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Post Info TOPIC: Gilead Announces SVR12 Rates For Three Phase 3 Studies of Sofosbuvir/Ledipasvir With and Without Ribaviran
Tig


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RE: Gilead Announces SVR12 Rates For Three Phase 3 Studies of Sofosbuvir/Ledipasvir With and Without Ribaviran
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I'm not sure what trial results have been seen or shared here. i saw this from August 2013 that came from Catie in Canada. It's one of their HIV/HCV info sources. Forgive me if this is a repeat. I thought the numbers may interest some of you.

http://www.catie.ca/en/treatmentupdate/treatmentupdate-198



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Tig

66 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 8+ years!

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Impressive, but, like Vertex, Gilead are good at publishing promising data.

Why the delay in reporting the Ion-1 24 week results?  Also, only 224 cirrhotics is a pretty small sample compared to the numbers Vertex and Merck needed for Incivek and Victrelis.

I'd like to see results broken down to Fibrosis Stage, and Geno 1a or 1b. The figures published suggest Ribavirin is not needed, but the Lonestar results suggested Riba was required for the 1a's and for the Rx- experienced.

Until we see the full results, it is uncertain as to the optimal Rx length for cirrhotics. The incredible cost differential will probably mean cirrhotics will be restricted to the 12 week course anyway.

Hurry up, Merck!



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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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Looks very promising.



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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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Amazing, bye bye Ribaviren. You lucky things geno 1s :P



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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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Hey all

This is a very aggressive indicator from Gilead that they want to be the first all oral treatment  for Geno 1 patients to hit the market. Check out this quote from the article

"said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. With the availability of these results, Gilead is finalizing its regulatory filing for sofosbuvir/ledipasvir, with the goal of submitting a New Drug Application in the first quarter of 2014. 

If that time line works out it means that this new Gilead combo could be available sometime between August and October of 2014. Abbvie has already announced it will most likely file its application for its triply therapy in the 2nd quarter of 2014  

Exciting times to say the least, we look forward to vanquishing the Dragon forever.

Check out these 24 week figures.    WOW, WOW, FANTASTIC, WOW

ION-2.  (including 20.0 percent (88/440) with cirrhosis)

 

SOF/LDV                24 weeks      99.1%    SVR12  (108/109)

SOF/LDV+RBV        24 weeks      99.1%    SVR12  (110/111)

 


-- Edited by Matt Chris on Wednesday 18th of December 2013 05:39:24 PM



-- Edited by Matt Chris on Wednesday 18th of December 2013 05:44:00 PM



-- Edited by Matt Chris on Wednesday 18th of December 2013 06:32:16 PM

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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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Hi Laura, thanks for posting this.  This fixed dose combo from Gilead is a very effective all-oral drug combo for those with genotype 1s, whether tx naive or tx experienced, and will greatly benefit many people who need or want to avoid interferon based treatment. 

The FDA granted Breakthrough Designation for the Sofosbuvir/Ledipasvir combination in August so it`s being fast tracked for approval.  Gilead is expecting to submit their supporting data for New Drug Application in the first quarter of 2014 and hopefully it will be approved later in the year. 

Good to see such fantastic SVR12 results from the Phase 3 trials!

 



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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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I wanted to share this with everyone. Gilead says they are submitting the application for this drug sooner than I thought.

http://www.gilead.com/news/press-releases/2013/12/gilead-announces-svr12-rates-from-three-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-and-ledipasvir-for-genotype-1-hepatitis-c-patients

 



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