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Hep C Discussion Forum -> Hep C News -> ABBVie Combo
Post Info TOPIC: ABBVie Combo
Groupergetter


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RE: ABBVie Combo
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I have an appointment with my liver doc October 15th.  The ABBVie tx may have been part of discussion and decision process of whether to wait or not?   Thanks Isis for sharing this.   



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.
Tig


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That's a very important consideration people have to make and you have to wonder how many are. Unless people have a very savvy doctor that considers this possibility, patients that are anxious to get started may fail to remember the calendar year policy change. It's a valuable reminder you've made, well done!

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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Isiscat2011


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While we are on the subject, December 21st is precarious timing for some patients, because they may have insurance changes beginning in Jan, 2015.  Or, if they are lucky enough to get immediate approval they could be slammed with two deductibles--one for 2014 and another for 2015.

Some things to think about for anyone considering this or any combo where the tx could continue into the next year, or if they are planning to change policies in Jan.  On my last tx I got hit with a double deductible because my tx began in November and carried into the following year.  



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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.
Tig


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Isiscat2011 wrote:

More like the investors.  They love this stuff--it is all a big game--It is about the profits not about people's lives to them.  

Bingo! Kind of like "Big Pharmopoly"!!

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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Isiscat2011


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Tig56 wrote:

I can just see the legal teams scrambling for position!

___________________________________________________________________________________________________________

More like the investors.  They love this stuff--it is all a big game--It is about the profits not about people's lives to them.  



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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.
Isiscat2011


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I think the confusion is that the review of the Abbvie combo is being listed in the FDA PDUFA calendar under the Pharma name of ENANTA (ENTA).  ENANTA is a pharmaceutical company that formed a partnership with Abbvie and is collaborating on the HCV combo.  

The review is scheduled for 12/21/2014 but under the ENANTA name.

http://www.biopharmcatalyst.com/fda-calendar/

Some biotech investors are yapping about it.  Bunch of dummies.  disbelief



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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.
Tig


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I see the the FDA Advisory Committee for 2015 still lists it as:

Antiviral Drugs Advisory CommitteeDate(s), if needed, to be determined

It would appear you're right and there has been a delay placed on the decision...  Hmmm?

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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Tig


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Where did you hear that report? I'm still finding dated reports mentioning the original decision. I did notice that the decision for approval in the EU is still slated for the first quarter of 2015. I can just see the legal teams scrambling for position!

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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Isiscat2011


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There is a rumor going around that the Abbvie combo, which was scheduled for FDA review in December of 2014, is no longer on the approval review calendar for this year.  I checked the FDA review calendar and it appears to be true.

Anybody know anything about this?  A significant development if true.  



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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.
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