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More Gilead BS 8 years 4 months ago #4483

  • klhilde
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God they lie!

In the article the Gilead spokesman talks of the non-existance of a pan-genotypic combo, and pumps up their application for approval of their Sofosbuvir/Velpatasvir combo which he says is especially needed for genotype 3 .... totally ignoring that Sof/Dac is approved in the US for Geno3 and approved in the EU as pan-genotypic. And also ignoring that there are two manufacturers of this combo as a single pill in Bangladesh.

While Abbvie, Merck, Johnson&Johnson and Achillion are all mentioned in the article, Bristol-Myers Squibb and their Daklinza (Daclatasvir) is never mentioned a single time.

www.bidnessetc.com/58694-gilead-sciences...ep-closer-to-market/

More Gilead BS 8 years 4 months ago #4484

Sof and Dac the best I think but marketing and greed will see Dac leaft out of the licensed picture at some point.
Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated :):):)

GT 3 - about 28 yrs with HCV

More Gilead BS 8 years 4 months ago #4605

Hi

I read today that Daclatsavir is not FDA approved. Is that just as treatment for Geno 1?


Thanks
Diagnosed in 2000, Genotype 1(b), no previous treatment,
Viral Load 90,700, ALT 86, AST 56 (as of Novemeber 15, 2015)
Fibroscan F0
Starting Redemption Sof/Led on February 2, 2016
Thanks to Greg Jeffries, Monkmed , FixHepC and Dr. Freeman

Feb. 29
Week 5 of tx
ALT 23
Undetected

May 26
4 EOT
ALT 25
AST 28

Didn't test for viral load. Will test is July at 12 weeks EOT

August 1
Liver enzymes in normal range
HCV UNDETECTED

More Gilead BS 8 years 4 months ago #4606

  • DrJames
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I read today that Daclatsavir is not FDA approved.


Here is the FDA approval announcement for Daklinza (Daclatasvir)

www.fda.gov/NewsEvents/Newsroom/PressAnn...ements/ucm455888.htm

So I guess what you read today was either Gilead marketing material or out of date.
YMMV

More Gilead BS 8 years 4 months ago #4614

Thanks. I dug a little further. It is definitely approved as treatment for Genotype 3 and, in certain circumstances for Genotype 1. news.bms.com/press-release/us-fda-grants...za-daclatasvir-sndas The way I read this, the US FDA has not yet approved it for wholesale treatment of Genotype 1.

Clearly this is a battle between Gilead and Bristol Myers. Canada and other jurisdictions have approved Dazlinka for treatment of all Genotypes without limitation.

Gotta love the USA.
Diagnosed in 2000, Genotype 1(b), no previous treatment,
Viral Load 90,700, ALT 86, AST 56 (as of Novemeber 15, 2015)
Fibroscan F0
Starting Redemption Sof/Led on February 2, 2016
Thanks to Greg Jeffries, Monkmed , FixHepC and Dr. Freeman

Feb. 29
Week 5 of tx
ALT 23
Undetected

May 26
4 EOT
ALT 25
AST 28

Didn't test for viral load. Will test is July at 12 weeks EOT

August 1
Liver enzymes in normal range
HCV UNDETECTED

More Gilead BS 8 years 4 months ago #4616

There is a battle going on between Gilead and everyone else in the world....
M
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
The following user(s) said Thank You: dointime, klhilde, honker

More Gilead BS 8 years 4 months ago #4619

  • Gaj
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Yep, and in 2012 Gilead refused to participate in the Phase 3 trials for Sof/Dac with BMS that had progressed through earlier stages under Pharmasett. BMS eventually went it alone.

hepatitiscnewdrugs.blogspot.com.au/2014/...plus-sofosbuvir.html
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:

