Hep C Discussion Forum

mallani · Guru

RE: Abbott Labs TURQUOISE-II Open label clinical trial

mehru · Member

Hi all, guess I'll have to google Miraviren. Has it been studied for those with compensated cirrhosis? I have not heard of it need and would like to read more. Thanks ã

ios9 · Senior Member

Hi Matt, Balagan, All,

Shall we give a conference somewhere ? we have so much knowledge lol

I just wanted to let you know about drops I took when I was up to 21 M of VL last March : my ostheopathe/Homeopathe told me to take drops of Desmodium adscendens.

I can't say for sure what helped the most (accupuncture, or Desmodium drops, or liver-healthy meals, or all of this) but my VL drops from 21 M to 17M in less than a month.

I stoped Desmodium when I started AbbVie Trial in April.

Desmodium was (re)discover by a couple of French physicians (Dr Pierre Tubery and Dr Anne-Marie Tubery-Crauzes) working in Africa in the early 60's. Some of their European patients told them they had been cured from acutte hepatitis with this plant. Back to France they started to study it in labs. Same studies have been made in Canada and UK too.

It has been found that Desmodium has capacities to normalise transaminases and more.

I can say that not only the VL but my transaminases did lower too.

May be you could ask your homeopath about this ?

Just a suggestion, of course, for our next International Conference :))

Take care all,

Do

ps : Balagan, I do not think we have Ezekiel bread in France, I will try the Jewish quarter may be. I had a look on the net, sounds nice, thanks for the advice !

-- Edited by ios9 on Tuesday 13th of August 2013 07:34:11 PM

balagan51 · Veteran Member

'can you find Ezekiel Bread in your area?"

the coordinator said the drugs were absorbed better with fat and it helped with the potential nausea.. ( it worked!)

I started with the ezekiel with my first dose! funny you should mention it. hadnt tried it before. toasted. a little organic butter, and some smuckers organic peanut butter with every dose.

I think we went to different schools together.

Matt Chris · Guru

Hey Do & Mike

Reading the list of foods I totally agree, limiting our sugar, dairy, meats, and cereals (boxed sugar types) is a wise path for diet.

veggies, fruits in season and avocados, nuts (walnuts, pecans, almonds, Brazil nuts ) have been my meat replacement for the most part, but when I can have a truly organic farm raise beef, chicken I will once in a great while enjoy them.

Do and Mike , can you find Ezekiel Bread in your area ? It's a sprouted grain bread, try the cinnamon raisin bread version.

Try this , toast 2 slices of Ezekiel breads Cinnamon raisin bread (all sprouted grain bread) then spread the coconut oil from Costco or Dr Mercola brand. You will never use butter again. I have also used it with lobster with similar success

I grew up enjoying breakfast cereal but I stopped eating the processed brands, and learned to make my own when I visited Hipocrates Health Instutute for 3 weeks in West Palm beach Florida, USA

It's a combination of sprouted buckwheat and Chia seeds , millet, fresh ground flax seed and other minor ingredients . I sweeten it with stevia and my milk substitute is Flax milk unsweetened .

I soak the buckwheat first then they sprout and then dry by putting them in my Excalibur Dehydrator then in glass container until use.

We all have so much to share , we need a convention. Ha, ha, ha

Matt

balagan51 · Veteran Member

Do,

Thanks for taking the time to post that meal plan.

Its going on my kitchen

might want to read up on this

http://beta-1-3d-glucan.com/

again, thanks

ios9 · Senior Member

Loopy Lisa wrote:
I have been following the Miraviren trial with interest. They are aiming this injection at people that are non-reponders or not able to treat. The results are looking fantastic! The virus is going so low at point it is not detectable. Also it is very mutation resistant.

Hi Lisa, Matt, All,

Lisa, do you know if Miraviren can be used on those who have experiment AbbVie or even Gilead's treatment ?

Matt,

Here is the diet the french patient I have told you about is using till the new treatments without interferon will be on the French market.

With this diet, in a few years he has his liver fibrosis which has lowered and so has his VL. He has never been F4 however and is walking 5/7 km each day (mornings). Very healthy life, healthy mental too.

Breakfast :

Red grapefruit

1 glass of soja milk with 2 spoons of flax powder seed

1000g Vitamin C

400Ui vitamin E

100mcg selenium

300mg Alpha Lipoique acid

300mg Sylimarine

Lunch :

Raw vegetables and steam cooked ones, with onion, garlic, pepper, mixed herbs, (every day), and turmura, saffron, seeds (fennel, aniseed, flax, etc.) as often as possible.

