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Post Info TOPIC: New upcoming trials?
Tig


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RE: New upcoming trials?
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Malcolm,

From what I've read, perhaps the reason the SVR 12 data hasn't been released may be due to Idenix' entry (collaboration) with Janssen Pharm. into the study. The date of the notice just happens to be the same date the SVR 4 results were posted, Jan. 2013. If I were to guess, any results after the collaborative date began would be restricted. Everyone wants their piece of the credit perhaps? What say you?

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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mallani


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Tig,

I saw that, but still only see SVR4 figures. Why aren't the SVR12 figures published? 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
Tig


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Malcolm,

We talked about this briefly today and had a few links to information there as well.

Tig

http://hepcfriends.activeboard.com/t56843411/helix-2-trial-by-idenix/?w_r=1398639216#lastPostAnchor



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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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mallani


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Hi rundout,

Do you have SVR 12 figures? Cheers.

http://ir.idenix.com/releasedetail.cfm?releaseid=818775



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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
rundout


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They wern't accepting cirrhotics,  only 1 person who finished the treatment didn't reach SVR  the other 5 dropped out for reasons that had little  to do with the treatment. so the 85% is not really accurate but who knows... 

 They are getting ready to expand the trial soon if yr still interested



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GT1a /1b  IDX719/Olysio/Tmc647055/Noravir/Ribavirian ..ST1/27/14..  EOT 4/21/2014 UND EOT+4 SVR
mallani


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Hi rundout,

The only results I've seen for Helix-1 was 85% SVR4. Do you have a link to any other data? As they were all Geno 1b's, Rx naive, and <F2 fibrosis, I wasn't that impressed.

Helix-2 may be more impressive with the non-nucleoside inhibitor TMC-647055 added to the mix. Do you know if they are accepting cirrhotics. 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
rundout


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Check out the Idenix Helix 2 trials they may still be accepting 1a for the phase 2 they are not getting as much press as the big guys but there results are impressive from the helix 1. My nurse told me most of them are  now approaching SVR 12  and so far at least from my location they are all looking good .



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GT1a /1b  IDX719/Olysio/Tmc647055/Noravir/Ribavirian ..ST1/27/14..  EOT 4/21/2014 UND EOT+4 SVR
suziq


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Hi Mcmaklin,

 I felt pretty good for most of the trial, but the last few weeks I just slept a lot.  I was on an 18 week trial--which is unusual for the new drugs. And I was on ribavirin I was the only one at my test center on 18 weeks--the rest were on 8 or 12 weeks  That seems to be the new treatment length for the newer drugs

 My trial was a phase 2 trial so Merck will be doing more trials in the coming year. If you fill out your signature card with your genotype and location then it makes it easier for us to be helpful in our responses.  I'm sure there will be a number of clinical trials this year.

I am 9 days post treatment and was still undetected at the end of trial.

SuziQ   



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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
mcmaklin


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Do you know what upcoming trials will happen again for Hepatittis C? I am interested in Phase 3. Maybe you know something is still in Phase 2...
Thank you. Becaause I am affraid that it is over with clinical trials already....

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2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
mcmaklin


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How do You feel on this phase 2 trial?

 



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2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
suziq


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The Merck trial that I am on is only in Phase 2 so I am sure they will be doing Phase 3 in 2014.  Most trial centers test for more than one company.  Once on several lists, I am sure you will be called next year.  I started looking Oct 2012, got screened in April 2013 and finally got a trial in Aug 2013.  My age and my cirrhosis were both factors  BUT I think my coordinator was really looking hard for me due to my age and, later, my cirrhosis. Many trials in 2012 had upper age limits. She once remarked that she called the ones most in need of treatment first, so many factors go into being selected.  We did not know I had cirrhosis until I was screened in April.  I just feel that I got the trial that I was supposed to get.  I have 3 weeks today to end of 18 week trial.

Good luck !!!

SuziQ 



-- Edited by suziq on Tuesday 24th of December 2013 04:54:32 AM

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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
Milliganus


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Update:  called lots of the trial centers and all are full for the latest BMS Triple combo.  I got on lists at all of them and sent many my records, so we'll see what happens in 2014.

Again..thanks for all your help.



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
Milliganus


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Thanks so much SuziQ.  It looks like I may be able to jump on this as we can travel.  I can't thank you enough!  I'll keep everyone posted.  



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
suziq


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Hi Marcy, BristolMeyers is starting a new trial #NCT01979939. Check it out on clinicaltrials.gov SuziQ

-- Edited by suziq on Sunday 22nd of December 2013 12:15:33 AM

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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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Hi Marcy,

Unfortunately none of us know what insurance companies will or won't approve in the coming year(s). Especially now with the insurance market being in complete turmoil in the US. Every one of us had to go through the same thing when seeking treatment. Once you find a doctor to treat you, they approach your insurance company and request coverage/authorization for your care. Most doctors will work on your behalf, so that's where you have to begin. Worrying about it won't help, trust me on that one.

As far as clinical trials in the US, the place to search is at http://www.clinicaltrials.gov/. You can use the forum search function for more info on this. Good luck!



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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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Milliganus


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I'm thinking I've missed the boat to participate in a clinical trial for Gileads sofosbuvir & ledipasvir dual therapy.  Does anyone know of any upcoming trials (U.S.) using these?  I so want to get treated but I'm skeptical that my insurance will cover this combo due to price when they are approved in 2014.

 

Thanks.



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
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