Hep C Discussion Forum

ios9 · Senior Member

Abbott Labs TURQUOISE-II Open label clinical trial

Matt Chris · Guru

Hey Guys

I also had been recently told by my trial study Doctor that Sofosbuvir (GS-7977), a uridine nucleotide analogue inhibitor of HCV NS5 B polymerase could used for re-treatment.

It might have something to do with it being a Nucleotide analogue versus the others being a non-Nuc. I will do some more research and if I find anything out I will post it.

Most Doctors have a very high opinion of Sofosbuvir because it is a Nucleotide and it does have a very high barrier to resistance. Most all of the other Pharma companies want to produce a Nuc. but it's very hard to so. BMS had tried but but failed.

Its true that most of the DAA's will have to improve because of Rav's but let's not jump to conclusions before the results are made known. Second and third generation DAA's are already addressing the Rav's issues.

It can be very depressing for us relapsers to hear negative thoughts without the benefits of up to date data, remember the pace of discover into HCV research has never been faster and more insightful.

In time hopefully we will have full disclosure about each DAA's Rav's and how they may address the problem.

Trying to stay positive

Matt

-- Edited by Matt Chris on Friday 19th of July 2013 11:13:31 PM

balagan51 · Veteran Member

Mallini

I may have misunderstood my trial coordinator Wednesday, but when i asked her about re treatment she said the GILD drug (when aproved) attacked a completely different molecule and ABBV patients will be able to be treated with it if they (we) fail to achieve SVR

As a matter of fact, when the dept head talked to me about enrolling, his view was to go with the ABBV in the event it didnt work, I would have the option to go into GILD

and even though the FDA is approving it and more than likely the ABBV (spring 2014) with IFN she says that no one will use the IFN due to the success without it.

and as far as being treated like rats, i guess my wife and i are very fortunate. we have been treated like family here.

On the subject of "possible" RAVs, they aren't seeing it.....anywhere

-- Edited by balagan51 on Friday 19th of July 2013 12:59:47 PM

-- Edited by balagan51 on Friday 19th of July 2013 01:01:01 PM

-- Edited by balagan51 on Friday 19th of July 2013 01:02:35 PM

balagan51 · Veteran Member

-- Edited by balagan51 on Friday 19th of July 2013 12:08:03 PM

garfield · Veteran Member

Matt Chris wrote:

Garfield, with all your contacts with the other people in your trial how are the EOT results going?
Has their been one in your group that has been getting info about the possible Rav's that they are finding in the trials participants during or after treatment?
Also has any in your group sign up for the optional Pharmacogenomic study that was offered with the Turquoise II Study.
I question that I asked my study doctor but has not replied yet is, with all the blood draws during the study are they not getting information about the Rav's that are appearing during the 12 weeks of Meds?
Matt

Hi Matt,

sorry for a late answer, but I am using my next study center visit on monday for a short holiday trip.

In Europe the Sapphire and the Turquoise II trial started in march, only american started earlier.

So the the earliest EOT was in June, all of the guys are waiting for their 4-weeks result. Up to now I have heard only of one relaps, unfortunately you.

I didn't ask the guys, if they signed for the optional study. I did it, and my study nursery and doctor told me all the others signed also.

Because my liver is quite good, I habe been offered for 4 studies in different locations. Never ever the doctors informed

me about additional risks than were written in the study informations. 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

-- Edited by garfield on Friday 19th of July 2013 11:08:51 AM

ios9 · Senior Member

Hi Mat,

About my feeling after EOT : no much changes, in fact ... none at all, as I started to feel more strengh back after week 6, so did another male patient on Turquoise too, also my immediate memory seems less good, I know of a patient on one of Gilead trial who has this secondqry effect too.

I am living in Paris, but right now am in Madrid for a week, visiting my daughter who is spending holidays there.

-- Edited by ios9 on Thursday 18th of July 2013 08:43:25 AM

Matt Chris · Guru

Hi Do

Yes we have the same scan but its called Ultrasound (pictures by sound waves) but I have only had one and one more next week. I think they messed up on having me take the others.

Hey do how are you feeling? Do you have a almost weightless feeling or do you have less energy or more ?

What part of France do you live in? I have visited Lion, Nice, Paris and a few more.

Matt

Matt Chris · Guru

Hello Dom & Garfield

Dom, the Sapphire trial I believe is only 12 weeks on the real Meds.

Garfield, with all your contacts with the other people in your trial how are the EOT results going?

Has their been one in your group that has been getting info about the possible Rav's that they are finding in the trials participants during or after treatment?