Olive oil, colza oil, and flax oil (in small quantities)

Fish, seafood, eggs (more white, less yellow) and very little meat

Fresh fruits as much as you like (do not add sugar)

Lentils or beans or broad beans once every week,

Steam potatoes once the week

Dinner :

Same, but in less quantity, more fruits, mostly dried fruits,

Plus :

1 capsule Vitamin B complex B100

100mcg selenium

300mg Alpha LIpoique Acid

300mg Sylimarine

Foods not to be eaten :

Milk and all diary products

Sugar

Cereals.

Matt, about cereals not to be eaten : I am having toasted whole spelts bread instead, every day, each meal. Also seeds.

About the no milk diet : I get mostly my calcium from almands and vegetables.

About sugar : we have all the sugar we need from fruits and fresh fruits drinks. But I do have a spoon of bio honey with my Royal Jelly.

Instead of the fish and seafoods he is eating, I have spiruline, fresh when I can get it, or in powder.

Good appetite

Do smile

-- Edited by ios9 on Thursday 8th of August 2013 09:47:29 AM

Matt Chris · Guru

Thanks Lisa

The technology looks very interesting with injections being the only drawback .

The mutation resistant profile is going to be one of the most important factors in all future drugs that are being bought to market.

So if this and all other HCV treatment are to compete with Sofosbuvir they will have to have a very high barrier to resistance. As long as Sofosbuvir side effects are less than current SOC it will have no real challengers unless they have a similar mutation resistant properties.

Also the different Geno types may play a roll in which drugs will win out.

Lisa again thanks for the up building positive interface it is well appreciated

Matt

Loopy Lisa · Guru

Hi Matt,

I have been following the Miraviren trial with interest. They are aiming this injection at people that are non-reponders or not able to treat. The results are looking fantastic! The virus is going so low at point it is not detectable. Also it is very mutation resistant. But we know Sofosbuvir is going to be your champion. Whatever way we look these days there is something popping up that is going to save our poor livers.

Have a good evening, L

ios9 · Senior Member

Dear Matt,

So nice to hear from you :)

Yes,I did have the EOT 4 weeks results : und. My hepato phoned me to let me know because she sort of knew I would not ask for.

I felt so surprised and relieved, event thought the doc said there is much more important results to come on 8th and 12th week.

Right now, like you, I help my body with health food, herbs and accupuncture treatment.

Problem with accupuncture is that only few docs are really performant. Mine did help one of my friend who had a brain tumour long ago. What I can experience is that I feel stronger on my legs and my mind (I fall asleep on his table some time, really intriguing) after each rendez-vous.

There is some Chinese accupuncturists in Germany, paid by the German Goverment to cure patients which can't be helped with our traditional medecine.

May be Garfield could tell us more about it, but I hear of them few years ago and they are very good to help people.

Any body here from Austria ? may be some one could tell us more about what is going in Vienna with Milk thistle. Their first patient was cured that way, but I do not know what they did later on with other patients. They insisted that only injections can help to cure, to drink it helps our liver, but does not kill the virus.

I know about Reiki power, however, once more , only few docs are really good, one has to look for.

YES carry on keeping your VL low and you will be fine. I am going to translate the diet of some one I know who has been refusing Interferon for 4 years and keeps his VL low with special diet and exercice (he walks 7 km every day, 5 day the week). Mental is the most important, of course.

Take well care,

Do

Matt Chris · Guru

Hi Do

I have had some acupuncture several years ago and thought of having some treatments during the trial but did not. I do believe in it concepts but have not not a lot of results.

As far as Reiki I know very little, but I am very acquainted with something similar called Body Talk that uses the Body Mind concepts to awaken the bodies natural healing systems.

You asked Did you get your stage for inflammation? No I did not, but it comes and go's based on emotions and diet. during my Ultrasound it was not noticed.

Dom , it is very interesting about the milk thistle experiment hope they get some concrete results.

I agree with you about the goal of keeping our viral load down. my last test showed only in the 8000 range which was lower that the previous test .

My goal to achieve is low viral count is, less stress and better diet along with exercise.

Dom. Thanks for all the loving support, hoping your latest test are UND.

Matt

ios9 · Senior Member

Hi Matt,

I hope you'r doing fine.

"Early cirrhosis" was associated with stage 3/4 (F3/F4) for me too.

