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#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks ago #13908
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 | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks ago #13936
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 | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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! | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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 The following user(s) said Thank You: beaches |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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. 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: LondonGirl | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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 The following user(s) said Thank You: LondonGirl | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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 |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks ago #13948
I hope yes. Dr.Gane said that
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 The following user(s) said Thank You: LondonGirl | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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. 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 | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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 |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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! The following user(s) said Thank You: mgalbrai | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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.... 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 | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks 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 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 |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks ago #14002
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:
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) | |
#Latest NZHF magazine (Generic Ledipasvir) 8 years 3 weeks ago #14003
Gilead seems to feels comfortable outsourcing their components to Chinese manufacturers. I would imagine Incepta feels the same. 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: LondonGirl, Greedfighter | |