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Hep C Discussion Forum -> Hep C News -> `OLYSIO` (Simeprevir) Receives FDA Approval
Post Info TOPIC: `OLYSIO` (Simeprevir) Receives FDA Approval
Zlikster


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RE: `OLYSIO` (Simeprevir) Receives FDA Approval
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My hepa told me, Incivek will maybe arrive to Bosnia in 2014, but at the price of 80k KM (55k $), considering that average salary here is barely 500$, i wonder what Vertex thinks it can achieve with this price setup over here?


(in the rant mood again) ;)




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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
Cinnamon Girl


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Thanks for your comments, Malcolm and Matt.  I read recently that Vertex is already reducing its workforce by 15% due to a fall in sales of Incivek.  Strange to think that, along with Victrelis, these first generation protease inhibitors still aren`t yet available in many parts of the world. 

Matt, I should imagine Olysio would be pronounced `OLIZIO`, but that`s just my guess, and maybe Americans would say it differently!

 



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
mallani


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Hi Jill,

Olysio certainly will certainly cut down the pill burden of Incivek and Victrelis, and hopefully improve the drop-out rate.  It is interesting that testing for the naturally occurring RAV is required, but the IL28B genotype is not mentioned. From Quest-2, we know the CC allele had much better results than the CT and TT alleles.  Also, the SVR rate was only 66% in F3 and F4 patients.  Another 'omission' was the fact that you needed to be Undetectable at 4 weeks to qualify for the 24 weeks treatment (RGT).  Otherwise, it's the good old 48 week trick.

I haven't seen a price-tag yet, but it's probably goodbye Incivek (and thanks). If Olysio is cheap, it may find a place in combination with another DAA. Another small step forward. Cheers.



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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
Matt Chris


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Hey Malcolm 

i agree with you, this is a short term solution because of its need for Peg & Riba.

With all the other DAA's that will likely be competing for the market it will need to team up with another DAA's . We can allready see this happening with the othe major HCV developers teaming with other company's and the FDA new guidelines are also recommending cross company collaboration. So the new OLYSIO (so how does one say it) needs a combo partner to survive it's future.

The beat go's on.

matt



-- Edited by Matt Chris on Sunday 24th of November 2013 02:48:18 PM

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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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That's great news Jill! Another weapon in the HCV arsenal is always welcome. I'm especially pleased to read that it's a 12 week addition at the beginning of treatment. As we all know, the longer we're on treatment, the harder it is to maintain the schedule for some. The once daily dose is going to be a great option versus the Victrelis regimen I'm on which requires 12 capsules daily split into 3 doses for the entire length of treatment. That has been one of the most difficult aspects of the Victrelis treatment, very high pill demands. Simeprevir will hopefully reduce the drop out rate for some, while increasing the odds of SVR for all. Thanks for posting this information!



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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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Cinnamon Girl


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Yes Tig, it`s definitly good news!  We knew FDA approval was going to granted soon, and it was approved by Health Canada just recently, on 20th November.  The dose of one pill a day for the first 12 weeks of treatment, plus Peg/Riba, will certainly make the pill burden much easier for people with gen 1, especially compared to the victrelis regimen, as you mentioned.  And hopefully the side effects will be easier, especially compared to incivek, although people will have to take precautions to avoid too much sunlight exposure.  Interesting to note the brand name `Olysio`!

 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Cinnamon Girl


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November 22, 2013 - `OLYSIO`  (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C

OLYSIO is the first once-daily protease inhibitor approved for the treatment of chronic hepatitis C in a combination antiviral regimen for adults with compensated liver disease

TITUSVILLE, N.J. - Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced today the U.S. Food and Drug Administration (FDA) has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hep C as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis, and may benefit those those who are treatment naļve or who have failed prior interferon-based therapy.

Full details..

http://hepatitiscnewdrugresearch.com/olysiotrade-simeprevir-fda-approved.html

 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
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