Thinking about quitting treatment

[susan400]

I just really don't know what I'm going to do with treating any more, maintenance dosing, a trial, etc.  Since the doctors seem to be telling me that I'm wasting my time treating, I lean towards weaning off and then, stopping.  But, a part of me did want to know what that final viral load would be.  I talked to the women at Shands today.  I don't know if I'll be able to do that trial because I won't have had enough time for viral clearance.  Also, this is not one of the Roche or Schering trials.  It seems like a Shands type of trial.  It was for a drug that was given to Aids/Hep C patients.  Those patients were given this drug for Aids related diarrhea and while they were on it got a remission for HEP C.  Now they're wanting to do a study in Sept. for non-responders.  My problem is that I have a chronic issue that I've dealt with for years with serious constipation and I'm thinking that this drug could really aggravate that problem even worse if it was given to AIDS patients for diarrhea.  I really just want to give up for a while and just see what happens in a year from now.  I'll probably go ahead and send her my records and attach a note addressing my concerns.  

Susan

[NYgirl]

I am so sorry Susan I know how hard you have been fighting this.

We don't have it easy being 1A/1B  and that is a fact.  You've tried so many things...it might be a good idea to take a break for a little while and let your body recup some of it's health and then see what is available to try if you want to.

How long have you been on tx in one way or another now?

[FlGuy]

There was some discussion about that drug in a thread last week.  In a quick look a minute ago I didn't find the thread.  I'll look more later on and try to identify the thread for you - unless someone else out there recalls it a little more readily than me.

[webprince]

Hi Susan,
One thing for sure, never give up hope. I am a junior in this forum but can recommend you one thing which i am trying right now, Use sylmarine on daily basis. It does not eliminate virus but it will prevent further demage of liver. Have you ever used it? I am not havent even started my treatment yet but my doctor prescribed me sylmarine+zinc+selenium capsules and in first 10 days my SGPT droped from 277 to 85. I am expecting that it will be normal in a month. however in your case, your doctor can tell you about the dose of sylmarine, zinc and selenium. and also try a little amount of vitamin E only, which prevents further scarstissue building. Please make sure that you take vitamin E along with selenium since when used together, they are very useful for liver. Please remember one thing, treatment is necessary but preventing further damage is more necessary. Have your doctor given you sylmarine during treatment to prevent damage to liver as well along with tx and other stuff which only destroys virus and doesnt protect liver?
As you told me about further damage on every biopsy, please take precations to protect your liver, and dont only target virus.
As far as i can understand with your data, your target was virus not liver damage. (TX, interferon, pgy etc are not the only hope in this universe)
Best of luck,
Thanks,
Naeem

[susan400]

I've tried Milk Thistle on 2 different occasions and it aggravates my allergies and asthma, so I can't tolerate it either.  It is a weed and I have a lot of weed, mold type of allergies.

I'm just going to quit, probably when I finish up the shots I already have sitting in my refrig. I don't see the point in wasting them.

Susan

[scruffy]

Susan, in my eyes ,and many others no doubt, you are victorious many times over. My prayers are with you all the way regardless of the path to ultimate success. Frank

[susan400]

My first treatment was in 1997.  I've been trying various treatments with periodic breaks off since then.  Somewhere on here listed is all the various treatments that I've tried over the years. But, for the newbies who don't know: I've tried, Intron-A/Riba (1st treatment for 48 wks)
Infergen 9mcg 3 x a week (for 6 mon. 2nd treatment)
Maintenance dosing with regular Intron-A  (3rd treatment)
Peg-Intron/Riba (48 wks) (4th treatment)

Pegasys (2 months and then switched back to Peg-Intron and Riba. Also, Zadaxin was used at the same time.  (5th treatment)

Double dosing with Intron-A and Peg-Intron combined and Riba  (6th treatment)

Infergen/Actimmune/Riba (for 8 mon.)  (7th treatment)

And now, this treatment with Infergen and high dose Riba (8 pills a day).   (8th treatment)

I've had 3 biopsies each one showing more damage.  

I really think I should stay about from treatment and leave it up to God at this point.  I may change my mind if they end up approving the Vertex drug.  I really don't know what else to do.

Susan

[FlGuy]

See the 'News Stories and Other Posts' from 6/1.  There ws mention of a drug called 'Alinia' from Romark.  Maybe there is some info there.  I think Forseegood made reference to it.

