The Study/trial I am looking into thru my GI

[Ryansmom17]

Study title: Infliximab (Remicade) as an adjunct to Pegylated-Interferon and Ribavirin in the tx of HCV

The standard tx for HCV is a cobo of Peg a man made protein that helps fight viruses, and ribavirin an antivirus medicine that you take by mouth. The purpose of this study is to find out if the addition of infliximad (remicade) to tx with peg interferon and ribavirin increases the amount of time that your body remains free of the HCV.
If screening evaluations show you can receive study tx, you will be randomly (by chance) assigned to receive one of the two tx's. This is like deciding something by the flip of a coin. each subject has an equal chance of given each tx. The tx can not be predicted.  You will receive either intravenous (IV) infliximab (remicade) tx along with peg/rib or you will receive a placebo that looks like the drug IV along with peg/rib. It is a blind study. Only the study Dr knows what tx you are given incase of emergency your Dr can contact him.  The tx phase for the infliximab (remicade) occurs IV at weeks 0, 2, 6, 14, 22, 30, 38, and 46. The tx will take about 3-4 hrs to complete. you have to stay at least an hour to be monitored after the tx.

Ok this is the trial I am signed up and almost ready to start. If I chose. As some of you know I have been having many other GI problems and have been hospitalized and am getting ready to do an endoscopy and colonoscopy next week. I am trying to get other issues out of the way first. My psych eval is next week also and that was my final step before beginning TX. Now that remiccade is already an FDA approved drug for RA and MS and some other things I am not sure of. So far for HCV geno 1a and 1b it has proved to keep them virus free for over a year. This is the trial I have spoken about that is in the last trial stage and is due to be approved for HCV tx in 2010. As I have said before I have RA and fibromyalgia and am in pretty late stages of RA. The 2 together have effected my legs greatly and somedays I can't even walk. So IU thought this drug trial would be GREAT for me  because the added drug will probably help the joint inflammation I already have and the added pain the tx is going to cause me! Im in stage 4 of HCV, I have pretty severe liver damage already. My GI thinks I will be needing a liver TP in the near future. I have already been in liver failure once. By the grace of God I was brought out of it. Drs had no explanation except one actually admitted I was a miracle and God must want me alive! I know I have to at least try 1 tx to even be able to get a liver TP, and I also know that because of all the pain I live in and the other illnesses I have this may be one H@ll of a year for me. It is 48, possibly 72 weeks. This trial. So, I am thinking if I am that bad already why not just hold my breath and pray I can last another year. That way I know I am getting the drug, not wondering which side the coin landed on. Or do the trial and pray I get the drug and not a placebo. This drug added with the others has had great success so far. And honestly with all of my other auto immune diseases and other sicknesses and pain.........I don't think I can handle one tx, better yet have to turn right around and do it again! I have been reading a lot of other peoples experience on here, and so far I have seen that us geno 1's are on their 2nd, 3rd, and even 4th time treating!!! I am a very strong woman. I have lived thru a lot. I live everyday is a battle for me physically and mentally too because I just can't do it somedays. I just stay in bed. I just have no strength and I hurt so bad I just do not want to move. How the heck am I going to make it thru 48 weeks of tx added to what I am already living? I mean I am signed on their calendar ready to go as soon as my GI says go, and of course I sign my life away on the consent forms. BUT I still think it is better to do the trial and hope for the added drug, then just do the tx thru my GI the regular way and ABSOLUTELY KNOW I am not getting a drug taht just may keep me virus free for yrs! Ok so I am scared. I am a trooper. I always saw myself as a weak person, but I am writing a book, and now that I am looking over my life. I am an A #1 TROOPER! So, I keep trying to tell myself I can do this, but the other side of me is just so very tired of fighting everyday of my life just to get up and take a shower. I mean if I put make up on and take pics I post them because it is rare. I went riding yesterday w/ the girls for a few hrs, hit the mall, and by time I got home I felt like just laying down and dying, the pain was so bad!! and I will suffer for that great fun day out, that normal people do all the time all weekend. Activity just knocks me down to 0 immune system and lots of pain! I mean I am already on so may narcotics, what more can be done for me? Im sure that my doses will be raised again my next appt because every few mos they stop working. I am so immune to them, and yet so physically addicted to them. I got of of illicit drugs to end up on hard core pharmaceuticals Joy Joy!! Ok so like usual I am going on and on, BUT as of now I am saying NO to tx.........Am I making a mistake at stage 4 late stages cirrhosis and abdominal pain, mild ascites, chronic pancreatitus, and enlarged live, colon and a paralyzed upper stomach? I have no GI system left! PLease any input or support is much needed now. The days are getting closer. My endoscopy/colonoscopy are the 8th and after that Im good to go, if I say so.............
Thank you for your time
Peace and Blessings
Jenn

[merryBe]

I'm no genius here, so you may want to ask the forum a question about how remicade downregulates Interferon and what this means as to treatment outcome in your case.

