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Hep C Discussion Forum -> Hep C News -> Simeprevir (Olysio) draft recommendations by NICE (UK)
Post Info TOPIC: Simeprevir (Olysio) draft recommendations by NICE (UK)
Cinnamon Girl


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Simeprevir (Olysio) draft recommendations by NICE (UK)
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Isiscat2011 wrote:

I suppose this was bound to happen.  Poor Olysio will never have its day in the sun (although Janssen has pulled in some decent profits already).  Not enough testing and too many newer, and potentially better, options on the horizon.  

The UK can use Sovaldi and Declatasvir, right?  So, the question will be affordability.  I wonder if Olysio still has a shot in Europe with additional studies.  The more DAAs the better in terms of driving costs down.  At least that is the theory. 

Yes, Isiscat, it was predictable really after the NICE decision on Sovaldi.  Some people in the UK are able to get Sov/Daclatasvir treatment, and ditto Sov/Lepidasvir, but only those in the most urgent need and on a `compassionate use` basis.  Hopefully the situation will improve in time as costs for new DAA`s go down, yes I agree.

I read in this article that Jannsen are 'extremely disappointed' with NICE`s draft recommendations and are continuing to work towards a solution.  Yes, we`re all disappointed, but I doubt we`ll see much change of heart if any.

http://www.hepctrust.org.uk/News_Resources/news/2014/September/NICE+recommendation+on+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.

 

 
Isiscat2011


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skewedButNotBroken wrote:

I guess the sun sensitivity issue with Olysio are for the really fair skinned people. 

________________________________________________________________________________________________________

Oddly enough skin pigmentation doesn't seem to be the reason for the sun sensitivity.  Certain patient populations experience higher exposure to Olysio meaning their bodies absorb the drug differently.   People with liver impairments and Asians fall into this category.  The higher exposure causes the photosensitivity reaction.

http://www.olysio.com/hcp/special-populations

 



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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.
skewedButNotBroken


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I live in Southwest Florida and I mowed my lawn today with short sleeves and no hat and no sunscreen. I guess the sun sensitivity issue with Olysio are for the really fair skinned people. I tan well, and have never wore sunscreen even when I was an avid sunbather -- I used to go out in the sun at 9:00am and strategically placed my towel to face the sun and moving it every 30 minutes to track the sun and stay out there until the clouds starting rolling in around 3:00pm. I used to get so dark that if it were not for my blue eyes no one would know I was Caucasian. I'll probably pay for all of that sun-worshiping as I get older



-- Edited by skewedButNotBroken on Saturday 27th of September 2014 01:03:49 AM

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Diag. with hep c in 1992; A3:F2;  GT 1a; IL28B CT; VL 900k, ALT 150, AST 100 on 8/5/2014; SOT 9/5/2014  S/O ---VL 127 after 6 days; VL detected on day 18 but < 15.; --> UND @ EOT+ 1 year SVR!
Dzdayscomin


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Isiscat2011 wrote:

I suppose this was bound to happen.  Poor Olysio will never have its day in the sun 

 I thought that was funny being the main sx from it was light sensitivity, and the ability to burn easily!

Good one Isis....lol



__________________

53yr M 1a acq 12/83 cirr pre tx MELD 17  tx nv diag 1/29/12  tx S/O 3/5/14  trans list.

EOT 5/28/14 UND 6/12/14 SVR 8/29/14 MELD 14 dx HCC 9/5/2014 tumor ablation 9/24/14

In the 10K lakes State It's not about us but those around us.
Fireman Rob


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Pretty general article. It makes the NICE recommendation to not use the S/O combo seem like a cost issue rather than effectiveness? I'm sure the small sample in the clinical trials didn't help prove effectiveness, however. 

-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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I suppose this was bound to happen.  Poor Olysio will never have its day in the sun (although Janssen has pulled in some decent profits already).  Not enough testing and too many newer, and potentially better, options on the horizon.  

The UK can use Sovaldi and Declatasvir, right?  So, the question will be affordability.  I wonder if Olysio still has a shot in Europe with additional studies.  The more DAAs the better in terms of driving costs down.  At least that is the theory. 



__________________

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


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NICE consults on draft guidance on the drug simeprevir (Olysio) for treating hepatitis C

17 Sept 2014 - In draft guidance published today healthcare guidance body NICE has recommended simeprevir (Olysio, Janssen) as a treatment option for some people with chronic hepatitis C. The draft guidance recommends simeprevir, in combination with peginterferon alfa and ribavirin as an option for treating genotype 1 chronic hepatitis C in adults.

Simeprevir has a marketing authorisation for treating two forms of hepatitis C, genotype 1 and genotype 4. Genotype 1 hepatitis C is the most common type of chronic hepatitis C in England, accounting for around 46% of cases. Genotype 4 hepatitis C accounts for around 4% of cases.

The independent Appraisal Committee was minded not to recommend the use of simprevir for treating genotype 4 chronic hepatitis C and has asked the company for more information on its use for this group of patients.

Because there was not enough robust evidence, the Committee did not recommend simeprevir in combination with sofosbuvir (with or without ribavirin), for treating genotype 1 or 4 chronic hepatitis C in adults.

This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

See article for full details and draft guidance treatment recommendations...

https://www.nice.org.uk/News/Press-and-Media/nice-consults-on-draft-guidance-on-the-drug-simeprevir-olysio-for-treating-hepatitis-c



__________________

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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