Your Question -Sofosbvir/Ledipasvir or daclatasvir/sofosbuvir and do you know if they will be out in the next year or so?
Gilead's Combo Sofosbuvir & ledipasvir would be available in Sept. or Oct. depending if the FDA grants Gilead's request for priority review which speeds up the NDA from 10 months to 6 months, hopefully that is what will happen because a lot of us relapsed patients are waiting for that combo because it has so far has the highest SVR percentages for a phase III study.
We all will keep a keen interest in the EASL convention on April 9-13 from London for the abstracts and trials info/data on many of the soon to be approved treatment regiments. This will tell us a lot about the success of the leaders in development, Abbvie, BMS, Gilead, J&J and Merck.
Daclatasvir and Sofosbuvir will be out likely sometime in the following year 2015 or 2016. BMS which developed Daclatasvir has its own all oral triple regiment so the combo Daclatasvir and Sofosbuvir may only be prescribed as a off label or later as a approved FDA treatment.
The first available and IMHO the best available will be Gileads combo in the fall of 2014, that is what I hope I can hold out for.
matt
Tig said
Mar 29, 2014
Hi Gracie,
Here's a little info from BMS and news on the release. Note the two studies currently mentioned, the phase 3 UNITY and ALLY studies. The Unity trials appear to deal with HIV, HBV and HCV studies. Information below.
"In 2013, Bristol-Myers Squibbs investigational all-oral 3DAA Regimen (daclatasvir/ asunaprevir/BMS-791325) received FDA Breakthrough Therapy Designation, which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic treatment naïve and experienced patients, as well as cirrhotic treatment naïve and experienced patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing. - See more at: http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata#sthash.zGjJFoXK.dpuf
In addition, enrollment has begun for the Phase III ALLY Program, in which daclatasvir in combination with sofosbuvir, is being studied in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients and patients infected with HCV genotype 3. - See more at: http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata#sthash.zGjJFoXK.dpuf"
I'm waiting now too gatekeep. Which one is better for triple treatment failures, Sofosbvir/Ledipasvir or daclatasvir/sofosbuvir and do you know if they will be out in the next year or so?
gatekeep said
Feb 26, 2014
Yeah I'm waiting to see witch way Rx goes. I bought myself some time.
Zlikster said
Feb 25, 2014
Hey Brian, that should be THE ONE :) hope u can nail that combo!
robertsamx said
Feb 25, 2014
gatekeeper, daclatasvir/sofosbuvir is coming to a phase 3 soon, keep your eyes open looking for this trial, should be soon. RC
i will look into the details and post today RC NCT02032875
-- Edited by robertsamx on Tuesday 25th of February 2014 12:51:02 PM
-- Edited by robertsamx on Tuesday 25th of February 2014 12:52:56 PM
Matt Chris said
Feb 25, 2014
Hey Brian
Yes, if you can wait this should be a powerhouse combo of DAA's that you have not been exposed to. Should be available in late 2014
matt
mallani said
Feb 24, 2014
Hi Brian,
If I were you, I'd wait for this one too. Good luck.
DJ said
Feb 24, 2014
I sure hope something better comes out for treatment. It would be wonderful if the virus became something that was easily treatment with little impact on people's lives during treatment.
gatekeep said
Feb 24, 2014
After relapsing after 48 weeks of hellish trip Rx. I went to Tufts Boston for the latest on new treatment. I was told to hold out a few months for the all oral Rx Sofosbvir/Ledipasvir fixed dose combination.
Fingers crossed
Hey Gracie
Your Question -Sofosbvir/Ledipasvir or daclatasvir/sofosbuvir and do you know if they will be out in the next year or so?
Gilead's Combo Sofosbuvir & ledipasvir would be available in Sept. or Oct. depending if the FDA grants Gilead's request for priority review which speeds up the NDA from 10 months to 6 months, hopefully that is what will happen because a lot of us relapsed patients are waiting for that combo because it has so far has the highest SVR percentages for a phase III study.
We all will keep a keen interest in the EASL convention on April 9-13 from London for the abstracts and trials info/data on many of the soon to be approved treatment regiments. This will tell us a lot about the success of the leaders in development, Abbvie, BMS, Gilead, J&J and Merck.
Daclatasvir and Sofosbuvir will be out likely sometime in the following year 2015 or 2016. BMS which developed Daclatasvir has its own all oral triple regiment so the combo Daclatasvir and Sofosbuvir may only be prescribed as a off label or later as a approved FDA treatment.
The first available and IMHO the best available will be Gileads combo in the fall of 2014, that is what I hope I can hold out for.
matt
Hi Gracie,
Here's a little info from BMS and news on the release. Note the two studies currently mentioned, the phase 3 UNITY and ALLY studies. The Unity trials appear to deal with HIV, HBV and HCV studies. Information below.
"In 2013, Bristol-Myers Squibbs investigational all-oral 3DAA Regimen (daclatasvir/ asunaprevir/BMS-791325) received FDA Breakthrough Therapy Designation, which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic treatment naïve and experienced patients, as well as cirrhotic treatment naïve and experienced patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing. - See more at: http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata#sthash.zGjJFoXK.dpuf
In addition, enrollment has begun for the Phase III ALLY Program, in which daclatasvir in combination with sofosbuvir, is being studied in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients and patients infected with HCV genotype 3. - See more at: http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata#sthash.zGjJFoXK.dpuf"
DACLATASVIR
Clinical Trials: ALLY Phase III
Clinical Trials: UNITY Phase Info
Tig
Hey Brian, that should be THE ONE :) hope u can nail that combo!
gatekeeper, daclatasvir/sofosbuvir is coming to a phase 3 soon, keep your eyes open looking for this trial, should be soon. RC
i will look into the details and post today RC NCT02032875
-- Edited by robertsamx on Tuesday 25th of February 2014 12:51:02 PM
-- Edited by robertsamx on Tuesday 25th of February 2014 12:52:56 PM
Hey Brian
Yes, if you can wait this should be a powerhouse combo of DAA's that you have not been exposed to. Should be available in late 2014
matt
Hi Brian,
If I were you, I'd wait for this one too. Good luck.