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Post Info TOPIC: EMA panel recommends approval of Epclusa (Sov/Velpa) for all HCV genotypes


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RE: EMA panel recommends approval of Epclusa (Sov/Velpa) for all HCV genotypes
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Hi guys - can you make a note for me as well? Just in case I fail EOT 12? It's coming up now, maybe three weeks before I have THE blood test. I want to be able to suggest that combo to my hepatologist - probably not approved in Oz yet but Sof/vel/Vox is what I've got to keep repeating to myself.

its such a journey this one, what would I have done without my friendS? And Tig - the avatar - leave it boy, just leave it. biggrin

Syd



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Contracted Hep C 1969. Genome Type 2, treatment naive. Began 12 week RIBA/sof/Dac on 12/11/15. Cirrhosis. VL before treatment 4m. Treatment extended another 12 weeks without Riba. No virus detected at 9 weeks.



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robertsamx wrote:

GREAT DATA.   This triple is my golden ticket.   Sof/vel/vox. Could be out as soon as November 2016 or early 2017.    I can wait.   Pablito you really scored on the trial you got into, congrats !!   The Sof/vel is a great treatment, and adding the vox puts it over the top.

RC


 LOL, I kind of made a note to self on this one as well. Ya never know...wink

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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GREAT DATA.   This triple is my golden ticket.   Sof/vel/vox. Could be out as soon as November 2016 or early 2017.    I can wait.   Pablito you really scored on the trial you got into, congrats !!   The Sof/vel is a great treatment, and adding the vox puts it over the top.

RC



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 M-64) 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   



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The data look great.  I would go as far to say that (for 12 week therapies) sof/vel/vox looks the best on the market with near 100% SVR rates for people with cirrhosis and past DAA failures.  Not sure why adding ribavirin seems lower the SVR rate but the science will no doubt explain this in time.

Feel very lucky to have got 8 weeks worth of the stuff for free c/o a trial.



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44 y.o. male, HCV G4 since 1996, F-scan score 9, F2, Failed prior I/R, finished sof/vel/vox 8 weeks 5/16, pre-treatment VL 2 million, EOT UND, EOT+4 UND, EOT+12 UND.

Tig


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Bump for Sue! Thought you might like this thread.

Also, here's a link to some Gilead information on Sovaldi backbone protocols.

Gilead Protocols



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Tig

66 yo 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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robertsamx wrote:

This combo is a silver bullet For all genos, However type 3"s with cirhorhosis  and 20 years or better under there belt with the virus may not fair so well. It will take a triple to stop that dragon. I'm hoping the sof-Vel-vox will be the winning ticket.  RC


 Hi Rob, I take it you failed previously. I hope the sof-Vel-vox combo will work. I guess its always the fear for us 3's as it is a tricky one that seems to relapse often. I know something will work eventually, and it makes me feel pretty sad, that I have been infected as long and my liver is good and yours is not. But I am rooting for you, and I hope you can kick its damn viral ass out of you!!!



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Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 



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This combo is a silver bullet For all genos, However type 3"s with cirhorhosis  and 20 years or better under there belt with the virus may not fair so well. It will take a triple to stop that dragon. I'm hoping the sof-Vel-vox will be the winning ticket.  RC



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 M-64) 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   

Tig


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I was excited (easily these days!) when I saw the name Gilead has given to the Sov/Velpa combo, EPCLUSA. Knowing we have several good people here on the trials, this is a signal that they are close to marketing the product. They don't name anything until it's got a stamp of approval. This is good news for all those following in your pioneering footsteps. If it wasn't for people like you, Canuck and the others, these tools of Hep C destruction would never be possible. We'll have to wait for the name given to Epclusa with GS 9857 (Vox). Exciting times for sure!



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Tig

66 yo 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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Tig

You're a fountain of knowledge on HCV.  You should write a hand book.

Pablo



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44 y.o. male, HCV G4 since 1996, F-scan score 9, F2, Failed prior I/R, finished sof/vel/vox 8 weeks 5/16, pre-treatment VL 2 million, EOT UND, EOT+4 UND, EOT+12 UND.

Tig


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May 27, 2016

 

 

 

Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) is an investigational, pangenotypic, once-daily tablet containing 400 mg of sofosbuvir and 100 mg of velpatasvir. The CHMPs positive opinion was adopted following an accelerated review procedure and will now be reviewed by the European Commission, which has the authority to approve the drug for the European Union.

The drug was looked upon favorably by the committee based on data from multiple phase 3 studies: ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4.

In the ASTRAL-1, -2 and -3 studies, researchers treated 1,035 patients with HCV with or without compensated cirrhosis with sofosbuvir/velpatasvir for 12 weeks and 98% achieved sustained virologic response 12 weeks post-treatment. In the ASTRAL-4 study, researchers randomly assigned 267 patients with HCV and decompensated cirrhosis 12 weeks of sofosbuvir/velpatasvir with or without ribavirin or 24 weeks of sofosbuvir/velpatasvir with ribavirin for 12 weeks. In those who also received ribavirin, 94% achieved SVR12. This rate was higher compared with those who received sofosbuvir/velpatasvir alone for 12 weeks (83%) or 24 weeks (86%). The most common adverse events in the ASTRAL studies were headache, fatigue and nausea. These were comparable in incidence to the placebo group included in ASTRAL-1, according to the release.

The FDA granted priority review designation for sofosbuvir/velpatasvir in January.

Link to article: Healio HCV Next



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Tig

66 yo 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!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

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