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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa

TOPIC: FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa

FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18692

  • Gaj
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The U.S. Food and Drug Administration (FDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), an all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

www.businesswire.com/news/home/201606280...es-Gilead’s-Epclusa®
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
Last Edit: 5 years 3 months ago by Gaj.
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18694

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Good news Gaj.
Wonder what Gileads price tag will be on it?
GT1a; Got it some time in the 70's; Diagnosed @1976
Tx naive
METAVIR: A2-F2
SOT May 18, 2016: CMP: AST 162 ALT 241 VL 13000000
3 weeks after SOT: AST 27 ALT 31 VL 138
Reached EOT Aug. 10, 2016 / Received svr4 results Sept. 20, 2016: AST 22 ALT 24
Hep C RNA "NOT DETECTED"
AS OF 3/20/2017 ,Hep C RNA PCR "NOT DETECTED" THAT'S SVR24!
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18699

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So, greediad has a presence on twitter....... :evil:
Genotype 1a
Diagnosed in 2004, had HCV for all my adult life. Until 2016!!!!
Harvoni treatment, started 19 March 2016
4 week results Bilirubin 12 down from 14 pre treatment,
Gamma 25 down from 52, ALT 19 down from 63, AST 19 down from 47,
VL <15 down from a lazy 6 million or so

EOT Results
Bilirubin 10, GGT 18, ALT 19, AST 21, VL UND

12 Weeks post EOT
Bilirubin 11, GGT 16, ALT 22, AST 20, VL UND
Cured baby
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18701

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My guess...
First born, right arm, left arm and one leg,(I'm terminally right-handed) both thumbs and big toes, life savings, or one testicle or a breast...
My bet: It will be closer to $1000 a pill than $500 or $2000.
Gilead's Mission Statement:
"Your life for your life's savings".
Preferably the latter, but....
Brought to you by pure, democratic capitalism, where the monkey's run the circus and everyone gets in free but the middle class....
m
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
Last Edit: 5 years 3 months ago by mgalbrai.
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18702

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Ty Gaj
This is exciting the news we were hoping for, phew! A drug that appears to
I have been lobbying, yes Gilead is all over Twitter and so are many hep activists!
Anyway here's the pipeline so far on this drug

hepatitiscnewdrugresearch.com/updates-so...atasvir-gs-5816.html

May have been posted elsewhere on the forum and apologies if I am doubling up citations if that's the case
Gen 1a
Peg/inf/riba 2012(!) stop @ Wk 43 potassium low +issues (rlps week 4 post tx, VL120,000) scnds eg. adenomas.
pre sof/led VL 240,000 Fibsc F0
Day 25 <30
Day 32 UND
Week 10 UND
EOT UND ALT11AST17GGT19
SVR4 UND ALT10 AST16 GGT13
SVR8 UND ALT <9 AST16 GGT15
SVR12 UND ALT14 AST19 GGT12 Bili 5
EOT +18 ALT13 AST20 GGT9 Bili 5
EOT +21 ALT11AST15
Cured SVR12
Dysplasia Adenomas RemvdAug '16
SVR24 UND ALT11AST16
ColonoscopyClear Nov17
LumpectomyClear ‘18
LithotripsyCytoscopyBiopsy 4/18
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18707

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Hi again I simply can't seem to post a graph
Here's another link from today's social media

www.hepmag.com/blog/epclusa-newest-hepatitis-c-treatment

Mike if you already popped this up elsewhere sorry #flower
Gen 1a
Peg/inf/riba 2012(!) stop @ Wk 43 potassium low +issues (rlps week 4 post tx, VL120,000) scnds eg. adenomas.
pre sof/led VL 240,000 Fibsc F0
Day 25 <30
Day 32 UND
Week 10 UND
EOT UND ALT11AST17GGT19
SVR4 UND ALT10 AST16 GGT13
SVR8 UND ALT <9 AST16 GGT15
SVR12 UND ALT14 AST19 GGT12 Bili 5
EOT +18 ALT13 AST20 GGT9 Bili 5
EOT +21 ALT11AST15
Cured SVR12
Dysplasia Adenomas RemvdAug '16
SVR24 UND ALT11AST16
ColonoscopyClear Nov17
LumpectomyClear ‘18
LithotripsyCytoscopyBiopsy 4/18
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18722

