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Post Info TOPIC: Australia New Zealand - TGA approves Gilead's Sovaldi


Guru

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RE: Australia New Zealand - TGA approves Gilead's Sovaldi
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That`s disappointing, Malcolm, and actually I was surprised to see this news item anyway.  Over here in England we should expect to hear a decision from NICE very soon on whether Solaldi will get approval for funding within the NHS or not, although it doesn`t sound very promising. 

No worse off at all, Paul, going by what Malcolm said, and I`m sure  you did the right thing by getting started with your victrelis triple.

 



__________________

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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31/2 weeks after I start triple therapy with Victrelis.  Mixed feelings about that. Although now that I read Mallani's post, approval is going to delay it for a while so I guess I am no worse off. 



-- Edited by Paul B on Friday 4th of July 2014 11:33:37 AM

__________________

57 Yr old, Diagnosed 1994 Geno 1a. 1995: Interferon 12 weeks.  1998: Int/Rib 10 weeks.  2014: VL 106,000. Peg Int, Ribavirin, Victrelis 48 weeks (commenced June 2014). UND after Peg/Int lead in week 4. Still UND at week 8, 24, EOT. SVR 12.



Guru

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mallani wrote:

Hi Wayne,

It's actually a surprise as the TGA here initially weren't interested. It doesn't mean much. The rich can now get Sovaldi shipped from the USA and it can be used by Australian hepatologists.

For Sovaldi to be available to the masses, it would need to be approved by our PBAC (Pharmaceutical Benefits Advisory Committee). Then the Government would have to agree to fund it. No chance.

Our best hope is AbbVie. Cheers.


Very sad indeed.   OTOH, the AbbVie combo should be here soon.  I wonder how long it will it take before it is available to masses in Australia.  I guess it depends on cost and whether or not the gvmt can cut a deal.   Soon I hope.



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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.



Guru

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Hi Wayne,

It's actually a surprise as the TGA here initially weren't interested. It doesn't mean much. The rich can now get Sovaldi shipped from the USA and it can be used by Australian hepatologists.

For Sovaldi to be available to the masses, it would need to be approved by our PBAC (Pharmaceutical Benefits Advisory Committee). Then the Government would have to agree to fund it. No chance.

Our best hope is AbbVie. 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



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Great news for all the people down under, from what I read it sounds like its totally approved and people can start to treat, curious what a 12 week course will be cost wise.

I'm out of touch with the drug approval system in Australia, but this comes as a surprise as I did not know that it was on the table for discussion. If this happen this quick maybe the Gilead combo SOF & LPV is not far off as well. Watch out Abbvie the guns of Gilead are coming.  Maybe Gilead cut a lower price deal if they were to release/approve  it sooner than later. I"m totally speculating of course.      

matt



-- Edited by Matt Chris on Thursday 3rd of July 2014 10:52:43 PM



__________________

"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! 



Guru

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Wow, fantastic news!  Thanks for posting this, Wayne.  smile



__________________

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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http://hepatitiscnewdrugs.blogspot.com/2014/07/hepatitis-c-news-australia-new-zealand.html



__________________

66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 

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