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Post Info TOPIC: ION-3 trial


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RE: ION-3 trial
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Congrats Sofi

I went in last Thursday for my 24 week draw and as of yet I have not heard back from them. They told me if I didnt hear back from them to re-test I should be good. It is still stressful all the same playing the waiting game. If I have not heard from them by Monday I will give them a call just so I can put my mind at rest.

Sofi we were on the same regiment for the shorter 8 week study it looks liike which I was always a little worried about, only 8 weeks.

Good Luck to all

Rick



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Genotype 1a Chronic Hepatitis C   Stage 2 Grade 3     Baseline  8810000  Alt 118   Ast 89 

Tig


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Hi Sofi,

Congratulations on your SVR 24! WOOT!! Enjoy your Hep free future biggrinbiggrinbiggrin

Best to you, Tig



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Tig

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

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RH, I'm glad to hear you got into another study. Hopefully, it being longer and no ribavirin will do the trick and be fairly easy to tolerate.  Best of luck to you.

Thanks Misfis. I'm trying to get out of this funk I have been in and be happy. Hopefully, the thyroid will help and I will finally feel good again soon!   

I just got my results. I am SVR 24. I am extremely happy about that. I don't think I could physically or mentally endure treatment again.

 

Sofi



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Genotype 1a- Stage One- Diagnosed 2001- currently on 8 weeks Sofosbuvir/Ledipasvir with Ribavirin (Ion 3 Trial)



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Thanks, RH, for keeping us posted.  Sofi, I hope this is the end to all the SX that you have been having, and they have it right this time.  It always feels so better to understand what is going on. 



__________________

genotype 1A,  baseline VL 4,000,000.  ION 3 --12 week sofos/ledis. UND at 4 week.  Probably contracted in early 70's. Diagnosed in Oct 2009.  Stage 1 to 2.  Treatment May to Aug 21st, 2013.  November 19th, 2013-- 12 SVR!!



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Hi all,

I went it for my 24 week appointment and my study nurse had gone home sick. Someone else did all the blood drawing. I chose not to continue any further after this is done.

So I am better but still have all sorts of things going on-- joint pain, swelling, itchy skin to outright rashes at times, depression, problems with endurance, and weight gain. I finally convinced myself I was crazy and it was all in my head-- since everyone seems to think the meds can't do all the crap I have been through with it and everyone is sick of hearing me complain, so yeah, I went to my primary doc and told him I was crazy and needed help, I even made an appointment with a therapist. But it turns out that I have hypothyroidism. I was checked for it at the start of treatment and did not have it. More than likely the meds caused it (according to my doctor). And it explains ALL my symptoms.  So within a week or two, I should feel better. 

It's a mixed bag. I am happy to find out that I am not crazy and there is a solution but I am also a little angry.

 

Sofi



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Genotype 1a- Stage One- Diagnosed 2001- currently on 8 weeks Sofosbuvir/Ledipasvir with Ribavirin (Ion 3 Trial)



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Hey Rick 

Thanks Rick for the update and congrats so far on the trial. I think it would be a real benefit to enter a after study if the medical center is not to far of a drive, the price of a HCV viral load check/load itself is very costly and most studies pay for your troubles with a small payout.

Thanks your contribution and wishing you well in the coming years, hoping you get some rain soon.

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! 



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I went in today for my 24 week blood draw and hopefully my last. They told me they had only one person relapse thus far and that person did at his 12 week. They did say I should dhear back by Monday or Tuesday if there were ant problems and I would be asked to do a re-test. They also told me that I would be put into another study as well if there was an issue. Keeping my fingers crossed. If there are no problems I would be asked to join another study with follow-ups ever 6 months for 3 years.

Wishing everyone the best, I know there should be others that are at the same stage I am currently at as well.

 



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Genotype 1a Chronic Hepatitis C   Stage 2 Grade 3     Baseline  8810000  Alt 118   Ast 89 

HR


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Hey Matt

Ido not know if it's on the clinical trials.gov yet but I will forward you the study info on Thursday. 

Apparently these new DAA's cross attack on whatever drug a person becomes resistant to. For example if I came resistant to Ledipasvir then the Sofosbuvir will step in and attack the virus and vice versa. That is how it was explained to me. There was probably more to it but that's the best way I can explain it.

I hope everyone is doing well and hangin in there. 

