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Post Info TOPIC: TURQUOISE II AbbVIE TRIAL.


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Thats amazing. 8 years UND and your cirrhosis is stable? Hurray! Livers are wonderful organs 



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61 y/o, Infected via transfusion Oct'83, GT-1a, F-4 cirrhotic,
tx Holkira pak/moderiba 12 weeks

4 years.... successful dragon slayer 

Tig


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Hey Mike! It’s great to hear from you! Congratulations are in order for the long term success. The forum isn’t very active these days, but that’s an indicator of the many successes brought on by these DAAs. Lets keep the beacon lit for those searching for the cure! 8 years SVR for me



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Tig

66 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 8+ years!

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I never lost this bookmark. I'm probably talking to the cosmos here. . I doubt anyone is still around ..But... I  went undetectable Jan 7. My clinical doc kept me in the trail for 6 months. July 6,2013 the trail ended for me  .  .. Since then im blessed to say my cirrhosis has been stable and my labs are all WNL.. I hope all who pioneered this wonderful therapy with me  are enjoying the same results .. Mike 



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Hi Dominique    Thanks for that information. I will again explain to them that I opened the bottle to take my afternoon dose with me so they don't have any confusion. I just didn't want to bring the bag that they gave us to the park because it's large and can get stolen. Not to mention it would create a lot of questions that I didn't want to answer at that time. It was much easier to just bring the pills in a zip lock bag and a sandwich to consume before the pills. I asked my guy about the timing of the pills and he told me that to try and make sure the variance was two hours or less. It makes sense because we would all absorb the drugs at some what different rates so keeping within two hours would insure saturation for the whole 24 hours.



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Geno Type 1a stage 4 cirrhosis EOT 52 weeks SVR !!



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I have been reading all the posts and yes it seems that there may be different rules with respect to the countries. Being from Canada we did not have any placebo but did have the 12 or 24 week duration of study.  And yes we are given bottles with the electronic caps that records the treatments. But one told me that it recorded the date and time and when he was away his replacement told me he though it just recorded the intervals but not the time. Because I had told them that because of my baseball I would take the afternoon dose with me so I closed the bottles after the first dose and reopened It again and took out the second one so the cap would record the two a day. Also all of our ribavirin are little blue tabs. So I guess the colour means nothing because so far I have read three different possibilities. I was also informed that nobody from the study in my hospital had relapsed to date and I will post back Friday on what I find out on the rest because my last pills will be taken Thursday and then Friday I have my blood test and an ultrasound. Then I guess I will be submitting to blood tests for the next 48 weeks.



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Geno Type 1a stage 4 cirrhosis EOT 52 weeks SVR !!



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Hi Garfield, Terry,

I was told that the electronic cap records the exact time (day and minutes), also it considers it has been opened even if you did not, just if you start turning it, that happens to me twice : I started to turn it then found out  it was the one I only had at morning, so I stoped, but it did record it was opened !

About the little blue tablet of Riba, it's the new one, in France, they used the old  big pink one only for Saphire they had told me. Same medicamentation but new easy size.

I had a monthly blood test from EOT 4 to 12, but will have to wait till EOT 24 for the next one (but will ask my private doc for one next time between).

Garfield : each medical center does what they want : some one on saphire told me she knew from the first week she was not on placebo (she was UND first week !) but at my hospital, I met a patient who was on saphire too and did not know if he was on placebo or not and he was getting very depressed  because of it.

Every body is UND at my hospital right now. But the ones on 24 weeks have only finish taking pills last week.

Do

 



-- Edited by ios9 on Wednesday 2nd of October 2013 06:12:46 AM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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ios9 wrote:

I went on the other international site and saw the bad news about Charlie, is it the case you'r speaking about ?


 That bites! - no. As Charlie is writing her relaps is definitly. But there is an other abbott sapphire failure, her additional test is still expected.