About inflammation, I made a mistake : it's not Fibroscan but Fibrotest which has given me the stage : A3.

Did you get your stage for inflammation ?

About your questionning about liver massage, my accupuncturist is on holydays, so I can't ask him right now, but I have a friend who has cirrhosis too and benefit from accupunctur and accupression (pression and massages). Her doctor told her one must not touch the liver itself.

I know accupuncturists work on the feet when it comes to liver illness.

Also I know of Reiki method which works with massages. I will ask the physician I know who use Reiki what can be done with liver so to help the blood to irrigate in all the liver parts. Right now, he is in holidays too. Ausgust is a very bad month in France, every body goes away !

Avout hvc and milk thistle : have you heard of what is going on in Vienna ? They use milk thistle by injection to treat HVC (started a couple of years ago) but to work one has to have a low VL.

Would be interesting to know more about this.

Does your hepato gives you any thing to keep the VL down to minimum ? this is the main goal right now for people who become detectable again : to keep a low VL. I know some docs gives Riba for this if their patients support it well enough.

Take well care,

Do

Matt Chris · Guru

Hey Terry

Sounds like your moving along nicely with your treatment, don't worry about the Rav's its only important if you relapsed which your hopefully not going to do. I think I remember you achieving UND very early on in week 1 or 2 if that is correct your odds go up for SVR. The jogging has done well for you Terry congrats

Pulling for you

Matt

Matt Chris · Guru

Hello Malcolm

You asked a week ago about why we describe ourselves as "early cirrhotics" and to enlighten you to as why.

Please find below copy of my personal Biopsy report which uses the term"early cirrhosis". Hopefully its just a way to communicate the staging not a new definition.

As far as your debate on the merits of Biopsy or Fibroscan both have their advantages and disadvantages but in the USA Abbvie required Biopsy and in Country's outside of the USA they allowed the Fibroscan, sounds like they trust each method to give a proper determination. Personally speaking the Biopsy was no problem but it take a whole lot more time and effort to complete compared to the Fibroscan.

bio#001.JPG

bio#02.jpg

-- Edited by Matt Chris on Tuesday 6th of August 2013 05:48:33 AM

-- Edited by Matt Chris on Tuesday 6th of August 2013 03:54:17 PM

-- Edited by Matt Chris on Tuesday 6th of August 2013 03:57:54 PM

Terry · Senior Member

Hi Matt I have read a few articles about how to massage you own liver but only tried one briefly so no idea if it works. But this last week I had a bit of a time with the anxiety taking over and making it hard to concentrate so I am taking some Ativan that seems to slow it down. My Jogging had slowed down but after reading what happened I have started it up much more. My hope is that with all that bouncing around all of the organs must take a bit of jostling and just maybe that's like a massage and tenderizer all in one ..lol I can't jog for long but just stop after I am tired and then start again. I got lucky to be on the 24 week program but there are still no guarantee's that the drugs will make it to all the virus because it does go through our blood and there maybe some small amounts of the virus that the blood doesn't get to. And then there are the RAV'S that I was not aware of but I have a meeting next Friday and I will be putting a lot of questions to them about why we are not hearing about the RAV'S and what they are doing to resolves this. I can tell you I was taking milk thistle tea that has been claimed to be very good for cirrhotics until they cut me off but I will be starting again after the pills are done. I have already started to look for other areas that might help us and if I find anything I will be posting it. I still believe we hold our future in our hands and if we all pull together we will find a way ! Take care and I will lets you know if I find out anything more.

ios9 · Senior Member

Good luck Balagan, near future, as far as treatments are concerned, can only be better :)

Do

garfield · Veteran Member

Hi Matt,

I wish you really the best and that abbvie will offer you soon a rescue therapie.

We will hear about us.

ios9 · Senior Member

Hello Cinamon,

Yes, this is Matt's thread, and Matt is a kind, lovable personne.

Sorry for the unconvenience Matt, love you :)

Do

ios9 · Senior Member

garfield wrote:
Hi,
first I had to search, now a link to liver biopsy an the possible complication.
http://emedicine.medscape.com/article/1819437-overview#a17
We have an approved alternative, why should I bear the risk.

Hi Garfield :)

Here is a part I've fo und interesting :

"Factors associated with increased risk of free bleeding include increased age, hepatic malignancy, multiple needle passes, and cirrhosis"

The cirrhotic liver has already so many scares, it's understandable to want to avoy any test which could make things Worth.