Also has any in your group sign up for the optional Pharmacogenomic study that was offered with the Turquoise II Study.

I question that I asked my study doctor but has not replied yet is, with all the blood draws during the study are they not getting information about the Rav's that are appearing during the 12 weeks of Meds?

Matt

ios9 · Senior Member

Hi Matt smile

I did sign for the optional Pharmacogenomic study, but they give us no return for the study. Do you get any ?

I had my week 2 EOT tests last Monday. However, the doc said week 4 is the one to look at.

I do not want to wait and stress, so I will have a private PCR on week 4 to know asap the results.

Your' right Matt about Saphir 12 weeks treatment,I got confused because of those on placebo who get 24 weeks "treatment/placebo".

Do

PS : Matt, do you have to have echography every 3 months because of the cirrhosis ? We do here, what a stress each time ! (had scanner too end of March).

-- Edited by ios9 on Wednesday 17th of July 2013 07:12:30 AM

ios9 · Senior Member

Oh yes you did said you were on saphire, sorry.

I only know of one on Saphire, and she got UND week 1, and is on the 12 weeks arm. Her doc told her her results :)

garfield · Veteran Member

Hi Do,

to correct a misunderstanding, about 50 Persons on all Abbvie studies.

I can follow the results from two german study centers and I am member different Discussion Forum.

Because I am on the sapphire trial my focus was on the message of relaps. Next time I will ask the ratio.

ios9 · Senior Member

May I ask you Garfiel another question ?

How many 12 weeks on your 50 Turquoise patients ?

We are only two at my hospital, the 3 others are on 24 weeks, lucky then :)

ios9 · Senior Member

Yes dear Garfield : I do keep hope as I am feeling better and better day after day... excepted my sleep

biggrin

Let's hold hands and keep good spirits smile

garfield · Veteran Member

ios9 wrote:

Did your doc tell you any thing about the necessity to use Interferon as well as other meds for the rescue treatment ? or just Sofosbuvir and other DAAs ?

Hi Do,

at first I asked my very young study doctor, he believed to remember, that the rescue therapie will consist of abt-450 , Interferon , Ribavarin.

in addition to this I found http://clinicaltrials.gov/ct2/show/NCT01609933?term=abt-450&rank=20

Last monday I asked the chief of the Hepatology and he maked no mention of Interferon, but perhaps, this based on purely private medical reasons.

Have a nice day

garfield · Veteran Member

Hi Do,

yes, I mean this link.

I have problems to copy a working link, I don't know why.

good luck and don't get overly excited. It is wise to inform prior, but till now you can hold the hope.

-- Edited by garfield on Sunday 14th of July 2013 11:52:03 AM

ios9 · Senior Member

Hi Garfield smile

I can't get nowhere with this link (?), but may be is it this trial you'r speaking about ?

......................................................................................................

A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous Abbott Combination Study

Conditions:

Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1

Interventions:

Drug: ABT-450/r; Drug: ABT-267; Drug: pegylated interferon alpha-2a (pegIFN); Drug: Ribavirin (RBV)

..............................................................................................

It's on "invitation" only, so it looks very much like a "rescue" therapie ...

I'll see the Head of the trials Department to morrow at my hospital, so I shall ask him and let you know what is his answer.

Thank you so much Garfield, and have a very nice sunny Sunday :)

Do

-- Edited by ios9 on Sunday 14th of July 2013 12:13:45 PM

balagan51 · Veteran Member

Sage advice

3 moore daze

24 weeks of Ribo is enough :)

mallani · Guru

Settle down guys. We are here to support, not question or criticize. I do agree that patients with the CC allele at IL28B fare better with Interferon, but we're trying to get rid of it. Do is Undet. and projecting into the future, which we all tend to do. It really doesn't help- just take our results as they come. Happy thoughts!

ios9 · Senior Member

Well ... nobody knows if it will work out or not, do not go too fast !

My doc did not give me Interferon because I refused it, that's all.

End of the conversation,

Have a good day :)

balagan51 · Veteran Member

From what it sounds like reading your posts, you refuse IFN , your doc offers you an unconventional, unproven, viable alternative, and when you don't obtain SVR you say the doc should have been more forthcoming about a clinical trial that the drug maker had no answers for..........?

Did you never mentioned if you had an IL28 drawn before refusing to be treated with anything including IFN ?

Sounds like your situation shouldn't be blamed on the doc.

Take some responsibility

I hope you take another look at conventional treatment if your blood work indicates you may have a favor arable outcome with IFN

Wishing you the best.

