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FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18692
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 | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18694
| 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! |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18699
So, greediad has a presence on twitter....... 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 | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18701
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 This email address is being protected from spambots. You need JavaScript enabled to view it. forums.delphiforums.com/generichcvtx 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 The following user(s) said Thank You: pat1, Tina-Hill-facebook, Matt-Kenney-google, cheese, fitz, Sven | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18702
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 | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18707
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 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 | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18722
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 17/6/16 FBG 5.7; PPBG (@14.22) 6.9 (@ 20.45) 7.1; BP 124/72 The following user(s) said Thank You: klhilde, mgalbrai, beaches, Hieupham, Greedfighter, Matt-Kenney-google, cheese, fitz | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18743
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. | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 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 The following user(s) said Thank You: mgalbrai, beaches, Greedfighter, Matt-Kenney-google, Bob in ireland, fitz |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18825
| OMG, you gotta love that there is already talk of a generic version of this drug coming soon! 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 |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 10 months ago #18845
I am relieved to see the Gilead CEO being so concerned that the cost of genotyping can be avoided.... What a magnanimous MF....... m This email address is being protected from spambots. You need JavaScript enabled to view it. forums.delphiforums.com/generichcvtx 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 | |
FDA approves Velpatasvir plus Sofosbuvir single tablet Epclusa 7 years 9 months ago #19157
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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