Anybody have a miracle stuck in their back pocket?

[susan400]

I have been feeling sort of down because of the prospects for me clearing this virus are dwindling up.  Yes, I know, that I'm far from hopeless and that there's still time, and blah, blah, blah.   But, I've basically been told that I can't do any of the protease inhibitors.  I was thinking about trying to get into the Boceprevir trials, but I've been told, flat out, nobody will take me into a protease inhibitor trial because of my having been exposed to the Telaprevir in the Prove 3.  I'm like, 'Oh terrific, so I'm like scr*wed?'   Schering has told me this, the former trial nurse at my last study site has told me this.  Whenever I inquire about the possibility of any other non-responder trials, nobody has anything available to me.  I suppose that there is always hope that eventually there will be a polymerase non-responder trial, but whether or not that they will take me, is debatable.  Waiting for a couple of years for one of these new drugs to be FDA approved really doesn't help me much because I have no prescription drug insurance, so I wouldn't be able to pay for them.  So, I'm left with, do I just hope and pray that I progress none?  Since I've had bridging fibrosis for 7 years, is that even likely?  I am praying for a miracle because nothing I have tried has worked.  I'm not trying to make anybody feel bad, or to just be a negative old grouch, but I'm really feeling down about this.  I don't understand why I have been unable to clear!  

Susan400

[Marcia2202]

Susan, you have every reason to feel upset and you may vent as much as you want. That's why we are here for each other. If you don't say how you feel, how would we know. I am so so sorry for your situation and I have no suggestions. Just wanted to let you know that I think of you and that you are in my prayers. I hope you will be able to hang in there and find some inner strength to cope with your situation. And that the right meds and opportunities will come your way very soon.

Hugs, marcia

[can-do-man]

Sorry to hear about your news but you have been a long time fighter on here. Your sure not a quitter so i have to believe you will pull something out of your hat girl. I have been talking with someone who is in this relapser trial for boceprevir that i'm also in. Not sure how they pulled it off but i do know they was in a early trial with telaprevir, they were given the real thing but relapsed. Likely do to early dose reduction because of not allowing rescue drugs.

Maybe one bright spot is that when these do come to market i'm sure there will be patient asst. programs along with the soc programs. Hang in the girl and keep a smile on that pretty face of yours. Always wishing you the very best.

[dointime]

I agree with can-do-man that there will be patient assist programs for the new drugs just like there are for SOC.  There's also going to be a big change in US medical provision when Obama becomes prez so you never know, that might provide for you.  

I am in a similar situation to you, hard-to-cure and already exposed to telaprevir but I think there will be a cure for me within 5 years and for you too.  I think that the intelligent use of a combo of SOC with alinia, a protease inhibitor and a polymerase inhibitor will do the trick.  It's no good doing trials for the likes of us.  One active agent is never going to do it for what we've got.  So we just have to sit tight and look after ourselves till all the drugs are on the shelves - hard to do I know.  Believe me I count every day.

And there's always the offchance that a vaccine or a microrna will come along and be the holy grail of cures - 3 shots and you are done - how cool would that be.  

Meanwhile they could get an effective antifibrotic that would halt liver damage.  That would be good enough for me.

So lots of reasons for hope.

I know that right now there's nothing out there for us.  Sometimes the hardest thing is to just to sit and do nothing and not know how long it will be, but I really believe it won't be that long.  Based on where these drugs are now in clinical development it is quite feasible for them to be on the shelves within 5 years.

dointime          

[Rockerforlife]

Susan?...how is your general health right now...do you have any HVC symptoms?..and do you think with all the treatments you have been tru has helped your liver ?

[susan400]

At the moment, I'm recovering from a upper respiratory infection for the past 11 days.  HCV symptoms...chronic fatigue, right upper quadrant pains-come and go, brain fog, on going low grade depression but not enough to warrant taking AD's, digestive problems.  As far as all the treatments and whether or not they've helped my liver...., not really.  I've had no improvement on any of my 4 biopsies.  Each biopsy from #1 to #3 showed further progression of fibrosis.  Biopsy #3 and #4 basically no change.  Biop. #3 & #4 both showed bridging fibrosis.  I have no problems with my A1C.  My blood pressure is great.  My weight is normal for my height.  I don't smoke.  I don't drink.  My heart is fine.  I'd say that my overall health is probably fair considering being a 47 yr old woman.  

