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Post Info TOPIC: Trial Offered


Guru

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RE: Trial Offered
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Hoping you'll get the result you and we all want to achieve  S V R 

We know GS7977 has good  track record   you'll know what to expect from the  Riba so sounds like a pretty good deal

It's the completely experimental drugs with no data on any past trials that scare me

By the way have you seen this petition 

http://hepc-cured.com/  If it makes sense to you please sign it

Good luck Steve

 

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.



Guru

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Please keep us posted Rockfeller

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JoAnne

Genotype 1a, Triple therapy w/Invicek started May 19, 2012

DET 4 wk. UND 2,6,12,24 48 treatment. Achieved SVR 2013!



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Mine will be a 2 drug trial GS7977 & Riba only.



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Steve


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Steve,  I just finished up a 12 week clinical trial of GS 7977, pegasys and ribavirin.  The SX from the pegasys and interferon seem to be cumulative, mainly with fatigue increasing from week to week, but now 2 weeks off meds and feel almost as good as I did before starting.  I'll find out how successful it was in 2 weeks, just had labs this morning.  Hope the 12 weeks works, because any longer and I fear the side efffects would get worse, as most of you know.

LC.  Go to http://clinicaltrials.gov/, and type "Hepatitis C and (your city or state)" and it will give you a list of all the trials that are recruiting in your area.  I was fortunate to find one locally in my hometown



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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



Guru

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Hi Steve, good to hear from you again!  smile  It`s up to you, of course, but I`d say go for it, it`s offering you a chance to clear the virus with no shots and no interferon sx.   And as Malcolm pointed out, here in the UK opportunities like this just don`t come along that often.

Let us know what you decide once you have the full info from the hospital and have had time to think it over.  Best of luck!

Take care, 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.

 

 



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Thanks for your encouraging words guys.

In answer to a number of questions.

I already have been diagnosed with Portal Hypertension and have 3 Varices, these are small at the moment.

The Legacy of TX, even though 12 months behind me has left stll visible scarring from the rash, and occassional discomfort from the sites.

It also appears that during one balmy evening last July, whilst I slept, a Stealth surgeon slipped into my bedroom, filletted out most of

my joints, and replaced them with those from a 95 year old former Tin Miner.

My memory not what it used to be either, but mainly recent events, rather than the past.

I do have a drug that appears to be wallpaper adhesive (Questran) to take every day to "Clean my Brain" on top of 60ml of Lactulose daily, along with my Calcium supplements, etc, etc, etc.

Isn't this fun? The Fairground ride never ends.

I will be attending Hospital as part of the study to get more info before I commit, but I will take on board all you have said and advised.

80 Grand!!!!!! Might have some of that, I've paid in for years, time to get more back.

 

Cheers Guys.



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Steve


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Go for it Steve,

My consultant told me a couple of weeks ago that when it gets registered here it will cost £80,000 and therefore unlikely to be licenced by NICE for the NHS.

Dragonfly



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LC


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Do people volunteer for these trials somewhere?

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Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 



Guru

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Hi Steve, as a fellow cirrhotic with a Childs-Pugh score of 5, here are my 2 cents worth.

You can live with compensated cirrhosis for a long time (10-20 yrs). You need regular ultrasounds 6 monthly) for HCC, and to check for portal hypertension. Your previous treatment may have modified your bodies response to the virus i.e. you may not be forming as much fibrous tissue as previously, so your cirrhosis may progress much more slowly. Quality of life is good until decompensation occurs.

You are in England so trials of 7977 will not be as readily available as in the USA. It's the same here in Australia. From reading the posts, GS7977 causes very few Sx so you would be left with the Riba Sx. These seem milder if not taken with IFN . You have a 3:1 chance of getting the good stuff. I would jump at it!



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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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I sure I am not alone in this thought: you guys knowledge and experience is invaluable
As none of us on tx are guaranteed.
I am 53 and have 48 weeks of tx. On week 22.
My doctor told me I could be looking at liver transplant
If tx failed. I asked when, he couldn't say but after talking
I felt 5 years it could happen if not sooner.
He suggested I sell my company! Who tells a healthy woman
Successful woman to retire if their liver looks good!!
Sold my company on tx since May. I know in my soul God is in control
And has a plan. I am right where I am suppose to be.
Steve, tough place to be.... ESP after 48 weeks!
I, too try to live in the present and enjoy my life but
48 weeks seems long enough; yet.....
Keep us posted and pray about it.
Your answers will come.
Thankfully you have options.
JoAnne

__________________

JoAnne

Genotype 1a, Triple therapy w/Invicek started May 19, 2012

DET 4 wk. UND 2,6,12,24 48 treatment. Achieved SVR 2013!