[honey11]

Susan,,,,I honestly don't know how you have endured the tx as many times as you have already and keep going!  And sane on top of it!  I know if it was me,,,,one more viral count to reassure what it is and if still registering a count,,,,I would give it a break for awhile just to recoup your own health.  You are such a determined,,,focused person though,,,,I know this will be a hard decision for you!  You know,,,,we all will support any decision you make!

[Mister beagle bailey]

Susan I am so sorry and lost for words.  Being a pro treatment kinda guy, in your case I would wait for better meds.  
Know you are in my prayers, let us know what you decide.

Beagle

[Bill1954]

Susan-- I wish you the best of luck with your decision. I would definitely contact the study director and express my concerns regarding chronic constipation, and see what they say before dismissing the thought. FLguy mentioned a previous thread on this subject; I remember it also but can’t remember how it was labeled. I wish we had a Google-type search capability here for the archives. The name of the drug is Alinia, by Romark Pharmaceuticals, and I found a press release about the upcoming trial. Here is the addy if you’re interested:

http://www.romark.com/index.php/media_center/press_releases/35.html

Again,  I wish you well with your continuing saga,

Bill

[friole]

Your attenmpts at treatment with the current drugs available have just not led to a successful outcome.  I would certainly vote for your quitting and giving your body a well needed break for awhile.  At this point, even if you do tolerate treatment, it just can't be doing your body well.  As for this new experimental drug, I would research very thoroghly before I jumped in.  I truly think you need a break.  Surely you have helped your liver with all you have done.
My sincerest regards, Kathy

[cuteus]

one more PCR, but since you are not in shape to do a yr from a negative, maybe forgoing the test will be best. You did respond to this last tx, better than I have seen you post before, what a shame that this strain has mutated to such a resistant level!
keep in thouch mith Miles, since he and you seem to be head to head in number of tx tried. take care the best you can.

[MissMiss]

I want to add my thoughts to the many here, all going towards you.  It is hard for me to believe there isn't some company out there who would look at your story and think that there may be something to be learned about this dreadful virus.  I mean, why, after all the tx you have been through are your bx's getting worse and why is the virus still living?  What is missing in the big picture?  

I pray someone somewhere will have an answer for your struggles.  You are a hero in my book.  Whatever you decide, we are all behind you.  Best of thoughts going your way.

miss

[sindog]

Time to live life.

[Galen]

Some of the oldies may remember me.  I finished up 48 of Peg/Intron in 9/03 and was blessed to beat the dragon the first go-round.

Susan, you have my utmost admiration for sheer determination and guts.  I only had to go through this sh*t once for 48 weeks and cannot, without hesitation, advise anyone to try it without a good soul searching.  Once was hard enough.  I don't know that I could ever be as strong as you.  You are in my prayers.

[jmjm530]

Susan,

You've fought long and brave, but if your doctors tell you that you're wasting your time, I'd either go with their analysis, or if still unsure, seek another opinion.

Also, if you've already decided, I see no reason to take whatever Peg is still in your refrigerator. Better to give yourself a few weeks of relief instead, and you can always donate the drugs back to your doctor or keep them in the fridge for possible future treatments.

Regarding the Alinia trials in the U.S. --  I'd make sure that they're not simply testing for viral eradication, as opposed to going for SVR. As I read it, in the Egyptian trial they just went for viral eradication and apparently stopped at the 24 week point with no SVR data being developed.    

Quoting from a recent <a href="http://tinyurl.com/muc3b">press release</a> on Alinia

"An interim analysis of the first 20 patients enrolled in the study showed that 50% of patients receiving Alinia administered orally as one 500 mg tablet twice daily with food had undetectable HCV RNA in serum at the end of 24 weeks of treatment compared to none of the patients in the placebo group (P=0.03)..."

Unless I'm missing something, these figures are not very impressive compared to peg/riba combo and especially not compared to the early Vertex data.

As you may know, Vertex has already scheduled trials for prior non-responders, and this might be something you or your doctors might want to look into.

All the best whatever you decide.

-- Jim

[GoofyDad]

To me, 'iterim analysis' suggests they are continuing therapy - this was just an early update. Although you would expect they would have issued a supplemental update by now.....so maybe not. Or suppressed bad news? Or as someone pointed out, perhaps there are back room negotiations underway? By now I realize this post is pointless. No stranger to me.....

[jmjm530]

I based my assumption they stopped at 24 weeks based on the fact that the Egyptian trial started "early 2005). So it seems extremely odd that if they continued past that point, no new data has been released, as that was 18 months ago! But like you say, who knows. If I were interested in the Alinia trial in the U.S., I'd call/email them and find out exactly what they did in Egypt.