Cinnamon Girl · Guru

Come on guys, let`s move on and leave it now, please. This is Matt`s thread and I don`t want to have to close it, so can you all just agree to drop the subject, and as Malcolm and Balagan51 have said, concentrate on the matter in hand, SVR for all!

ios9 · Senior Member

balagan51 wrote:
Why don't we all agree to disagree and move on.? Obvious no argument is going to change any opinions. Hope and pray everyone obtains SVR This is after all what this is all about.

What is your real problem about our discussion ? Malcom, Gerfield, Matt, others and I appreciate the opinion of each other, and to get a different opinion is a rich experience (for those who can get it, which does not seem to be your case, as it's not the first time you come right in a discussion like a bully, just to make people feel guilty and nervous). Sad.

Hope you will feel better soon .

Have a nice calm day.

Do

balagan51 · Veteran Member

Why don't we all agree to disagree and move on.? Obvious no argument is going to change any opinions. Hope and pray everyone obtains SVR This is after all what this is all about.

garfield · Veteran Member

Hi,

first I had to search, now a link to liver biopsy an the possible complication.

http://emedicine.medscape.com/article/1819437-overview#a17

We have an approved alternative, why should I bear the risk.

ios9 · Senior Member

Hi Malcom,

You 100% agree with my close friend (anatomic-pathologiste and cancerologiste). He works on samples from biopsies all the day long, he does not beleive biopsy hurt the liver, he really wanted me to have one, even proposed me to do it himself, but... I am overprotecting my liver like a chicken protects her babies lol

No hole in it, because hole = more stress for the liver. But, as you know, I am not a doctor, I only express my own feelings.

About Fibroscan not giving information about liver inflammation : yes it seems it does, as for me it was "A3/F4". (A3 being the inflammation), at least this is what the paper said.

I have a questionning : are you sure the Trials have the same demands for every countries ? I'm not really sure, because French rules are over protecting when it comes to medicamentation and medical tests (because of a tragic event few years ago) and I beleive (but of course not sure) it would have desagree to "force" patients for a biopsy so to have access to a trial.

I always appreciate to get different opinion, so no problem to read any comments.

Thank you so much for your time Malcom, I really do appreciate,

Do

garfield · Veteran Member

mallani wrote:
There were at least 2 Phase 2 Trials in Europe last year. All required liver biopsy to enter the Trial, and all Trials were completed.

Because doctor told me, no biopsy for trial at all, I am interested to know, which trials from which company do you mean?

mallani · Guru

Hi Do,

You are entitled to your opinion on liver biopsy. Some Forum members have the same opinion. However, many Forum members have had biopsies. If your read their posts you will notice that most had no problems at all. I have had 3 biopsies, and many Forum members have had more than one.

There were at least 2 Phase 2 Trials in Europe last year. All required liver biopsy to enter the Trial, and all Trials were completed. I suggest your opinion about Europeans refusing to have a liver biopsy is not correct. You are partially correct about biopsy not including the whole liver. When I performed biopsies, I always did at least 2 passes through the R liver lobe. Remember, HepC is a DIFFUSE liver disease. It is possible to have more severe fibrosis in one area of the liver, but it is not possible to have cirrhosis in e.g. the L. liver lobe, and only F2 changes in the R. liver lobe. If you have cirrhosis, the changes will be seen in the whole liver, but may be more severe in one area. You are incorrect when you talk about damaging 'your poor liver'. I have done a high resolution CT scan immediately after doing a biopsy. There was no sign of bleeding or any other damage. As biopsy is now done under Ultrasound guidance, the risk of hitting a blood vessel or bile duct is very rare. If adequate local anesthesia is used, there should be little pain.

I have a high regard for Fibroscan, when done by a qualified Hepatologist on a quality machine. I believe it is >95% accurate for F4 and F0-1 patients, but less reliable for the F1-2 to F3 range. It's drawback is that it does not give any information about liver inflammation. A biopsy will tell you how much inflammation there is( expressed as A0-4), and this is important in deciding how active the HCV process is. Another problem with Fibroscan is that it gives falsely high readings in obese patients, those with a fatty liver, and those who have acute inflammation. So far, Fibroscan has not been widely accepted in the USA.

I have performed a FibroTest on myself on at least 4 occasions during the last 5 years. My last result was at EOT and my score was 0.34 which is just into the F2 range. My scores have always been low, between F2 and F3. This is obviously incorrect, as I have cirrhosis from biopsy and Fibroscan. FibroTest (FibroSure in the USA), uses the liver enzyme GGT, which is very labile. I am sure some patients will obtain accurate results from this test, but for me, it is too unreliable.