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The Business Wire link quotes Gilead’s CEO as saying:

“Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens,” said John Milligan, Ph.D., President and Chief Executive Officer of Gilead. “As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.” See:

www.businesswire.com/news/home/201606280...es-Gilead’s-Epclusa®

Generic Darvoni (SOF 400mg + DCV 60mg) was the first and only pan-genotypic cure for HCV(until now), see:

fixhepc.com/forum/media-news/1053-darvoni-story.html

Therefore, Epclusa (SOF + VEL) is the second pan-genotypic cure … the first to be FDA approved … only because Gilead (SOF) and Bristol-Myres Squibb (DCV) didn’t want to work together and share profits. It’s all about trying to corner the market with a one pill cure all. In other words, it’s all about maximising profits, NOT about maximising the number of HCV sufferers being cured.

Epclusa may be an advancement for difficult to cure GT3s, however, it is NOT a significant advancement for GT2s who have a very high clearance rate taking Generic SOF + DCV on this forum. All you need is Darvoni for approximately USD700 + shipping & handling for a 12 week treatment. See:

www.darvoni.com/

Knowledge is power. Knowledge shared is power multiplied.”
Robert Noyce

Cheers
GT2
1983: Hospitalised with Acute non-A, non-B Hepatitis after ICU blood transfusion 3mths earlier => HCV GT2
22/02/16: (pre-tmt) ALT 61, VL 2.48 IU/ml Hepascore 0.32 (F1/2), fatigue, brain fog, bloating (Treatment Naïve)
10/04/16: (Start tmt) Sofovir +DaclaHep (SOF + DCV) by Hetero Labs in India
09/05/16: ALT 34, VL: NOT Detected :cheer: :) , FBG 11.9 :huh:
17/6/16 FBG 5.7; PPBG (@14.22) 6.9 (@ 20.45) 7.1; BP 124/72
:) (Accu-Chek Mobile & Omron Auto BP Monitor) :)
Last Edit: 5 years 3 months ago by GT2.
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18743

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Yes GT2, keep pounding that drum! I've been pounding it for months now and I can't understand why journalists have to be so lazy as to not do a little research and instead simply accept a company's press release as gospel.

Velpatasvir may be slightly better, and it is definitely good to have alternatives for the few who need it, but Gilead's repeated statements that this is the first pan-genotypic solution are a form of deception. I wish some writer for some major news outlet would have the balls to say so.
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18789

Another one cures all DAA to hit the market shame the USD $74000 price tag means that the majority of the worlds 150 million HCV population will have a shit show in hell to get a hold of this pill. Just as well there are generic's out there right now that do the same thing for approx $1300 USD for a 12 week treatment.
SVR 24
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18825

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OMG, you gotta love that there is already talk of a generic version of this drug coming soon! :cheer: :+1:
Gt 1a, F0, VL 6.5 million, AST 59, ALT 62
Started Twinvir 1/15/16
6 wk. labs VL UND, AST 27, ALT 20
EOT labs VL UND, AST 23, ALT 19
SVR 16, VL UND, AST 28, ALT 17
SVR 24 , VL UND, 10/8/16
SVR 125, VL UND, 9/22/18
SVR 230, VL UND, 10/3/20
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #18845

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I am relieved to see the Gilead CEO being so concerned that the cost of genotyping can be avoided....
What a magnanimous MF.......
m
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 5 years 3 months ago #19157

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Says at the bottom author is a Gilead shareholder. Fun and games in the boardrooms, really putting their minds to pricing:
www.pantagraph.com/business/investment/m...7d-00eb484768a9.html
Genotype 3 30 years, 2x treatment interferon/ribavirin non responder. Cirrhosis 17 years. Fibroscan, decompensating, 40 down to 22 by 29/3/16- now down to 6.5, normal, no cirrhosis. Started Buyers Club Sof/Dac 14 Nov 15. SVR 12 29/0716
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