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TOPIC: Treatment over waiting for SVR

Treatment over waiting for SVR 3 years 4 weeks ago #2736

  • Seymour
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I consider myself to be extremely lucky to have had access to treatment with the new drugs before the majority Australians, especially as my liver is in pretty good shape. After two unsuccessful attempts with interferon based treatment, I wasn’t too impressed at being told in 2012 that I would probably die WITH hepatitis C, not OF it. Actually it is just luck that I happened to fit the criteria for a clinical trial in August of this year. What is not luck, is the three years I spent asking, negotiating and regularly turning up for my appointments to see if there was any way I could access interferon-free treatment. With my treatment over, my mind is now focussed on enabling other people to access treatment.

I celebrate the efforts of individuals like Greg Jeffreys and Dr James Freeman, that have made access to generics possible. There is no doubt that this is the prime reason why hep C treatment is in the news so much at present, and this must be causing Governments to squirm. I completely support people taking the initiative and helping themselves where bureaucracy has stood in their way.

I've been undetectable since week two of my treatment but my first post treatment blood test is on 20 November. I've been undetectable after treatment twice before, so this is a crucial test for me. I am trying not to think about it although I worry that every itch, chill or pain is the virus rebounding.
Diagnosed with the filth in 2002
Two unsuccessful battles in the interferon war of attrition
Almost beaten into submission between 2008-2014
Finally got the good stuff in 2015 - awaiting SVR
Currently releasing my inner activist. GRRRRRRR!
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Treatment over waiting for SVR 3 years 4 weeks ago #2742

  • berrinice
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I was told by my treating doc that I will die not because of Hep, he didn't think my fibroscan 18 at the time was a big deal. My gut instincts told me otherwise. Changed hospitals and hopefully this round of generic treatments works. kindly
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Treatment over waiting for SVR 3 years 4 weeks ago #2749

  • zhuk
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Can imagine its an anxious wait, Seymour, esp with two previous treatment attempts. Great that you were able to get on a trial - and hopefully the 2wk undetected is a good sign for SVR.Fingers crossed for you :)

You are right mate - I hope the publicity and media focus is causing the Govt to squirm uncomfortably too, as it bloody well should. As Dr James has pointed out, no one in authority seems to be pulling their finger out in the way NZ does when negotiating meds pricing, to their shame.
GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 - 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 - 6 weeks UNDETECTED
AST 26
ALT 26
Last Edit: 3 years 4 weeks ago by zhuk.
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Treatment over waiting for SVR 3 years 4 weeks ago #2754

  • berrinice
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I was wondering Zhuk why are new zealander's buying thru the buyers club then?
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Treatment over waiting for SVR 3 years 4 weeks ago #2756

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Believe they are in the same process as we are, re the new meds berrinice - but the Dr pointed out they are generally able to negoitiate lower pharm prices than Aust does...at least we could try his suggestion of not asking for all the new drugs at once but maybe a couple of start with, to keep the price more affordable.

And they are advising a 2-3 yr wait before expected approval of sovaldi + Intf/Riba, according to the hepatits Foundation of NZ


http://www.hepatitisfoundation.org.nz/index.php/hepc/treatment/
GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 - 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 - 6 weeks UNDETECTED
AST 26
ALT 26
Last Edit: 3 years 4 weeks ago by zhuk.
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Treatment over waiting for SVR 3 years 4 weeks ago #2757

  • Seymour
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Sadly, approving funding for only one drug doesn't make it any cheaper for Government because the number of people requiring treatment is the same. Government pays a fixed price for a cure no matter what drug is used.
Diagnosed with the filth in 2002
Two unsuccessful battles in the interferon war of attrition
Almost beaten into submission between 2008-2014
Finally got the good stuff in 2015 - awaiting SVR
Currently releasing my inner activist. GRRRRRRR!
Last Edit: 3 years 4 weeks ago by Seymour.
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Treatment over waiting for SVR 3 years 4 weeks ago #2760

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Sure Seymour...why they will be forced to triage the meds, as every other Western country has had to do. Its never going to be universal access for everyone affected.
GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 - 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 - 6 weeks UNDETECTED
AST 26
ALT 26
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Treatment over waiting for SVR 3 years 4 weeks ago #2762

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Sadly, approving funding for only one drug doesn't make it any cheaper for Government because the number of people requiring treatment is the same. Government pays a fixed price for a cure no matter what drug is used.

I would have to disagree with this. New Zealand uses precisely this strategy. Their policy is that we need 1 or 2 good treatments for this problem, not every treatment from every manufacturer.

This translates into a reverse auction where manufacturers are invited to submit their best prices to get and keep the Government subsidy.

New Zealand's prices prove beyond any doubt that hard negotiation encourages Big Pharma to sharpen their pencils.

We pay 8 times more than New Zealand for the 73 common drugs - I am not making this up....

www.australianprescriber.com/magazine/37/5/150/1

The population of New Zealand is similar to that of Sydney. By rights we should be able to negotiate better volume discounts.