I have done posts about this before, and it remains an area of controversy. Lets forget all this, and get SVR's!!

balagan51 · Veteran Member

It is Matt's thread.

Sorry for being part of hijacking it.

Matt, i KNOW with all my heart you get another shot at IFN free TX in the next 18 months.

As I am being far from out of the woods myself it goes for me too.

Hang in there bro.

-- Edited by balagan51 on Thursday 1st of August 2013 05:06:53 PM

-- Edited by balagan51 on Thursday 1st of August 2013 05:07:19 PM

garfield · Veteran Member

Tig56 wrote:
the incidence of complications is so low and the quality of results is typically very high. JMHO

Nevertheless a biopsy is an invasive bloody procedure with some risks ( may be the likelihood is low ).

I never got the advice for a biopsy neither I would have got my approval. I had 3 Fibroscan, it was a noninvasive 10 minutes ultrasonographie.

Tig · Admin

I wasn't given the option of the fibroscan. I went through two multi sample biopsies and had zero complications and only minimal discomfort after the procedures. I'm satisfied knowing the samples were accurate as well. I wouldn't want to worry anyone going in for the procedure because the incidence of complications is so low and the quality of results is typically very high. JMHO smile

balagan51 · Veteran Member

I find it interesting that anyone would be allowed to participate in the tourquoise trial without a biopsy. It was a mandatory prerequisite at my location. As this particular trial was cirrhotic specific. I even had a recent Fibrosure . I too have never heard of a diagnosis of mild cirrhosis . Like Milliani I have always understood we were either compensated or not. Interesting how things work in different countries.

mallani · Guru

Hi Do,

It's no big deal, but as the Turquoise-II was for cirrhotics, I wondered how AbbVie decided who was cirrhotic. Until recently a biopsy was required for all Trials, but I think Fibroscan is now accepted for some Trials, particularly in Europe where Fibroscan has been widely accepted since 2008 ( after all, it is French!!). Quite a few cirrhotics have normal Ultrasounds and blood tests, so these are not very useful. The nail, skin and other changes you mention are also not very common. It is really a problem when cirrhosis is diagnosed without a liver biopsy. There is so much disagreement about Fibroscan and FibroTest that I think many people will be classed as cirrhotic incorrectly. Don't worry about it for now, finish your Rx and get your SVR. Bon chance!!

ios9 · Senior Member

garfield wrote:
balagan51 wrote:
I find it interesting that anyone would be allowed to participate in the tourquoise trial without a biopsy.
Hi,
I think most European will refuse a biopsy. There a some studies, showing that both procedures (fibroscan/biopsy) have their advantages and disadvantages.
Abbvie will market their drugs also in Europe, so they have to offer their trials in Europe and so they have to accept Fibroscan.
Fibroscan accurately predicts liver decompensation and death in HIV/HCV co-infected people http://www.aidsmap.com/page/2696884

Hi Garfield,

I totally agree with you, and thanks for the link. Biopsy seems to come from the middle age period, how agressive for our poor liver.

Also problem with biopsy is that it would need to take more than one spot to really know about the liver state, as it's not the same from part to part.

However, we know Fibroscan and Fibrotest can also give wrong answers, so ...

My preference goes to doubt from both F. reither than having one or two more holes in my poor liver and still have doubts.s

It's obvious that labs have a great market with european countries, and they would not be able to find enough patients for their trial if they were asking for biopsy.

Have a nice end of day,

Do

-- Edited by ios9 on Wednesday 31st of July 2013 07:25:41 PM

mallani · Guru

Hi Do and Matt,

I follow the posts from the Trials with great interest. I can't contribute much as I haven't been on these drugs.

Could you help me out? I notice you both describe yourselves as 'early cirrhotics', and to me there is no such term. You either have cirrhosis or you don't- it's a bit like pregnancy. Cirrhosis is then divided into compensated or non-compensated. This division relies on Biochemical and Clinical findings. The Child-Pugh Score and MELD Score help in this regard.

Cirrhosis was always a histological diagnosis, usually from a liver biopsy. As liver biopsies only sample a small part of the liver, if the findings indicate cirrhosis ( regenerating nodules, disrupted architecture, haphazard bands of fibrosis etc.), the specimen is reported simply as cirrhosis (F4). No Pathologist attempts to classify cirrhosis as 'mild', 'early' or 'patchy'. These days, FibroScan is accurate enough to diagnose cirrhosis on the basis of a high kPa reading. Again, this is just called cirrhosis (F4) with no attempt to classify this further. Even dodgy tests like FibroTest give a reading of cirrhosis, full stop.

