emo #Latest NZHF magazine (Generic Ledipasvir)

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6 years 2 months ago #13908

MODERATOR COMMENT from Gaj: I've moved this thread and the link below as a container to allow a separate discussion of generics issues raised in the magazine.

www.hepatitisfoundation.org.nz/files/4014/5980/2980/final.pdf

For those interested in the technical basis of Prof Gane's comments Ledipasvir can be made, but yes it's hard. As far as the solubility goes it is a BCS class II drug meaning it is relatively insoluble but highly permeable.

For the full run down on that feel free to read: www.sciencedirect.com/science/article/pii/S1818087614000348

It's not unusual for a drug to be relatively insoluble but highly permeable and the techniques used to help absorption are many, various, and all well known.


YMMV
Last Edit: 6 years 2 months ago by Gaj.
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6 years 2 months ago #13936

I know you are brilliant, but come on, Ed. Just because you are smart doesn't mean everyone else is stupid. If someone can make something, someone else can make a perfect copy. This isn't art, this is science.
Party pooper..

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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
Last Edit: 6 years 2 months ago by mgalbrai.
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6 years 2 months ago #13937

Bangladesh generics attacked again - does anyone know where the Ledipasvir in Twinvir is made?


M, 57, Live in Wellington,NZ.
Genotype 1a diagnosed in 2013.
Treating for the first time since October 31 with Buyers Club Sof/Led. Thanks so much guys. Minimal side effects apart from sore throat at the start..
Viral load 5.4m when treatment started, Undetected at 4 weeks, 8 weeks, End of Treatment and 12-weeks post EOT. Yay!

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6 years 2 months ago #13938

You know what ive been thinking.... maybe Ed should go check out the processing plant at Incepta and Beacon to put his mind at rest.


SVR 24
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6 years 2 months ago #13940

I imagine Incepta might have found this link helpful when in their ledipasvir quest:
www.halosyntech.com/en/

In addition,it appears Incepta has very sophisticated R & D and production facilities.
____________________________________


During the course of the last couple of years the company has received accreditation from many other countries of the world and currently holds the following GMP certificates from their respective Ministry of Health.
European Union GMP Certificate
Turkey GMP Certificate
Yemen GMP Certificate
Kenya GMP Certificate
Democratic Republic of Congo GMP Certificate
Ethiopia GMP Certificate
Uganda GMP Certificate
_______________________________

I believe Dr. Gane is a "company" man,
spouting the "company" line,
in support of the "company" bottom line.
That "company" being Gilead...

That doesn't mean the manufacture of ledipasvir isn't complicated. I'm sure it is.


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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
Last Edit: 6 years 2 months ago by mgalbrai.
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6 years 2 months ago #13944

There is a patent about spray-drying technique (mentioned by Gane) for ledipasvir - www.google.com/patents/US20140212487 If i correctly understand, food has negative effect on absorption of ledipasvir, and spray-drying is applied to mitigate this effect. This does not mean that ledipasvir will not absorb "at all" without spray-drying. If ledipasvir is used in fasted condition - their absorption, possibly, may be good even without spray-drying...


Probably infected in 1977
2005 - diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 - PegIFN/rib 48 weeks treatment, relapse
2016 - compensated F4, MELD 8-9, ALT 100-160
2018 - compensated F4, MELD 8, ALT 91
Last Edit: 6 years 2 months ago by Serg.
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6 years 2 months ago #13946

I suppose the licensed meds would have more checks on these processes ?


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 HepC

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6 years 2 months ago #13948

I hope yes. Dr.Gane said that

Gilead has licenced 11 generic companies in India to produce sofosbuvir (and very soon the ledipasvir/sofosbuvir combination tablet) for the local markets. Strict quality control from Gilead ensures that these drugs are identical to those produced for European and American markets.


Probably infected in 1977
2005 - diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 - PegIFN/rib 48 weeks treatment, relapse
2016 - compensated F4, MELD 8-9, ALT 100-160
2018 - compensated F4, MELD 8, ALT 91
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6 years 2 months ago #13949

The proof is in the pudding.
The pudding is Humble Pie.
It's coming out of the oven.
The first bites have tasted very good.
Dr. Gane is about to eat some.


