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Author Topic: AbbVie Drugs Approved Today  (Read 15106 times)

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Offline Rubye

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  • Posts: 130
AbbVie Drugs Approved Today
« on: December 19, 2014, 03:54:43 pm »
Here we go --

http://www.businessweek.com/news/2014-12-19/abbvie-wins-u-dot-s-dot-approval-to-sell-new-hep-c-competitor

The price has not been released yet. We shall see if this makes a difference for those having a hard time getting treatment.

Offline sunrise

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  • Posts: 463
Re: AbbVie Drugs Approved Today
« Reply #1 on: December 19, 2014, 06:08:53 pm »
Really good info Rubye. How you doing today? This new combo might give Gilead a run for their money huh. Well I just downed my 1 out of 3 doses left. I will be done Sunday. thanks for the info... Blessings sunrise

Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: AbbVie Drugs Approved Today
« Reply #2 on: December 19, 2014, 06:55:19 pm »
Great find Rubye, thanks!

Hopefully none of us will need it and we will all beat it with our current meds but it's nice to know we will have a new option if we need it!

Wow, just read it 4 to 6 pills a day? I sure hope we are SVR, that's going to be a lot harder to maintain over 24 weeks.

"AbbVie’s combination will require most patients to take four to six pills a day for 12 weeks, compared with one pill a day for Gilead’s drug. If patients have a subtype called genotype 1a and cirrhosis, a condition that scars the liver and affects functioning, they may have to take the drug for 24 weeks, according to an FDA update."

Mel
« Last Edit: December 19, 2014, 06:57:36 pm by BattleTheBeast »
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Rubye

  • Member
  • Posts: 130
Re: AbbVie Drugs Approved Today
« Reply #3 on: December 19, 2014, 07:14:58 pm »
As for the number of pills, I read elsewhere that they are all in one packet that has a good design. I just hope so much that they are a lot cheaper than Gilead because there are so many people in my state who can't get prescriptions because of the high price of Harvoni.

I'm good Sunrise. Just playing the waiting game. You're almost home! What a great Christmas present eh?

Offline sunrise

  • Member
  • Posts: 463
Re: AbbVie Drugs Approved Today
« Reply #4 on: December 19, 2014, 07:29:17 pm »
You bet Rubye
          So close. I have bloodwork Monday.  Then a break for a few weeks. Gonna have a holiday and cast my doubts out the window!. Merry Christmas Rubye. Feel well.... Sunrise

Offline penny

  • Member
  • Posts: 52
Re: AbbVie Drugs Approved Today
« Reply #5 on: December 19, 2014, 10:59:49 pm »
Common side effects of VIEKIRA PAK when used without ribavirin
include:
• nausea
• itching
• sleep problems

Someone said Vekira will be 84,000

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: AbbVie Drugs Approved Today
« Reply #6 on: December 19, 2014, 11:29:36 pm »
Found some additional information

Full prescribing information sheet for VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), co-packaged for oral use.

All genotype1a are to take Ribavirin so between the VIEKIRA PAK (4 pills, 2 at the same time and a different pill at two seperate times) plus the Ribavirin hi-dose (2 pills) that would be 6 pills a day.

http://www.rxabbvie.com/pdf/viekirapak_pi.pdf

About pricing

AbbVie Prices Hepatitis C Drug 12% Below Gilead Rival

The cocktail of pills, which will be sold under the name Viekira Pak, will cost $83,319 for a 12-week course of treatment, AbbVie said today.

http://www.businessweek.com/news/2014-12-19/abbvie-wins-u-dot-s-dot-approval-to-sell-new-hep-c-competitor
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline sunrise

  • Member
  • Posts: 463
Re: AbbVie Drugs Approved Today
« Reply #7 on: December 19, 2014, 11:53:05 pm »
Geez thats a mouthful. Literally and figuratively speaking. Not much difference on the price for also having to add ribavirin . Yikes!

Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: AbbVie Drugs Approved Today
« Reply #8 on: December 20, 2014, 10:57:57 am »
Can you imagine with brain fog trying to take all those meds? I would need to set alarms!

But you know what? If it ends up I have to do this to kill this beast I will do it!

