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Hep C Discussion Forum -> Clinical Trial Participants -> Abbott Labs TURQUOISE-II Open label clinical trial
Post Info TOPIC: Abbott Labs TURQUOISE-II Open label clinical trial
JoeV


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RE: Abbott Labs TURQUOISE-II Open label clinical trial
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Hello Matt! I went through the same <25 measurement result for 2 weeks in a row prior to going undetected. As the doctor at the Mayo Clinic explained it to me, the test algorithm has detected the virus in your blood but it is so minimal (<25) that it is not able to quantify it. This is a good thing, especially so early into the treatment. You should be undetected on the next blood test and, if not, certainly on the following test. Best wishes!



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Matt Chris


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Update on week two lab results

Viril load is now < 25

What really does this mean?

Is the lab unable to figure out the number, or is there methods of figuring data on very small amounts not reliable?



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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! 
mallani


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Hi Matt,

Your Hb drop is almost certainly due to Ribavirin. Riba causes an haemolytic anaemia so it is common for drop your Hb to about 10.

We are interested in the progress of all Trial members. The Abbott drugs may be approved before Gilead's GS5885, which would give Abbott a huge advantage, provided the Trial SVR rates are satisfactory. Cheers.



__________________

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
Matt Chris


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Post week three update

After my week two high level Billirubin scare,  all of my levels are within Abbotts trial study range criteria

Billirubin 1.9  (thankfully my body has made an adjustment to handle extra load)  

AST 35  (lowest ever in many years)

ALT 59  (lowest ever in many years)

Hemo 12.2  (Pre Tx its was averaging around 14, need to understand why the drop)

WBC 2.23  (Seems low to me, but all other components within the WBC like neutrophils read in the normal range)

Platlets 83  ( have been lower because of my enlarged spleen according to my Doc,  but is slowly improving)

Viril load info not received yet

Side effects of Meds as of end of week three.

A slight drop in energy level during the 6:00-7:00 PM time range

Transit time of ingested foods seems to be longer, and a little more stiff upon exit.

One odd change is I cannot self adjust my spinal alignment (noticed by hearing my vertebrae pop and click in my back and neck) may be due to more stiffness in general,  I really don't know why.

Have occasional mild itching on legs, was much more intense during the first week.

Insomnia seems to be noticed more, I guess I have yet to  learn how to work the meds in with my sleep cycle.  ( I may bring this up as a topic for disscussion)

One of the great positives is the meds have not curtailed any normal day to day activities, such as work, social interaction, concentration or coordination. The only normal human function that seems to be effected is regular sexual activity, this coud have a psych. element because of the warning that the Doc told us about being very careful about about using birth control. (he said "use two forms of BC at all times while on the meds")

Overall its feels like I am over the first few weeks of my body adapting to the meds and its response to the meds in a positive or negitive way, but who knows what the future holds.

Disclaimer: These thoughts and observations are not intented to be understood as facts or recommendations for the Forum or medical diagnosis, they are just my own personal experiences related in a unscientific matter.

Thanks Matt 

 



-- Edited by Matt Chris on Monday 4th of March 2013 07:48:23 PM



-- Edited by Matt Chris on Monday 4th of March 2013 07:50:32 PM



-- Edited by Matt Chris on Tuesday 5th of March 2013 03:16:17 AM

__________________

"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! 
Matt Chris


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Hey Mallani 

Congrats on making it to the end of your treatment , and your first improved labs.

I am really impressed at your age that you made it , it's shows your inter strength.

By the way thanks for your putting up with my Newbee stupid enthusiasm and directing me about how to consider other members, as regards my personal  views on treatment and optional supplementary additives.

Also what is your opinion on how one can expunge all remants of the HCV after one reaches undetectable?  

Does the the HCV hides it self somewhere in the body?

 

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! 
mallani


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Matt,

We understand some Members have views on Natural and Alternative Remedies. They are entitled to them. We ask they do not try to influence other forum Members. Some remedies, such as Milk Thistle, should not be taken with Victrelis and Incivek.

The dose of Ribavirin has been fixed by Abbott for the duration of the Trial, on the basis of data from Phase1 and 2 Trials.