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Hello Do & Garfield

I believe the reason for the addendum to these trials has  to do with Abbvie's legal department looking over the participants trial agreement and wanting to cover themselves from any future problems. In both your cases because you will likely achieve SVR it really not a big deal to sign or not to sign the addendum other than the principle of the matter.

Because the laws on Drug trials are different in every country what I see in the USA and what you see in Germany and France very well could be different. For example my Turquoise II trial we signed an addendum in my 12 week in May 2013 but it had nothing to do with Interferon. Most of these addendum are for full disclosure purpose so they can't be sued.

You members have been a wonderful additional to the forum with your interest in the fellow members, keep up the good work.'

Matt       



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi Do and Matt,

                        Matt is right it could be a question of country-specific laws.  

But in germany are also differences between the study centers. The participants of the sapphire (double blind) study in Hamburg

had to sign that it is forbidden to them to induce to determine the virus load. We didn't see this paper.

During the treatment I were informed about all examined blood values (without Hb, VL, ASAT), in Hamburg the study docs refused this.

 

Here, unfortunately heating season has begun      

best wishes

 

 

 

 

 



-- Edited by garfield on Tuesday 1st of October 2013 07:39:28 PM

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Hi Matt,

This is the problem : it's not legal (in France)  to add such important information (interferon) when too late for patients to decide if they want to do the Trial even with the risk of having interferon at the end. Of course they want to cover themselves, but not in an elegant way, as most of people do not read what they sign, just because they do not understand it.

AbbVie also changed the part where they wrote first that they may change from 12 to 24 if they feel some individual or the entire group need to be on 24 weeks. (you and I did mentionne it at the time we were complaining about not being able to do 24 weeks). I'm quite sure they are having problem right now and try to cover themselves as you suggest.

Matt, it's not because I might be cured that this is not important to my eyes, just think of others who have choosen to be on AbbVie because they could not be put on Interferon. They have lost their "naive status" for other new trials, can't be helped by Interferon, so what are they going to do by now ? may be if they had known that interferon was at the corner, they would have choosen another trial.

Well, honestly, I might be a little harder than I would be with lot of sleep. Forgive me for being bad moody yawn

 

Do

 

 



-- Edited by ios9 on Tuesday 1st of October 2013 07:08:53 PM



-- Edited by ios9 on Tuesday 1st of October 2013 07:19:35 PM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Garfield : for what I understood, it's not our docs who decide if they want us to know about AbbVie adding Interferon, AbbVie asks them to present us the addendum so for us to sign.

I refused to sign and got a phone call from the hospital from the Trial doc asking me why I refused, saying he agrees it's late but this is only for information. He said he will write in my "Trial document" that I have refused to sign. 

No comment.

Sure you will still be UND, look at me : very little sleep, bad withdrawal symptoms,  but still UND biggrin

Have a nice evening, it's really automn by now in Paris, but many tourists still there.

Do



-- Edited by ios9 on Tuesday 1st of October 2013 06:02:43 PM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi  Do,

           I don't know if this addendum exists in german language. 

If I have relapsed, I would get a call from the study doc prior next wednesday .

I had visited the chief of the gastroenterlogy at the end of treatment to ask him what to do in case of relaps. Interferon was out of discussion for him.

Perhaps this is the reason why they haven't informed us about abbvies ideas in case of relaps. 

They had up to now no relaps with abbvie drugs and I think they hope let this cup pass from us.

A therapy with Interferon/Ribavarin I could have had more than a year ago, probably with only a slight chance for svr.

In my german forum only a few people have no persistent side effects after therapie, starting with chronique fatique through to diabetes.

This side is for me warning enough, but read it only in good mental condition: http://www.interferon.ws/Hepatitis-C-Trust-Interferon-Treatment-Survey.html

Fortunately my lever gives me the time to wait.

 

cheers



-- Edited by garfield on Tuesday 1st of October 2013 05:26:35 PM

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I went on the other international site and saw the bad news about Charlie, is it the case you'r speaking about ?

Because the explanations she seems to have been given is :

"Something about the virus being deep deep in the liver". I undestand they have found a VL of 1.6 million! ? from less than 15 (UND) to 1.6 million in only 4 weeks ?