Susan400

[susan400]

Thanks everybody, Marcia, Can-Do-Man and Dointime, for your encouraging words.  I guess I'm just having a down day since I just got the letter from Schering today.  

Susan400

[Rockerforlife]

I feel for ya woman...im sure in the future there will trials out there for you...i wonder how much it will coat for the PI`s when they go main stream?.....if i win the lottery by that time..i would get you  treated...i know this sounds crazy...but i honestly would...you deserved it

[comeagain]

I´ve been infected +35 years if I not clear this second time I´m gonna try to be as nice to my self as possible no stress, exercise in my own rythmen, eat healthy try to enjoy the positiv parts of life more then ever such as nature music all culture that I like.

And girl I believe the same as doing time in five years there will be a cure for most people and just as polio it will soon no longer be.

Your one of if not the biggest hero here at forum, and such an inspiration to us all I really admire you and wish you the very best possible.

Good Gods blessings to you.

ca

[Andiamo1]

I also feel that you will be cured within five years.   You are a fighter and you had bad luck being randomized into the arm without riba.  You are do for some good luck now and I hope you get it soon.  Treat yourself well in the mean time.

Eric

[kickboxingmom]

I just want to send encouraging words your way.You are an Inspiration to some of us newbies out here treating.You have been through it all with this HCV.Do keep marching forward.I can't beleive there won't be  something  in your future's as for treating.Something will come up.Please keep fighting the good fight.As for paying for the meds when it comes time I'll pitch in for you.As I'm sure other people would when a fellow hepper needs help, we'll see each other through .
God Bless,
Tammy

[nygirl7]

My friend,

I just saw this in here now today - a few days later but of course I had to chime in to say if I had a miracle in my back pocket you know I would have shared it with you alreadyand you know it.

You will get there, I keep tellin' ya it's just that stubborn streak of yours ran straight through to the virus and now you gotta beat it outta there.

Until then.......I'll keep looking for our miracle and buying a lotto ticket.  Hey if I cant cure your HCV at least having some $$$$$$$$$$$$$ would make it much better :)

[Trish77]

I'm a little late to the party here myself ... just wanted to drop in and throw an arm of support around your shoulder like you did for me when I was down ... I know you're a fighter and you'll get your second...no wait.. ninth? wind again and you're more stubborn than the virus is.  There have been various developments between the alinia, the statins, the polymerase and protease inhibitors, there is the 1728 in trial now from Roche and you're not resistant to that and from what I understand doesn't show signs of developing a resistance, that's a polymerase .. so that might be a possibility for you yet perhaps, yes?

Always something coming along in the last while it seems....keeping the faith for you and in the meantime, plenty of support here when you need it.

Take care of yourself in the meantime and treat yourself well.  

Trish

[GreatBird]

I think you have a miracle and that miracle is you. You've handled so much for so long that you probably don't realize just how remarkable you are. While you haven't cleared, you have hung in there, maybe your histology would be worse without all that treatment, and you've certainly helped so many people on these boards in all the years I've been coming and going.

You will be cured. One of these days your virus will come up against it's nemesis in just the right cocktail of drugs and that will be that. Game over.

In the meanwhile, you have a life to live and enjoy as best as you can. Flowers to smell. Things to create. And people here who are grateful to know you.

[CockSparrow]

Susan
I pinched this from CoWriter, she says it better than I can.

1. Insulin resistance is a strong predictor of non-response.
2. Insulin resistance results in hyperinsulinemia and high levels of insulin make interferon ineffective.
3. A study was done on non-responders and co-infected patients and it showed that treating insulin resistance lowered the viral load and resulted in an EVR of 71%.

The important one for you is Point 2. High levels of Insulin make Interferon ineffective.
Now we at least have an explanation of why IFN didn’t work for us.

From Insulin resistance and hepatitis C

Insulin resistance has been found as a common denominator in patients difficult-to-treat like cirrhotics,
overweight,
HIV coinfected and
Afro-American.

