay for picking the girl over the boy answer hahahaha!)

Dont worry about it around here basically we all share what info we have and then add on to others thoughts and basically what is is is one big long list of best answers all compiling on top of each other.  That's what makes it so successful (in most cases don't let me say that we've never had some big disagreements of opinion in here!).

My insurance paid for my Procrit.  My  hemo was over 15 and in ten days dropped six full points.  It was pretty bad.  Without the procrit I would have had to quit treatment (but this was MY fault I decided that I needed 'extra' ribavirin and so increased the dose by myself.....a very stupid thing to do but at stage 3 with two strains of HCV I convinced myself I had to do it - I was wrong).

Treatment is a tough but doable thing.  I think the first thing you have to check out is if you do this treatment it doens't work for some reason - will you be able to use another PI or new drug in the future?  To me, that would be the most important thing of all.  Hopefully they do come out soon and hopefully they change the landscape of HepC forever.

I'm sorry about your mom, it certainly seems like you have had a rough road (like unfortunately most of us have - certainly with me it is one of the reasons I ended up with the disease.  Pretty common type thing to happen.  

But we persevere and can beat this thing - that is what you have to always remember!

Deb

[susan400]

Many insurance companies have a drug formulary and if the medication that you want is not on their formulary then, you end up with an extremely high deductible (something to keep in mind).  My insurance company I have now, is a Medicare Advantage Plan HMO and quite frankly it su*ks!   They want to charge you outrageous prices for non-generic drugs.  Almost all name brand drugs have a huge co-pay.  AND, once you reach the GAP, you basically have to come up with 50% of whatever the drug costs.  I.E. if your interferon is (for example)  $5,000.00  then, you have to pay $2,500.00 out of your own pocket w/o any expected reimbursement.  You have to be below the poverty level and qualify for Medicaid to get any additional help.  That leaves me out because with the SSD check + my husband's work, I don't qualify for Medicaid or the additional help, but I'm too poor/broke, to ever be able to pay those high dollar figures.  That's just for interferon. When you throw in the Ribavirin cost, any new drug (which I might add will not be on their formulary for 2011) + any necessary rescue drugs (not on current formulary), I would not be able to have electricity, gas money, food money, or any other money left, all to pay for the meds.  I simply couldn't do it.  The only way that I'll ever be able to get Boceprevir (which is what I will go for), will be if my husband gets insurance (which he currently has none) and it will cover it.  Or, on the outside chance that I can somehow qualify for some indigent assistance from the drug company.    I just wanted to shed some different light on this subject.   Susan400

[nutpea]

Susan you sure shed some light and brought back a vague memory. about 7 mo ago I looked @ treatments covered and meds covered by my bluecross/blue shiels. I remember it said it covered hepC tx.I do not remember which interferion it covered,but it had it listed along w/rabi. I dont remember if procrit was on the list or not. I have lost the paperwork but Im going to call and have them send the list back out to me. Now I am wondering if your husband could apply for health insurance on his own. Out here a few years ago, alot of churches were attempting to offer health insurance to their members as a group. I do not know if this ever succeeded or not, nor if a preexisting condition would null and void it. But Maybe? I take it you have not tx'd and I see you have been here since 2003. I also wonder if you might try benifit suppers and bake sales. Out here when ever some one passes they put a sack @ our one and only convience/gas station for donations for the family to help cover the cost of ? I dont know how successfull it is. but its just a thought I thought I would put out there. Thank You nutpea...Ps hopefully obama will get this thing passed, where you cant be denied for pre existing condition by insurance companies.

[nutpea]

haha, of course us girls have to stick together. But out of fairness next time I may spread the next best awnser. Yaa I know the best awnser does not mean nothing to me as its all good advice. And I will have to deside what to do. I need to learn more about this new drug but I am not a rocket scientist. And this new drug is suspose to attack the nr3a or something. I gotta go back and look for exact name and then google that name and try and decipher what that means. Ive noticed the other pi's that do have good record are targeting the nr5a or b or something like that. I am concerned that if I allow myself to be soiled by tx. It may exclude me to other trials or tx.