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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
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6 years 2 months ago #13950

Well that's good to hear Serg, +1: if a little out of date!


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 HepC
Last Edit: 6 years 2 months ago by LondonGirl.

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6 years 2 months ago #13955

The APIs in Twinvir are from China; this from searching `Twinvir Ledipasvir' in the forum. So, Dr Gane was maybe talking about another Bangladesh drug maker?


M, 57, Live in Wellington,NZ.
Genotype 1a diagnosed in 2013.
Treating for the first time since October 31 with Buyers Club Sof/Led. Thanks so much guys. Minimal side effects apart from sore throat at the start..
Viral load 5.4m when treatment started, Undetected at 4 weeks, 8 weeks, End of Treatment and 12-weeks post EOT. Yay!
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6 years 2 months ago #13956

The Chinese manufacturer.

www.halosyntech.com/en/

I think Gane feels anything thats not approved by Gilead (and paying them) is suspect.
Just my opinion....


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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
Last Edit: 6 years 2 months ago by mgalbrai.
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6 years 2 months ago #13962

China has the technology to produce the API's. And Twinvir is made from Chinese API's run through a tableting machine in Bangladesh by Incepta.



SAVE $1112 a pill....No more hookers and private jets for these douchebags :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
Last Edit: 6 years 2 months ago by Greedfighter.

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6 years 2 months ago #14002

mgalbrai wrote:

The Chinese manufacturer.

www.halosyntech.com/en/

I think Gane feels anything thats not approved by Gilead (and paying them) is suspect.
Just my opinion....

And a doctor should just keep his mouth shut if he has any doubts? He's only saying that the chemicals from Bangladesh might not be up to scratch, not damning the properly licensed components at all, including the ones that many of us have benefited from.

By saying this:
Of particular concern is the recent availability of generic ledipasvir from Bangladesh (either separately or coformulated with sofosbuvir). Unlike the manufacturing of sofosbuvir, which is relatively simple, ledipasvir is very complex, requiring almost 20 separate steps. One critical intermediate step is Spray-Drying Dispersion, where the ledipasvir chemical is mixed with another substance to improve solubility. Without this step, the nal ledipasvir drug will not be absorbed when taken by mouth. Spray-drying for ledipasvir requires large purpose-built facilities, of which only a few exist in the world and none in Bangladesh.
It therefore seems likely that generic combinations of ledipasvir and sofosbuvir from Bangladesh will only contain active sofosbuvir. As a result, although the hepatitis C will disappear during treatment (because of the active sofosbuvir), it will relapse after treatment is stopped (because of the lack of active ledipasvir). Secondly, individuals need guidance on what treatment is best for them.

he is only talking about one particular problem that has caught his eye. Maybe you don't like some of the implications, but if there is any doubt, I would prefer my doctor to at least air the concern.

Personally, I don't agree with the second paragraph – if the ledipasvir was completely useless, the virus would not disappear during treatment (except for some genotypes in combination with ribavirin). However, if it was not optimally absorbed, it might make the long term outcome unfavourable for some patients.

I think he's overstated his case, but that he did the right thing by pointing out discrepancies in the unlicensed manufacturing process that could conceivably affect the effectiveness of the drug. Better to go with the licensed generics that seem to be working so well and cost about the same for us.


G4, F4, cirrhosis.

Thank you to Gilead, Michael Sofia, and the terrific folk at FixHepC for making this adventure possible.

YEAR..... ALT..... AST..... GGT... FERRITIN........................................
2009....... 210..... 215..... 953..... 1400........... (Bad health, stupidity)
2015....... 60....... 45....... 150..... 360............. (Improved diet and health, FixHepC treatment)
2016....... 20....... 24....... 25....... 156............. (SVR 12)
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6 years 2 months ago #14003

Gilead seems to feels comfortable outsourcing their components to Chinese manufacturers. I would imagine Incepta feels the same.


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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: LondonGirl, Greedfighter

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