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Hep C Discussion Forum -> Hep C News -> Olysio with Sovaldi: FDA approved
Post Info TOPIC: Olysio with Sovaldi: FDA approved
Isiscat2011


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RE: Olysio with Sovaldi: FDA approved
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The only way this could possibly make sense is if the cost of Sovaldi is reduced well below the cost of Harvoni and then paired with either Olysio or Daclatasvir and the cost of both of those pairings still came in well under Harvoni and below Abbvie.  (Daclatasvir is still in the running despite BMS pulling asunaprevir out of the game.)  The only way this works, however, is if Gilead substantially reduces the price of Sovaldi and that seems highly improbable. 

 



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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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mallani wrote:

Hi Isis,

Who on earth would want Olysio/Sovaldi at $150k for 12 weeks? What strange people you must have in your FDA.

P.S. I saw the 'Dallas Buyer's Club' for the first time last night. Not good PR for the FDA! Cheers.

It makes no sense whatsoever.   Perhaps if Janssen reduced the price of Olysio from ~67K to about 10 dollars (ok maybe a bit higher than that).  By the time Olysio could become a player in the new HCV market the next generation of PIs will be released.  Poor Olysio.  

 



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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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Yeah Malcolm, our government routinely puts the cart before the horse.... They call it trying!

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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mallani


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Hi Isis,

Who on earth would want Olysio/Sovaldi at $150k for 12 weeks? What strange people you must have in your FDA.

P.S. I saw the 'Dallas Buyer's Club' for the first time last night. Not good PR for the FDA! Cheers.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
Fireman Rob


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Thanks for posting this, Isis. Options are good!

-Rob



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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On May 7, 2014 the manufacturer of Olysio (Janssen) submitted a supplemental new drug application to use Olysio in combination with Sovaldi.  Up until now the use of S/O has been off-label.

I just got an email update from the FDA that indicates the FDA has approved the S/O combo.  It states in pertinent part:

 

On November 5, 2014, FDA approved changes to the Olysio (simeprevir) label to include use of Olysio in combination with sofosbuvir for the treatment of patients with chronic hepatitis C virus genotype 1 infection.

 

Highlights of the label changes are summarized below.

INDICATIONS AND USAGE

OLYSIOŽ is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection as a component of a combination antiviral treatment regimen.

Limitations of Use:

  • OLYSIO monotherapy is not recommended.
  • OLYSIO efficacy in combination with peginterferon alfa (Peg IFN alfa) and ribavirin (RBV) is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism at baseline compared to patients infected with hepatitis C virus (HCV) genotype 1a without the Q80K polymorphism. Screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline is strongly recommended. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism.
  • OLYSIO is not recommended in patients with severe hepatic impairment (Child Pugh Class C) due to substantial increases in simeprevir exposures, which have been associated with increased frequency of adverse reactions.
  • OLYSIO is not recommended in patients who have previously failed therapy with a treatment regimen that included OLYSIO or other HCV protease inhibitors.

As I recall the HARVONI label specifically excludes the use of Harvoni with Olysio but the Sovaldi label does not.  Will have to recheck this.  

Another FDA approved option for HCV tx!!   Now, the big question is COST, but that has always been the question.  



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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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