-- Edited by balagan51 on Saturday 13th of July 2013 10:23:39 PM

mallani · Guru

Hi Dominique,

Here's another link which is more specific. Look at para. 2 of the Exclusion Criteria.

http://clinicaltrials.gov/show/NCT01704755

mallani · Guru

Hi Dominique,

The question of resistant variants (RAV's) has not been fully assessed. Almost all relapses after or during Rx are due to RAV's. These specific mutations develop, and each of the DAA's have two or three dominant RAV's. These disappear over time and are replaced by the original wild-type virus, but the duration is variable. I have enclosed a link that shows the current data on RAV's, and it is important for the AbbVie patients to look at the RAV's found particularly for ABT-450. I mentioned in a previous post that Merck's MK-5172 is very resistant to mutations, and may be of use for the failed antiprotease patients. ABT-450 appears to be mutation prone, and as Matt has said, perhaps AbbVie need a better antiprotease.

If you look at the criteria for inclusion in a Trial, all exclude patients that have had previous DAA treatment.

http://www.iasusa.org/sites/default/files/tam/20-4-139.pdf

ios9 · Senior Member

Hi Garfield,

I have my 2sd week EOT check up next Monday, so I will ask my doctor about this. My main concern is Interferon.

Did your doc tell you any thing about the necessity to use Interferon as well as other meds for the rescue treatment ? or just Sofosbuvir and other DAAs ?

Thanks Garfield :)

Do

balagan51 · Veteran Member

It is a clinical trial. How can you expect your doctor to have answers for a trial that is looking for answers to questions that aren't known.?

again , it was and is a clinical trial, not a proven protocol .

im sorry that it didn't work out for you and quite frankly am surprised your doc would place you in a clinical study without giving you the option to be treated with an approved protocol first

-- Edited by balagan51 on Saturday 13th of July 2013 04:37:19 PM

-- Edited by balagan51 on Saturday 13th of July 2013 04:38:08 PM

ios9 · Senior Member

Matt,

I was rereading my Turquoise agreement, and found out that they have insure us for any prejudice which could result from having taken their drugs.

One of us wrote some where here :

"The Abbott Trialists are in a difficult situation. The Abbott drugs block NS3/4A, NS5A and NS5B. If a patients relapses, all the new DAA's and even Incivek and Victrelis, are off-limits for re-treatment. This is the current situation. I am not sure what the future holds for those with RAV's."

If there is proof that we can't be any more treated with new DAAs nor even Incivek and Victrelis, can't we ask for the insurance to play its part ?

Must of us has choosen Turquoise II because we could not take Interferon, if the only choice Abbott gives us (like Gilead) is a rescue treatment with Interferon, then this a great prejudice. Am I right ?

Nobody beleives me here (France) when I wrote about this, they ask me where did I find the proof that one can't be treated with new DDAs any longer after having receive Abbott's drugs.

So do you have any link about this I could communicate ?

Thanks Matt. I like you new signature :)

Do

ios9 · Senior Member

Balagan,

I am the exception :)

How would I have known about it ? I was on Turquoise II only few weeks after having been told I had hepatitis and cirrhosis. One can't compare some one who has known this illness for years and some one who has just discover it.

I trusted my doc, may be should not have, that's it.

Mallani : thanks for the link. How do you explain that we do not have this Exclusion Criteria on our French AbbVie's paper trial ?

I see you are Australian ? I have been living for 3 years in Australia, I miss it, what a country ! you'r just too Lucky :)

Do

-- Edited by ios9 on Saturday 13th of July 2013 04:19:50 PM

-- Edited by ios9 on Saturday 13th of July 2013 04:21:26 PM

balagan51 · Veteran Member

There shouldn't be anyone here involved with these trials excluding IFN that should be surprised that there might be some resistance issues.

They are trials.

I enrolled because I knew I was never going to do IFN again,period. My IL 28 typing is the worst

For me having cirrhosis to be even given a shot some hope is a gift.

As i understand it In previous ABBV trial they are seeing 94% SVR

There are some of us , myself included, that might fall in that 6%. I knew that going in.

According to the head of the GI dept. in the teaching hospital where the study group I am in feels

GILD will be approved late this year and ABBV spring 2014

Unfortunately both will include IFN

Im trying to stay positive........ My last dose is July 16.

I'm just grateful that I have been virus free for 6 months and was given the opportunity to be treated when up until now was given no hope at all.

GT 1b Cirrhotic failed peg/ribo 2004 acquired Hep C from experimenting with IV drugs 1972

Started treatment Jan 17 24 weeks UND since week 2 with all other labs WNL since 1st Draw

a gift........