ask your doc as well.  When reading on drug interactions I came across some cautionaries in the way these two interact with each other, but I'm sure there must be more to this if they are doing trials with it.  
For your own personal sanity in making a quality choice you need to know what both the upside and any potential downside is to taking these 2 together. From your posts I'm not sure if you are clear on how this drug might help you, and I sure as heck don't understand it.

maybe Cowriter, Willing or Hepatistis researcher could explain, try to get their attention mb

[Ryansmom17]

Thanks so much for all of the support, and prayers! Thank you MB for that post. It does make a lot of sense for me to at least try it, and I figured the same......I may actually get more pain relief, and then I will be KNOW I am on the remecade. Even tho it is a blind study, I am sure I would be able to tell the difference. Altho I have never treated before. At my Drs office they are only taking 12 candidates. So I need to make this decision this week! I mean there are other study sites, but this one os directly thru my Drs  office, and would be much easier for me to be able to follow up with my own GI thru out the whole tx.
So, lets hope for the best with my tests this week, and seeing the psych......Then I see by next week or week after I will be in with the rest of you!!! Oh Joy Joy! lol
As for having a great attitide and srtrength. I hear that a lot from friends of mine and all. I guess I don't see it as much, but when I tell them some of my stories, their mouths are usually on the floor! I have had a heck of a life and fought hard for it. Funny for someone that used to always be trying to off myself every six mos or so? Now I want to live and I have to fight for that too? I HAVE TOO HAVE A SENSE OF HUMOR! I can very easily fall into a very deep dark ugly PIT! I have been in a few, and I am sick of falling into them. I am by nature a goofball, or a nut. My tattoo on in my pics of my flying kitty with wings, is me in cartoon form. If ya googled SkitzoKitty you would find me everywhere. That is my riding name lol and that tattoo is me lol So yea I thunk me being nuts helps. If I was a serious minded person, I think I would of gave up a long long time ago. I even have a Christian ministry online that I help ppl all over the world thru cyberspace! I use my weaknesses to make me strong, to reach out to others, and help them TO NOT go where I went, or help them out of it if they are already there. I have a heck of a book Im writing too!! I put a post up with the link to my site, but medhelp took it down??? I don't know why? It is faith and hope and I am sure many ppl on here would love to read stuff like that? But I write about my trials and the strength of God that is getting me thru it, and focusing on others helps me not so much focus on me and my pain. So I am babbling again!!
Well, it is Sunday and tomorrow morn I call the psych to make a new appt. I do my Tests Thurs, and hopefully will see psych Dr too this week. Or early next week. Then I sign this book of consent.........And begin Tx!!
Thx again everyone........Now I am posting a silly question next lol
Much Peace to you all
Jenn

[Sunny37]

I haven't been on-line for a long time but thought I would look tonight and I saw your post. Just thought I would let you know that I have chrohn's and am genotype 3a and took remicade through 24 weeks of tx. I am SVR and was UND at week 4. The remicade will hopefully help with your RA and give you relief with your pain. Everybody responds differently to tx , I was on this site for 3 months before starting and thought I was going to die taking it......but really.....my own personal experience, already having experienced surgeries and pain before wasn't that bad. I lost alot of weight and felt tired and sore but it was manageable with an end in site. Stay positive, you have already been through so much you will get through this.
My thoughts are with you and good luck.

[Marcia2202]

I just wanted to say that you are an amazing woman and that one can only love and respect you. You are truly a ray of sunshine and I am holding you in my prayers!

May God bless you over and over, many times!

Much love, Marcia

[merryBe]

anyone reading this must want to go immediately into prayer for you.
It's heart breaking and wrenching to be dealt so many blows and yet to keep up the brave front.

I know it's scary, and I can think of as many reason to talk you out of this as to talk you into it. I'm enough of a coward to admit I'm glad to leave this aspect to you and the Lord....this is not an easy call.

That said, I'm with epiphany...you can always drop out. Let's say you get the remicade, it theory at least you should notice some relief of your RA at least fairly soon. Maybe not total (since we know Interferon can exascerbate or even cause RA, but maybe if you get the trial remicade as well, it may balance out whatever extra pain you may have had.

If it doesn't look like you are getting any relief or are getting worse, then yes you can drop out. Obviously don't mention this intention going into the trial. They are looking for those willing to commit. Yet they know a certain number will not be able to handle the sides and will drop out.  In one respect this trial could be a Godsend for you if you are getting the remicade. But if you could get it anyway, assuming you have insurance for SOC, then that combo would be optimal if you want to treat. Try it, since it's helping in the trials, I think any doc willing to treat you with your RA etc would be willing to add this. Plus, you could then have rescue drugs as well. Thats if you have ins.

The difficulty in trials is sometimes even depression is left untreated, and most often blood builders such as procrit are disallowed. Since you already have immune system breakdown the last thing you need is a long tx period with NO helper drugs. This could mean adding severe anemia and more infections to your already long list.

