Gilead announces 3rd phase 3 trial of all oral sofosbuvir and ledipasvir combo, ION-3
Loopy Lisa said
May 15, 2013
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.....
mallani said
May 14, 2013
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.
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.
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.....
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.
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