So, I'd be grateful if you could enlighten me on the 'early cirrhosis' diagnosis. Thanks.

garfield · Veteran Member

balagan51 wrote:
I find it interesting that anyone would be allowed to participate in the tourquoise trial without a biopsy.

Hi,

I think most European will refuse a biopsy. There a some studies, showing that both procedures (fibroscan/biopsy) have their advantages and disadvantages.

Abbvie will market their drugs also in Europe, so they have to offer their trials in Europe and so they have to accept Fibroscan.

Fibroscan accurately predicts liver decompensation and death in HIV/HCV co-infected people http://www.aidsmap.com/page/2696884/

-- Edited by garfield on Wednesday 31st of July 2013 05:02:14 PM

-- Edited by garfield on Wednesday 31st of July 2013 05:02:43 PM

ios9 · Senior Member

Hi Matt,

I felt pretty bad yesterday when my study referent told me about AbbVie decision.

Like if "slow"patients like you and me do not deserve to be care for.

Whatever will be my 4 weeks results I am desapointed by the way they have handle our trial.

I feel exactly the same way you do : I was so sad to have my tablets taken off from me on week 12, I thought about keeping the rest so to benefit of few more days of treatment.

Felt so, so alone and abandoned that tragic day, I cried.

Oh well, at least, you and me have the "luck" to suffer from an early cirrhosis, so we may keep hope for a good solution without interferon suitable for us next year or so.

And I want to beleive that AbbVie is working hard so to offer to those who are child B a very fast, sastisfactoring treatment.

Let's hope this is not just a dream and that they will take seriously those problem into account.

Hugs from your French friend,

Do

ios9 · Senior Member

Hi Malcom,

I was told last February/March that I had an "early stage cirrhosis" but I also heard a doctor saying it was a child A.

- The ultra sound tests (echographie) did not show any thing wrong with my liver, they said "every thing perfect",

- The scanner exam said "liver image is normal" and no problem around the liver neither.

but the Fibrotest and Fibroscan both said F4.

Right now : my blood tests are said to be "perfect".

I refused to have a biopsie last March, I do not want to hurt my liver, but one of my friend who is anapathologist did not beleive I was really F4, he kept questioning the results of the Fibroscan and Fibrotest.

Right now, the liver does not seem "hard" at palpation, so it seems there might be a doubt.

Also I do not have signe such as white round nails, darker skin, brooses (my plaquettes are good) no albumine, etc. And my "waters" are of light color like with normal livers.

Honestly ? I was told by the radiologist who made the Fibroscan my liver had less than 2 years to go.

When the hepato heard about this few weeks ago he got mad, saying nobody is allowed to say such thing, he was very upset. The hepato before him too, so Malcom, I 'm trying not to think about it, because I 'm lost.

The only reason why I agree to be on this trial was this "less than 2 years".

May be this radiologist was right in pushing me, who knows ?

I beleive I will never get a truth answer.

Do

-- Edited by ios9 on Wednesday 31st of July 2013 02:13:16 PM

-- Edited by ios9 on Wednesday 31st of July 2013 02:17:31 PM

Matt Chris · Guru

Dom. & Loopy

Thanks for the hug, its helps rebuild confidence for the next go around.

As far as the speculation on the trial success %, if that ends up being the % of SVR its pretty good for cirrhotics, but they could have had even a better % if they would have guided the therapy according to normal established RVR guidelines.

In my case I felt like a boxer in a heavy weight 12 round fight with having my opponent (HCV) down for the count in the 8th round ready to give up, them having someone stop the fight (Abbvie) before it could be finished only to be jumped and beat up in the alley on the way home after the fight.

Hopefully there won't be others with the same story.

Whatever the results, most of us will live to fight another day, and will pick our match ourselves.

Matt

-- Edited by Matt Chris on Wednesday 31st of July 2013 12:03:41 AM

ios9 · Senior Member

Lol Matt ! About "Milk Thistle" you'r all speaking about here, I was wondering what animal it could be, which gives such a magical milk. Had a look at the dictionnary, then discovered that it's " Silybum marianum" !!!