-- Edited by balagan51 on Saturday 13th of July 2013 03:52:27 PM

-- Edited by balagan51 on Saturday 13th of July 2013 03:53:37 PM

-- Edited by balagan51 on Saturday 13th of July 2013 03:57:46 PM

ios9 · Senior Member

Thank you so much Mallani.

I had a look at my Turquoise agreement, they do not mention in their list of non elligible patients, those who had had DDAs before.

But in the elligible list they mention :

- 300 patients with cirrhotis, geno 1, never treated or treated before with riba and interferon.

So you'r right, but they should have include this in the non eligible patients too.

Thanks for the link, I am to study it.

Have a nice day,

Do

-- Edited by ios9 on Saturday 13th of July 2013 01:07:08 PM

garfield · Veteran Member

Hi Do,

I asked to this point my hepatologist. Indeed it is, he diffused that only Sofosbuvir will not be a problem.

After a relaps the personal RAVs have to fix, and then the next therapie will composed of Sofosbuvir and other DAAs

against one will not have RAVs. Tell your friends they should ask unmistakable their doctors.

-- Edited by garfield on Saturday 13th of July 2013 10:09:38 AM

edmed · Veteran Member

Matt sorry to hear this, I feel your pain. This is my 3rd time in TX and I feel like I'm in limbo with triple therapy because I'm still detectable at 12 weeks. The only hope for me is to be undetectable at 24 weeks or I have to wait for the newest and latest miracle therapy coming down the pipeline. Keep your spirits up. I'll be praying for you.

balagan51 · Veteran Member

Matt,

On my last visit I actually signed a new consent form because they had made some changes.

They are offering a rescue plan.

My study doc believes that the Abbvie protocol will be approved mid 2014

Can't say if it won't include IFN or not.

I am so sorry, but I honestly believe we will all be around when the breakthrough treatment is

available for everyone

Biggyb · Guru

Very sorry Matt, it's something we all know we might face. Sometimes 48 weeks is not enough. I have relapsed twice now and hoping this time works but with this dragon we just never know. I am fully prepared for whatever happens. It's the gamble every one of us takes. New tx coming out regularly. Wishing you all the best, and we will all beat this thing someday. (i have faith)..~Bob~

Cinnamon Girl · Guru

Oh Matt, really sorry to hear this. Very disappointing for you and for all of us here who`ve been following your progress. You did all you could possibly do, but it seems that the 12 weeks wasn`t enough for you, and even though you`ve contributed to the trial data it`s you who`ve had to live through this and take it on trust. It was worth trying though and you`ve given your liver a break, but the final result was out of your control.

This isn`t the end of the line for you though, take some time for yourself to recover and `lick your wounds`, and then you can start looking into your future options. Your time will come!

Take care of yourself and do keep in touch, we`re always here for you. All the very best to you, Jill

garfield · Veteran Member

Hi Matt

I'm so sorry.

Because of your last posting, I asked my study doctor, if and what kind of rescue therapy abbvie will offer.

He was surprised about the question, but he believes, the therapy will include abt-450, ribavarin and interferon.

I wish you the best

Matt Chris · Guru

Latest update / results on retest of viral load

Test showed still have a small amount of virus and increasing / they call it relapse.

Abbvie says they might offer a retreat of the Meds if I qualify but would likely include interferon.

Abbvie wanted to figure out if 12 weeks is long enough of a treatment for cirrhotics, well in some of us it's not. No fun in being a ginnepig.

The sad thing about my trial I requested to be extended to the 24 weeks group, but they rejected my request.

I will be posting my epilog on my experience of being on this trial in the near future if I can find the heart and bring my self to do so.

I would like to personally thank all the members that have given their support and response over the last six month, it's been a real fantastic support in every way possible. Our collective consciousness has been very special indeed.

Sometimes when our hopes are not realized we get down, but life has a way of working out things on a different time table and later they are realized and do happen.

" All things in time" Is one of my all time favorite sayings.

Trying to build my confidence for other future options.

Matt

LUV2RYDE · Senior Member

Matt,

I too am so sorry to hear about the news. My RN was talking to me about all of the other trials. I know there will be something to take care of you. You really have givenme a lot of hope through all of this and words of wisdom. I will be praying for you and I'm always here for you!

balagan51 · Veteran Member

Matt,

Im so sorry about your results and have much respect for how you dealt with that and the way the trial nurse handled it.

