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Hep C Discussion Forum -> Clinical Trial Participants -> Abbotts Sapphire II clinical trial
Post Info TOPIC: Abbotts Sapphire II clinical trial
Cinnamon Girl


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RE: Abbotts Sapphire II clinical trial
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Great news, Scott, well done!  And how amazing that your side effects were so easy, even with riba in the mix!

Looking forward to hearing your results, fingers crossed for you, and thanks for sharing your joy!  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.

 

 
dragonfly


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Well done Scott,  I've been trying to get on a trial. They are rare here unless you have Geno 1 now.  Good luck in your new life. Dragonflyxxx

 



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Biggyb


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Very good news Scott, fingers are crossed.



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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~
scott


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Hi Everyone,

Didn't come back last week as nothing had changed, today however is a different story, June 3 2013. I woke up this morning and didn't do something that I have for the last 90 days and that was take meds...

Got to the doctor first thing this morning to see what the study has to say for itself and guess what?  Gotta wait another 2 weeks...WTF?  At least some good news came out of it they unblinded the study and I was not on the placebo! YIPEEEEEE I got the real meds..

Someone had posted some time ago about the colour of the meds, I can tell you that I am in the UK and the riba I received indeed had a grey capsule, so I am not sure what the colour thingy was all about.

" 2 weeks " until I find out the results, but I gotta tell you this I am one happy guy to think that I am now hopefully cured! My centre has been having the same results everyone is clearing this bugger!!

As for side effects once again nothing! Not even the Riba could get me down, a little tired I must admit but that was it after week 2.

Anyway I am babbling mostly through excitement!! O and the beer on the way home!  Just kidding.,

I have one thing that I wish to say, Thank you ABBOTT! (maybe premature but staying positive)

IF you have a chance to take the ABBOTT meds go for it!  Truly a somewhat easy ride....... at least for me.

Thanks to everyone for their support through this, I will check in with the final results in a couple of weeks time.

One happy guy...  " Hep C get out of me" wink

 

 



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scott


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Hi Eveyone again,

Not much to repost here, just finished week 8 of the Sapphire II and feeling pretty good. No side effects since week 3 just life as normal. Not sure what else to say right now other than fingers still crossed that I am on the real meds,. my nurse confirmed today that the first person in our blind trial was unblinded to day an it was placebo so going on that hopefully it is the first batch of patience not the last as i am in the last group.

Anyone just starting these trials or treatment with the abbie/abbott meds let me tell you this, dont sweat the side effects they are negligible to non-existent.... just keep the faith.

 

"Hep C get out of me "

 

Until next time, keep the faith everyone !!  A new day is here #!  WAHOOOOOOOO



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Matt Chris


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Hey Scott

Great news, sounds like your blind study is not so blind. I'm happy for you, knowing where your at is a much better way to go. On my Abbott study I was at <25 VL on week 2 and 4 then UND on week 5-6 .

The study does seem consistent in its results from what our members are reporting.

Your point about staying consistent on every 12 hours is a good habit , but reading the Pharmacokinetics about this Meds you can see the the time frames that their effective life in the body last. Just google the Meds name (ABT450) and the word pharmacokinetics and then read the report, it's give all the pertinent time frames.

Keep looking forward 

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! 
scott


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Hi Everyone,  I just returned from the hospital and week 4. The good news is that the Dr. still believes that I am on the real thing as some of the tests are showing activity that indicates that something is happening.

Next week I should have a better analysis, it seems that all the data from these trials shows that by the end of week 4 you should have cleared the virus or at the very least have <25. She said that after todays bloods are analysed if I am not responding that they will call me back in next week to re-test. So I guess if no phone call next week I can assume that I am responding well ! !

The biggest factor that they have been able to identify so far is keeping to the 12 hour regime of meds. My advice is to take the meds no later than 30 mins on either side of 12 hours!!

Ok,  side effects for week 3+4 were pretty much non-existant. I had a couple of small headaches, no nausea, dry skin so a little itchy but that was about it.  Feeling good, keeping the faith, crossing my fingers etc....

Will check back in next week or 2 weeks from now.

My mantra is Hep C get out of me... I repeat it everyday,  "Mind over matter"!



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scott


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thank you LUV for your kind words of encouragemet. I wish you all the best next week.

smile



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LUV2RYDE


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Scott,

Welcome and that is awesome news. I am on the blinded study too. I will know next Thursday April 4th if I am on the placebo or real drugs. All I have had has been a headache every now and then and this week a little dizziness(could be cause I'm blonde and Polish) ....LOL...just kidding. I am excited and looking forward to my appt. Yeah I hate the blood vamps taking my blood every two weeks too but thank god my RN who is heading the trial is an expert...I never even get a bruise! Best of luck on your treatment.