Must be so difficult for her, especially if she knew the results AbbVie gave with the "nobody has relaps after 4 weeks" ... let's hope it's a mistake and the next test will be negative.

Back to the other message :

The addendum I was given was delivered in English in April then in French in July but I only get it end of September. I'm not that sure it's legal to give us informations about how they are going to handle the treatment when it's too late for us ?

When will you get your results ? may be they wait for your 12 week result to give you that information about interferon ? Also they say in this add that they will give Interferon for free, but it's already free for us here, anybody can get free Interferon when needed, so what's the idea ?

Would be interesting to ask your head doctor about it, what do you think ?

Do

 



-- Edited by ios9 on Tuesday 1st of October 2013 03:41:30 PM



-- Edited by ios9 on Tuesday 1st of October 2013 03:43:34 PM



-- Edited by ios9 on Tuesday 1st of October 2013 05:09:05 PM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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ios9 wrote:

Oh I did not know of some one who has relapse between week 4 and week 8 after EOT,  on the Saphire groupe. Is it on the other site 


 

Hi Do,

It was written last saturday in an other forum. She has finished sapphire in july and got the call "detected" recently.

Certainly she is very unlucky because escpecially her familly was so glad. She hopes an additional test will reserve the result.

I was wondering whether I have also to sign an addantum. Yesterday I was only meeting three others from our sapphire group, but nobody of us got any papers.

cheers



-- Edited by garfield on Tuesday 1st of October 2013 03:17:50 PM



-- Edited by garfield on Tuesday 1st of October 2013 03:18:51 PM

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Hi Garfield,

Oh I did not know of some one who has relapse between week 4 and week 8 after EOT,  on the Saphire groupe. Is it on the other site ?

Good I did not know, I was already so stressed because of the problems I had ! Must be so so hard for that personn, just too sad.

Did they ask you to signe an addendum too ? I'm curious because a patient I know, from same hospital, and on Turquoise II 24 weeks, did not get it . Hope it's not only me hmm

Do



-- Edited by ios9 on Tuesday 1st of October 2013 12:17:21 PM



-- Edited by ios9 on Tuesday 1st of October 2013 12:19:10 PM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Do,

       Congratulations,  I'm so happy for you.

Today I'm back from my EOT12 visit. A small anecdote from there.

I asked my very young study doc, if all of us (sapphire and turqouise participants) have received SVR8 - yes his answer.

I told him that I had heard from a relaps between EOT4 and EOT8 in the sapphire group.

In the late evening I got a phone call from him, from whom I had got this information. He had rung abbvie Wiesbaden

(I believe the european headquarter) and they wouldn't know from a relaps. I told him I know it from a international forum,

probably happened in the USA. He was a little bit bewildered, that we are better informed as docs.

 

cheers



-- Edited by garfield on Tuesday 1st of October 2013 03:20:09 PM

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Hi all,

Some news : on the 12th week EOT (last week) the ultrasounds gave good results : every thing looks fine.

When I saw the hepato a day later, she said my platelettes are getting down because I have a "big spleen " from the cirrhosis, however the doctor who did the ultrasounds told me my spleen and liver have the normal size. So, I'm not questionning anymore, just hoping it does not get lower. I agree 147 is not that bad after all. And no more bruises any way.

Also I have no more funny dark lines mooving in my eyes when I wake up in the morning, every thing is clear, I have had those bad lines for about a year and it's all gone, but I still do not see well, very probably because of the dry syndrome.

And the great news, as I wrote on an other thread is that I am still UND week12 EOT.

Now, no more blood test before 16th December smile

I understand how lucky I am and hope all of us will have the same chance soon.

Thanks to all and warm regards

Do

 

 

 



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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mallani wrote:

Hi Do,

Platelets of 147 should not cause bruising. Before Rx, mine were 160, and now, at 6 months post-Rx, they are only 125. During Rx, they dropped to 38. All cirrhotics have low platelets, and mine will gradually climb up. If they reach 150 I'll be happy. I haven't had any problems with bruising, but if I get a knock, I will get skin discoloration from an ecchymosis. Cheers.


