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Post Info TOPIC: A journey through the twists and turns of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin


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RE: A journey through the twists and turns of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin
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Hi Karen,

Good luck! Hope all is in order for you to srart. Cheers.



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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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Was giving some thought tonight about how bizarre the setting was for my screening visit.  I was instructed to go to a plastic surgeons office, ring a portable doorbell that was lying on the counter and wait for someone to open up the locked door behind the reception area.  Upon leaving, I was escorted out a back elevator....What the HELL!  Talk about protecting your privacy...Maybe I should wear a disguise on the next visit...Just trying to find the humor in all of this...

 



-- Edited by Karen on Sunday 7th of April 2013 04:50:16 AM

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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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The day has finally arrived...went for my screening (blood, EKG, etc.), to sign consent form(s) and meet the PA.  If all tests meet the criteria - treatment phase begins in 28 days.

There are 4 groups in the open labeled study.  24 weeks and 12 weeks-Sofosbuvir/GS-5885 with and without Ribavirin.  They tell you what group you are assigned to on the first day of taking the study drug.

If any of the labs do not meet the guidelines set by Gilead-only "one" repeat test is allowed.

Actually, feeling very calm and at peace today...

 



-- Edited by Karen on Thursday 4th of April 2013 10:05:00 PM



-- Edited by Karen on Thursday 4th of April 2013 10:37:31 PM

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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Karen

Stay as positive as possible the days leading upto your visit.

The Doc will most likely do a quick physical and ask some questions then have you read the consent form and sign off right there or after you read it.

In my case, my choice was to read it there quickly and sign off and get on with the blood draw and the other necessary items. 

I reasoned because they let you stop and remove yourself at any time from the study that signing it really does not have any immediate power.

I have been waiting long enough and these Meds are on phase IIII which is addressing  not so much safety concerns as much as dosing and portions.

Keep your faith high and good things will come...

Matt

P.S. Karen thank you for the encouraging response to my last post it touched my heart.



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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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Very good to hear this, Karen!  Take some time for yourself to relax and unwind over this Easter weekend, you`ll be fine!  smile



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Jill 

(69 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.

 

 



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Thanks Jim...I needed that..

 



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Wait till you get on the riba, if you do.   I was crying at picutres of kittens....lol........I kinda miss it.



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jim

GT1a, St2 Lv2 last biopsy 2002, VL  11.4m,  start triple tx 9/30/11

VL 470 @4wks.....VL 22,000 @8wks  stopped tx

Round 2-  Started 3/16/12   PSI-7977, BMS-790052, Riba Undetectable day 14

Did 24 weeks Still UND 12 weeks post tx, SVR24!!!!!!! 2/14/13

 

 

 

 

 



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Back on!!!  Scheduled for next Thursday...

Had a melt down this week...Shoot!  

Overly emotional....breaking down in front of the clinical nurse will be a no..no...!  



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Karen

Your on the right track Karen, about needing to be a very strong advocate for yourself.

Always remember the nurses and doctors want you to make it on the study, their job depends on getting participants for the study. 

Also remember that if they called you , that you allready passed there first pre-screening criteria So you should feel good about that.

Try to have them reveal as much information about the study as you can get, just be kind as you can.

On my study the nurse has a very large binder with a ton a info, it may be than they have not read the in depth particulars yet.

Keep the faith

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! 



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Yes I think you`re going to have to be quite assertive, Karen, and press them for the info you need.  It`s perfectly reasonable to want to know all the details.   Best of luck, and let us know when you find out what`s going on!

I`m moving this thread to the `Clinical Trials` section so it doesn`t get lost.  Jill



__________________

Jill 

(69 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.

 

 



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(;( hope it's just postponed.)

Hi Zlikster,

Thanks for asking...not sure yet!  If so...not sure that would be great news for this trial.



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Hi Jill,  Always good to hear from you;)

Based on my experience last year and the week prior to this appointment-my guess, the nurses' in charge are lacking in "attention to detail".  Last week when they set up this appointment-knowing they were going to be running a load of blood work-I asked whether I needed to fast, they could not give me an answer....Seems like a simple and reasonable question to me!  This makes me a little nervous!  

Looks like I will need to be a very strong advocate for myself...as I do not have a high confidence level with this group...For that reason, (I apologize ahead of time) I will driving everyone able and willing to help, batty with questions during the process.  That said, hopefully it will give others a load of information should they have a similar situation.

Stay tune!!!  See what happens next!



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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;( hope it's just postponed.



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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!




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Oh no, Karen, why?  Have they given you another date?  How frustrating when you`re all set to go...  h



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Jill 

(69 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.

 

 



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The twists and turns have begun....My pre-screening for tomorrow has been cancelled.  no.gif

 



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Thanks Matt....You have provided me with questions I would not have thought of...wonderful!

Hi Malcolm...Yes, that was a great disappointment. Hopefully, what happen over half a life time ago will not resurface this time.  Thanks always for your supportive words.

Ok....until next week.

 

 



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Hi Karen,

That's a great trial to get on. I remember your troubles in July 2012 when you were trying to get on a Gilead Trial. I hope that's all resolved.

From the data so far, there would seem be be little difference between the Abbott trio and the Gilead trio. Good luck!



__________________

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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Karen

Congrats on your journey,  I been down this road with my current trial (Abbott Labs)

Yes , first find out what are their pre-qualifier lab results. Some of them are listed on the government web site for trials, but they have more intensive list based on CBC and Liver panel results. 

You should have your own very current CBC and liver panel. Ask you current Doctor or you can walk into Any Lab Results Now, or any other self guilded walk in lab that does blood work. 

Knowing where I was at before I was tested was important to me to get psyched up to pass there requirements.

Ask for a copy of there Research Subject Information and Consent Form,  this form had most of the details about the study, though I had to ask for another form that had the finer exclusionary criteria that they based there decision on. 

Also ask if they allow you to retest if you fail by just a small amount on one of your labs.

For me knowing ahead of time if I had a good chance of qualifying was important, but I was deemed cirrhotic by my Doctor so I had a lot more hoops to jump through.

I am hoping the best for you, just keep your eyes on the prize.

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! 



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The call came today to start pre-screening (March 26) for the open-label study to investigate the efficacy and safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.  

I am wondering if there are questions I should be asking?  Are there any questions that others wish they had asked before starting on a trial/treatment?  

How things change...a year ago I had made up my mind to live out my life with Hep C... Today I am trying to prepare for the most challenging decision of my life. I feel fortunate to have such a wonderful place to come to at this time...The knowledge, strength, and bravery of all that have been through treatment or are currently on treatment has inspired me to move forward. 

This moment is surreal....the journey is about to begin.

 

 

 

 



__________________

Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014

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