 



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



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Hey RH

That is really good news, did they say that they might add a third Tx or test for mutations?

Is the trial listed in the Clinicaltrials.org ? 

24 weeks is what I think all DAA's relapses should try, pulling for you all the brother, the extra time should do the the trick.

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! 

HR


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 Hello All,

Trial place called yesterday and I go in for screening on the ION relapse trial Next Thursday. The meds will be Sofosbuvir and Ledipasvir for 24 weeks. I hope it works this time.

Anyway,just a quick update.

Take Care 



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



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Jim,

Best wishes, Hoping for some smooth sailing for you.



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John


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Please don`t feel guilty, Jim, we`re all very thankful for people like you who go through these clinical trials.  If it weren`t for the trial studies there would be no new drugs!  You are the pioneers, you lead the way, so be proud!  smile

 



__________________

Jill 

(70 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 for the support.  Really, the only sx from this routine is the normal fatigue, but the best part of it is that I retired the first of the year, so I can take things at my own pace.  My day now starts at 6 am instead of 4:30 (wife works until February, I fix breakfast), walk the dogs, and go to the health club, where I'm just trying to maintain my self so I won't be totally out of shape when rx ends.  Then I take the doods to the dogpark, after which I spend the afternoon recovering.

I hope this protocol is the answer, there are so many out there much worse off than I.  And I hope it becomes more affordable.  I feel guilty getting paid to take these pills when so many are struggling to pay for treatment.



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genotype 1a, viral count 7 M

7/12/12 started triple with GS-7977(400 mg 1/day), Peginterferon and Ribavirin  12 wk  trial

11/2012 no svr

12/10/13 new trial with sofosbuvir/ledispavir combo and riba12 wks

3/10/14 UND

3/16/15 still UND, and feeling great



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Hey Jim

thanks for those 4 weeks results , it's just what the doctor ordered UND at 4 weeks , all right way to go. The rest is down hill so stay compliment 100% and you will be on your way.

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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Hi Jim,

Great start! I know you've been there before, but this combo will be the one. Best of luck. 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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Hi Jim, good to hear this news, you`re off to a great start, congrats!!  

Must be great not to have all the sx you had to go through last time, and no shots to do!  Just keep on going...this is an excellent combo, so fingers crossed for you this time round!  smile



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Jill 

(70 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 Jim,

Thats great news! Just keep plugging away and soon that elusive SVR will be yours. It's a long journey and one you've taken before. I believe a strong desire and positive attitude is more than half the battle. Keep that and your goal in mind and good things will follow! Best of luck buddy! Us Florida boys will own this battle, remember that!

Tig



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Tig

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

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They just called with the results of last weeks 4 wk draw and it came back undetectable.  Having been there  before, and having relapsed, I guess I'll finally know in another 35 weeks



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genotype 1a, viral count 7 M

7/12/12 started triple with GS-7977(400 mg 1/day), Peginterferon and Ribavirin  12 wk  trial

11/2012 no svr

12/10/13 new trial with sofosbuvir/ledispavir combo and riba12 wks

3/10/14 UND

3/16/15 still UND, and feeling great



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Hi Jim,

Good to hear from you. Good results so far. I wouldn't worry about the Riba reduction. With this combo, there is doubt whether it is needed anyhow. Best of 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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Good to hear from all of you! I still wonder about side effects. I had an extremely fast growing cataract and have to have surgery on it. Probably will never know if there is a connection--- I'm young for cataract surgery.... Aside from that, I feel good. A little nervous about my 6 month blood draw.

__________________

genotype 1A,  baseline VL 4,000,000.  ION 3 --12 week sofos/ledis. UND at 4 week.  Probably contracted in early 70's. Diagnosed in Oct 2009.  Stage 1 to 2.  Treatment May to Aug 21st, 2013.  November 19th, 2013-- 12 SVR!!



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I guess this is the same protocol I am on now, don't know if it has the same name or not.  In 2011 I did a 12 week trial with sofosbuvir, riba and pegasys, but did not achieve SVR.  12/10/13 I started on a 12 week sofosbuvir/ledispavir with riba.  Originally the riba was 600 mg/day, but they cut it down to 300 after 10 days due to a high bilirubin level.  Had 4 week draw done today, and got the 1 week results.  

