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Post Info TOPIC: Epclusa and Vox


Guru

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Epclusa and Vox
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That is great news! I am very excited how research is going. Old age one day will not be a luxury, but a certainty. Considering the average age of life expectancy with Hep C and chronic Hep B was only 55 years of age (average) years ago, a lot has changed swiftly. Happy days for everyone. :D



-- Edited by Loopy Lisa on Friday 29th of July 2016 08:01:36 AM

__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 



Guru

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Hi Canuck,

This is really interesting information and as usual your skills in finding and presenting it are great and much appreciated.

 

SF



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65 yo, GT1A, , Cirrhosis, F-Scan F4 33.5, TX Naive Harvoni 12 wks

SOT 2/9/16 / ALT 187 AST 114 VL 2.3M.    POSTS

EOT 5/2/16  ALT 35/ AST/25  platlets 126 C/B VL UND

EOT +12 7/26/16  ALT 25 /AST 22/ ALP 83  platlets 129 C/B VL UND

EOT + 24 10/18/16 ALT 27/ AST 20/ ALP 71 platlets 153 C UND

 * SVR *



Senior Member

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Hi Canuck,  thanks for update... Can not wait until the VOX comes out for RC.   That will be our hope.   Good to see you back ...appreciate all your R & D work , your sense of humor and your kind words.   God Bless.   CC



__________________

F 63,  1b  1974, no cirrhosis, fibro scan 5.8 F0-F1,fibro test .37 ,V/L 702987, ALT 90, AST 75.  ABBVIE Topaz II on 10-30-14 Viekira Pak no RIBA , EOT 1-22-15 SVR, ALT 37, AST 29, 4-15-15 SVR12 - fibro test .22,  1-21-16 SVR 52 ,  1-21-17 SVR 104! 1-21-18 SVR 3 years.



Guru

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Hi Canuck,

Very interesting read! Says a lot about Gilead moving forward.

It's good to see them zeroing in on Hep B.

I'm pleased to also see the three drug combo (sofosbuvir, velpatasvir and voxilaprevir) as an extremely effective "Plan B", backup plan, universal drug combo as needed.

Thanks once again for being one of our most informed research scouts Canuck ... this article says volumes in not so many words.

 

Thanks,

Dave



__________________

63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 



Guru

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Gossipy stuff / Marketing type interview ...

GILD's plans for its HCV treatments: clear and concise

The company's EVP and CSO, Norbert Bischofberger, presented last week at a Goldman Sachs (NYSE:GS) conference. One of his comments about GILD's HCV plans was quite revealing. He said:

That is the end of the development [of HCV drugs for GILD]. I mean, there will always be some more studies that you do for a commercial product to look at different patient populations or elderly or pediatrics we're still doing that, but we actually stopped hepatitis C drug discovery about two years ago. We moved everybody in research from hepatitis C on to hepatitis B. And because we simply don't see what the additional needs there are. If you have one pill that's very safe you can treat somebody for eight or 12 weeks and you get cure rates of close to 100%, but that's a difficult thing to improve upon.

That's pretty clear, and beyond that, it looks to me as an almost direct challenge to J&J's (NYSE:JNJ) plans to enter this field (As a relevant aside, I think that JNJ should see if it buys GILD at some low price).

He also confirmed GILD's goal is to use its SOF/VEL combo (Epclusa will be the trade name) internationally for countries or regions where genotyping is not readily done, for cost and/or technical regions.

The questioner asked him to clarify the plans for GILD's three-drug HCV combo (sofosbuvir, velpatasvir and voxilaprevir = SOF/VEL plus a protease inhibitor), in this exchange:

 

 

Terence Flynn

Okay, fair enough. Separately you are conducting a Phase 3 program with a triple combo, maybe just remind us of the target profile here and then again where this drug will be positioned given what we just discussed.

Norbert W. Bischofberger

Yes, so what we're pursuing our Phase 3 studies with a triple combo in HCV is two populations, one for frontline therapy with eight weeks treatment duration in everybody without viral load cut off and the second I think that's the more important application, it is a universal salvage regimen. So you could use this drug if you have failed other direct acting antivirals you have acquired resistance mutations like in the NS5A or in the protease you could use this drug. And if of course if the Phase 3 would support that and you would then be able to achieve cure rates, high cure rates.

It appears from ClinicalTrials.gov that the Phase 3 studies could be completed by Q1 next year, thus if successful, the three-drug combo could reach the market in H1 2018.

 

GILD is pulling a Larry Bird on its competitors in HCV. It is saying that everybody else is playing for second; it's won the HCV battle and is moving on. Or to mix a sports metaphor, it's about to cross the finish line, and all the others are far in the jockey's metaphorical rear-view mirror.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

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