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Post Info TOPIC: Phase III Abbott Trial Participant-Sapphire I
BP


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RE: Phase III Abbott Trial Participant-Sapphire I
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Hey Bob.   Same numbers.  F2-3 based on a biopsy 11/09.  No cirrhosis. 



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I completed Abbott sapphire 4/4/13. Similarly to you, my recent biopsy, precirrhotic F2-3 done by hepatology HCV MD in 1/2012. i was undetected at trial end. it was a double blind study. how along are you?



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BP


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3 more weeks to go and I'll be told if it was placebo or the real thing.

A cooment about apparent side effects.  The day before my week 6 Dr's visit, I began to get fatigue(and a foggy head) which is unusual for me as I normally am high energy around the house.  The fatigue/fog has been with me since that time.  Somedays better and somedays worse but always there.  However never bad enough to disrupt my daily routine.  Maybe slow it down a notch, but never bring it to a halt.

Starting getting headaches again yesterday.

The coordinator I deal with also has access to the open label study with the same drugs and has told me that what I am experiencing is typical.

To answer Matt's query, I did ask when I would get the results and she did not know as a couple of people had just finished the trial and two weeks later she still had not seen anything from Abbott.

 

 



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BP


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Hi Matt-I am actually not Robert.  He is just the name of the guy whose post I copied and pasted from another forum.

You know, I don't remember when they said the results would be ready.  The paperwork, bloodwork etc were all a little unnerving so I may have signed away my granddaughter and not even realized it.  I'll have to ask next week when I go back.



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Hey Robert

The way you described your dizziness and headaches sounds like you might be on the real Meds.

Do you happen to remember on your consent form at what time you participants are able to access your labs results?

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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LUV-I kept daily notes the first couple of weeks so if you want to compare...

But you might be comparing with placebo notes!  : )

It's probably better to just gobble down the pills and hope they work. 

Later.

 



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BP~ Just found out hours ago I was on placebo.

disbelief

But I have the real drugs now and start tomorrow morning. 12wks down 12 more to go on these pills. Now my riba bottle looks different (skinnier). But the panel pills look the same....dang it I kinda felt like I was on placebo. Will keep ya updated. I want to hear your UND here soon BP!

 

Trish



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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.

 

BP


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It's been interesting reading about all the folks in the trials.  I'm finishing up week 5, almost half way.  I was looking back at my notes that I kept at the beginning.  The first few days were foggy with headaches.  Then the next couple of weeks were intermittient short lived headaches and sometimes heartburn which were also vere short lived.  So far no nauseau, but my typical MO is that I could eat a box of rocks and it wouldn't bother me.  The last 2-3 weeks have been uneventful.  It's getting so routine that the last few days I've had to remind myself to take my pills.

This is sick, but I tell my wife that if I almost wish I  felt bad so it would confirm that I got the drug instead of the placebo.  If I did get the drug then, for me anyway, this has been very easy up to this point.

As I recall without looking at the thread, LUV is a month or so ahead of me.  I'm anxious to hear what she finds out.

 

Good luck to all.



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Hello Robert

That is indeed very encouraging for all the other Abbott trialees in the same study group or the Turquoise II group, and for thousands of HCV patients waiting for this good news.

Is seems the strategy that Abbott Labs took of having four DAA's is keeping the virus boxed in and at bay for the most part.

Time will reveal most all things by the results in the real world of diverse patients.

Keep in touch

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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Just read this on another forum I was browsing.  I thought it was worth sharing as I know there are a couple of us in this forum doing the Sapphire trial.

 

Hello ALL,

I ust wanted to let everyone know I finished the Abbott Saphire Trial and took my last 6 pills yesterday. This trial was blinded but it was confirmed yesterday that I got the real drugs!  I still have not seen any blood work results.

However, I had to see my outside hepatologist for a previous appt. that was set up before I started the trial and they did some blood work on me between week 3 & 4 of the trial and my blood work came back UD! So I don't know exactly when I was UD but it is still grteat news! Also I kind of new I was on the real drugs I could sense the riba.

 Side effects were minimal. Headache first week. A little fatigue/winded started setting in around week 6 due to the riba. I also noticed a little more heartburn but not sure if that was medicine related. All in all treatment was very doable. 

I go back in two weeks for my first follow up and will keep you all my fellow Abbott trialees  and others up to date on my status. I believe I am the first one to finish any of the new phase 3 Abbott trials?

God is great keep me in your prayers!

God Bless

Robert

 



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Hi guys,

The current large Phase3 trial for sofosbuvir, GS5885 and Riba is listed for completion in Dec 2014. This trial is for Rx naives only. Further Trials for Rx experienced, cirrhotics etc will also need to be completed. Going on that, 2015 would seem the earliest for GS5885. Gilead may be able to speed things up with Abbott poised to blast them out of the water.



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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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Bill: I don't think Gilead is working with Bristol Myers, I think Gilead according to my doctor will be filing for GS-5855 next year.

But, there are clinical trials for Abott and Gilead here in Texas, I think Gilead is for geno type 1. Let's hope that it will be approved next year. I am trying to get into one of these trials in Texas.



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Geno type 1b, F1 vl 640,000 enrolled in Gilead's sofosbuvir/ledipasvir -week 1 66, week 2 <25



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mallani wrote:

Hi guys,

Thanks for doing the Abbott trial which will probably be #2 on the all-oral DAA's.

Abbott are clever using three different DAA's to reduce the effect of RAV's. Their NS5B blocker may not be as effective as sofosbuvir but excellent SVR results are expected.

