Gilead Announces SVR12 Rates For Three Phase 3 Studies of Sofosbuvir/Ledipasvir With and Without Ribaviran
Tig said
Dec 18, 2013
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.
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!
Biggyb said
Dec 18, 2013
Looks very promising.
Loopy Lisa said
Dec 18, 2013
Amazing, bye bye Ribaviren. You lucky things geno 1s :P
Matt Chris said
Dec 18, 2013
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
Cinnamon Girl said
Dec 18, 2013
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!
lauralou57 said
Dec 18, 2013
I wanted to share this with everyone. Gilead says they are submitting the application for this drug sooner than I thought.
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
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!
Looks very promising.
Amazing, bye bye Ribaviren. You lucky things geno 1s :P
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
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!
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