The cost savings to the PBS on this have been estimated to be more than $1 billion a year.
YMMV
Last Edit: 3 years 4 weeks ago by DrJames.
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Treatment over waiting for SVR 3 years 4 weeks ago #2764

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There are no valid grounds for access restrictions based on scientific evidence, current treatment guidelines or clinical data. Such restrictions contradict the American Association for the Study of Liver Disease and the Infectious Disease Society of America treatment guidelines which support treatment for all HCV-infected persons. We will have to wait and see what happens in Australia, but Government will have a tough job imposing something which goes against treatment guidelines.
Diagnosed with the filth in 2002
Two unsuccessful battles in the interferon war of attrition
Almost beaten into submission between 2008-2014
Finally got the good stuff in 2015 - awaiting SVR
Currently releasing my inner activist. GRRRRRRR!
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Treatment over waiting for SVR 3 years 4 weeks ago #2765

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That's interesting James, and I don''t doubt you are right, but some drugs are more effective with different genotypes eg Viekira Pak with 1b. Wouldn't it be better if Government negotiated the best price for a cure for each genotype.
Diagnosed with the filth in 2002
Two unsuccessful battles in the interferon war of attrition
Almost beaten into submission between 2008-2014
Finally got the good stuff in 2015 - awaiting SVR
Currently releasing my inner activist. GRRRRRRR!
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Treatment over waiting for SVR 3 years 4 weeks ago #2766

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James-Freeman-facebook wrote:
Sadly, approving funding for only one drug doesn't make it any cheaper for Government because the number of people requiring treatment is the same. Government pays a fixed price for a cure no matter what drug is used.

I would have to disagree with this. New Zealand uses precisely this strategy. Their policy is that we need 1 or 2 good treatments for this problem, not every treatment from every manufacturer.

This translates into a reverse auction where manufacturers are invited to submit their best prices to get and keep the Government subsidy.

New Zealand's prices prove beyond any doubt that hard negotiation encourages Big Pharma to sharpen their pencils.

We pay 8 times more than New Zealand for the 73 common drugs - I am not making this up....

www.australianprescriber.com/magazine/37/5/150/1

The population of New Zealand is similar to that of Sydney. By rights we should be able to negotiate better volume discounts.

The cost savings to the PBS on this have been estimated to be more than $1 billion a year.


Very interesting link, thanks Dr James.


This is particularly pertinent - seems the majority oif drugs listed on the PBS are adjuncts to existing publicly-funded medications, not those which are "important therapeutic innovations". And that NZ funds less of these adjunct-meds than we do, leaving more $ for other drugs with new therapeutic advantages:
Only a minority of new drugs provide a definite therapeutic advantage over standard treatments. Of the 217 approvals by the Australian Therapeutic Goods Administration between 2005 and 2007, only seven were rated as important therapeutic innovations.8 Most of the drugs funded in Australia and not in New Zealand were additions to an existing therapeutic class rather than new drugs providing important therapeutic benefits.4 New Zealand is less likely to fund 'me too' products.
GT1a since 1988, diagnosed 1990
F0, tx naive
VL 262,000 ALT 40 AST 26 GGT 13 Fibroscan 04/12/15 - 2.9
Started Mesochem sof/dac 12 weeks 01/01/2016
11/02/2016 - 6 weeks UNDETECTED
AST 26
ALT 26
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Treatment over waiting for SVR 3 years 4 weeks ago #2767

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The immediate problem is there are people who need treatment NOW. The government knows people are dying and will continue to die unless they get treatment. Like Dr Miriam said about 20% need affordable treatment NOW. The rest of the schmozzle about pricing can come latter. kindly
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Treatment over waiting for SVR 3 years 4 weeks ago #2775

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With the exception of Havoni, for which there is trial data from ION-1 for n=1952 people (enough to make the margin of error roughly +/- 2%) pretty much all the other HCV trials have been so small that the margin of error is +/- 5% (n=384) or +/- 10% (n=96). See the trials and the discussion of margin of error here:

fixhepc.com/getting-treated/major-clinical-trials.html

As a result claims of superior clinical performance lack the raw statistical horsepower delivered by a large n to prove that. It's simply a marketing smokescreen.

Even Gilead has adjusted the goals. The commercial Sofosbuvir is NOT the medication used in the Phase 3 trials where Form I crystals of Sofosbuvir were used. In the commercial product it is the Form II crystal (also known as Form 6) that is used. Forms 2-5 are all hygroscopic and un-useable. Form II is more stable but less soluble than form I. In other words the Sofosbuvir on sale is actually a GENERIC of the original Phase 3 trial medication that proved it up.

See page 12 of the TGA submission and the AUC data showing that Form II is not as well absorbed as Form I (it's good enough to be considered the same for generic purposes, but it is less) and that also confirms Form I was used in the Phase 3 trials.
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YMMV
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Treatment over waiting for SVR 3 years 4 weeks ago #2776

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OK Dr so how effect is the stuff we are taking.? kindly
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Treatment over waiting for SVR 3 years 4 weeks ago #2779

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The Buyers club uses Form I because this was what was proven up in Phase 3 and has better solubility.

The Form II is available but we choose to go with what was actually tested, not the internal generic.

Form I and Form II are the same chemical but in a different crystal structure that can only be shown by melting point analysis or Xray Crystallography.

Diamonds and Graphite are different crystal structures of carbon. With Sofosbuvir the difference is not so marked but you get the idea....
YMMV
Last Edit: 3 years 4 weeks ago by DrJames.
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