Mel~
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Rubye

  • Member
  • Posts: 130
Re: AbbVie Drugs Approved Today
« Reply #9 on: December 20, 2014, 02:11:21 pm »
I had to have daily alarms as it was with only my two pills Mel.

I really cannot imagine why anyone would go with AbbVie when they cost the same as Harvoni. That is if you're GT1.

I just don't get it. Something is rotten in the state of Denmark.

Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: AbbVie Drugs Approved Today
« Reply #10 on: December 20, 2014, 02:32:09 pm »
I had to have daily alarms as it was with only my two pills Mel.

I really cannot imagine why anyone would go with AbbVie when they cost the same as Harvoni. That is if you're GT1.

I just don't get it. Something is rotten in the state of Denmark.

Well I guess if Harvoni or S/O doesn't work, it's another option, I agree something is rotten in the state of Denmark and it's the Pharma's and our Insurance Companies playing with our lives....

Do I dare say "Thank you so much for having an amazing treatment that we can't get approved until we are almost dying and oh by the way; once you are decompensated the medications won't work for you and can't be approved."

So you have to be at a minimum F3 and almost F4, sick as a dog but not decompensated basically. It's insanity!!!!!!!

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Rubye

  • Member
  • Posts: 130
Re: AbbVie Drugs Approved Today
« Reply #11 on: December 20, 2014, 03:22:27 pm »
Well said Mel.

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: AbbVie Drugs Approved Today
« Reply #12 on: December 20, 2014, 07:17:33 pm »
Hi All

I have read that Express Scripts was holding off patients with less fibrosis in the hope that AbbVie 3D would come in lower priced than Harvoni.

Well guess they will have to rethink that idea especially if the patient can treat for 8 weeks of Harvoni Gilead wins on price. For the 12 week treatment the price is very close when you add Riba.

On the AbbVie combo with 6 pills a day, remembering to take which ones when, and slightly less effective it seems to me Harvoni is still the winner
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline BattleTheBeast

  • Member
  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: AbbVie Drugs Approved Today
« Reply #13 on: December 20, 2014, 08:19:47 pm »
Hey Lynn,

I have to agree with you, Harvoni has been a piece of cake for me so far and when it cures me I will have been really happy to have had it as my treatment.

The AbbieV combo adds so much more into the mix, 4 different medications plus the Riba, seems like a ton of medications.

I am with you that if Harvoni is an option, I would try that before the new AbbieV Pak.

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: AbbVie Drugs Approved Today
« Reply #14 on: December 20, 2014, 09:08:17 pm »
I think the AbbVie Viekira Pak consists of a combo pill ombitasvir ABT267, paritaprevir ABT450 and ritonavir ABT450r two of which are take together, plus a second medicine ABT333 dasabuvir tablet one each taken twice daily. So that is four pills.

Plus the high dose Ribavirin either 500 or 600 mg weight based but either way 1 each twice a day so that brings us up to six pills total. The only ones who dont need the Riba are genotype 1b without cirrhosis.

Prescribing Information Sheet Viekira Pak

http://www.rxabbvie.com/pdf/viekirapak_pi.pdf

Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline Rubye

  • Member
  • Posts: 130
Re: AbbVie Drugs Approved Today
« Reply #15 on: December 21, 2014, 03:39:33 pm »
What's so interesting to me is how most doctors, non-profits, and insurances kept saying oh, wait for AbbVie and then the competition will drive the prices down. Well, it looks like that's not about to happen with AbbVie going along for the joy ride of bringing home the dollars. I find it hard to believe that all these people who are supposed to be experts in the field had no idea that AbbVie would charge the same amount as Gilead while a simple person like myself watching from the sidelines could see that AbbVie would want their piece of the pie also. There is some brilliant manipulation going on behind the scenes here and it not being done with the patient in mind.

I remember back when Sovaldi and Olysio first arrived and Medicare and Medicaid were okay with paying for these drugs. Sovaldi was actually approved by the Oregon Health Plan (Oregon's ACA) and then a bit later the AIDS people started circulating a letter to all the U.S. Medicaid directors to not allow their agencies to give these drugs to their patients. And now the AASLD is starting to support withholding of care, except for the very ill, also. My hope is this action by the AASLD is an attempt to drive prices down. It's kind of like watching a chess game but not being able to see all the pawns. Just my random thoughts on a Sunday morning.
 

 


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