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14 April 2016 at 3:52 pm #15476
Did we help ? There is mention of generic success rates from Australia. Thought worth posting here from Medscape report
From Medscape 6th April 2016Miriam E. Tucker
BARCELONA, Spain — Hepatitis C will top the agenda at the International Liver Congress (ILC) 2016, as it did last year, with presentations on treatment regimens for difficult-to-treat patients, the cost burden of the new direct-acting antiviral therapies, and real-world data.
“In hepatitis C, the big wave was 2 years ago. Now that we’re beyond a 90% cure rate, it’s a different landscape,” said Laurent Castera, MD, who is secretary-general of the European Association for the Study of the Liver (EASL).
The cost of the new treatment regimens is a major problem, and a late-breaker study from Australia on an imported generic direct-acting antiviral treatment will likely draw a large audience. [ ? us mob in Aus ? ]And several presentations of real-world data could provide reassurance that regimens proven highly effective in controlled clinical trials are achieving the same results in clinical practice.
“Hepatitis C still dominates the field, but the focus is shifting to difficult-to-treat patient groups, other genotypes, and a lot of real-life data,” said EASL Vice-Secretary Tom Hemming Karlsen, MD, PhD.
Other hepatitis C trials will address regimens for difficult-to-treat patients, such as those infected with genotype 3, transplant patients, and patients who failed previous treatment with a direct-acting antiviral. There will also be discussions on post-treatment monitoring for patients with hepatitis B or hepatitis C, who could still be at risk for hepatocellular carcinoma.
A group from China will present results from a randomized trial comparing systematic transient elastography monitoring with liver biopsy in patients with hepatitis B. “The issue is whether the noninvasive method can assess regression of fibrosis and cirrhosis in patients treated for hepatitis C and hepatitis B,” Dr Castera told Medscape Medical News.
With previous interferon-based treatment, “there was a significant decrease in hepatocellular carcinoma risk, but some risk persisted,” he explained. “With the new direct-acting antivirals, we don’t know. We anticipate that the risk might be even lower, but it’s difficult to identify these patients. You still need to monitor all these patients, even though only a few will develop carcinoma.”
“The point is, the story isn’t over with the cure of the virus,” Dr Karlsen explained.
Care delivery is now an issue. “How should hepatitis C care be administered? Is it done by hepatologists, or more broadly within the healthcare system? This is an interesting discussion that will emerge now that the regimens have become easier and easier,” he reported.
Beyond Hepatitis C
Among the other late-breaker topics are phase 2 data on norursodeoxycholic acid for the treatment of primary sclerosing cholangitis, a first-in-class hepatitis B virus core inhibitor (administered alone or in combination with pegylated interferon), and a new oral therapy for patients with cirrhosis and high MELD scores at baseline.
One of three general sessions will examine several different antiviral regimens for chronic hepatitis B, a marker for mortality in nonalcoholic fatty liver disease, a genome-wide association study identifying risk loci for alcoholic hepatitis, and a phase 2 study of a bone marrow stem cell treatment for cirrhosis.
New EASL clinical practice guidelines on autoimmune hepatitis, nonalcoholic fatty liver disease, benign liver tumors, vascular liver disease, and liver transplantation will be presented during dedicated sessions at the congress. As well, updated hepatitis C treatment guidelines from EASL and from the World Health Organization (WHO) will be released.
Some of the guidelines will be issued jointly with other liver societies, and there will be two sessions held in conjunction with the WHO.
Dr Karlsen said he is most excited by the global outreach aspect of the congress, which began as strictly a European meeting but now welcomes more than 10,000 attendees from all over the world.
“There is a strong direction toward collaborative efforts among the major liver associations — European, American, Asian, and Latin American,” he said. “You will see some very concrete output from that collaborative effort at a global level being presented and showcased at the meeting.”
Much of the global cooperation was spurred by the advances in hepatitis C, but it has now expanded to include collaboration in other liver diseases, Dr Karlsen reported.