I do eat fresh artichockes, really good for our liver too, do you have any in the States ? same family as Milk Thistle but test wonderful too :)

Here :

Loopy Lisa · Guru

Matt,

There is nothing I can say that could make you feel any better, so instead I am sending you a huge cyber hug! I believe that Sofosbuvir will be the winner. Keep believing! x

ios9 · Senior Member

I just had a phone call from my study referent : he said he has received an email from Abbott/AbbVie saying the results for Turquoise II 12 weeks being satisfactory , there will be no change on this study.

As they had expected 8 on 10 patients to be undectable after EOT, it means they find normal that 2 patients on each groupe of 10 to have fall.

It would be interesting to know when during the treatment those 20% patients who have fallen became UND ?

Because this could confort your theory Matt ?

Do

-- Edited by ios9 on Tuesday 30th of July 2013 02:05:44 PM

Matt Chris · Guru

Hello Dom

Because I missed the 12 week EOT blood draw ( trip to Copenhagen) I had a test on week 1 and week 2 which both where UND result, then week 4 came with a detectable viral reading.

The timing on the vacation was a problem and I also caught a bad head cold from the stupid cruise that I went on. Timing was bad but it could not be helped, planned long before I new about the trial.

I believe the reason the FDA allowed Abbvie to treat cirrhotic HCV patients for only twelve 12 weeks is they convinced the FDA that it would be a guided therapy. Meaning they would shift The 12 week patients to 24 if they had issues, but that was poorly thought through because they ignored one of the most important indicators RVR. In most guided therapy if UND is not reach by week four they realize that they need to extend the treatment. In both mine and yours we did not reach UND until week 6, instead they used a end result as a gage.

How stupid and irresponsible could they be when they have the life's of their patients in there hands and there future possible treatment to consider, really bad planning to say the least.

Sorry about the Ranting and writing it out Dom, but this really helps me express myself, to get it out of my mind because I really can not talk about it to anyone else.

Dom, your platelets look really good, mine have not been that high in years. Keep up the good work. I recently started spirulina and chlorella hoping to keep my ALT and AST at a lower level. Did your trial nurse allow you to take herbs? My nurse stopped most all of my liver aiding herbs.

Thanks Dom. for responding to my thoughts, its really helps me get through the day.

Matt

ios9 · Senior Member

Matt,

A doc I have known for long told me last week that the reason why the hep C had not shown any signe for 42 years is that I am vegan (she eats a lot of meat herself).

Also I agree that stress plays a geant issue : it's a very great stress which made the virus get control of my body in a few months last year.

Also, during the treatment, I (wrongly) understood my son was suffering of a skin cancer, then the VL which had got down from 17M to 670 iu in an only week, started to resist and it took 4/5 more weeks to get UND !

About nutrition during the treatment : for the first time in my life my blood platelets got down to 130 right before I started the treatment. I took spiruline all through the 12 weeks of treatment and by now the platelets number is a nice 212.

About water : I do drink a lot of natural spring water because I am suffering of the hep. C dry syndrome since end of last year. Even thought I have been UND for 10 weeks now, it is still there : eyes, ears, mouth, throat and lungs.

(my words "sun, songs and water" was a jock, no sea side here in Paris, nor in Madrid where I was).

I do beleive that there must be possibilities to help with cirrhosis. Massage could be one of them.

Also have you ask an osteopath about your questioning ?

Matt, did you get the EOT 2 weeks results or did you have to wait till week 4 ?

Take care smile

Do

Terry · Senior Member

Hi Matt I am sorry to hear about the news. I am on the same program that you were on but got lucky to be put on the 24 week program. My blood work has been excellent but my fear has always been the drugs ability to get to the virus that will hide in the scarred parts of my liver that started in much worse shape then yours. Try to look at the fact that adjustments are being made to rectify the RAV'S that have turned up and you did give your system a break while you were on the program. I was told that the doctor at my study clinic wanted to add the interferon to the regiment if we were not UND by week twelve but by the time I got even near that I was UND so I believe that will be the rescue plan. The two things I want to find out is if I can go back and take my milk thistle and the rest of the antioxidants the minute the treatment is finished. Keep your head up because they need us all to beat this dam thing in order to get clearance to sell these drugs. Let's pool our resources and come up with our own answers. Take Care Matt... We will find a way!

Matt Chris · Guru

Hello Terry & Do

Thanks for the encouragement. Terry I also wondered about those areas of our Liver that are harder to reach. I'm going to ask my Hepatologist if there is any physical massage or any other therapy that can possibly be done to increase blood flow to those cirrhotic areas.

