Abbott Labs TURQUOISE-II Open label clinical trial
JoeV said
Mar 7, 2013
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!
Matt Chris said
Mar 7, 2013
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?
mallani said
Mar 5, 2013
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.
Matt Chris said
Mar 4, 2013
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
Matt Chris said
Mar 1, 2013
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
mallani said
Feb 28, 2013
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.
Matt Chris said
Feb 28, 2013
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
BP said
Feb 27, 2013
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.
LUV2RYDE said
Feb 27, 2013
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.
mallani said
Feb 27, 2013
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.
Matt Chris said
Feb 26, 2013
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
Matt Chris said
Feb 26, 2013
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
mallani said
Feb 24, 2013
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.
Matt Chris said
Feb 24, 2013
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
balagan51 said
Feb 23, 2013
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
Cinnamon Girl said
Feb 20, 2013
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.
Matt Chris said
Feb 20, 2013
Thanks Cinnamon Girl
By the way, how does one get a Avatar on the site?
Is there instructions?
Matt
Cinnamon Girl said
Feb 20, 2013
I`m making this thread a `sticky`, Matt, so that it stays at the top with the other clinical trial threads.
Cheers, Jill
LUV2RYDE said
Feb 20, 2013
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.
Trish
Matt Chris said
Feb 19, 2013
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
Cinnamon Girl said
Feb 19, 2013
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. ~ Jill
Biggyb said
Feb 19, 2013
Try putting Clinical Trials in search up above. There are a few people in trials.
Matt Chris said
Feb 19, 2013
I have just completed my first week in the study.
Is there any other people in any other Abbott clinical trial?
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!
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?
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.
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
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
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.
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
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.
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.
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
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
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.
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
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
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.
Thanks Cinnamon Girl
By the way, how does one get a Avatar on the site?
Is there instructions?
Matt
I`m making this thread a `sticky`, Matt, so that it stays at the top with the other clinical trial threads.
Cheers, Jill
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.
Trish
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.
~ Jill
Try putting Clinical Trials in search up above. There are a few people in trials.
I have just completed my first week in the study.
Is there any other people in any other Abbott clinical trial?
Matt