Hep C Discussion Forum

Members Login
Username 
 
Password 
    Remember Me  
Chatbox
Please log in to join the chat!
Hep C Discussion Forum -> Hep C News -> Gilead announces 3rd phase 3 trial of all oral sofosbuvir and ledipasvir combo, ION-3
Post Info TOPIC: Gilead announces 3rd phase 3 trial of all oral sofosbuvir and ledipasvir combo, ION-3
Loopy Lisa


Guru

Status: Offline
Posts: 895
Date:
RE: Gilead announces 3rd phase 3 trial of all oral sofosbuvir and ledipasvir combo, ION-3
Permalink  
 

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 
mallani


Guru

Status: Offline
Posts: 3398
Date:
Permalink  
 

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
Cinnamon Girl


Guru

Status: Offline
Posts: 5629
Date:
Permalink  
 

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.

 

 
Page 1 of 1  sorted by
 
Quick Reply

Please log in to post quick replies.
Hep C Discussion Forum -> Hep C News -> Gilead announces 3rd phase 3 trial of all oral sofosbuvir and ledipasvir combo, ION-3
Legal Disclaimer:

THIS FORUM, IT'S OWNERS, ADMINISTRATORS, MODERATORS AND MEMBERS DO NOT AT ANY TIME GIVE MEDICAL ADVICE AND IN ALL CASES REFER ANYONE HERE TO SEEK APPROPRIATE MEDICAL ADVICE FROM THEIR DOCTOR.