More Gilead BS 8 years 4 months ago #4620

Who are the criminals anyway. Cheers
Diagnosed in 2000, Genotype 1(b), no previous treatment,
Viral Load 90,700, ALT 86, AST 56 (as of Novemeber 15, 2015)
Fibroscan F0
Starting Redemption Sof/Led on February 2, 2016
Thanks to Greg Jeffries, Monkmed , FixHepC and Dr. Freeman

Feb. 29
Week 5 of tx
ALT 23
Undetected

May 26
4 EOT
ALT 25
AST 28

Didn't test for viral load. Will test is July at 12 weeks EOT

August 1
Liver enzymes in normal range
HCV UNDETECTED

More Gilead BS 8 years 4 months ago #4621

I have been wondering for a while why Sof and Dac isn't used more for GT1 and figured it was Gilead pushing BMS out and not wanting to collaborate. Actually my specialist told me in 2011 that there was a drug combo that was near perfect but the companies won't work together. I am guessing he meant Sof and Dac, that was after I failed the Dac Peg and Riba trial.

www.hepatitisc.uw.edu/pdf/treatment-infe...e-1/core-concept/all

www.finance.senate.gov/newsroom/ranking/...4c-ba92-562723ba5255
Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated :):):)

GT 3 - about 28 yrs with HCV
The following user(s) said Thank You: zhuk, honker

More Gilead BS 8 years 4 months ago #4624

  • Gaj
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I saw somewhere that they said 'no more' as soon as they bought Pharmasett but can't find that only the 2012 reference confirming.
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:

More Gilead BS 8 years 4 months ago #4639

Thanks to the Senate for confirming that Gilead is price gouging. They are long on identifying problems, and short on solutions.
Diagnosed in 2000, Genotype 1(b), no previous treatment,
Viral Load 90,700, ALT 86, AST 56 (as of Novemeber 15, 2015)
Fibroscan F0
Starting Redemption Sof/Led on February 2, 2016
Thanks to Greg Jeffries, Monkmed , FixHepC and Dr. Freeman

Feb. 29
Week 5 of tx
ALT 23
Undetected

May 26
4 EOT
ALT 25
AST 28

Didn't test for viral load. Will test is July at 12 weeks EOT

August 1
Liver enzymes in normal range
HCV UNDETECTED

More Gilead BS 8 years 4 months ago #4658

The U.S. Congress......
They will probably pass a Senate "resolution", which means exactly nothing. Or they might set up a committee and recommend a bill. It will then go to the floor for debate and then go back to the committee. They will insert the recommendations from the debate into the bill and it will go back to the floor for a vote. If it passes, it will go to the House, where the process starts all over again. After they have made their changes and voted, it will go to conference committee to resolve the differences between the bills. Then both houses have to vote and pass it. Then it goes to the president's desk.......
How many people will die?
Or will they wait until after the presidential election to consider some kind of reform?
The bureaucracy is a ponderous beast.
I don't think we can count on much help from them in the foreseeable future.
We have to do this ourselves. Treatment will continue to be prioritized and people will be waiting for years. Market pressure is our best hope.
Mike
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forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
The following user(s) said Thank You: Gaj

More Gilead BS 8 years 4 months ago #4661

GAJ wrote: Yep, and in 2012 Gilead refused to participate in the Phase 3 trials for Sof/Dac with BMS that had progressed through earlier stages under Pharmasett. BMS eventually went it alone.

hepatitiscnewdrugs.blogspot.com.au/2014/...plus-sofosbuvir.html


Which is how Harvoni came into being for GT1 patients even though it's quite possible Dac may be the superior drug.
Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated :):):)

GT 3 - about 28 yrs with HCV

More Gilead BS 8 years 4 months ago #4772

This email address is being protected from spambots. You need JavaScript enabled to view it.
forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
The following user(s) said Thank You: Joy

More Gilead BS 8 years 4 months ago #4793

  • zhuk
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"Dressed as butchers", lol love it!

And so richly deserved

“let’s hold our price higher regardless of the uproar.”

:pinch:
GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 - 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 - 6 weeks UNDETECTED
AST 26
ALT 26
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