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Hep C Discussion Forum -> Clinical Trial Participants -> Sofosbuvir
Post Info TOPIC: Sofosbuvir
Cinnamon Girl


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RE: Sofosbuvir
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Hi Nirmalee, sorry to hear your didn`t make it onto the trial.  Very disappointing  but it was well worth a try. 

You have good reason to stay optimistic though as it`s looking increasingly likely that Sovaldi will be available over here in the UK at some point later this year, and being a priority case you`ll be one of the first to get it. 

Wishing you all the best.  Take good care of yourself, and keep in touch!  ~ Jill xx



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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.

 

 
JIme


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Well, that's too bad. You tried your best and now just keep moving forward and stay the course of healthy living. I hope it will be approved soon for you.  Have a great day!

Jim



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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

 

 

 

 

 
dragonfly


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Got booted off the trial as my bilarubin level was too high.  Gutted but things will get better I'm sure as I'm down as a priority when it is licensed.  Good luck to all who were able to pass the tests.

N xxx



-- Edited by dragonfly on Tuesday 21st of January 2014 11:05:06 AM

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Cinnamon Girl


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Hi again, Dragonfly,

Just to say...I`ve joined all your current posts together into one thread so that we can follow your progress more easily. 

Best of luck, do keep us posted!  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.

 

 
Cinnamon Girl


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RE: Screening again
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Hi Dragonfly, good news that a biopsy wasn`t a requirement for the trial, I had assumed it would be.  Great, so you`re still in the running then, as long as your high bilirubin levels aren`t going to be a problem.

I heard from someone else recently that Sovaldi could be available over here in the UK that soon, on a priority basis, which is absolutely amazing! 

Things are really looking up for you now, and I`m so pleased for you!  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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Hi All,

I have been to the hospital today.  I'm actually glad not to have the  biopsy and it wasn't a requirement for the trial - they just wanted to keep the sample in a vault somewhere in Geneva.  The problem is my bilarubin level which is high.  However these drugs will be liscensed over here in September and prescribed on a patient by patient basis.  My consultant has assured me that I will be a priority for this so all is not lost!  Thank you for your support.

Dragonfly xxx



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Matt Chris


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RE: scrrening
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Hi Dragonfly

I was sad to hear your news, are they allowing you to re-test ?

You should ask what the limits on the labs are to qualify, typically the study nurse has the figures that within the target range to qualify.

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! 
mallani


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Hi Nirmalee,

Sorry to hear about the biopsy. Can you tell us your platelet level? Good luck.



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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
Cinnamon Girl


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Sorry to hear this, Dragonfly.  I`m really hoping things turns out well for you...let us know how it goes, we`re always here for you.

Sending hugs xx.

 



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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.

 

 
Karen


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Oh my....I was sure hoping for the best for you.  

Sending you a big hug...warm wishes that things turn around real soon.....they will.



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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
newmex


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dragonfly wrote:

I've just had a call from the hospital and they aren't going to do the biopsy as my platelet level is ltoo low.  However my biliarubing level is high which may be an exclusion criteria - I'm very worried.

Dragonfly,

So sorry its not working out yet but hang in there, Wishing all the best for you.

 



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John
dragonfly


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I've just had a call from the hospital and they aren't going to do the biopsy as my platelet level is ltoo low.  However my biliarubin level is high which may be an exclusion criteria - I'm very worried.



-- Edited by dragonfly on Wednesday 15th of January 2014 06:29:02 PM

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mallani


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RE: Screening
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Hi Nirmalee,

Good luck with the screening and presumably the Bx will show F4. I'm assuming cirrhosis is OK for the Trial. I see it's 2 years since you got the bad news after your previous Tx- this one will work! 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
Matt Chris


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Hey Dragonfly

That is good news, if they already scheduled your biopsy its a good sign.

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! 
Karen


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Fingers crossed Dragonfly...



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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
newmex


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Best of luck to you, let us know



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John
dragonfly


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I went for my screening today and have a biopsy booked for next Thursday so fingers crossed.  They are couriering over my bloods to Geneva today.  Everything else seems ok.  Will keep you posted.

Dragonfly xxx

 



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Tig


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RE: Sofosbuvir
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Hey Gig,

Thanks for sharing that great news with us! UND since week 3?? That's nothing short of fantastic and obviously a sign of great things to come! I'd say your high hopes are well founded and wish you continued good luck. Ribavirin can be a real bear at times but I know you've got the strength and obviously the desire to see it to the finish line! If we can give you any tips regarding those issues, just let us know.

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Gig


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Hey All starting 6th week of Gileads trial Sofosbuvir with Ledipasvir and Rib. worst is usual for Rib. insomnia bad belly but have been putting up with bad belly for a long time. Have high hopes for this combo so far vral is undetectable since week 3 pretty incredible if it stays that way. My true hope is that we can wipe this out so the many people that are suffering can be cured.