ALT  68 to 39

AST 61 to 34

HCV RNA  7,400,000 down to 61

 

Next week I should get the results from this week, but it looks good so far.  The sx are much better than the first go round, especially since they cut the riba in half.  No complaint from me on that decision.  The only problem I seem to have is fatigue, but nearly as bad as last time.



__________________

genotype 1a, viral count 7 M

7/12/12 started triple with GS-7977(400 mg 1/day), Peginterferon and Ribavirin  12 wk  trial

11/2012 no svr

12/10/13 new trial with sofosbuvir/ledispavir combo and riba12 wks

3/10/14 UND

3/16/15 still UND, and feeling great



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Hi Misfis, I had been thinking the same as well just the other day, had not heard much from anyone in group. Hope everybody is doing well and Happy New Year to all.

I believe I have my last appointment with the study within the next cpl of weeks, reminds me I need to check on that date. The last blood draw. They mentioned something about perhaps having me join another group after this next appointment. They said it would be located somewhere else.

Still a little nervous in regards to this last blood draw.

Anyhow wish all well and the best

 



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Genotype 1a Chronic Hepatitis C   Stage 2 Grade 3     Baseline  8810000  Alt 118   Ast 89 



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Hi All,   No has posted on this group for a while, and I'm curious as to whether there has been any new develpments for any of us.  Karen, I was wondering if you got the results of your three month post treatment blood draw yet, and what ever other news there might be.   Hope to hear!



__________________

genotype 1A,  baseline VL 4,000,000.  ION 3 --12 week sofos/ledis. UND at 4 week.  Probably contracted in early 70's. Diagnosed in Oct 2009.  Stage 1 to 2.  Treatment May to Aug 21st, 2013.  November 19th, 2013-- 12 SVR!!

HR


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Looks like the FDA approved Sofosbuvir and the price tag will be $1000.00 a pill (wholesale cost) or $28,000 a bottle.. They are saying it's the wholesale acquisition cost.. Not sure if patient gets it for that or if the wholesaler marks it up 30% or what. 



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



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Hi Lil Eddie,

Congrats. You guys are on a roll!  Enjoy a happy, HepC free life.  Cheers and thanks for sharing.



__________________

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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Hey Lil Eddie

Super Congrats , wow this Sofosbuvir, Ledipasvir Alone Or With Ribavirin is a fantastic combo. The FDA should just approve it and be done with it.

Have any of you Ion-3 participants had any side effects after the 12 weeks EOT or any comments about any physical or mental problems after or during treatment ?

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! 



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Congrats!!, best of luck to you!



-- Edited by newmex on Tuesday 3rd of December 2013 04:03:02 AM

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John
Tig


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Outstanding news Eddie!! What a great bit of information that is for you and all who helped you reach your goal!!



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Tig

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

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CONGRAGULATIONS!!!!! 

 



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Excellent news, Lil Eddie, congrats on such a great result...SRV12!!  So pleased to hear this!  smile



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Jill 

(70 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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Wow!  Li'l Eddie, that is great news.  I just just thinking of you this morning and wondering when we would be hearing about your results.   You must be one happy person!



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genotype 1A,  baseline VL 4,000,000.  ION 3 --12 week sofos/ledis. UND at 4 week.  Probably contracted in early 70's. Diagnosed in Oct 2009.  Stage 1 to 2.  Treatment May to Aug 21st, 2013.  November 19th, 2013-- 12 SVR!!



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Congratulations Lil Eddie!!  That is great news.

Congratulations to Misfis on your SVR 12!

Welcome to the forum David. Congratulations on your SVR12 too!

I hope I didn't miss anyone. There are so many SVR12s being announced i can hardly keep up with them all. Onwards to SVR24!



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GT1A, Currently on 8 weeks Sof/Led with RIBA (ION3) 

HR


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Great job Lil Eddie.. Well done sir.



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ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



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Another HOME RUN!! Congrats! Seems like Im seeing more and more lately. 



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John


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Congrats Lil Eddie!  Lets get the party started....



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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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Lil Eddie wrote:

Just got my post treatment 12 weeks results...... Wait for it........ SVR12!!!  Now on to six months!!!



 That's great news, love hearing this kind of news...



__________________

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~



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Just got my post treatment 12 weeks results...... Wait for it........ SVR12!!!  Now on to six months!!!