“The hepatology arena has become very global. It’s a healthy direction, to see the field moving concertedly, along with the other associations, all in the same direction. It makes me happy,” he said.
Dr Castera has served on the speaker’s bureau for Echosens, which manufactures the FibroScan elastography device. Dr Karlsen has disclosed no relevant financial relationships.
14 April 2016 at 4:32 pm #15478Hi Annasnow,
Yes, Dr James is presenting the mentioned study on generics in Barcelona this Saturday 16th at 4:30pm their local time. (12:30am Sunday AEST)
And the large audience expected isn’t just “us mob in Aus?”, with an international patient cohort there is huge global interest in the results.
More details here: http://fixhepc.com/forum/media-news/819-generics-late-breaker-accepted-for-easl-in-april.html
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
14 April 2016 at 6:02 pm #15479Hi Gaj
I had not seen that entry on here – only last night I saw how the forum worked…a bit daunting for a naive user. I get a Medscape feed and laboriously copy n pasted it to put on here. I thought the post treatment care was also of great interest.
I am very chuffed the Good Doctor is presenting and presumably a standing ovation will greet him from his peers – it is like Robin Hood and bigPh. Would have got an EOT stat if I had known this was happening – at least he has my UND from 4 weeks. I meant our stats on generics by ‘us mob’ – we have our lives fed into his presentation that may really change some unjust aspects re treatment. The anarchist side of me was thrilled to circumvent the formal treatment system.
Cheers and many thanks to all on this marvellous information and support ship.14 April 2016 at 6:48 pm #15481From the HCV News Blogspot
•Does sustained virologic response represent a cure for hepatitis C virus infection?
http://hepatitiscnewdrugs.blogspot.com/2016/04/expert-svr-does-not-equate-to-cure-in.html•13 April 2016 – WHO issuing updated guidelines for treatment of hepatitis C infection
http://hepatitiscnewdrugs.blogspot.com/2016/04/13-april-2016-who-issuing-updated.html•ILC2016 Treating patients for Hepatitis C could reduce the need for liver transplants
http://hepatitiscnewdrugs.blogspot.com/2016/04/ilc2016-treating-patients-for-hepatitis.html•Study raises questions about the risks of treating patients with late stage Hepatitis C virus
http://hepatitiscnewdrugs.blogspot.com/2016/04/study-raises-questions-about-risks-of.html•ILC2016 Sofosbuvir/velpatasvir and experimental compound GS-9857 shows promise in Hepatitis C infected patients whose previous treatment has failed
http://hepatitiscnewdrugs.blogspot.com/2016/04/ilc2016-sofosbuvirvelpatasvir-and.html
Curehcvnow@gmail.com
http://forums.delphiforums.com/generichcvtxG 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 2414 April 2016 at 8:04 pm #15485Great links -Thanks – Keep ’em coming !
I saw (via Twitter) that Dr Freeman spoke this morning, I guess stating what he is presenting on the 16th.
Exciting.Really, this EASL meet is pretty awesome, but it’s not good unless Drs and more to the point, Health Authorities listen put these recommendations into practice. Here’s hoping hey
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC15 April 2016 at 12:02 am #15494For James Freeman and Greg as they are carried on by the flood of undetecteds and SVR’s coming in, this is how I would like to think of the collective strength of our feeling, as you represent us all and are vindicated by our lives. The haka reflects mana which is the Maori concept of the respect you command and the pride your tribe has in your achievements- off the scale in your case.
Kia Kaha (stand tall with the support of your tribe)
https://www.youtube.com/watch?v=e6RlUYtSnLY
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
15 April 2016 at 5:31 am #15506Who might these scoundrels be???
This is WHAT they are!
http://youtu.be/lRqxoM7iqoY
Curehcvnow@gmail.com
http://forums.delphiforums.com/generichcvtxG 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 2415 April 2016 at 7:23 am #15509Looking very flash indeed Am I able to share this photo on my FB to show all my friends these wonderful people or should I not?
