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Post Info TOPIC: Gilead announces 3rd phase 3 trial of all oral sofosbuvir and ledipasvir combo, ION-3


Guru

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RE: Gilead announces 3rd phase 3 trial of all oral sofosbuvir and ledipasvir combo, ION-3
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I think they are afraid their drug wont perform as well as the Abbot combo. I understand they are having good results across the board.....It will be a tough time for companies touting their drugs with so many coming out on the market within a short time span.....



__________________

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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Hi Jill,

I don't understand why Gilead are so reluctant to do a Phase 3 Trial with a reasonable number of cirrhotics.

The Phase2 Lonestar Trial only included 20 patients with cirrhosis, and the Phase3 ION-2 Trial will only have an arm with about 40 cirrhotics. What are they worried about ?

Abbott ( AbbVie) are including an adequate number of cirrhotics.



__________________

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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Gilead announces 3rd phase 3 trial of fixed dose oral pill

May 2 2013 - Gilead Sciences today announced plans to initiate a third Phase 3 clinical trial of the fixed-dose combination tablet of sofosbuvir and ledipasvir for the treatment of chronic hepatitis C virus (HCV) infection. The study, called ION-3, will evaluate the once-daily fixed-dose combination of sofosbuvir and ledipasvir for eight weeks with and without ribavirin (RBV) and for 12 weeks without RBV in 600 non-cirrhotic, treatment-naïve genotype 1 HCV-infected patients.

Full article...

http://www.hepctrust.org.uk/News_Resources/news/2013/May/Gilead+announces+3rd+phase+3+trial+of+all+oral+pill



__________________

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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