 

Keeping positive thought for the rest of "our gang"!

 

 



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Thanks, Matt, for the info!



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genotype 1A,  baseline VL 4,000,000.  ION 3 --12 week sofos/ledis. UND at 4 week.  Probably contracted in early 70's. Diagnosed in Oct 2009.  Stage 1 to 2.  Treatment May to Aug 21st, 2013.  November 19th, 2013-- 12 SVR!!



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Hey Michele

I believe the answer to your question is the relapsed rate after 12 weeks of SVR is only 2% and then it goes down to 1% after 6 months. 

The thing we have to remember is with all the new DAA's these percentages will moderate in the comings years?

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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Hi all,   I just emailed my clinical research person with this question, but she is out of the office until Dec 2.  Maybe some of the gurus know.  To what degree is the 6 month post treatment blood draw just a formality?  What are the statistics, as far as people know, of clinical trial participants relasping between 12 and 24 weeks?   I was on the 12 week sofos/ledispavir no riba arm of the ION 3 trial.



__________________

genotype 1A,  baseline VL 4,000,000.  ION 3 --12 week sofos/ledis. UND at 4 week.  Probably contracted in early 70's. Diagnosed in Oct 2009.  Stage 1 to 2.  Treatment May to Aug 21st, 2013.  November 19th, 2013-- 12 SVR!!



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Hi David, welcome from me too, and congrats on your SVR12! 

Thanks for sharing your story with us, it will give hope and encouragement to many.  Best of luck with your next viral load test in February, keep us posted!  smile



__________________

Jill 

(70 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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Congrats and welcome David 

Excellent experience and even a better result, wow 8 weeks can really work for some.

With your kind of result it's now a brave new world.

Thanks for the hope and information

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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Hi David,

Congrats on the SVR 12. You were lucky to be on that Trial and best wishes for your SVR 24. Cheers.



__________________

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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Welcome DAVID, glad to hear it..



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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~



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Congratulations David!  I'm so happy to hear your success story and wish  you continued health.   I am sure you will hear good news in February.  I too consulted with Dr Schiff although he was not my treating hepatologist...but he was the one who I believe saved my life with his advice and guidance.  A wonderful person and doctor. 



__________________

GT 1b, VL5Mil+ when diagnosed in 2012, acquired HCV 1970; BMS 3 drug clinical trial 2/13, und 12 weeks post treatment, UND 24 weeks post treatment; UND at 18 months, UND at eot + 2 years. Still UND at +5!



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yes, David, welcome!   The 8 week two drug combo is one that is new to me.  Good to hear you are 12 week SVR!



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genotype 1A,  baseline VL 4,000,000.  ION 3 --12 week sofos/ledis. UND at 4 week.  Probably contracted in early 70's. Diagnosed in Oct 2009.  Stage 1 to 2.  Treatment May to Aug 21st, 2013.  November 19th, 2013-- 12 SVR!!

HR


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Hey David, welcome to the forum. Congrats on the SVR 12. Great job.



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



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Hello to everyone,

I'm David. A Miami, Fl native of Cuban descent. I was 1st diagnosed back in '98 after my mom regrettably passed away from HepC. What I realized then was that I had been born with it. So now at age 43, and after wisely having chosen over the last 15 years to not participate on the Ribavirin/Inteferon "cure", I was blessed enough and basically won the lotto, to be 1 of 600 I am told, in my area to be chosen for the naive ION 3 study. The final phase before approval by the FDA. 

 

Well I was given an 8 week, once a day pill with both inhibitors with no ribavirin. I was contacted a week or so ago, that 3 months out after finishing my dosage, I am still reading undetectable on the HepC virus, and the final test will be in February at the 6 month out mark. I am so thankful and truly know that I am so fortunate to be able to give my poor liver a break from 43 years of damage. 

To all, there is hope and a definite cure has been developed. My Dr., Eugene Schiff is beginning to battle Gilead in price control matters. Hopefully, he strikes a blow to the supposed cost of what it is estimated to be.  

 

 



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Congrats Misfis! That is so good!



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Genotype 1a- Stage One- Diagnosed 2001- currently on 8 weeks Sofosbuvir/Ledipasvir with Ribavirin (Ion 3 Trial)



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Hi Michele,

Congrats on a great result! The next one will be a formality.  Party time!  biggrinCheers.



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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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