YMMV
15 April 2016 at 10:57 am #15520Its from Greg’s Blog. Public domain. Share away!!!
Curehcvnow@gmail.com
http://forums.delphiforums.com/generichcvtxG 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 2415 April 2016 at 12:03 pm #15521Tweet tweet !
Shame our lovely MonkMed aren’t there too, so much good work done by them quietly behind the scenes to help patients.
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC15 April 2016 at 12:04 pm #15522The Căluşari were the members of a Romanian fraternal secret society who practiced a ritual acrobatic dance known as the căluş. The Călușari group is a secret, male-only society associated with a spring rite, possibly a remnant of tribal warrior societies. They were known for their ability to create the impression of flying in the air, both the galloping of a horse and the dancing of the fairies . Due to their connection with the fairies, the Călușari were believed to be able to cure the victims of fairies and for around two weeks – from three weeks after Easter till Pentecost – would travel to all the local communities where they would dance, accompanied by a few fiddlers, in order to do so.
https://en.wikipedia.org/wiki/C%C4%83lu%C8%99ari
Because is spring time in the northern hemisphere and hep C warriors, Dr. James Freeman and Greg Jefferys, are fighting for affordable cure (we all know who is the bad fairy in this story), I wish them good luck!
Forever grateful
https://youtu.be/qTlmPgaXdoM
HCV since I don’t know. Diagnosed in 2010.
GT1b, F0/F1, VL 9M, ALT 44, AST 42, Tx naive,
started 12 wks Twinvir on 06.12.2015. Feeling great and grateful 🙂
virus not detected 06.02.2016 & SVR24
isaing4@gmail.com15 April 2016 at 12:22 pm #15523If anyone from the UK is willing to talk to the Daily Mail (not my fave paper !) – They want to run a sympathetic article on treating with generics via FixHepC – PM me. They say it can be anonymous and via email or phone.
ps This came via the HepC Trust.
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC15 April 2016 at 3:06 pm #15524MonkMed. Who knows?
They might be there as well.
Agent 86
Curehcvnow@gmail.com
http://forums.delphiforums.com/generichcvtxG 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 2415 April 2016 at 7:15 pm #15529More links:
AbbVie’s Investigational Regimen ABT-493 and ABT-530 Shows High SVR In HCV Genotype 1 Patients Who Failed Previous Therapy
http://hepatitiscnewdrugs.blogspot.com/2016/04/abbvies-investigational-regimen-abt-493.htmlEuropean Medicines Agency’s PRAC extends the scope of its safety review on direct-acting antivirals for hepatitis C
http://hepatitiscnewdrugs.blogspot.com/2016/04/european-medicines-agencys-prac-extends.htmlImpact of Viekirax (ombitasvir/parataprevir/ritonavir and Exviera (dasabuvir) Real-world experience with 3-D regimen lives up to phase 3 studies
http://hepatitiscnewdrugs.blogspot.com/2016/04/ilc2016-coverage-impact-of-viekirax.htmlShorter treatment course potentially on the horizon for Hepatitis C patients
http://hepatitiscnewdrugs.blogspot.com/2016/04/interim-data-on-rg-101-at-international.html
Curehcvnow@gmail.com
http://forums.delphiforums.com/generichcvtxG 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 2416 April 2016 at 1:00 am #15533Dr James has done a request for UK patients here
http://fixhepc.com/forum/media-news/902-uk-patients-willing-to-speak-to-the-media.html
I read it yesterday morning our time
I went in media here in Oz it’s a good thing to do. Tina did in NZ.
They edited some of what I wrote but no significant changes to ruin the truth of my story.
I’m not popping up the link for privacy reasons this is just me haha. It has my real name etc.
Go for it somebody
And thanks James for all you’ve done for us worldwide with this weeks work
Ariel -
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