-- Jim

[jmjm530]

In case I forgot, thank you for that little<href="http://www.medhelp.org/forums/Hepatitis/messages/41086.html";>tutorial</a>tutorial yesterday in how to code in an html link.

-- Jim

[NYgirl]

I think one of the biggest problems for someone like you or I is admitting a tentative (and not permanent) defeat of ANY kind.  You are so conditioned to fight fight fight right now that it must seem just impossible to stop = even for a while.

It's going to be a tough mental adjustment - one I can't imagine.

But you have tried all of the toughest things - did even the Infergen. I really hope that you think of the rest of your body now and rest.

It's GOT to have taken a huge toll on your OVERALL general health (not just the liver).

Wait, see what happens with the new drugs and then get in one of their trials.

Or wait and then think about a new way.

Right now you sound so tired = while it's not admitting defeat in ANY way you just have run out of viable options and the rest of your body needs PEACE.

I hope to GOD there was fibrosis reduction with the Infergen combo.  

Why don't you just rest for a few days and then decide what to do. I know it sounds easy not to think of it = it's easy for me to say that huh?
You know I wish there were those magic words/answers and I just don't have them. It's driving me crazy I wish I did so much.

[sunspot]

In the battle of the Dragon, you are the Ultimate Warrior. I wish the very best to you.

Dana

[GoofyDad]

What's done in Egypt stays in Egypt. And as ugly as some of those camels are, that's probably a good thing.

Do I remember you had a highish ALT reading at some point after tx? Was it a blip, or had it remained high through tx?

[jmjm530]

Goof: Do I remember you had a highish ALT reading at some point after tx? Was it a blip, or had it remained high through tx?

It was "higher" not high. Around 32 if I remember and still well in normal range but up from around 22 earlier in tx. Now it's back in the low 20's again. My GGT which was also elevated is now also trickling back down. I guess tomorrow's the day they start poking around in our blood :)

My other point on Alinia that might have not been expressed clearly enough is that only 50% of the the Alinia trial were non-detectible at 24 weeks which isn't much to toot your horn about. Peg and riba do much better than that. Still, you gotta hope, especially when a drug comes out with so little side effects.

-- Jim

[Forseegood]

Yes, I'm the one who mentioned the Alinia and I'm glad someone found the thread, cause I stink at finding things on this board, can't figure out the search engine here...

I mention it because I already have 4 friends on the stuff...one of them was able to get a six months supply from the pharma co itself because she filled out some hardship papers....it is expensive...one thing Susan, this drug is for a particular type of diahrrea(I never know how to spell that word!!!) and none of them, so far, have reported worse then normal constipation issues...if you were to try it (as everyone here knows, ad nauseum) I sure know a helluva lot of ways to keep your plumbing going smoothly...

In reading Jim's concerns (which seem, at this point, inconclusive) maybe this would be a good drug for maintenance? to keep the little suckers at bay at least? if nothing else...I believe Kalio brought up a good point in the thread that hep c duplicates(?) (busy right now and can't remember the word she used) mostly in the intestines? this would make sense if it were true...I agree with most here that it sounds like you should give your body a break to recoup and regroup...sometimes we have to measure the cost/benefit of going on with these drugs at some point...if you want updates on the women taking this drugs, two are on Janis, one named Boomer and the other Shiela....

Not to start a prairie fire here, but I do know a lot of people who were non-responders, relapsers, years ago now...and they are just going on with their lives and they are not *particularly* ill with this disease, not everyone graduates to pre-transplant status on some type of rapid timeline...

just spoke to one of my friends, he's a plumber and still works 4 days a week, tried the treatment 3 times, then the infergen, it just didn't work out for him...the last time he treated was 3 1/2 years ago now...he's 64 and his last biopsy was a 3 as it was years ago...he's waiting on the new drugs and other then that, just going on with his life...I know others with similar stories, some cirrhotic as well...one of the only good things about this disease is it is slow moving for the most people...keep that in mind if you can and enjoy some time off...my two cents....

[DoubleDose]

My input would be to have that last PCR very soon before making any final decision.  If you are negative at this point, you might find some ways to keep going, while slowly decreasing one or both components to the tx.  If you managed to remain undetected, you could run the tx out long term at decreased dosages, and maybe find the whole thing much more tolerable...while saving a chance at SVR...if you extended for a long enough period of time (at reduced doses, of course).

