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Hep C Discussion Forum -> Hep C News -> Sofosbuvir/Ledipasvir FDA Decision Anticipated by October 10, 2014
Post Info TOPIC: Sofosbuvir/Ledipasvir FDA Decision Anticipated by October 10, 2014
Isiscat2011


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RE: Sofosbuvir/Ledipasvir FDA Decision Anticipated by October 10, 2014
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Hey Matt:  

It hasn't been calendered yet but a September hearing date sounds about right.  The first Sovaldi advisory committee hearing was on Oct. 25, 2013, and the approval decision came down on December 9, 2013.  Barring some unforeseen catastrophe I would expect to see a unanimous vote in favor of approval. 

I do expect to see a fairly fast roll out of the S/L combo drug because Gilead has been gearing up for a long time.  They are running print ads and tv commercials regularly now.  Even at break neck speeds, however, it would have to take a couple of weeks just to get the script and find a pharmacy to fill it. Also, there will be the insurance payment struggles which could slow things down considerably for many people.  I'm thinking of a January, 2015 start date but that could certainly change.  Honestly, if I was at F1-2, I would probably sit back and wait awhile for the dust to settle and to get a good look at all of the options that will be coming on the heels of the S/L.

I'm curious about your Riba decision and have been thinking about that myself.  The clinical trials did show 100% SVR for the 24 week S/L combo for cirrhotics, right?  OTOH, it was a small sample group, and I still have some reservations about the S/L combo being able to do the job permanently without a 3rd.  What is your thinking on this? 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Rybronco


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One thing you CAN count on is that S/L will be available almost immediately after approval. They will be locked and loaded for distribution with very little lag time.  There is no need for approval to produce this product, (only to sell it) and the risk is low for a hicup in the approval process. Therefore S/L will be ample supplies stocked on the shelves and ready for delivery once the word is given. Demand is the big unknown and this may slow down things initially.

The launch preparation for this product has been underway for long time.

Rockon!

 



__________________

49 yo. G1a prior tx 2005 with peginf and RIBA 12 weeks dc due to side effects. vl 7.8mm Current tx Sovaldi/Olysio 12 weeks started 2-21-2014,  UND at 4 weeks, EOT+12 SVR
Matt Chris


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Hey RH

I love your thought about the drug lobbyist putting pressure on the FDA. I wonder if the six month priority review has ever been shorten before.

Isiscat the FDA advisory met to review Oyliso and Sovaldi 30 days before they approved it in late Nov. and early Dec.  So following that time line the FDA advisory board should meet around Sept. 10, 2014

When Sovaldi was approved in Dec, it took only a week or so for Doctors to prescribed the new meds and they were filing them within a week. I would estimate that Gilead will be gearing up for production of S&L well ahead of time to take care of the massive need that is pent up in Hep-C patients especially all the GT1a and GT1b patients waiting for the all oral treatment.

I believe the key will be arranging an Doctors appointment shortly before or after the Oct approval date to be in line for the first pipelines worth.

My personal challenge will not being approved for S&L but getting the necessary 24 weeks with Riba. I should have a solid case but need a Hepatologist that can articulate it and is use to fighting for his patients rights with the insurance company.

matt

    



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
HR


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Seems like the insurance companies would be lobbying the FDA to speed up approval. This in turn would save them money by not having to buy the extra drugs that' they are having to do so now( ie Interferon, Olysio)

Just a random thought :)



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ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
patiently_waiting


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Isiscat2011 wrote:

Just in case anyone is planning their schedule around this anticipated date please note that the S/L combo probably won't actually be on the shelves for a while following the decision.  Could be within a few weeks or could even be a few months depending on Gilead's marketing and distribution plans.  

Remember, the objective for Gilead is to maximize profits, so that will be calculated into their release date.

The FDA Advisory Committee Hearing for the all oral combo hasn't been held yet, has it Matt?

No reason not to be excited;  just saying I wouldn't expect anyone will actually be able to begin tx on Oct 10.

 I'm glad you brought this up because it is very easy to hear that Oct date and get it stuck in your head that's when help is coming.  It's a very good point you're making.  I hope they will be prepared to distribute as soon as they get the green light, but there's no guarantee of that.



__________________

42 yrs old: geno 1b, 23mil VL, ALT/AST 269/94 as of Apr '14.  Got HCV when I was 16.  Relapsed from Peg/Riba twice, last time in '08.  Completed Sol/Oly on 9/2/14, UND as of 10/7/14
Isiscat2011


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Just in case anyone is planning their schedule around this anticipated date please note that the S/L combo probably won't actually be on the shelves for a while following the decision.  Could be within a few weeks or could even be a few months depending on Gilead's marketing and distribution plans.  

Remember, the objective for Gilead is to maximize profits, so that will be calculated into their release date.

The FDA Advisory Committee Hearing for the all oral combo hasn't been held yet, has it Matt?

No reason not to be excited;  just saying I wouldn't expect anyone will actually be able to begin tx on Oct 10.



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Sierrajen


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5 months to go!. I am really excited to hear that the FDA is scheduled to release this new drug into the wild in October. My Hepa told me that since I have no symptoms I can afford to wait. I'm not at all sure I could have handled the interferon/riba part of the current treatment. trying to keep busy so the time passes faster.



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Gen 1a -  treatment naive  HepC since mid 70's

started Harvoni 11-06-2014   for 12 weeks

13,000,000 VL to 50 VL in just 4 weeks- 

Post TX Labs 5/5/15 Undetected! CURED!!

 
Matt Chris


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Six months and counting, following this required waiting seems like a waste of time but even the best most well tested drugs have to follow this course. Seems stupid but not all of the trials data is ever disclosed to the general public so the FDA has to do its due diligence. 

Good thing that time flys faster when we get in our late 50's and 60's, hoping my liver and many other HepC friends can hold on another 6 months.

matt    



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Tig


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Hi Wayne,

It's amazing to witness this incredible turn around! Within one year we've gone from a Tx protocol of 24 to 48 weeks. Often requiring the patient to go through life changing side effects, with questionable rates of success, to new reports of 6-12 week treatments, with little to no SFX and 95+% cure rates. It's just mind blowing! The news just keeps getting better!

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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OldenSlow


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Link to article:

HCV New Drug Research

 

 

 



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
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