Forum Replies Created
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That’s great news Karilo.
Are you able to share how you did it so others in France may benefit?
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
Okay, on the question of quality control the licence requires that the products are manufactured in compliance with:
1. World Health Organisation requirements
2. Any other relevant authorities (e.g. Indian health requirements, GMPs, ISO9001, HACCP, local council by laws, etc, etc.)
So BMS and MPP expect the manufacturers to have standard quality control procedures in place.
Edit: I will note here that while I haven’t seen the Gilead licenses (has anyone?) I would expect they would be very similar in what they stated with regard to Quality Control. This isn’t rocket science, manufacturing is global these days as are quality standards. And no company is going assign it’s own “policemen” to oversee compliance by a licensee.
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
Hi Serg,
Just a few thoughts on this. I’ll start by saying I don’t know all the Indian laws that need to be complied with nor fully understand how this sort of international licensing agreement involving the MPP would work. My comments are based on some understanding of generics manufacturing processes and licensing agreements (food, additives, cosmetics rather than pharmaceuticals) and a quick scan through of one of the agreements attached to your links. I am not endorsing or criticising anything, just commenting on what I can see and speculate about.
– The licenses may not be very similar to Gilead ones in that while they allow manufacture of product and sharing of IP there are no fees and a third party involved (MPP) so there are likely to be very different clauses regarding responsibilities and liabilities.
– There are four Indian manufacturers licensed but from what you say only two of them are currently using that right. Anything made by them for their own sale would not need the “manufactured by” bit but probably requires the “sold under license from”.
– There are multiple agents/distributors such as Dr Reddy/Mylan who sell products under their own brand names that are produced by the four (two?) manufacturers. I would expect that their packaging would need to carry “manufactured by” and “licensed from” information either under Indian law or the licensing agreement but this may vary a bit depending on whether they were a tied agent (part)owned by the manufacturer or an independent distributor.
– As Dac was being made in India prior to the signing of the licenses, there may be stock in the market that does not fully comply with whatever the final rules and agreements are. I would suspect that if this is the case there may be a fair amount of it as the manufacturers were getting ready to launch new products. Normally this would be a manufacturers worst nightmare as all the packaging would need changing but in this case, in the spirit of cooperation and distribution of affordable lifesaving medicines, it may have just been agreed that the old packaging could be used until it ran out then the necessary changes made.
– Technology handover in the license seems to amount to electronic and hard copies of BMS technology that were handed over during signing of licence agreements. Dac is not that complex (and it wouldn’t surprise me if they are buying in the APIs anyway) so could be made prior to this happening without a lot of difficulty. It is more likely a symbolic “we are all on the same page” thing than resulting in any great revelations.
– The 25°/30° Storage temp split is likely along manufacturing lines and may be due to different binders or other incipients in the pills. But it could also be to give different shelflife for different markets or a purely marketing decision.
Anyway, those are my thoughts on the situation. I suspect that most of the anomalies will disappear with time as the market settles. But as always with generic HCV medications, Supply Chain integrity is vital and caveat emptor (buyer beware).
Edit: hehe, took so long to type that, the story has mostly moved on.
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
Hi Juen,
I take my Sof/Dac when I first wake in the morning then have my morning walk (45mins) to pick up milk and a paper before breakfast. While I suspect it maximises absorption, for me it means I don’t forget to take them as they are first task for the day. I haven’t had any issues with nausea with the Sof/dac. (Riba is different and I take those with my food)
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
Hi MtGoat,
How are you shipping? Would FedEx door to door help shorten timing? I can usually get US to Aust in about 5-6 days including w/ends.
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
Hah, you name dropper!
I must admit that with three weeks to EOT I am feeling some apprehension myself and I suspect that will increase once I’m waiting for SVR results.
And with HCV it’s not always easy to find someone to share those fears and doubts with. We need to find ways to cope with the uncertainty as we move on from the disfunctional relationship we had with the virus for so long. I’m sure your GP will make some useful suggestions.
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
While there is some suggestion that Silybum marianum (who thinks up these names?
) reduces inflammation and improves liver function there doesn’t appear to be much solid evidence regarding cirrhosis regression.http://www.mayoclinic.org/drugs-supplements/milk-thistle/evidence/hrb-20059806
Hopefully, if SVR resolves my liver inflammation and improves its function anyway then I think I would prefer to let my body heal naturally for now in the area of cirrhosis regression. But with a watchful eye on the large amount of research that is happening in this field.
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
I guess if I had been hacked by a professional, I would l be shopping for a new computer now instead of posting.
Nup, you would be happily posting away secure in the knowledge that you had fantastic anti-virus protection while your computer told all its computer friends otherwise.
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
Hi Stew,
Like you, I’m F4. I recently spoke with my specialist who told me that with the inflammation caused by HCV gone my cirrhosis was unlikely to worsen and would probably improve. He also mentioned that in some people the improvement can be remarkable. He did mention that my platelets steadily inproving back into the normal range was a positive sign for me as platelet count is linked to cellular repair.
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
Congratulations Stew!
Next stop SVR!
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
Hi Paul,
Great to hear your good news!
As Coral said, the second 12 seems to fly.
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
FF, your GP has told you that “it’s gone!” but the certificate you have been given doesn’t clearly state that. Your GP needs to clarify what he told you and why the certificate doesn’t state that. If that means he needs to contact the lab then that is what he should do.
But as you say, either way it is a good result and within expectations after 4 weeks.
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
mgalbrai wrote:You’re
Only
As
Old
As
You
Act
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
Fantastic news Mike!
You certainly deserve your 22 oz Arkansas Farmhouse Ales tonight TUM. Then you can….
…..in celebration.
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
Congratulations Ken!
Look your brain fog has lifted too!
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