Dom, hopefully you and Terry are correct about Abbvie coming out with newer and improved versions of their DAA's to address the Rav's issues. I have read only one article about them which they say the new versions ABT-493 and ABT-530 but who knows.

Hey Dom, sounds like you are into the same health foods I am, Garlic, berries, Vegggies lots of good healthy foods.l

Thats another question I will be asking my Hepatologist, " do people with a high nutritional diet (health foods) do better on HCV treatment or does it even matter?"

I was thinking that stress might cause more issues that diet in being successful or not, but again there are no concret answers.

Dom,like your ending salutation , " Sun, Song and Water " did you mean water as in being in it or drinking it?

Keep the vision you two because your going to make it.

Matt

-- Edited by Matt Chris on Monday 29th of July 2013 04:42:54 PM

-- Edited by Matt Chris on Tuesday 30th of July 2013 05:10:34 AM

ios9 · Senior Member

Hi all, Matt, Terry,

Terry your words to Matt are so wise, yes you'r right all the way long. Thanks for him, and all of us !

I started to go back to my antioxidants about 10 days after end of treatment, but there is no scientific reasons for it, I just felt I should may be wait a little before going back to it.

I am even back on grapefruit seeds extract, raw garlic and all berries too. Did not start Brazil nuts yet...

By the way, I got the results for EOT2 : UND.

Yes, I know, this is only week two, but it's a good start :)

Will get results for EOT4 next Monday.

Sun, song, water :)

Do

-- Edited by ios9 on Monday 29th of July 2013 03:02:40 PM

-- Edited by ios9 on Monday 29th of July 2013 03:07:47 PM

mallani · Guru

Hi guys,

Matt is correct- worrying about future developments is futile until we get the full Trials information. Gilead and AbbVie are naturally playing their cards close to the chest, so it will be some time before we get full information. Matt is also correct about the difference between the nucleotide analogue NS-5B blockers (eg Sofosbuvir) compared with the non-nucleotide blockers (eg ABT-333). Both do the same job, but essentially block different sites on the RNA polymerase. Gilead initially had some problems with a resistant mutation to Sofosbuvir called S282T. This was mostly in Phase 1 Trials and has not been confirmed in the limited Phase 2 Trials published to date. The Phase 3 Trials should confirm whether this will be a factor. The non-nucleotide blockers have a low resistance to RAV's, and Gilead will want to study the AbbVie data to see whether the S282T mutation appears in treatment failures. If this does not happen, Gilead may be more accommodating in allowing use of Sofosbuvir. Cheers.

balagan51 · Veteran Member

Milani,

thanks for the clarifaction

Do you think that after FDA approves these drugs that GILD will still not allow non responders from other protocols restricted access to Sofosbuvir?

mallani · Guru

Hi Balagan,

ABT-333 is an NS-5B inhibitor, same as Sofosbuvir. ABT-267 is an NS-5A inhibitor, same as Ledipasvir. Both these non-Structural sites are complex proteins, not molecules. As of now, Gilead will not allow use of Sofosbuvir after previous use of an NS-5B inhibitor. The NS-5A protein is very complex, and all inhibitors will invariably develop RAV's, particularly for the Genotype 1a's. All this is hopefully theoretical as you will obtain SVR, but ' a completely different molecule' is incorrect. Cheers.

ios9 · Senior Member

garfield wrote:

Hi Matt,
(...)
In my opinion the study doctors aren't doctors, who have our interests at heart. They are mainly scientists. They work in the interests of the pharma industry. They are paid to run studies and our well-being is on second place.
Good luck

Hi Garfield, Matt,

This is what the doc I met last Monday said too.

I will let you know about the 4 weeks EOT results of my own groupe (only two on Turquoise II 12 weeks) beginning of August.

There is only 3 hospital in France who have got Sapphir or Turquoise Trials. One of them, near Paris, has 20 Turquoise patients, I am to try to know the 4 weeks EOT results for those who were on the 12 weeks run.

Hot hot hot here in Madrid yawn

mallani · Guru

Hi guys,

This article is over a year old but shows that the Abbott trio of drugs have a low resistance to mutations. Until Abbott release data of the RAV's found in Rx failures, it remains a guessing game. However it is obvious that treatment failures will have RAV's, probably to all three viral sites, so re-treatment will not be an option. Let's hope you all SVR and won't have to worry.

http://f1000.com/prime/reports/b/4/5

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