I was just down for my 20 week draw and ABBV just amended their protocol pages. they specically showed me their plans for an alternate treatment, but it includes IFN.

she thought Gilead was to be approved sooner than expected and that might be something to look at

Ckncali · Veteran Member

Hi Matt, I am sorry to hear your news but you might take a look at the papers you signed when you entered the Abbott clinical trial and see if they offer a "rescue" clinical trial for participants who do not clear the virus. I am on Gilead trial and they do offer a rescue trial if this trial does not work for me. The rescue trial includes the current drugs I am currently on and interferon. I think that Abbott will offer you something similar. I wish you the best.

mallani · Guru

Hi Matt,

Sorry to hear the news. Hopefully the retest will be undet. I agree with you that cirrhotics will probably need a longer course of Rx. The Trials should give more information, but it is logical that patients with under-perfused liver nodules should have a longer drug exposure. Even though the new DAA's are potent, they need to reach all places where viruses can hide. Research has shown the HCV can spread from hepatocyte to hepatocyte without entering the blood stream, particularly in cirrhotic nodules. Good luck.

Cinnamon Girl · Guru

Let us know what the retest shows, Matt. It`s quite shocking that you were given the wrong information, and it must have been a real blow to get this news. Keep your chin up... I`m still hoping for the best possible outcome for you. Fingers crossed..

Karen · Senior Member

Hey Matt...sending a big hug to you...

Your thinking is impressive, now is the time to tap into all the encouraging words and thoughts you have sent my way during down days...they provided great comfort.

What I keep finding through all of this...it is a reflection on how I view life in its whole. It is not about hep c, cure or no cure but how I deal with life. It has been an eye opener and the message keeps getting clearer...There is always something that requires us to exam our thinking and in order to do that, we need to have moments like this...You have always seemed to have a great spirit and it is that which will carry you through...

Time to get cooking and share a food post with us ....Healthy eating-great distraction!

Praying for the positive....Thanks for sharing

HR · Senior Member

Matt

It seems the study nurse could have given you the wrong numbers again. Let's pray on the retest that was the case. Praying for you brother.

Randy

Kellie · Senior Member

Matt, Where else are you going to go who understands what you experienced.

Thanks for having the courage to write it down in black and white, then share it too...........you are most correct in saying all is not lost Kellie

Matt Chris · Guru

Updated EOT week 4 report

Bad News - Error in report

I received a call from my study nurse and she said she looked at the wrong patients Viral load report when she told me that I was UND at EOT post 4 weeks.

I now here is the worst, my report after waiting an additional week (2 weeks total) is showing a small but significant amount of virus.

So tomorrow I go in for a retest for viral load, it's not looking good but who knows .

But hopefully will have options for additional treatments.

Maybe 84 days (12 weeks) of treatment for cirrhotics is not enough for something that been with you for 40 years.

Its depressing I know, but not all is lost.

My future has not been decided yet, their is a lot of living yet to be done.

I'm sorry to be a downer but have to keep it real.

Matt

garfield · Veteran Member

I'm so sorry. I hope, they have an idea for an additional therapie.

I consider, what I can do to minimize the risk of relapse at EOT 7/7.

worth consideration :

Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

http://www.biomedcentral.com/1471-230X/12/32

-- Edited by garfield on Wednesday 19th of June 2013 11:11:41 AM

Biggyb · Guru

Good job Matt !!

Karen · Senior Member

Hey Matt....thanks for a good and positive read.

LUV2RYDE · Senior Member

Matt,

I'm so happy for ya. My end of taking these med's is at the end of the month two weeks left! Then I start with the (your still UND)hurdles....CAN'T WAIT!

HR · Senior Member

Great job Matt!!!

Matt Chris · Guru

Good News , Good Report

Received my 4 weeks EOT lab report , after my Doctor placing such high importance on the 4th week lab results I was considerably anxious for the viral Load report.

After waiting for eight days in came back negative or UND, yet another hurtle made with several more to go. The hurtles should be getting easier or lower but in the mind is only concerned about the next one.

You would think that a person going through this type of treatment would be able to tell or judge how his body feels as a basis for if he is improving or not, but that is very hard to judge for us that are cirrhotics or have lived with this malady for 40 years.

It seems that I've learned that the various foods and drinks I consume have a way of effecting the way my liver feels for good or bad, sometimes minor inflammation and sometimes a funny irritation. It's hard to remember if I was this hyper aware before treatment but it seems that I am more now. Because I had a gluten problem (celiac disease) I notice that eating just a little wheat products cause liver inflammation.

With every good report or UND the psychosomatic effect has a real boost to the positive attitude and it can really make a person feel better, and so it go's with all of humanity.

Matt

Hep C Discussion Forum

~Bob~

Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

~Bob~

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