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Hep C Discussion Forum -> General Discussion -> Not sure where to post this.....sovaldi and olysio....FDA approved
Post Info TOPIC: Not sure where to post this.....sovaldi and olysio....FDA approved
Marypetrecz


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RE: Not sure where to post this.....sovaldi and olysio....FDA approved
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It is!!!!!  I just showed undetectable on my 4 week vl!!!!!!!



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Turnsit


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Yea! I see you sooon on solvaldi/olysio! On it, very easy and getting lots of improvment in my labs. Am 1b for 42 years, still very strong can cycle 35 miles on race bike on hwy. in the country and am 62. Never give up hope! Did riba and interferon 1 yr. did not work for me, hope this does! Aloha



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A. M. Turner
Marypetrecz


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I saw my docs June 12.  It's a pretty amazing group and one of my docs, popped their head into my room and told me....FYI.....because they know I follow all of this,....that the combo s/o is being approved....so my guess is we'll see something more on it soon.

i picked this group because of their involvement and reputation.... And I couldn't be happier with them....i truly have a great team on my side,  I really hope everyone can find a team like this.....and that the way they handle patients and treatments becomes a standard for all the hospitals and docs.



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Cinnamon Girl


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Hi Mary, yes they did.  I haven`t seen any further updates since then though.



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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.

 

 
Marypetrecz


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I just read the janssen applied on May 7th for approval of the two drugs s/o.



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Isiscat2011


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Marypetrecz wrote:

i was surprised, they are from different companies and I thought they'd never even try to have them approved together,,....

Just a little background on this:  Sovaldi and Olysio were FDA approved separately in late 2013.  Both drugs had limited clinical trial data at that point but the need was great to provide hepc patients with an alternative to the SOC which was Interferon/Riba plus a first generation protease inhibitor, Incivek or Victrelis.  This was due to the emerging safety concerns, particularly with Incivek, and the less than stellar SVR rates the SOC was delivering.  

Enter Sovaldi and Olysio.  When Sovaldi was approved Interferon was expected to be part of the Sovaldi tx combo for most patients.  At the FDA hearings (the transcripts are public record) some of the voting practicing physicians made it clear that they would only be considering Interferon containing treatments for patients who could not wait for the all orals. They approved Sovaldi but with some reservations. 

Later on it was discovered that Sovaldi and Olysio worked well together especially with sub groups who had the Q80K polymorphism.  It was also good for the Interferon ineligible groups.  

Gilead did not volunteer to work with any other pharma co; the FDA strongly  suggested it should, and if you are pharma you do need to keep the FDA happy. 

Since then Gilead has done much more clinical testing consequently beefing up the evidence for the FDA approval of the S/L combo which is pretty much a shoe in at this point.  In the meantime, Janssen has been testing the S/O combo and many physicians have been approving it off-label.



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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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Finbar wrote:

Hi what is the S and L combo they want me to start the s/o treatment in August but if something else is going to be available which is better ,I would do that 

Hi Finbar:  As Cinnamon Girl indicated the S/L combo should be approved Oct 10.  Both the S/O and the S/L combos have done exceptionally well in clinical trials.  The S/L combo has gone through more clinical trials with various subgroups so they know a bit more about how it should perform. 

Both combos use the drug Sovaldi as the core virus butt kicker but the second drug in each combo is different.  Olysio is in a class called protease inhibitors while Ledipasvir is a NS5A inhibitor.  The S/L combo is one pill per day.  

I am genotype 1a who has previously used the protease inhibitor Incivek.  My SVR odds are a bit better with the S/L combo and I also like its safety profile.  

I noticed you had a liver transplant in 2010 and you are feeling great.  Congrats!  I expect you have a very experienced hepatology team so I would talk to them in more detail about the best treatment plan for you and don't be shy to ask them specifically about the S/L combo.  

P.S.  Thanks for the IM and I will send this reply to you via your IM as well.  Take care.



-- Edited by Isiscat2011 on Saturday 14th of June 2014 05:56:11 PM

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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.
Cinnamon Girl


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Finbar wrote:

Hi what is the S and L combo they want me to start the s/o treatment in August but if something else is going to be available which is better ,I would do that 

Hi Finbar, Isiscat was referring to the treatment combo of Sofosbuvir and Ledipavir which is expected to receive FDA approval on or about 10th October this year after being fast tracked with priority review.  Here`s some information about that...

http://hepatitiscnewdrugs.blogspot.co.uk/2014/04/gilead-announces-us-fda-priority-review.html



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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.

 

 
Cinnamon Girl


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Hi Mary, Isiscat is correct, as far as we are aware the combination treatment of Sovaldi and Olysio hasn`t yet been approved by the FDA, and there have been no official notifications of this on any of the websites we would expect to see it announced on. 

So far only the phase 2 `Cosmos` trials have been completed for this combo and the phase 3 `Optimist` trials have only recently started, and Janssen would need to have the full data from all trials to present to the FDA for approval.  In the meantime it`s still an `off label` treatment.

Thanks anyway!



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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.

 

 
Finbar


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Hi what is the S and L combo they want me to start the s/o treatment in August but if something else is going to be available which is better ,I would do that 



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Barry C
Isiscat2011


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Marypetrecz wrote:

She said it was just happening, as of yesterday,,,,as I said I was surprised.....

I think your doctor is mistaken, Mary.   FDA approvals are public information and there is no news of this at the FDA website or elsewhere.  

I would expect approval of this combo to follow the results of the OPTIMIST trials.  Janssen (Olysio manufacturer) is presently testing the efficacy/safety of the S/O combo for the purpose of obtaining FDA approval but there are some indications that Janssen will be limiting its trials now.  The S/O combo will probably have a limited lifespan in any event due to the upcoming approval of the S/L combo.



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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.
Marypetrecz


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She said it was just happening, as of yesterday,,,,as I said I was surprised.....



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Isiscat2011


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Hi Mary:

The supplemental new drug application was filed on May 7, 2014 but they have not been FDA approved yet for use together.



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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.
Marypetrecz


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My doc told me yesterday as an FYI, that the FDA is approving or has just approved olysio and sovaldi together....

i was surprised, they are from different companies and I thought they'd never even try to have them approved together,,....



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