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Hep C Discussion Forum -> General Discussion -> Where are all the Gilead Trialists?
Post Info TOPIC: Where are all the Gilead Trialists?
Karen


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RE: Where are all the Gilead Trialists?
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Jim, Michael and me!  The Three Gilead-teers...lol!

Listened to the Gilead conference-5885 for GT 1 maybe the winner....Sounds like they are starting another trial- 8wk treatment.



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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
JIme


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Yea, anything with interferon has got to be on it's last legs. I hope somebody comes up with that second drug to go with the 7977. BMS must be trying to make their own 7977 I would guess.


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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

 

 

 

 

 
gsx1250fa


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Well...I'm one :) Ledipasvir/sofosbuvir w/riba. I will have my 8 week post tx draw next week. Hopefully still UND. Hopes and prayers for all of us :)



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Biggyb


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Maybe they just haven't found our forum yet. Soon i hope.



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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~
Karen


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Malcolm-I have thought this my self-where are the Gilead folks! Guess it is just me, Jim (past) and I believe one other on this forum.  I am the only one on Sofosbuvir/Ledipasvir without Riba.  I can tell you....if this combo works alone, we have a real winner here.  So glad I waited...I will continue to post my results as I go along.

Hot off the press-Just received: 9:59 AM  Gilead Sciences plans to initiate a Phase III trial to evaluate a combination of sofosbuvir and ledipasvir in patients with hepatitis C. Phase II results suggest "once-daily oral therapy with [the combo] may have the potential to cure most genotype 1 HCV infected patients with a remarkably short treatment duration," says Dr. Eric Lawitz, the study's principal investigator. Some have suggested a combination of sofosbuvir and BMY's daclatasvir is preferable, as both are active in genotype 3 HCV whereas ledipasvir may only be effective against genotype 1



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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
Loopy Lisa


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I am also disappointed at the response rate of genotype 3. Saying that, I have read with the inclusion of Ledipasvir this has made a vast difference. I'm willing to wait for the release of Sofosbuvir predicted in 2014 and to give a try. Saying that, I wonder what overall repsonse will be in the clinical world? It appears that Sofosbuvir has most impact on treatment niave, fibroses stage 0-2 and those without a high viral count. For the rest of the Genotype 3 infected, I suspect that the continual use of Interferon will be still prefered at this moment in time. It has been suggested that Genotype 3 may still need the full 6 months with Riberviren to have continued SVR. Saying that, I would rather try and if that fails, there are other options. I will not be waiting until 2015 to treat, this is already hard waiting a few months.

I think that Gilead is intending to have full dose Riberviren and Sofosbuvir in a one a day pill regieme. It appears for the full effect to work there can be no riberviren reduction, but as this is a shorter time period, most people can tolerate the full dosage in comparison to the interferon groups.

I think a lot of us are watching and waiting too!



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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 
mallani


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Looking at new posts on the Forum each day, it seems that Abbott (AbbVie) is top dog. In a multi-billion dollar race, I wonder where all the Gilead people are. I know we have a couple on the Forum, one doing ION-1 and one doing Neutrino. Gilead have ~1000 patients doing Phase 3 trials-  Neutrino, Fission, Positron and Fusion. These appear to be regulatory in support of Gilead's FDA application for Sofosbuvir.  Where are all the trials and trialists using Ledipasvir?  There must be thousands of patients scattered around the world.   As there seems to be little doubt that Sofosbuvir will be approved, there is pressure on Gilead to have Ledipasvir approved quickly.  For Geno 1, there will be little support for Sofosbuvir, Peg and Riba.  Most will wait for Sofosbuvir, Ledipasvir +/- Ribavirin. Also the 61% SVR rate for Geno 3's using sofosbuvir and Riba is not impressive. I doubt whether Gilead will dispense much Sofosbuvir in the first year or two.

I think it is agreed that Sofosbuvir is the best NS-5b blocker around, with the fewest drug-resistant mutations. Time will tell whether Ledipasvir is anywhere near as effective as Daclatasvir as a NS-5a blocker. NS-5a is a difficult site to block, and drug-resistant mutations develop rapidly because of the complex structure of this protein. While Daclatasvir is regarded as the best NS-5a blocker, BMS has suffered an embarrassing setback. The Geno 1a patients have been dropped from it's Command-3 Trial, as the results were poor. The Trial continues, using 1b patients only (rare in the USA). BMS really needs to buy a Company with a good NS-5b blocker.   This Sofosbuvir/Ledipasvir combination should be the sentimental favourite for Hepatologists, but Abbott may get FDA approval first for all 3 drugs in it's combo. At least Gilead will get all the patients with Victrelis/Incivek treatment failures ( whose numbers are growing) as these will be excluded from the Abbott drugs. The result will be close.

The other DrugCo's will fight it out for third place.

There was a suggestion that Hepatologists may wait for FDA approval for Daclatasvir, then use it with Sofosbuvir. This will cost a fortune, and Gilead will offer special inducements for Gilead-only drugs.

In future, as a result of the Trials, Geno 2 will no longer be 'lumped' with Geno 3 as the SVR results are so markedly different. Different protocols will also be developed for Geno 1a and 1b, as geno 1a is giving poorer results.



-- Edited by mallani on Wednesday 1st of May 2013 09:07:48 AM

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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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