Be very careful using infrared. Ribavirin has a direct effect on sweat glands depressing sweat production. That is why patients on Riba develop a dry skin, are intolerant to sunlight and many develop the Ribavirin rash. The Riba rash can be mild or severe and the management has been discussed (use the 'Search' button).

Daily water intake requirements varies from person to person, depending on age, diet, level of activity and ambient temperature. Fluid intake should be adequate for good hydration, and normal urine production. There are articles on this on the Forum.



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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
Matt Chris


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Hello Mallani

Thanks for the advice it was well received.

The reason why I mentioned Check with your Doc about Ribavirin reduction,  was reading abstract and phase II Abbott study report conclusions they talk about exact problem being addressed by adjusting the Ribavirin.

So it was not my conclusions but, but the report that was published by Abbott Labs at the 47th Annual Meeting of the European Assoication for the Study of the Liver (EASL) 

check out this link for the info http://www.viraled.com/modules/info/files/files_4fa2acbbd11d2.pdf

As far as the natural remedies, they have there place, but one should run it by your Doc. 

The most important things was to be properly hydrated with quality water and other high quality nutritional rich foods and juices because during the first weeks we flushing out over 5,000,000 these viral copies

That is why the Infared Sauna is great because it will help sweat out the toxinsl without having to do physical exercise.  

What one has to remember both Abbott and our doctors are learning about these new drugs as they go along. that's why is important that we  read and study all the data about previous phase I and phase II study that we can so we can be totally informed, because we are the Ginny pigs not the Doctors,  its our bodies being tested , and we are in the best position relate its feelings and reactions.

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! 
BP


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I'm with LUV.  I take only what they say is ok to take.  Which for me is my daily vitamins and the pills they are providing.



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LUV2RYDE


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mallani wrote:

Matt,

Your 'real world experience' should remind you that you are on a carefully controlled Trial. Suggesting patients ask about Riba reduction is really odd. If you have taken any of your 'natural' remedies for lowering bilirubin, I would hope they were approved by your Trial Coordinator.

These 'natural' remedies have been around since the 1980's- none has been proven to have any effect.

Be careful about what you recommend to fellow Trial members.

 

Malcome I run everything through my RN cord...I dont take anything other then what he hass approved which is just diabetes and my bc pill. I don't want to screw anything up...I have been doing whatever has been asked. But very good point to bring up.

 



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Geno type 1A Started Abbott clinical trial mid Jan 2013. :-)

Viral load when I started this trial 4.75million  Went 12wks on placebo and started real meds on 4/5/13 after 1wk  on real meds 25 after UND @3wks,6wks.w00t: Done trial 6/27/13 and still UND.

 
mallani


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Matt,

Your 'real world experience' should remind you that you are on a carefully controlled Trial. Suggesting patients ask about Riba reduction is really odd. If you have taken any of your 'natural' remedies for lowering bilirubin, I would hope they were approved by your Trial Coordinator.

These 'natural' remedies have been around since the 1980's- none has been proven to have any effect.

Be careful about what you recommend to fellow Trial members.



__________________

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
Matt Chris


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Additional update info from Labs 8 days into the study Meds 

Day one baseline Viral loads were 6,639,000

after 8 Days Viral load are 163

very powerful Meds

Matt



-- Edited by Matt Chris on Wednesday 27th of February 2013 03:30:51 PM

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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! 
Matt Chris


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Update on my Turquoise II trial problems 

My Last post my Billirubin was very high at 5.3 on Tuesdays blood work,  but by Thursday it went down to 3.7 and by Monday it fell to 1.9  which is great news.

The obvious question is how?  The answer is three fold 

1- our program coordinator did not advise the participants on proper hydration.

2- My real world experience show me that some or all the things listed below help lower both direct Billirubin and indirect Billirubin 

    Starting with water, coconut water, juicing carrots and kale

And finaly spending time in the infared sauna with chromotherapy set on blue light

3- Asking your Study Doc to cut back on your Ribavirin dose 

Learning to help your body's system through understanding how our body eliminates dead red blood cells (Billirubin) is the key picking the correct therapy. 

We HepC people have to be our own investigative doctors

Then finally after we understand the flow of Billirubin through are organs, then we can meditate on and ask our body to follow through with the process.