 Hi Malcom,

I do not know the difference between bruising and ecchymosis ?

I 've asked a doctor about the origine of my "bruises" because it is slowing down, nearly to only a very few. I made a mistake in my diet and took 3 pièces of fresh garlic every day instead of 3 every week. When I understood my mistake, I stoped having that much garlic and my bruises are less and less, so that could be the reason. Like you, the doc said 147 as platelets does not cause such bruises.

I started to have diarrhea too and it also stoped when I stoped the fresh garlic.

My blood test is totally normal excepted the platelets (went from 210 to 147 in 6 weeks after EOT) and vitamine D (went from 20 before treatment to 8 after treatment).

ASAP are 35 and ALAT 36, they were too elevated when I started the trial.

Looking the results of week 12 confuse



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Do,

Platelets of 147 should not cause bruising. Before Rx, mine were 160, and now, at 6 months post-Rx, they are only 125. During Rx, they dropped to 38. All cirrhotics have low platelets, and mine will gradually climb up. If they reach 150 I'll be happy. I haven't had any problems with bruising, but if I get a knock, I will get skin discoloration from an ecchymosis. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Hi Garfield,

No they have no explanation right now, it seems there is a problem with coagulation. My platelets which were good at EOT 2 (212) fall down to 147 EOT 8, but no idea why, excepted I have stoped Spiruline (?) but HG is ok.

Do



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Do,

         that's awful, has your doc any idea of the reason or explanation? 

best wishes



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Hi Matt, Terry,

Thank you so much for your nice words !

I'm not feeling as free as a bird right now, but the door of my cage is half open :)

In fact, waiting for the EOT 8 weeks results has been the most stressing and painful period since April, when I started Turquoise II. My body is covered with haematomas (bruises), each morning : more and more. Only this morning there is no new one I can see. Doc has asked for more blood tests because of that, also I have had muscles fatigue and sudden sweat too since about 2 weeks.

Docs have ask me to have an ultrasound the day before my EOT 12 weeks blood test. Then, more worries right now : has the treatment make my liver state worth ? etc.

But YES I am really happy to be UND right now and hope the same for you all soon :))

 

 



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Congrats on your results! You are doing great and we all wish you the best. I hope the rest of us will soon be feeling like you must feel right now. All the best Terry



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Geno Type 1a stage 4 cirrhosis EOT 52 weeks SVR !!



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Hi Do 

Congrats on your 8 EOT results,  your going to make it and by now your likely feeling free and easy as a bird.

Lots of Love

Matt



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61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi Garfield,

Thanks ! I asked my Dr this morning about what you wrote before about Riba and people who do not get anemia : she thinks it's not a real pb with the new trials, it seems Interferon has something to do with large anemia from Riba, but without Interferon, and on 12 weeks, Riba has no much impact as long as anemia is concerned. So it seems it should not mean our syteme did not absorb Riba correctly. At least, I hope so end that my results brings you hope smile

Crossing my fingers for you, let us know as soon asyou have the results,

 

Do



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Do,

       I'm so much happy for you.

best wishes



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To day was the results for EOT8 : UND :) one more month to go and .. final results.

Platelets have gone from 210 to 147, no idea why ?

 

Do



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Thank you Matt :)

I really did not expect to be und, it's real good news. However, as labs and my doc say : 12th week is  the ONE !

My goal is to protect my liver as much as I may so cirrhosis does not progress. Sure, to be und helps, but it's not enough. So the battle is still here.

Take well care,

Do

 



-- Edited by ios9 on Wednesday 7th of August 2013 02:17:18 PM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hello Do

Congrats on your 4 weeks EOT UND test result, it's one of the most important weeks after treatment. I know 12 weeks is the new gold standard but the Abbvie trial for 12 weeks is in undiscovered country so your result is great news.