As they use an antiprotease, previous Rx with Victrelis or Incivek is an exclusion. These patients have to wait for a NS5A-B blocker combo, and Gilead are the only Drugco offering this. Sofosbuvir will be approved later this year then we have to wait for GS5885 approval.


 Thanks for that update

   I'm waitin on the sofosbuvir / Gs 5885 or the  Bristol Meyers version Thank God somethings are moving  

BillS 



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

BP


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Dog-it's a double blind study.  75% get the drug and 25% get the placebo.  Neither the Dr's or me will know until week 12 whether I am getting the placebo or the drug.  If I've been getting the placebo, then I'll do another 12 weeks with the drug. 



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Brad: 

Aren't they supposed to tell you if it is placebo or the real deal? How does placebo help the HEP C?



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Geno type 1b, F1 vl 640,000 enrolled in Gilead's sofosbuvir/ledipasvir -week 1 66, week 2 <25

BP


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Now into week three and other than headaches and occasional tiredness, it's a piece of cake.  Won't know for another 10 weeks if it's my mind is creating the discomfort, or if it's real. 



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Hi guys,

Thanks for doing the Abbott trial which will probably be #2 on the all-oral DAA's.

Abbott are clever using three different DAA's to reduce the effect of RAV's. Their NS5B blocker may not be as effective as sofosbuvir but excellent SVR results are expected.

As they use an antiprotease, previous Rx with Victrelis or Incivek is an exclusion. These patients have to wait for a NS5A-B blocker combo, and Gilead are the only Drugco offering this. Sofosbuvir will be approved later this year then we have to wait for GS5885 approval.



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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

BP


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Thanks for the thoughts CG.

Just got back from my week 1 appointment.  Had blood drawn and pills counted.

The study coordinator that I deal with today also is heading an open label trial with the same drugs.  She says some were past week 4 and the only side effects are nausea and headaches but nothing debilitating or that affects a normal daily routine.  If this drug combo is as effective as they think it will be and gets rid of the virus, it will be truly be a breakthrough.

 

 



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Please don`t think that, Brad, none of us here would think it was petty!  Everyone who is effected by Hep C should be grateful to all of you who take part in clinical trials.  Without people like you paving the way we wouldn`t be seeing advances in treatment drugs, so be proud of what you are doing!  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.

 

 

BP


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The last two days I've been normal, well, as normal as I ever was. : )   I actually feel a little petty talking about my experience compared to what others have experienced or are  currently going though, both here on this forum and people that I know.  But odds are that I'm probably not the only one out there like me,  so rock on!



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I`ve made this thread a `sticky` for you, Brad, so it stays at the top of this section with the other clinical trial threads.

I`m sure we`d all be the same, wondering whether every little headache or tired feeling is a sx or not.  It`s easy for any of us to tell you to try not to think about it, but I expect you`ll stop worrying soon and relax into it. 

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.

 

 

BP


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Day 5 with just a slight headache that comes and goes.    As LUV says, the mind isa funny thing.  The RN told me to not dwell on the treatment and just keep pushing on.  But then my minds thinks, "If I feel bad, then I must have gotten the drug and not the placebo'.  Just dang crazy! I figure it will take me a week or two to quit obsessing on it.

 

Good luck to all.



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BP~ Yeah we are on the same one....I went into it feeling great...other then the usual  don't have alot of energy....so I push myself. But I went into this trial feeling good and with nothing but positive thoughts....I didn't really ant to hear the side effects...didnt want that to cloud my feelings. I am going into my 7 week and I dont feel any different then I did going in. I almost wish it was a straight 24 weeks and they didn't tell us squat at 12 weeks. Cause if I am placebo and feeling great....I don't want to hear "Now your starting the real drugs" I think it will cloud my true feelings...if ya know what I mean. My RN won't tell me anything about the other 5 people in the study...I've tried every trick in the book and nadda.

Just seriously think your feeling great and you will....the mind is a powerful tool. Good luck and I will share with you  what happens with me on my sticky thread.

 

Trish



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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.

 



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Hi Brad, welcome!  Good to hear about your trial, let`s hope those sx are real then!  wink

Looking forward to following your progress.  ~ 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.

 

 

BP


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I started my trial Wednesday 02/13/13.  During the screening process, there was almost a  4 week wait before the treatment began and  I was obsessed with finding information about Phase II and getting information about folks who were currently in the same trial as myself.  I just came upon this site yesterday and thought I would share my story and progress in the hope that someone will benefit from it. 

It sounds like I am in the same study as LUV2RYDE.  It's a 12 week double blind study for treatment naive(never been treated), non cirrhotic patients  with Genotype 1. There are a little over 2,000 participants across the world.  I'm in the US.   It's an Interferon free regime using antivirals and Ribavarin.  6 pills in the morning and 4 pills in the evening.  The Dr's told me that the side effects were minimal and the cure rate was 97% in Phase II.  Sign me up!  It's also cool to know that what I am doing could help others down the line.

I won't know until May whether I am getting the drug or the placebo, but here's how I have fared so far.

Day1-took the first dose at 11:00 am.  That afternoon and evening I experienced a really heavy spacey feeling and a slight headache most of the afternon and evening.

Day 2-less of a heavy feeling.  more foggy.  Headache in the evening.

Day 3-today-woke up with the headache and a not quite on top of my game feeling.

Still adhering to my daily routine, albeit maybe a little slower.

It's really going to irk me if I am on the placebo and my mind is doing this to me...

I'm a 57 year old male in otherwise good health

Diagnosed in 2002

Biopsies in 2002 and 2009

I will try to update my progress frequently and it'd be nice to hear from others in the same study.



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