   Another BIG concern of mine is I have heard from some ladies that tx aged them 10 yrs or so. I probally need to post this question along w others. But I couldnt help but notice that you are a very attractive woman. Im worried about loosing my looks and I do look younger than others my age (no children and gene's I believe is my secrete or luck lol) So did you notice any aging after tx? How do you feel now both physically and mentally? I googled sx from tx. And I kept stumbling on these Posts all by a Loydd Wright I believe. I did notice he is selling a book or herbs or both. But the letters people posted were horible. Do you have to still take meds for things such as depression, loss of energy, insomnia or anything. Are you still able to work? I know final stages of liver failure are no good. And I have taken care of people on hospice. Had I been in some of their positions I would of ended my missery before it got that far. Not that i am suisidal by any means. I just dont believe in letting any animal suffer needlessly. And since I dont believe in letting a animal suffer. I certinally dont believe in letting a person suffer. But then again I guess that would be the Lords choice.

[susan400]

I have treated too many times to count, but about 10 times of various types of interferon, all with Riba except for the time that I was in the Prove 3 Telaprevir trial when I was randomized into the no Riba group.  I've just never been able to get undetected.  So, basically, I'm almost at the point of just saying to h*ck with it and giving up on the idea of expecting that I'll have a way to pay for it whenever the right treatment comes along.  I'm not quite there yet, but with the more time that goes by, life goes on and Hep C becomes not as much of a priority for me.

You are correct, NYGirl is very attractive.  I've never met her in person, but in her pictures, she's a very pretty lady and more importantly, a very nice person, too.

Susan400

[RobertBeWell]

IMO, this trial is a tough call. 66% chance of getting the real drug is a bit low for my comfort level, but still fair odds. Of course, you are guaranteed SoC which, if I remember, insurance is an issue for you, so that part is good.

You have lots of time, no damage. Choose wisely.

Robert

[blondie717]

oh my, were those all clinical trials? I believe I have seen a post that said you basically had not had any luck w/getting the right arm of the trials. My goodness, sure shed's a bad luck on clinical trials. Are you working now? do you have health ins? I just asked because you mentioned not being able to afford treatment. I took a looksie @ your profile. and saw that note from ? about teplivir and vx222 combo along with Soc. Maybe that will be right for you huh?   I am not meaning to imply that I am so vain that I would put off treatment because it would age me. I just want to know what to expect , and it is something to think about, after all I have about another birthday till I go down hill. lol.. but another thing to think about is sooner tx rather than later....
      Your luck has gotta change, Maybe you should go to Vegas... I honestly hope it does and you rid the virus. After that many attempts, I feel your intittled to be free of it. What stage are you in and how do you feel?

[blondie717]

Maybe tela and bi and vx222 are going to be it with SoC and maybe thats all a person can hope for. Im getting discouraged. Im close to fifty. my mom and dad both died prior to 65 way prior. one from booze (I dont drink) and one from diabeties relaited heart failure (but that has'nt hit me yet eighter and it seems to bite the males) I could probally do nothing and die from something else. My Doctors nurse said her mom had it and died from something else.

[Kathyo17]