Insulin resistance together with fibrosis and genotype has been found to be independently associated with impaired response rate to peginterferon plus ribavirin. Indeed, in genotype 1, the sustained response rate was
60.5% in patients with HOMA less than 2
40% in patients with HOMA between 2.- 4
20% in patients with HOMA greater than 4

Its even lower for Diabetics at around 12%

Once I found out that Insulin Resistance was associated with African American’s poor response to treatment this was like a eureka moment for me.
Now I had something that is associated with virtually all negative predicts excluding those that have to stop Tx because they run out of blood cells. And it crosses genotypes. IR greater than 2 is associated with G2 & 3 Tx failure as well.
I
So How strong is the correlation between IR and NR.
Well I am Insulin Resistant, Miles is, hell he is diabetic. And Bandman probably is.
When I see that someone isn’t responding the first thing I think of is Insulin Resistance.
And you know what they all have signs of it. Yes all of them, at least in my eyes.

How can you tell if you are Insulin Resistant.
Well have a blood test for Insulin and Glucose and calculate your HOMA-IR score.
Signs of it are craving sweet food such as Ice Cream and Candy. Although this doesn’t necessarily mean you are IR. But if combined with going to the loo frequently, it does. But that is also a symptom of diabetes, and drinking too much water.


So don’t give up hope there are reasons why Tx fails us, all we have to do is find out what and then fix it.
And Insulin effectively being an antidote for Interferon is a pretty good place to start.

I’ll let you know how well dealing with IR works after I Tx again early next year

All the Best
CS

[comeagain]

I was rereading this thread to day and i was thinking got to ask Susan about IR
but you know i know to little about it and the language difficults and all.  so I was thinking of sending cowriter a pm and ask her to contact Susan and inform her but i don´t have to because  theirs an Australian guy thinking the same.

God  Bless you CS

ca

[CoWriter]

I'll just add to what CS said....


What is Insulin Resistance and how does it lower SVR?????

Insulin Resistance means that the body becomes less sensitive to insulin. Even though the insulin may be there, the body does not recognize it or use it.

When you first start becoming insensitve to insulin, the pancreas notices that you don't have enough insulin to keep your blood sugar under control. So the pancreas starts working faster to produce more insulin.  And that works fine for a while, but if the insulin resistance gets worse (lets say because you gained a bunch of weight), then your blood sugar starts going higher.....and the pancreas works faster and faster go make more insulin to be able to keep your blood sugar under control.  But since your body is insensitive to insulin, you end up with a bunch of insulin you can't use.....WAY TOO MUCH INSULIN......that's called HYPERINSULINEMIA .  So INSULIN RESISTACE.....results in HYPERINSULINEMIA (high levels of insulin).

And all that extra insulin.......is what lowers SVR....because it makes interferon ineffective.


Here's a study that showed that during Hep C treatment, HYPERINSULINEMIA (high levels of insulin).....MAKES INTERFERON INEFFECTIVE.
  

"interferon alpha blocks HCV replication. However, when insulin (at doses of 128 microU/mL, similar that seen in the hyperinsulinemic state) was added to interferon, the ability to block HCV replication disappeared"

http://www.ncbi.nlm.nih.gov/pubmed/1713 ... d_RVDocSum



Insulin Resistance is now considered THE MOST IMPORTANT host factor in the prediction of treatment response.

The worse the insulin resistance is, the lower the SVR.   The same study showed that people who had a HOMA Insulin Resistance test result of 2 or less (which is considered normal), obtained an SVR of 60%.   On the other hand, if the HOMA result was 4 or above, the SVR was only 20%.

And a recent study showed that treating insulin resistance with medications like Metformin and Avandia resulted in a 71% EVR on non-responders and co-infected patients.......

http://aasld.scientificposters.com/epsAbstract.cfm?id=3



Susan:  "I have no problems with my A1C."

-----------------------------

A1C......a Hemoglobin A1c test is a 3 month AVERAGE of your fasting bood sugar.  During treatment, that test tells you nothing.  Why?

