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Post Info TOPIC: One Shot Cure Clinical trials start approved by FDA


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RE: One Shot Cure Clinical trials start approved by FDA
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Hi Lisa.

I'm glad it made you laugh. We all need as much humor as possible. It's certainly something I haven't had enough of lately. This 'Twilight Zone' helps me to laugh at myself sometimes.

I hope you are doing really well.

jimbob

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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.



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suziq wrote:

Thanks Tig,

I just have used the internet for info on Hep C for years.  Along the way I have subscribed to websites about Hep C and they send me information.  And sometimes when I double check info, I find more websites.  Most of my searching is because I am in a rural area with doctors who don't have or look up information--so I find out for myself. 

For instance, today I checked to see what ObamaCare offers my daughter who is 61 and unemployed in both Texas and Louisiana.  Fun, fun--ABSOLUTELY NOTHING.  People to 65 without children and with low incomes have NO safety net for health care.  The policies are in the $500 a month range--with deductibles.  Affects a lot of those with Hep C as well.  Clinical trials may be their only hope.  I am not a happy camper with this information.  Some states opted in to provide health care through Medicaid for this group--but not these lovely poor states. From So California to Texas was a definite cultural shock.  Does this belong on the Rant Section???

SuziQ  


 SuzeQ, as a fellow Texan I'm equally appalled at this situation.  We unfortunately still have to live with the anxiety if we lose our job while sick we're screwed.  I wonder what the possibility is to become a resident in another state, if only temporarily (nobody has to know), until treatment is complete?

 



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42 yrs old: geno 1b, 23mil VL, ALT/AST 269/94 as of Apr '14.  Got HCV when I was 16.  Relapsed from Peg/Riba twice, last time in '08.  Completed Sol/Oly on 9/2/14, UND as of 10/7/14



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Hahaha Jimbob, you made me laugh :P

I think everyone deserves a cure, one shot, I'd give it a go, seems all the options available curently are not without side effects...



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Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 



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I bought coffee at McDonalds this morning along with a biscuit and cup of water to take meds. I finished and placed eveything in the trash. On my way home I realized I threw the coffee away without ever opening it. What brain fog?

 

jimbob



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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.

Tig


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Hi JB,

Not to worry about that. That's a function that the admin team can utilize. You can edit posts using the tools provided in the post box. We keep an eye open for things like that and is something we've all done at one time or another. You have to love that brain fog, lol!!

Tig



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Tig

68yo 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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Tig--

Yes, it would be sweet. I too hope that day is sooner than later.  i think it might help many on here who are non-responders.

Thank you for correcting my double.  Kinda like my vision nowadays.biggrin If you can explain to me how it's done I will correct it my self next time. I'm using a hand held and it proves to be difficult at times.

jimbob

 



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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.

Tig


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Jimbob,

Wouldn't that be sweet? I can envision the day that not only will there be a one shot fix, but likely a one shot vaccine that bans that nasty bug from our global society. Lets hope it's sooner than later!. I corrected your double post, that stuff happens, and is easily corrected.

Tig



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Tig

68yo 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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Depends on what one is facing Zilkster, and their options,  remember the ole saying 'desperate times call for desperate measures .'if I had no other option i.e. insurance, I think I woulld go check it out to find out more about it. i'd probably take it if i like d what i heard. Someone on this board flew to their clinical trial out of state each time they had to go. Questions is, how many times would you need to go back after a single shot? Might be worth looking into at Duke U. just to check the parameters. It sure would be nice to take shot and be done with it all.biggrin

Jimbob



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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.



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alyways up for a good rant, so rant away :)

to be honest, i wouldn't dare to go to Phase I clinical trail. Too much guniea pig thing for me ;)



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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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Hey Suziq

Read that report and checked out the companies web site. Looks like it might be great technology the company has many other items on their plate as well. It's another avenue to fight the HCV monsters

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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susiq,

thanks for sharing the info w/ us. i can't wait to see results from the 1st human trials!!!!!

this kind of stuff gives us all hope for bigger & better options for treatment.

sandy,ucbgal



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Please feel free to rant wherever you like, SusiQ, you have good reason to by the sounds of it.  Many thanks for posting this information and for all your posts, very helpful. 