Sorry for getting so heady on this but this new Abbott DAA Combo therapy commonly cause elevated Billirubin , so understanding how to deal with is critical to staying on the Meds

Matt

 



-- Edited by Matt Chris on Wednesday 27th of February 2013 03:22:24 PM

__________________

"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! 
mallani


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Hi Matt,

Do you know what units your Lab is using? Bilirubin can be expressed in mg/dl or mmol/l. Also are you talking about Total Bilirubin, Direct Bilirubin or Indirect Bilirubin ?

eg: Normal range for Total Bilirubin: 0.3-1.0 mg/dl, or 5.1-17 mmol/l . As you can see, there's a big difference.

Bilirubin is formed in the liver from the breakdown of old red blood cells. There is no way you can modify bilirubin levels.



__________________

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
Matt Chris


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Received first week Lab results,  had some great news and no so great news

The good was my AST went from baseline of 128 to 35

and my ALT went from 181 to 54. Very dramatic changes 

The bad was my bilirubin went very high to 5.3

Doc says if it stays high I will be booted out of the trial 

Any suggestions on how to lower Billirubin fast?

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! 
balagan51


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In ABBOTT Turquoise Trial (cirrhotics)

intial screen VL 8.9 million .

1 week  VL 200

2week VL <25

All my enzyeme levels are normal since first draw,(first time ever) 

CBC is normal. Bilirubin up a tad

I'm going in for my week 4 labs this Wednesday. 

I'm starting to develop a rash and pray they dont take me off the trial.

Does anyone here have any experiences with rash issues?  If so, was there anything that you did to ease or allieviate it?

Thanks



-- Edited by balagan51 on Sunday 24th of February 2013 04:46:56 AM



-- Edited by balagan51 on Sunday 24th of February 2013 02:21:16 PM

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Cinnamon Girl


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Hi Matt, have a look at your user details and click on `Avatar` in your `Profile` settings.  Then you`ll be able to select and upload a photo from your picture files.  If you have any problem with that just let us know.  smile



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Matt Chris


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Thanks Cinnamon Girl 

By the way, how does one get a Avatar on the site?

Is there instructions?

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! 
Cinnamon Girl


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I`m making this thread a `sticky`, Matt, so that it stays at the top with the other clinical trial threads. 

Cheers, Jill



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
LUV2RYDE


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Matt~ I am happy for you. I am also in Abbott as well. I am on week 6 getting into my 7th week this friday. My trial is blinded so either I am on the real drugs or the placebo.....either way in my case I wish all of us in my study would just do a straight 24 weeks. I feel wonderful....and am keeping a very positive attitude on this. I have a sticky on my trial...so lets K.I.T.

 

Trishsmile



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Geno type 1A Started Abbott clinical trial mid Jan 2013. :-)

Viral load when I started this trial 4.75million  Went 12wks on placebo and started real meds on 4/5/13 after 1wk  on real meds 25 after UND @3wks,6wks.w00t: Done trial 6/27/13 and still UND.

 
Matt Chris


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Thanks Cinnamon Girl All should know that Abbott labs has two different study's going on now. One for non cirrhosis HCV called Sapphire and one for Cirrhosis HCV called TURQUOISE-II The only difference is our group (Turquoise) is open label with one group 12 weeks and the another at 24 weeks. What I have experience so far in the study is the meds are no problem, but the whole process of qualifying and the possibility of being disqualified because of some bad lab results brings unnecessary stress and worry. But like one great quote I read from one our members said "Feed your Faith and fears will starve to death" I am very thankful of this opportunity to the Abbott Labs and also to the members of this forum for being to express myself among people who understand how we feel and think. Keep the Faith 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! 
Cinnamon Girl


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Hi Matt, welcome!  We do have other members currently on Abbott trials...have a look through the `stickies` (the threads at the top) in this section.

Best of luck, keep us posted.  smile  ~ Jill



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Biggyb


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Try putting Clinical Trials in search up above. There are a few people in trials.



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58 yo..Relapsed in 99 and again in 2004. Started triple therapy with Victrelis July 22,2012.  genotype 1a. week 8,12,16,24 VL Undetectable..E.O.T -- 6-22-2013,,,EOT + 24., UND. 

SVR !!!

 

~Bob~
Matt Chris


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I have just completed my first week in the study. 

Is there any other people in any other Abbott clinical trial?

Matt



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