Do, onward and upward toward SVR

Matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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I beleive your doc is right :) good advice.

Also, yesterday, the professor I spock to said one can't take another treatment before the virus is back to its old self.

And as Abbott wrote they do not know how long it will take ...

 



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Do,

         I assumed there is no official rescue plan in France, because if you open "Show 30 Study Locations" in 

http://clinicaltrials.gov/ct2/show/NCT01609933?term=abbvie&rank=2

the rescue plan will only be offered at the USA and the European cities Madrid, Frankfurt and Berlin.

I think my hepatologist won't recommend the rescue plan, he is convinced, it makes more sense for me to wait.

 

 



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Hi,

Here some news : the next Professor (his research experience is focused on viral hepatitis and he is the author of many papers published in peer-reviewed medical or scientific journals. He is the head of the French early access program for the use of protease inhibitors). I wrote to yesterday is in holidays.

However, one of his patients who had readen my message speaking about AbbVie's rescue plan  on a French forum, has asked him about it before he left :

He told her not to worry as French patients are not concerned, because Abbot is not offering this rescue plan to French and few other European patients.

So no rescue plan for us is ... a good news ???!!

No Interferon is a good news, but no "rescue plan" is a really bad one.

Garfield, do you know if German patients will get this rescue plan or not ?

Wait and see, right now summer, sea side, cool place is all what we need  :)

 

 

 

 

 

 

 

 

 



-- Edited by ios9 on Tuesday 16th of July 2013 03:41:01 PM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Garfield, Mallani,

Thanks for the fast answers.

There is  no reason why it should  be different in France,  so I suppose he must have been "playing with  me".

If you allow me, I would like to send his proposal and your comments to the other "head" doc and ask him what is his opinion.

Pb is more time go pass and more I doubt of what I am been told here;

I am not home and not on my computer, but will come back to you to  morrow.

Thanks for being there in time.

Do



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Do,

Unless things are different in France, all current publications disagree with your doctor. Abbott's trio of drugs all have shown RAV development, but AbbVie have been reluctant to disclose much data. The RAV's from ABT-450 are similar to some of the RAV's from Victrelis and Incivek. Their NS-5A blocker, ABT-267, follows the pattern of all blockers at this site, being prone to RAV's due to the complex structure of this protein.  Daclatasvir is the most RAV resistant DAA so far, but it will not be approved for a long time and certainly Gilead will not be keen for it to be used with Sofosbuvir.  Gilead will be pushing to use it's own NS-5A blocker, Ledipasvir. There has been virtually nothing published about RAV's to ABT-333, their NS-5B blocker, but I'm sure we would have heard if it's as good as Sofosbuvir.

Up until now, the Gilead drugs have not approved for any patients that have previously used another NS-5A or 5B blocker. FDA approval for Sofosbuvir is being fast-tracked, but there will be stringent rules for it's use. I wonder whether your doctor is thinking some years down the line, and would be grateful for any further information.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Hi Do,

       except for the results of the abbvie/gilead studies his statements don't agree with the statements of my doctor.

see http://hepcfriends.activeboard.com/t54157979/how-to-evaluate-a-clinical-trial-extra-consideration/

It seems he has laughed a little bit at you/us. It doesn't matter, anyway we can only wait and we have a real chance to reach svr.

 

 



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Hi smile

 

So I had a long talk with the Chief Department of my Hospital this morning (there is two leaders for hep C in France and he is one of the two).

I told him about our group... he was surprised lol and I said I will give the group his answer about what can be done for those who failed treatment from Turquoise II and can't have Interferon.

He showed me the results of a Gilead's trial with Sofosbuvir and Ledipasvir and told me that those who failed with Turquoise can try those meds.

Also Sofosbuvir (Gilead) and  Daclatasvir (BMS-790052, a highly selective inhibitor of HCV NS5A) can be a reliable treatment too.

 http://www.aidsmeds.com/articles/sofosbuvir_daclatasvir_1667_23846.shtml

So it seems we could still benefit of treatments without interferon after having had Abbott's meds.