If your PCR shows detectable virus at this point, then I think you are fully justified in stopping the tx.  

My best wishes to you, whatever you choose to do.  

DoubleDose

[webprince]

I am feeling worried about you. Ok if you are alregic with MT, then what about Vitamin E, Zinc and selenium. Atleast some thing should be taken to protect liver from further damage while off the treatment. Is it possible foryou to tolerate MT with any anti allergic medicine. Have you consulted with you doctor for allergy with MT?
Take Care,
Thanks,
Naeem

[GoofyDad]

Just one comment on the Alinia. I remember it was developed to go after a parasite that causes constipation. So if you don't have that parasite, it's very possible that it would not have any binding effects.

Best wishes to you. This has been a long battle.

[willing]

I'm also a tentative member of the alinia fan club and am very interested in any additional information you want to pass along (did you or your Dr. suggest it? How long are you planning to continue  ? Do you know of anyone combining it with other meds?).
My major beef with ifn is that it's not  a medicine, it's a supplement, and one the virus has already found effective ways of disasrming...not so for NTZ.

A couple of additional items that came out of the fda sheet and some studies :
- normal rx  for anti-bacterial effect is 3 days
- anti-bacterial effect is wide ranging (bacteria causing abortion in cows, neuromuscular disease in dogs, myeloncephalitis in horses in addition to those that cause diarrhea in humans); in fact, FDA first approved it for veterinary use
- documented nonmutagenic, though studies not finalized(same as rbv) and unlike rbv is not teragenic (yay!)
- likely mechanism of anti-bacterial action described in FDA drug sheet is not supported by later studies <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16127045&query_hl=15&itool=pubmed_docsum">Esposito'05</a> so neither the documented anti-bacterial nor the putative antiviral effects are understood (same is true for anti-viral effect of rbv, though this has been studied thoroughly and various theories proposed).

The 50% odds might seem slim to some but they look pretty darn good from this end of the relapse pool. Of course until the SVR stats come in for both this and for vx-950 there's not much definite to go on, but so far, so good.

When you get to the Sierras, if you see a guy holding a casket catalog, walking kinda funny, and nervously scanning the horizon for an outhouse you'll know my Giardia hunt was successful!

[jmjm530]

Forsee,

Yes, I was concerned whether this study was too preliminary to help Susan, and I thought contacting Alinia with some questions might be helpful both to her and her doctor.

I am curious how long have your friends been on Alinia and do you know what their PCR results are? Are they part of a formal trial or taking it privately under the care of a doctor? What is the plan in terms of length of treatment?

Thanks.

-- Jim

[jmjm530]

Forsee,

Just did a quick search for "Alinia" over at Janis where I believe you first saw it posted. This excerpt from a lady named Sheila caught my attention:

"I wrote to Dr. Schiff about Alinia, the drug they have tried in EGYPT, Karen, I hope you are reading this, we don't have to go to Egypt, it can be rx right here.  Dr. Schiff says he is skeptical, but if it's safe, he has no reason why I can't try it."

Assuming this is an accurate representation of what Dr. Schiff said, then it at least appears to be safe and probably worth a shot for certain individuals. I believe someone posted that Dr. Dieterich said something similar in his advice column.

Still, if one isn't in a rush, it might be worth waiting another six months to a year to see how things pan out. And if one needed to treat immediately, not sure if current data is sufficient enough to dive in. And then, of course, there are the Vertex trials with Peg and Riba. However, it certainly would be wonderful if a drug came along without Peg and Riba, without side effects, that would kill the virus. Hopefully, Alinia will be the drug and time will tell.

-- Jim

[jmjm530]

Forsee,

If this quote is accurate, Dr. Schiff does not state Alinia is safe, but says "but if it's safe" then he sees no reason not to take it. A fine but important distinction. I believe Dieterich said something similar.

BTW I hope I'm not giving the impression I'm anti Alinia -- in fact, should I relapse, I'd be trying to dig up as much information as possible on the drug because as much as I like the potential of Vertex, for the time being it's only being served with two of my least favorite dishes -- peg and riba :) SVR data will tell more, however you do bring up a very interesting thought regarding "mainteance". If it turns out that Alinia suppresses the virus without side effects, then maybe one would just continue to take it indefinitely, and therefore take the whole relapse issue out of the equation. I'm sure this will be studied as well.

