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Post Info TOPIC: New treatment
Huey


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RE: New treatment
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Groupergetter wrote:

If Gilead says the new tx will be effective in treating those who relapse, and wants to show that true, one would hope that Gilead would have some type of program to reduce costs on retreatment. 

Perhaps this should have been posted in the Daily Funny thread.  aww

Would be nice if someone asked this question at the FDA hearing.



-- Edited by Groupergetter on Tuesday 7th of October 2014 11:49:31 AM

 I thought Gilead Guaranteed it so re-treatment of more Sovaldi should be free.



__________________

  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 
Gator Man


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Isiscat2011 wrote:

I was looking forward to reading the transcripts and perhaps seeing some questions answered directly by Gilead.  Not that the committee members ask many difficult questions at the hearings but one can hope. 

... One thing I have learned through my HCV saga is this: The FDA is a dysfunctional mess.

My experience representing and dealing with governmental agencies has at times made sausage making resemble afternoon tea. Having been in executive sessions and off mike discussions, difficult questions are only asked when someone is trying to make a show. Most questions and resultant decisions have already been discussed and made prior to the public forum. I've never dealt with the FDA and rue the day when I handle a federal matter, but "softball" questions at a public hearing comes as no surprise.



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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
Tig


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Isiscat2011 wrote:

One thing I have learned through my HCV saga is this: The FDA is a dysfunctional mess.

 Ding, ding, ding, ding!!!!! Dysfunctional is quite accurate... Unfortunately, we seem to be stuck with the mess as well. As citizens we will never truly know how deep the roots extend into their ineffectiveness. Maybe effectiveness (or not) is a hard thing to put a finger on. Perhaps determining their actual benefit to BS ratio would be a more accurate indicator of their benefit... IDK?

Tig



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Tig

68yo 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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No advisory committee hearing for the S/L combo?  I was wondering how they intended to have the hearing and do the approval on the same date but they do take the approval vote at the end of the hearings. This is probably typical for the expedited review process.  So hard to get complete information from the FDA web site.

I was looking forward to reading the transcripts and perhaps seeing some questions answered directly by Gilead.  Not that the committee members ask many difficult questions at the hearings but one can hope. 

I am officially disgusted with the lack of transparency in the FDA drug approval system.  Not to mention the FDA's convoluted data system that has even physicians, who are trying to make responsible prescribing decisions, scratching their heads.  Most of what occurs between the FDA and Pharma is behind closed doors.

One thing I have learned through my HCV saga is this: The FDA is a dysfunctional mess.



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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.
Matt Chris


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Hey Greg

Just a side note, the FDA did not have an official advisory committee for S&L as they did for Sovaldi 30 day before the release date. I called the FDA and asked for the transcript and they told me there was no meeting.

During the time from Gliead's filing for a NDA in Feb, 2014 and until Oct 10, 2014 they will communicate back and forth on questions and concerns. It seems to me that because Sovaldi/Sofosburvir is the major element in the combo most of the questions had been answered.

The big concern for us cirrhotics is the duration issue, namely will they have an 24 month recommendation criteria for certain conditional patients. 

Also Jlynch I would guess you would fall under a re-treatment protocol that might include a longer duration with Ledipasvir.

matt   



-- Edited by Matt Chris on Tuesday 7th of October 2014 06:51:16 PM

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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! 
Groupergetter


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If Gilead says the new tx will be effective in treating those who relapse, and wants to show that true, one would hope that Gilead would have some type of program to reduce costs on retreatment. 

Perhaps this should have been posted in the Daily Funny thread.  aww

Would be nice if someone asked this question at the FDA hearing.



-- Edited by Groupergetter on Tuesday 7th of October 2014 11:49:31 AM

__________________

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.
Isiscat2011


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Hi John:

Since you are cirrhotic you should be able to get tx without much hassle from your insurance company when the new DAAs are FDA approved.  The question will be what drugs to put you on. 

There may be a question about retreating you with Sovaldi.  Gilead has not given adequate guidance about retreating with Sovaldi yet but I expect Gilead's reps will be asked this question at the FDA hearing on Friday.  The information about whether or not Sovaldi should be repeated has been conflicting.  A second question will be whether your insurance will pay for Sovaldi again. If not the Sovaldi/Ledipasvir combo then you should be able to get on the Abbvie combo in December.

Did you find a new doc?  That is really important and what I would be doing right away if you haven't yet.    



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
JLynch30


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I relapsed on solvaldi/ribravirin/interferon - any word if I will be eligible for new treatment?



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 
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