1.  If some days your blood sugar is LOW....and other days it's HIGH.....it can average to a good result.

2.  The test is done on hemoglobin.....so that means that if you're anemic (like during treatment), the result will be low.  And therefore, inacurate.

A  HOMA test to check for insulin resistance uses the results of a fasting blood sugar and a fasting insulin.  So it's totally different.  (Just in case you have to explain it to your doc).


Best of luck and may you find your miracle.

Co  

[CoWriter]

"I pinched this from CoWriter"
------------------

What's mine is yours.  

Co

[CoWriter]

"I was rereading this thread to day and i was thinking got to ask Susan about IR
but you know i know to little about it and the language difficults and all."
---------------------------


Check out my other post.....hope it helps.

Co

[Lady Lauri]

Dammit! Just lost my post!


Susan, so sorry you've gotten another let down in this. I'm not too up on the trials lately as not here as much (and haven't been in touch) , just wanted to say hi and wish you that miracle soon. Totally understandable on the down days with that letter coming and after that last Debio trial at Shands. Amongst all the others also. You've maintained a good attitude thru out all your disappointments in treating. For you, and all above, it has to be just devasting to hear viral break through, relapse, especially time and time again. I agree with all in the new tx's will soon be out, even less than 5 yrs. and that assistance programs will be available. Allow yourself the upset, down days-often needed to build yourself up to fighting again.

You have a great Thanksgiving, love ya, LL

CS, Co writer...that's all very interesting! CS, as always, the man in studies! You were so helpful in my tx, you surely do the research. Can't wait to see you get started on tx, get through it and reach SVR!

All have a Happy Day, LL

[susan400]

I don't know if this will mean anything, or address your comment, but I had my A1C test 1 month ago and I've been off of the treatment drugs since the 1st week of July.  My A1C test was normal.  My blood sugar was slightly high, but not yet into a diabetic range.  My weight is normal.  Does this answer it?  

I certainly appreciate, so much everybody's help and encouragement.  I don't know what I'd do without you!  You all are the only one's who really understand!

Blessings to you all on this Thanksgiving day.

Susan400

[can-do-man]

Many blessings to you to girl !!!

[CockSparrow]

My blood sugar was slightly high, but not yet into a diabetic range.  My weight is normal.  

If your glucose is above 100 mg/dL which is only slightly high then it likely you are Insulin Resistant. If most of you Glucose levels have been around 100 then you are definately Insulin Resistant.

You dont have to be Diabetic to be Insulin Resistant.
Below is from the American Diabetes Association.
Its in regard to the risk of developing diabetes but you will get the idea

Glucose tolerance is classified into three categories based on the FPG:
• Normal:  FPG 5.6 mmol/l (100 mg/dl) but 7.0 mmol/l (126 mg/dl)

IFG is comparable to impaired glucose tolerance (IGT), which is defined as plasma glucose levels between 7.8 and 11.1 mmol/l (140 and 200 mg/dl) 2 h after a 75-g OGTT.
Individuals with IFG or IGT are at substantial risk for developing type 2 diabetes (a 40% risk over the next 5 years) and cardiovascular disease.

If you get you insulin tested you can then calculate your HOMA-IR score

CS

[CockSparrow]

Keep forgetting this site hates greater than signs.
Here is the missing bits

Glucose tolerance is classified into three categories based on the FPG:
• Normal:  FPG Less than 5.6 mmol/l (100 mg/dl)
• IFG: FPG Greater than or =5.6 mmol/l (100 mg/dl) but <7.0 mmol/l (126 mg/dl)
• Diabetes: FPG Greater than mmol/l (126 mg/dl)

CS

[CockSparrow]

You may want to check this out.

http://www.natap.org/2008/HCV/031008_01.htm

Glucose >100 mg/dl Reduces Interferon/RBV SVR
  
Effect of sustained virological response to treatment on the incidence of abnormal glucose values in chronic hepatitis C

As has been reported previously with respect to insulin resistance, abnormal glucose values (>100mg/dl) have been shown in our study to be associated with a lower rate of SVR to treatment.

The question of whether intervention using oral hypoglycaemic drugs, or diet and exercise, improves the response rate in this group of patients warrants further exploration...

Your glucose is above 100. See the connection.

CS