 

About those who have been on the 12 weeks Turquoise : he says results from the previous Abbott trials do not show any real difference between those on 12 weeks and those on 24 weeks, but he does beleive that us cirrhotic would have had better benefit if on 24 weeks.

For those who had their treatment stoped after 6 weeks because still not UND : it's only when the results showed the VL was getting higher during the trial. 

He probably said more, will try to remember and get back to you confuse

 

 

 



-- Edited by ios9 on Monday 15th of July 2013 03:32:25 PM

__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Mat,

Yes, the reason why I signed for Turquoise II is that it was written that patients on 12 weeks can be change on the 24 weeks trial "if AbbVie feels necessary to do so".

When I have found out that I was the last one (on 5 patients) to become UND (weeks 5/6) I asked my doc to ask AbbVie to put me on the 24 weeks as written in the protocole I signed, but the Medicine Department Head of my hospital refused saying AbbVie will desagree with that demand ... no comment.

Nice to hear that next patients might have a stronger  ABT-450.

May be you will get that one together with Interferon ?

Thank you so much dear Mat for being here. I feel less alone by now. To have your own doc not saying the total truth is always a bit disturbing, is n't it ?

Kindest regards

Do

 

 



__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Dominique

The Abbvie Turqouise II study started recruiting and enrolling participants in November and December of 2012 and stopped sometime in the 2nd quarter of 2013.

As far as results there is nothing official yet.

As far as your questions:

I asked to be moved to the 24 week arm during the last 4 weeks of the 12 that I was on, because I just did not have a good feeling on how things were going.

I asked my study nurse to ask her Abbvie monitor for the request, I was going to make a written formal request directly to the Studies head coordinator Rogar Trinh but never did. Guess I should have  but was trusting their program to know what to to do and when to do it.

One of the things we learn about  HCV trials is there is not a lot of Guided therapy involved. 

The shame of the Abbvie Turquoise II trial is that they actually had written the protocol / agreement that the participants might have the option to be put in the 24 week arm if necessary, to bad for me and others that they choose to ignored there participants gut feelings and not take advantage of what they original thought might be necessary for some of the patients.

Sounds like they where not watching the results and feedback close enough to keep on top of the curve.

But I have a feeling that Abbvie is very conscience of any who failed treatment and want to do right by them, and actually they are already in the process of upgrading the main drug ABT-450 to a 3rd generation DAA's called ABT-493 and ABT-530 that will have even a higher barrier to resistance for future HCV treatments.

There will be many more enlightenment's to this study as time moves forward, so hang in there.

Matt   

 

 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi :)

Does any one knows when Turquoise II started in the US ?

I was told by my doc that AbbVie has already the results for the US on Turquoise, is this truth ?

Any article about it ?

Thanks

Do



__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Garfield,

Yes I know about Geno 1b, however here the problem is that some cirrhotic levers do not work fast enough to be ok after only  a 12 weeks meds.

I am told that my lever did a great job with the meds and is working like a normal one, so I beleive it's this high VL which is a problem for me.

Thank you so much for your concern Garfield :)



__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hi Dominique,

                    it's a disaster for Mat, I'm so sorry. You can hold out hope of svr, because you have genotype 1b.

In the aviator study svr24 for 1b naive patient was nearly 100%.        http://www.natap.org/   from 06/07/13



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Hi Mat,

Thanks for your kind advices.

I feel really sad about what has happen to you, and the way you were told about it is so stressful. Was it your first treatment ?

To offer you a "rescue treatment" is not that generous if there is Interferon included, as most of cirrhotic people who has choosen Turquoise is because there is no Interferon. AbbVie is not really honnest with us, really.

But any way, if this can allow you to get the dragon off, and if interferon is for a reither short time, should be a good go, yes ?

Some questions, if you allow me to :

When did you ask to be on the 24 weeks arm ? at the beginning or in the middle of the treatment ?