I think you need to read the fine print. Maybe trying treatment and dropping out would still qualify as treating once, find out. It seems cruel, but remember even after transplant if you get one, you would have to treat.

Yet my emphasis would be could you endure the tx. Lets say you get the remicade, and the RA settles down...you still have to contend with possibly needing boosters for your red or white cells, especially if going beyond 24 wks.
I've dealt with about 3 dozen major and minor infections over the course of the last 15 months, and can say that it all went with the territory, so I'm not complaining.
Still it was wonderful to get procrit when my oxygen suppy was cut in half, and antibiotics when my kidneys of bladder became infected. All the little things that creep up during treatment, be they anxiety, depression, infections or whatever are all serious matters that need addressing. So given your state already, I'd think long and hard about all this, and ask them how low they would allow your HGB or your platelets to go before cutting you off treatment.  
Also ask if trying the treatment, and failing would still count as having treated once.   If you get on a transplant list you will still have to treat for the HCV or that liver will succoumb quickly to the disease, but at least with the new liver you'd have some resislincy in that organ that your current liver may not still possess, thats the good news, the bad news is immunosuppressants could worsen your other stuff.

Having read a lot of borderline stories in here, I'd have to say your's is up there with the toughest of calls.  One thing I would want to find out SOON is how your other conditions effect your chance of recieving a transplant.
The person most knowledgable to ask in here is Mike Simons.
Since you have the several autoimmune things, this makes you a questionable candidate for a transplant in that they have to further suppress your immune system to fight rejection and this can help certain conditions and hurt others. I'm not well versed enough to tell you where exactly you would fall in this high risk category, but it could be your risk factors would play a part in whether you got a liver...unless you were some rare blood type, and they just happened to get one of your type in that no healthier person in the line could use.
It's hard to think this way, I sure wouldn't want to be the docs deciding....but who do you give a liver to, a sickly 70 year old or a still prime 40 year old...when it's down to one or the other, It's not about age as much as state of decline...the one most likely to survive is usually who gets the liver.
What I'm saying is not to discourage you, but make you aware that there are risks either way. Do the trial, it could succeed, or fail, same with the transplant list, same with treatment after transplant. There is no easy answer here. Sometime you just have to go with your instincts and try something because doing nothing is not an option.

For Chrismas my daughter gave me a little plauqe.....it said : Faith is going up the staircase, when you can only see the one step in front of you.

I think that sums up how each of us approaches our treatment. We can learn, we can ask for wisdom and recieve it, but in the end we must all just take that one step each day, not seeing or knowing the end of our destination.
my hopes and prayers are with you.
mb

[epiphiny]

Just wanted to say I have read your post, and I truly do not feel qualified to answer your question as I have no medical background and you have a great deal to to consider.

From a simple perspective tho, you could look at it this way....

Just because you start the trial doesn't mean you have to continue on it if it proves to make your already difficult life more difficult and unmanageable.  I am pretty sure you will find that in your trial consent form.  You can withdraw from the trial at any time for any reason.

If you need to have at least one attempt at treatment before you can get a transplant and given what stage you are at, it would seem prudent to treat soon.  Do you think you can wait until the drug comes to market and will you be able to get it if you do wait?

Doing the trial is like doing SOC but with a 50% chance of getting the added real drug so if you compare the two then the trial has to win hands down.  I know it is awful to consider you might get placebo and then have to do treatment again but I would suggest that you don't focus on that at this stage, one step at a time right now, and nice little baby steps!!  Remember, you can always withdraw from the trial...

Also, Rocker posted info on another trial that is recruiting now that you could perhaps your Doc to look into for you.  Here's the link:

http://clinicaltrial.gov/ct2/show/NCT00797745

Next-Generation HCV Protease Inhibitor SCH 900518

from Schering Plough

As part of its long-term commitment to hepatitis C therapy, Schering-Plough also is developing SCH 900518 ("518"), a next-generation HCV protease inhibitor. A Phase IIa study with 518, known as the NEXT-1 study, is currently ongoing. The company said that 518 has been shown to be 10 times more potent in-vitro than other protease inhibitors currently in Phase III development and has the potential for once daily dosing. 518 also has shown decreased emergence of resistance in vitro. Given its pharmacokinetic (PK) profile, the company anticipates that 518 may be active against some HCV strains that are resistant to other protease inhibitors. Phase I proof of concept studies with 518 in treatment-naive patients and those who failed prior treatment, both as monotherapy and in combination with peginterferon (without ribavirin), demonstrated enhanced antiviral activity, with up to 4 log10 and 5 log10 decreases in circulating HCV, respectively.

Full results of the boceprevir HCV SPRINT-1 study and early phase clinical results with SCH 900518 are being submitted for presentation at a future medical meeting

http://www.natap.org/2008/HCV/121608_01.htm

All the best my dear,

Epi :)