About 5 or so years ago I took pegasys  and co-pegasys(ribaviran), the treatment was for 9 months. I tested undetectable for about 2 months after tx. ended and in the 3rd month my levels were right back to where I started from. My GI at the time tried to set me up in a clinical trial but it was for "non-responders" and I was considered a "relapser" because my levels were good for 2 months after initial treatment. During treatment I suffered some of the common side effects, some which were very painful like muscle and joint pains, nausea, depression ( which hit suddenly and in full force), insomnia,and fatigue. My GI was not very helpful with those effects and always told me to call my PC dr. when I mentioned anything to him. My Pc dr. would then say that everything was from my hep. treatment and I should call my GI dr. (it was total back and forth). Needless to say I got zero help with any of it. In my 8th month of tx. the combination of hep. meds and depression meds (paxil I think) made my vision get really blurry and my GI stopped ALL meds for a month or so, then resumed for another 30 days. All of my treatment was to no avail and I "relapsed". I was lucky to be able to get an appointment with a true liver specialist in Phila.,he told me that halting my tx. for a month was a very bad thing to do and that it probably messed up the whole course of treatment. I was also told that I should of NEVER have suffered so much and there WAS things that should of been done to help me through things; he also did alot of bloodwork and tests but at the time there really wasn't anything but the meds I already took and similar ones (Pegatron and ribaviron too). My options were either take the Pegasys shots daily for 6 months or do nothing and wait for new drugs to be approved. Since I had a small child and I barely made it through the last tx. ( I went down to 89 lbs. I had to buy my clothes in the kids dept.) I figured I should wait for new meds. Now that dr. is no longer there and I lost my ins. I had before. I have state medical assistance now. I don't know if I can get tx. covered now.  I don't think I aged 10 years from the tx. but I certainly suffered, it even put me into early menopause. Now I have been getting alot of pain on my right side and stomache bloating. I am afraid that my hep. c is back with a vengence. I am on the waiting list for a different GI locally now. So hopefully I can do something constructive and less debillatating this time. I need to get more info. on current tx. options so I can go into this eyes wide open and would appreciate any insight given to me. Right now I don't know what stage I am in but I do feel not healthy and I doubt it iis stage one. My genotype was a 1 and I don't know much else right now except that liver specialist told me I also have a genetic hereditary disease called hemochromotosis. The "iron" or "bronze" disease. It isn't something common but it can cause liver problems too........lucky me, huh? :) gotta laugh cuz I certainly don't want to cry. Luck to all.

[susan400]

I know that many of you are probably new to the message boards here at Medhelp and aren't aware of my history.  No, all of these treatments WERE NOT trials, only some of them were.

TX #1  1997-98     Intron-A and last phase of trial for 'new' Ribavirin    Back then, Intron-A was 3 x a week.

TX #2  end of 1998    Infergen   (yes, it was available way back then)  Back then, the theory was that a loading dose of Infergen taking it every day and then, after the first 30 days, switching back to 3 x a week.  Plus, Ribavirin.

TX #3  Peg-Intron + Riba

TX #4  Pegasys + Riba + Zadaxin(which is Thymosin), the Zadaxin was able to be legally shipped here from Mexico.  FDA allowed that.

TX #5  Just maintenance daily Intron-A of a very low dose (can't remember actually how low it was, but it was extremely low) and 1 Riba.

TX #6  Peg-Intron + daily Intron-A + Riba  (Initially on the first month, it was Peg-Intron twice a week)  This higher dose was on the advice of this supposedly expert doctor on Hep, who was consulting with my regular doctor.

TX #7  Infergen + Actimmune + Riba

TX #8  Daily Infergen at the highest possible dose, 1600 mg of Riba daily.  I also needed rescue drugs for the 1st time out of all of these treatments.  I used Procrit and Neupogen

TX #9  Clinical Trial for Telaprevir called Prove #3.  I did NOT get all 3 drugs.  I only got randomized into Group C with the Telaprevir and Pegasys.  I did not clear and was left with a 'Telaprevir-failure patient' label.

TX #10  Clinical Trial for Debio-025  (A cyclophillin inhibitor)  I did not clear.