-- Jim

[Forseegood]

As much as I love ya Jim, you are a Cautious Cat, of that I'm sure..he he he...no offense intended...anyway, yes, Shiela is one of my friends and she's been going to Schiff for a long time now...she is 70 years old and and 0 liver damage, although she has some hcv symptoms...though the energy of someone much younger...I'd like her energy...

he's going to supervise her treatment, but she's getting the rx on her own and paying out of pocket, I was actually going to talk to her soon and mention that she try to get the hardship forms from the drug co herself, being that they don't check on your stats (from what I know now) you just fill out the forms...keep that on the qt...they both said no sides at all, cept a few hot flashes for Boomer, but that could be from hormones as well, the way I look at it, if it's not causing a bunch of sides, could it be THAT harmful? of course that is my own editoral...anything's possible..

he feels she's too old for the meds at this point...being a stage 0 liver damage...she's jumping in on Alenia, to see if it will knock her viral load down, as a type of maintenance or perhaps to even clear? what the hay...I'll keep you guys posted on what Boomer, Shiela, and a few other friends are doing...Boomer actually got the drug co to give her a six month supply cause she told them she couldn't afford it, they were pretty cool about it she said...

more on this later...gotta go exercise the pooch...

[jmjm530]

Forsee says: As much as I love ya Jim, you are a Cautious Cat
-------------
I love you too, but if you knew my life story, you might call me a lot of things, but certainly not "cautious" LOL.

But real life aside and back to treatment:) -- I wasn't being cautious when I upped my Riba from 1200 to 2000 mg a day while double-dosing Peg BUT I did do as much research as I physically could within my self-imposed time constraints before making the decision. Even so, I didn't up the dose gradually enough, and got pretty darn sick because sometimes things are just too new to find out much about.

BTW found Dieterich's exact quote regarding Alinia in his column:
He says: "Worth a try. Not much reliable data on it so far, but not very toxic. As long as your hepatologist is monitoring you carefully for side effects, it is OK to try for a few months. Good luck! Let us know how it comes out!"

Of interest is that this particular questioner is taking Alinia along with a mainteance dose of Peg and Riba.
Search link here but you have to scroll down:
http://www.hivandhepatitis.com/doctor/topics/hcv1.html

BTW I bought some Aloe Vera gel today, do I get to join the club or do I have to buy out the health food store first :)

-- Jim

[Forseegood]

hey, just yanking your chain, I'm prob one of the most cautious people on this board, I'm doing all I can before I even take treatment! ha ha! and I know some people think I'm so "cast your fate to the wind" cause I take supplements, you should see me, when I try something, I take a microscopic amount at first, see how it effects me, then titer up and up till I get to half dose, ha ha!

I'm going to find out all I can on this stuff, from people who are actually on it, and everything else I can get my hands on...I do know one person who's on treatment, didn't clear till 12, and she's doing Alinia with the rest of her treatment w/ her doc's okay...

Willing sounds like youre on the case too, good to have some logicians with me on my quest...I can be a kind of an airhead about these things sometimes...not that you'd notice, snortle, snortle...

And Jim, I woudn't worry it so much, youre SVR dude...

[Forseegood]

I also have a reaction to milk thistle like you do, but there are plenty of other things I take (along with what some of Naeems recommendations were) that help with the liver, I have a very good regimen I feel, it's helped me a lot, and Tallblonde just came in with a ringing endorsment vis-a-vis her recent labs...maybe you'd like to discuss that in the future, maybe not, but I'm glad youre going to quit for now, and regroup...

[strator]

Susan -  My prayers and support are with you for whatever you decide. After all those treatments  I can only imagine it’s an extremely difficult decision for you. Your inspiration here is as amazing as your perserverance. A decision either way at this stage is just as courageous as the other. I’m sure your experience and wisdom will guide you. Thank you for always posting both the hope and realities of tx and your battle.
God Bless,
Don

[OnAPrettyPoison]

You are one amazing person!  I can't imagine that many treatments over that many years.  Whatever you decide, you can know you did all that you could with the meds we have now.  I hope you can take time to rest and recover.  I wish you the best of luck whatever you decide and do.

[Forseegood]

how are you? I miss youre family stories and such, hope youre doing well...

[willing]

were those real snortles ? actual snort and chortles ? wow...what talent!  I'd like like to snortle some more more but got to  go now - new casket catalog just arrived (very exciting, way bigger pillows, much more leg room). Please consider (yes, I'm a cautious cat too) that even if everything seems just fine extra CBCs, etc. are not a bad idea when snortling off where none have snortled before...

[beamishboy]

just wanted to wish yu Best of Luck.....and Strength,tho does not seem lacking on your part..