Great news that you`ve finished your trial now, how fantastic!  Wishing all the best of luck to you, and to your daughter too. 



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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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Suziq,  What a deal. Wow. I pray this works out for the millions of people who still have the disease. Also hope its at a price that the average person can afford. And I am sure you deserve the right to rant if you please. Best of luck to you and all. Thanks for the info.

 



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John


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Thanks Tig,

I just have used the internet for info on Hep C for years.  Along the way I have subscribed to websites about Hep C and they send me information.  And sometimes when I double check info, I find more websites.  Most of my searching is because I am in a rural area with doctors who don't have or look up information--so I find out for myself. 

For instance, today I checked to see what ObamaCare offers my daughter who is 61 and unemployed in both Texas and Louisiana.  Fun, fun--ABSOLUTELY NOTHING.  People to 65 without children and with low incomes have NO safety net for health care.  The policies are in the $500 a month range--with deductibles.  Affects a lot of those with Hep C as well.  Clinical trials may be their only hope.  I am not a happy camper with this information.  Some states opted in to provide health care through Medicaid for this group--but not these lovely poor states. From So California to Texas was a definite cultural shock.  Does this belong on the Rant Section???

SuziQ  



__________________

Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR

Tig


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That's some pretty amazing information Susan! Where do find all this stuff? I'm thankful you are a friend and member here. It's obvious that you care about this and we're certainly better for it. Thanks for your dedication and compassion, it does make a difference!

Tig



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Tig

68yo 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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Benitec Proceeds With First In Man Trial for TT - 034: A Single Injection To Treat Hepatitis C

 

Posted: 14 Jan 2014 10:02 AM PST

 

Hepatitis C Trial To Proceed
1/14/2014 9:04:01 AM 

Sydney Australia, 14th January 2014: RNAi - based therapeutics company Benitec Biopharma Limited (ASX: BLT) today announced that the US Food and Drug Administration (FDA) has advised the Company that it may proceed with it s first in man clinical trial for TT - 034, a ddRNAi - based therapeutic, designed to treat Hepatitis C with a single injection .

This follows the FDAs review of Benitecs Investigational New Drug (IND) application, which was filed on 6 December 2013.

Benitec Biopharmas CEO and Managing Director, Peter French said, We are very pleased with this outcome which establishes Benitec as a clinical stage company .
 

 Excerpt From:March 2013/ Benitec Selects the Duke Clinical Research Unit as a Site for Hepatitis C Phase I/II Clinical Trial

About TT-034 
TT-034 is a potentially transformative therapeutic that is intended to provide a "one-shot-cure" for Hepatitis C with a single injection. TT-034 works through RNA interference (RNAi), which is a naturally occurring regulatory process in cells that acts to "silence" genes after they have been transcribed from DNA into messenger RNA. Benitec's proprietary ddRNAi approach involves the introduction of a DNA vector that produces short hairpin RNAs (shRNAs) that are processed by the cell into siRNAs. This approach emulates the cell's own gene silencing mechanism and provides long term activity (months). Moreover, the virus vector used to deliver the TT-034 construct, an engineered non-replicating adeno-associated virus (AAV8), targets almost exclusively liver cells (where HCV replicates). TT-034 is further designed to prevent viral escape through mutations (a major problem for most HCV drugs) by using three different shRNAs to simultaneously target three separate highly conserved regions in the HCV genome. In mice and monkeys, TT0-034 has been shown to transduce 100% of hepatocytes in the liver and provide high shRNA activity for 180 days (the duration of the studies), without adverse effects. 


For further information, please contact the persons outlined below, or visit the Benitec website at www.benitec.com 


-- Edited by suziq on Wednesday 15th of January 2014 04:59:12 PM

__________________

Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR

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