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My journal is here. I forget how to get to it sometimes?!?....

http://hepcfriends.activeboard.com/t48295757/7977-journal/



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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

 

 

 

 

 



Guru

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hey you, !!smile...I have heard good things about the GS 7977, (at least Jim's symptoms we few), and I can understand your apprehension about doing it blind...I would so want to be the one who got the drug...(selfish?)uhhhh... I cannot say about the rest, I worry about the dinners as well, and am hoping this drug is approved soon. You and I are about the same age, but I have less info on status. I would go for it... Keep on ridin' my dear, I try to treat each day as 'the present' even though it wears my ass out sometimes. It's great to hear from you, Blessings, Iris



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in the silence of the woods, you will not be alone- Chief Seattle

60 years on planet, Female, diagnosed 1978 as non-a non-b, VL 8mill+, Fibro f-1f-2, Genotype 1a, treatment naïve....UNTIL 7-01-18  !!!! started Harvoni 12 weeks. :)

4 weeks=UND, 8 weeks=UND, 12 weeks=UND (EOT= 09-23-2018)



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Hi Peeps,

I have been asked to take part in a clinical trial of a "New" Drug GS7977 with Riba.

It will be over 24 weeks and is aimed at Type 3 non responders, like yours truly.

The trouble is it is blind, You will be split into 4 groups, 3 will have the drugs, one will have Placebo's.

I am unsure about this..............................why?

24 weeks of TX and then a 24 week wait until SVR yea or nay.

Or, the same TX period to be told you were in a Placebo group, and would have to go again!

There is, of course, no guarantees, of anything. Having done 12 months of failed TX I am reluctant to commit to anything

that may affect my quality of life at the moment, I can now admit that I had a rough time on TX and really enjoy

the "Health" I am left with. I am also gifted with Cirrohsis at level 5-6 on the Childs-Pugh scale.

I am 54 now, what could I be left with?

Does anyone know or have experience of a situation where, let's say "Taking My Chances" and letting the HCV & Cirrohsis

"Do Their thing"

How many Christmas Dinners would I have left? Well, ones I could enjoy anyway.biggrin

You are all fairly smart, straight up kinda Guys.

Give it to me straight-What do you think?

 



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Steve


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Steve-o wrote:

Hi Peeps,


I have been asked to take part in a clinical trial of a "New" Drug GS7977 with Riba.

It will be over 24 weeks and is aimed at Type 3 non responders, like yours truly.

 


 Hi Steve and Jim

I love Jims story and results for him and his friends and I would have killed to get on it  I've been watching this since July

Steve     Please calrify if I'm wrong You dont mention a triple therapy TX you only have 2 drugs here 

    New" Drug GS7977 with Riba. It will be over 24 weeks

If I'm not mistaken

Jim  was on a study That had GS 7977, bms 790052, and riba for 24 weeks. The bms Bristiol Myers 790052 was a important part of the sucess of the 100% cure  you can read up on this this artical has more links for more detail

http://www.laprensasa.com/1644_front-page-news/1754529_companies-may-be-holding-back-hcv-cure.html?utm_source=supporter_message&utm_medium=email

GS  forced study to be put on hold after success in phase II becauise they won't partner using Bristol Meyers  daclatasvir

Gilliad is trying to duplicate the Bristol's daclatasvir at the same time. May take a while ( trial and error??? and time  )

and this arical
http://www.fidelity.mobi/fiw/GetNewsDetail;jsessionid=0000_x7coF9xbVaeMNskt_8Xt2D:-1?__JWTS__=0&f_symbol=BMY&action=detail&STORYID=~201204270600STREETCMREALTIME_11510797&IMG=&pageoff=0&CUR_STORYID=200908191409MTLYFOOLFINANCE__rx23772&cur_action=Prev

GS 7977 is the one to watch  but how long will it take to match the BMS drug?

If GS is making combos thet match the 100% cure already Then it is how lucky do you feel  but get satticis on what their using or how it has done  

AS always Please Please ask your doctor Mention this study and get his opinion 

And Note there are many more here with alot of soid knowlage about these studys  

I sincearly wish you The best of luck  and SVR whatever you choose to do

Bill S

 

 

 

 



-- Edited by Bills on Tuesday 16th of October 2012 11:29:01 PM

__________________

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.



Guru

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Steve, I was on 7977, bms 790052, and riba for 24 weeks. I just finished 8/30/12.  I had some sx from the riba but nothing much worth mentioning from the other two.Nothng I recognized anyway. My VL was gone within 14 days and all my other numbers came into normal range within a few weeks. Pretty amazing.

I don't like the "blind" part of it though.  Are you feeling lucky?  Then I would do it. But to be comittted for such a long time without knowing what was going on is tough. So you won't know what your blood work or VL is for a whole year?  I don't like that.

Maybe there are other studies coming or maybe they can guarantee you will be given the drugs?  It is an awesome drug so far.

Good luck.



-- Edited by JIme on Tuesday 16th of October 2012 10:01:33 PM

__________________

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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