Where am I at now?  I have been treatment free for 2 yrs and 3 mon.  I have never obtained viral clearance. However, I have not given up as I think that all of these treatments helped me to not progress.  Initially, I had genotype 1A and 1B.  Somewhere along the way with all of these treatments, I lost the 1B and now, I only have 1A.  Also, on my previous biopsies, I had shown bridging fibrosis.  Now, my last biopsy did not appear to show bridging.  I don't do any herbs or natural supplements other than omega-3's and I take cinnamon for blood sugar regulating and a non-Iron multivitamin.  I exercise alot.  My ability to be able to pay for the new drugs is hampered by financial.  No I do not work.  After all of these treatments, my brain is toast.  In fact, I may have gotten the order of which treatment came next like, number 4, 5, 6, etc. out of order, but I still did them!  I am on SSD.  Due, to my brain function, not the Hep C.  I would do another trial if they would take me, however that seems to be very unlikely with the Telaprevir-failure label.  

I'm not some sort of super hero.  I'm not a crazy woman.  I'm just a woman who wanted to get rid of Hep C and I went out of my way to try to get there.  Unfortunately, I was not successful.  Many and most people are able to clear with using a 3 drug combo.  I'm basically trying to put the Hep C on the back burner for a bit and just live my life because for the past 13 yrs, it has been too much of my focus.  

Susan400

[nutpea]

good greif dear woman. If I were incharge of telapervir I would open another study.  I might name it the Susan400 super trooper study( by no means am I making light of your trials) I would include folks like you with multi attempts and be sure to give you all real drugs. I would not care if it were on the record or not.  I could be very wrong but I believe it may have been nygirl whom said you never have got a break. And if I am wrong about who said what. It does seem like you have not got a break. I wish I were computer litterate enough to paste this some how on a email and send it to some bigwig @ telapervir, whom has a heart...Maybe they would do something for you.  Just think if telapervir took you and 100 people like you and had a great success, what a wonderfull indorcement that would be to the world and the FDA... Maybe someone will see this and do what needs to be done... You must of been really with it in the head, because I would be lost on trial # 2 or 3....Im happy that you are improved as far as damage goes. It would seem to me that would make you yet a good canadaite for another try. Oh lordy nutpea

[nutpea]

Do I already have brain damage Im thinking like 1/3=33.3? X 2 = closer to 67% odds. But I get your drift....Hope you are feeling well, dont quit working your arce off. cause its working for ya,as far as side effects go.  be well nutpea....

[nutpea]

Hi I had to look that big word up on google(hemochromatosis) it can be treated by pulling lots of blood @ one time I believe its (alot) then you have it pulled perodically. it can cause anemia if they pull too much... Im wondering if you could treat after you get that under controll.... I looked @ www.clinicaltrials.gov  I did not see any clinical trials listed by hep c and hemochromatosis... I read a bit about not eating red meat, liver and having a iron free diet. I dont know much, so maybe someone else can help/advise you in this area. I noticed you are new to this forum. So welcome to this forum... You may post what you said on a new post and see if anyone can offer advice to you. When you get to the forum section it will say post a question..Believe me im still stumbling around computers.  I think this forum may have a doctor section too. But I could be confused with another web sight. You will find lots of good suggestions, advice and wisdom on this forum.. I see you have only posted 3 times and 1X on hep C. Try to put your post up, becuse so far Im probally the only one who saw your post,and im no help as I am new too. Well Susan400 might of seen it maybe. Be well Nutpea

[nutpea]

Wow I just got accepted into trial BMS791325 study trial. Now Im nervous...Gotta call her back today. And tell her when I want to start next week. Real nervous. off to job interview I go. When it rains it pours. Today I should gamble?

[nutpea]

the more I think about it , the more I think. They must not be very confident in this drug if it only has 36 persons in the world. What do you think.   Or maybe it is just really intended to be an accompany drug to The other BMS drug. Sorda like VX222 to Tela. Im scared and I got 3 days to chicken out. Maybe I have trust issues?

[RobertBeWell]

If you're unsure about the trial in any way, the best thing you can do is just say no.

You can leave a trial anytime you want, for any reason, without explanation. They are forbidden to pressure you by law, thusly:

"Hello trial person, I've decided I'm stopping participation immediately. Goodbye."

You're out.