To who did you ask ? to your doc, or directly to AbbVie ? my hospital refused to ask AbbVie because they say they would refuse..

I just can't beleive they do not care about the initial VL when they decide to give us an agreement, it's really insane.

I was told the reason why they try 12 weeks with cirrhotic is they wanted the shortest time to protect our liver which suffers from med.

What do you think ?

In 3 weeks time I will know my results for 4 weeks after end of treatment. I will have two tests as I will do a private one to know the results asap. Just do not want to fall in tears in front of my doc when she will get it from AbbVie.

You are in my thought, as I am to travel too during this scary period.

Take great care, we will win one day soon :)

Dominique

 

 



__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 



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Hello Dominique

Welcome to the forum there are many hear who can be very insightful regarding your journey.

I also was in the Turquoise II 12 week arm which I completed in early May.  I relapsed four weeks after end of treatments.  But there are others who have not relapsed after completing 12 weeks. So don't give up your positive attitude it very may work out for you.

The USA Turquoise II trial has all the same protocol as the EURO. the person or disscussion that you mention was talking about Abbvie's other trial called Sapphire which has the scenario which you mentioned.

I totally understand how you feel regarding 12 weeks versus the 24 weeks, in my opinion Abbvie should have only done 24 weeks. They are being very aggressive almost to the point of being irresponsible considering the cirrhotics groups are the most difficult to treat.

Your point is well taken regarding patients that achieve UND in the later than 4 weeks should have been extended into the 24 weeks arm. I also requested to be changed to the 24 week group by was rejected. 

Because I did relapsed, Abbvie will be offering a re-treatment if I can qualify so that is good planning on their part. I hope that you have that option as well if nessesary.

Hoping the best for your future 

Matt



__________________

"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi all,

I beleive may be I can share my new experience with you.

I have the feeling that may be AbbVie Turquoise II is not totally going the same way in the US and here in Europe ?

For example, I saw a message here from some one on Turquoise II who had placebo the first 12 weeks.

Well, here, this can't happen because AbbVie has made special rules as Turquoise is only for cirrhotic patients.

So, with TURQUOISE II, no placebo, and it's all open from the first day to the end. It runs 12 or 24 weeks, depending of the hazard.

All tablets are pink, and Riba is given in tiny pink tablets, easy to swallow.

The tablets are being kept in special bottles with electronic caps so the lab knows at what time, twice the day,  one open each bottle (they aske us to take the med every 12 hours).

On day one, they make blood test right before you take your first med, then they make tests again two hours later, so to know if your cirrhotic lever is doing fine or not.

What is surprising me is that what people here experiment during the trial (secondary effects) is exactly what I had experiment few months BEFORE taking the med :

- some rush from time to time (but not much), some headack but not once the month, dry eyes, dry nose and ears, dry mouth and dry limbs with caugh.

I did not have any side effects during the 12 weeks trial, excepted my hemo went from 13.2 to 11.8 at the end.

Even more : I have been feeling much better with the med than before.

My VL was very high on day one :  17 M. so it took longer for me to become UND.

I was 670 on week 1, 60 on week 2, and less than 25 on week 3/4, then UND week 5/6.

We were 5 to be on TURQUOISE II in my parisian hospital, and they all became UND before me because there VL was much lower.

I've asked to have 12 more weeks to feel secure, but the docs said AbbVie would refuse, so they did not ask. I felt very sad they did not listen to my demand.

Docs said the treatment was doing very well, all my blood tests were very good (perfect they said) so they were not really worried.

It's truth I felt I was a rat, so for AbbVie to know that one has to have a longer treatment when too high VL if I become detectable again. Hard to take, but I do understand in a way.

Right now, docs say they do not know about this matter for sure.

I had the help of an acupuncturist during the treatment, and still have.

I have never been ill before few months ago, not even a cold. I hope this will help not to become detectable again. One can dream, yes ? 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



-- Edited by ios9 on Wednesday 10th of July 2013 07:57:15 PM

__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 

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