 

Prayers and good thoughts to all

Gig



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Karen


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RE: Waiting for screening
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Hey Dragonfly...   After my experience (laughing), just go in with a smile and act like your on top of the world...like life is great...no issues or problems...Any sign of the contrary and you will have to steal the drugs and run for the nearest exit.

Best of Luck...Looking forward to hear a positive outcome...it is your time!

karen



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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
dragonfly


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Thank you for your input - after a hectic Christmas with 2 small nieces and godchildren I have been resting and watching my box set of Harry Potter! Internet access and the roof doesn't blow off!



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Tig


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Sofosbuvir
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Hi April,

Sovaldi is the brand name given to it by Gilead. The name Sofosbuvir is the generic name used throughout the development phase.

 Sofosbuvir (formerly referred to as both GS-7977 and PSI-7977) is a nucleotide analog polymerase inhibitor - See more at: http://hepatitiscnewdrugresearch.com/gs-7977-formally-psi-7977.html#sthash.swlANR2C.dpuf

Hope this helps!

PS: What you're calling Ribosphere, while correct, is more commonly referred to as "Ribavirin" or Riba.



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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aprileee


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I thought it was called Sovaldi?? lol

This is what I hope to start in the next few weeks along with the dreaded Ribosphere! (again) But I'm probably spelling that wrong too! The "S-drug" and "riba-rage" works for me! As long as its not called Pegintron!! :)



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33 years old Genotype 3a NO luck with Peg & Riba in 2013 but am undetected after 2 weeks of Sovaldi with Riba 2014 :)
Matt Chris


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RE: Waiting for screening
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Hi dragonfly

Been down that trying to qualify for the trial road before and the best advice is to remember that you have already been filtered by your doctor so you are most of the way there.

Some trials will have limits on Liver Functions tests and other labs works, if you ask the study nurse  she might be able to tell you what the upper limits on those tests results are so you can compare your current lab numbers to the limits to qualify. Some trials will give you two trys to make it. Before you go eat good and get a lot of rest and de-stress as best you can.

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! 
Tig


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Thanks for that information Jill! I failed to track that post down yet it was right in front of me. My bad blankstare. I wish you good luck at your screening Dragonfly! I'm sure the anticipation is big, but the opportunity will be great. I look forward to hearing about the process.



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Cinnamon Girl


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Hi dragonfly,

Great to hear this, hope it goes well. As far as I know the sort of things that you can expect at the screening include a physical examination, blood and urine tests, maybe a heart EKG, as well as going though your medical history.  You should have the opportunity to discuss the details of the trial and which arm you`ll be allocated to, so have your questions prepared in advance.  I expect you`ll also need to read and sign an `informed consent` form.

I expect others who`ve been through the screening procedure will add their own experiences.

Let us know how it goes, I`m keeping my fingers crossed for you.  smile

 

PS - Hi Tig, this was dragonfly`s last post, with details of the sofosbuvir (sovaldi) trial..

http://hepcfriends.activeboard.com/t55871108/sofosbuvir/



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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.

 

 
Tig


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Hi Nirmalee,

I tried to look back a few posts but didn't see mention of your Tx plan. I understand that you're preparing for round #3 and expect with all of the recent advances, your chances for SVR are good. How has your fibrosis score held since your last biopsy? I saw the news that cirrhosis had set in and I'm hoping it hasn't progressed too much. What's your current MELD score? The newer drugs should reduce your Tx time significantly if thats your plan.

Can you explain what screening you are going for? I'd be glad to talk about it, may not know the answer but I'll sure try to help you with it! I'm sending positive vibes your way! I also saw you mentioned that you were studying at OU in Planetary Studies. How has that been going? Sounds interesting! Good luck!

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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dragonfly


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I go for screening on the 9th an am trying to maximise my chances, any tips? 



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Cinnamon Girl


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RE: Sofosbuvir
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Hi Dragonfly, thanks a lot for the information, it`s good to hear about trials in the UK. 

This looks like it could be the clinical trials you`re referring to... Gilead phase 3 trials for gen 2 or 3, tx naive or tx experienced, 16 or 24 weeks of sofosbuvir + riba, or 12 weeks sofosbuvir + peg/riba. There are various locations in the UK, plus the US and Canada, still recruiting.

http://www.clinicaltrials.gov/ct2/show/study/NCT01962441?term=sofosbuvir&rank=2&show_locs=Y#locn

All the best of luck with the `S` drug, keep us posted!  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.

 

 
lauralou57


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Don't feel bad - I have been trying to pronounce the word sofosbuvir correctly for months - even my friends in medical research pronounce it in different ways. So I gave up on pronouncing it and just call it the S drug which will save many lives!



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dragonfly


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Can't even spell the name of the drug which I hope will save my life.  At last the UK is doing widespread trials for geno3 - lobby your consultant.

Dragonfly xxx

 



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