 

 

 



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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.

 
scott


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Hi evryone,

Well 2 weeks are behind me and so far so good. Checked in with the clinic yesterday same routine as last time except this time I was feeling fine not like last week.

The Dr. said that she thinks that I must be on the real meds because she can see one of my liver test results and it indicates treatment so I am thankful for that.

I asked how they did in the phase II and she said that they had 5 non-responders and all 5 cleared, now this goes against an article i read on here that said ABBOT had reported only a 50% success with non-responders and about 90% for naive.

As we all know this is a double blinded trial and noone knows for sure but I sure do like the fact that my particular centre is batting 100% Can anyone shed any light on this?

Had problems getting the ole nectar out me this week, dont know if the guy was sleepy or mind somewhere else but you know what they say 3rd time lucky!

Side effects in week 2 - non existant really, a headache on Mon/Tue and then clear sailing..

see you next week!

scott

 



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scott


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b Well Hi there,

Im scott and I am glad to have found this site and the thread here, I am Geno 1a, null-responder was diagnosed back in 2008 and have probably been living with the virus for about 15-20 years. I had tried the SOC and at 6 weeks didnt achieve the log drop necessary to continue on, just as well as I hated those bloody shots. n

Anyway I live in the UK and after the initial SOC, my doctors basically put me on a wait and see scheme, this means dont do anything and be good.. lol How can you??

Well 3 weeks ago I got a call from the trials team at King's College in London and someone had failed the requirements for a study and was I interested? I had been offered this trial at phase 2 and turned it down as I was sceptical and not feeling like guinea pig material, but this time a year on and nothing else in the future I decided to go for it!!

Treatment started on March 11th 2013, the Abbott double blinded trial that it sounds like quite a few of you are on. All the same parameters, I will get them hump if I am on placebo, however after the first week there aint no way, definately getting the headaches. but they came at the end of week 1 and I didnt do a good job of hyderating that week so take note, they felt like I had been out the night before on the piss big style!, so the first one came on Friday, I started meds on the Monday so Five days of meds, and when it came F**k it was like a locomotive. I hid in the darkest room in the house. No meds to offset, didnt even know if I could take paracetamol.

Sat and Sunday were about the same, then Monday I had to check in so an hour and half train ride and I make it to my appointment just as I sat down hot flashs started happening, headaches, nausea but only temporarily though. The nurse gave me paracatamol after my bloods of course and then prescribed something a little stronger to offset them. The headaches seemed to arrive about 4-5 hours after dosing..

Other than that little hickup I am here on Friday of week 2 and feeling right as rain (hoping not to jinx it by saying this) I am optimistic and feeling like this might be the beginning of a great futrure without hep C.

I managed to get to the gym the other day and it helped relieve some stress, I have told people at work and this also has helped relieve stress. My partner is very supportive, we are fairly new but she says she is in it for the long haul, thanks honey!!

I will keep you updated with my progress.

Keep the faith and pray please, mind over matter!!



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Matt Chris


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Hello Scott and welcome to the forum

There are many many benefits to be gained from the resources of this forum.

Many members here can provide insight and real help on the journey from people that have had the same questions and concerns.

Some members in the forum are a cornucopia of knowledge to demystify our day to day worries about how are bodies are reacting to the Meds.

I am on the same Meds but a different Abbott Labs study called Turquoise II it's for Cirrhotic Patients. Your experience during the first week seems typical because these new Meds are purging millions of the HCV in a very short time. My study gives us data from week to week and my viral load Dropped from over 6,000,000 to less than 200 in just one week, so that's a lot of change going on within our bodies.

Keep up a healthy life style and high quality diet because this will help you stay on the path to a undetectable level and SVR. 

In my opinion these new drugs do what could not be done with a healthy diet and herbs,  but the super healthy Diet will help your body recover from its years of abuse by the HCV and build your immunity system to fight all other maladies.

Keep your eyes on the prize.

Matt

 (Post script; I wish that I took more seriously grammar class when I was in school,  I can't spell or put a correct sentance together.)



-- Edited by Matt Chris on Friday 22nd of March 2013 05:28:16 PM



-- Edited by Matt Chris on Friday 22nd of March 2013 06:15:13 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! 
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