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Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 2 months ago #23795
Maybe. At any rate, good news as it means Vox is coming soon........ This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James The following user(s) said Thank You: Greedfighter | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 2 months ago #23796
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 The following user(s) said Thank You: Ariel, Greedfighter | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 2 months ago #23797
| I did not understand that an intermediate is not a good product. The bottom line, American manufacturers are sourcing API's in the 3rd world. I was cured by Incepta Twinvir that is produced with Chinese API's, perhaps even an exact copy of Harvoni. The generics are the same meds as the name brand. You guys are going to be cured.....and will join me in giving the middle finger daily to the companies like Gilead. 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 The following user(s) said Thank You: splitdog |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 2 months ago #23798
Greedfighter, it means intermediate is for factories, home compounding is not possible, unlike with some other drugs. The quality of drug depends on quality control and chemical processes employed by both ingredient and pill manufacturer. Every factory is different, but both Bangladeshi manufacturers have been successful so far at ensuring the quality of the final product. Gilead produces api in factories in many countries, the data is publicly available. Gen 1b VL pre treatment 29000 ME/ml AST 32 ALT 94, F0 Started treatment 13 January 2017 Generic sofosbuvir/velpatasvir (Incepta) VL 9 days into treatment <300 (undetected) AST 13.8 ALT 22 Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60. The following user(s) said Thank You: Gaj | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 11 months ago #24564
Curious to know of any updates on the general availability of voxilaprevir – or any of the other second generation NS3/4A protease inhibitors. Gilead submitted their three-drug combo (voxilaprevir/velpatasvir/sofosbuvir) for FDA approval here last December – have not read of their progress. Are the manufacturers of generic medicines moving closer to the release of NS3/4A protease inhibitors ?? GT 1a (~1968) Diagnosed Non A/B ’85 – HCV ‘89 Rebetron INF/RBV 17 months 2000 – Failure Infergen INF/RBV 11 months 2002 – Failure Viekira Pak + RBV 12 weeks 2015 – Failure VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k Resistance Tests – NS5a Q30R SMV/DCV/SOF + RBV 24 weeks 2016 VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT SVR4, SVR12 and SVR24 Undetected | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 11 months ago #24571
Hello J. Eugene, I know at least one of the generics manufacturers are looking at it. FDA approval has to happen first but it will probably go down as observed before with Bangladesh first and India 6-9 months after FDA approval. We do have a very good NS3/4A and NS5A combination now - Viekira. As you can see, in GT3 paritaprevir is almost as good as Vox (GS-9857) and better than the Elbasvir in Zepatier (which is approved for GT3 with Sof). The ombitasvir is just as potent as Velpatasvir and stronger than the Grazoprevir in Zepatier. On the practical side of things, Abbvie Viekira is marketed in Egypt and can be sourced reasonable affordably, meaning a Sof+Vel+Vox potency combination is available now. The trials of Sof + Viekira and Sof + Zepatier show it works well: www.aidsmap.com/Treatment-intensificatio...atment/page/3014995/ YMMV | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 10 months ago #24713
I thought the US FDA had established fast-track on pending Voxilaprevir approval. That means within 6 months. Tomorrow is 6 months. No word yet? This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 10 months ago #24716
YMMV | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 10 months ago #24726
Thank you Dr. Freeman. I was going to say the wait is killing me.....but no. How long after that do you think it will be before Beacon is ready to dispense Vox? My Vel expiration date is Jan 2018. This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James The following user(s) said Thank You: coral | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 10 months ago #24733
Hello Splitdog, It will definitely be after the FDA approval, but how fast depends on things that have not happened yet. They were pretty quick last time, but lots of things have to happen internally before they can release it. YMMV | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 10 months ago #24887
Some progress – and a name for Gilead’s new 3DAA Vosevi Gilead Press Release – June 23, 2017 European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes www.gilead.com/news/press-releases/2017/...epatitis-c-genotypes Not certain how long the European Commission will take to approve the drug. The FDA here has a target action date under the Prescription Drug User Fee Act of August 8, 2017. It will be very interesting to see how Gilead prices Vosevi and how it is marketed alongside their existing Epclusa (Sofosbuvir/Velpatasvir) and Harvoni (Sofosbuvir/Ledipasvir) Will be watching – and watching too for the generic counterparts J GT 1a (~1968) Diagnosed Non A/B ’85 – HCV ‘89 Rebetron INF/RBV 17 months 2000 – Failure Infergen INF/RBV 11 months 2002 – Failure Viekira Pak + RBV 12 weeks 2015 – Failure VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k Resistance Tests – NS5a Q30R SMV/DCV/SOF + RBV 24 weeks 2016 VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT SVR4, SVR12 and SVR24 Undetected | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 9 months ago #24984
Any day now............. This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 9 months ago #24996
So ... FDA approval date will be August 8 ... ... and ... Alibaba already shows a trading company, Zhejiang Chemicals, listing three different intermediates ... Therefore ... Beacon should have Magicavir* available on August 10. (Okay, maybe not quite that fast.) Recent history suggests it won't be long now Splitdog. I bet Dr. Freeman actual has a pretty good idea of when it will be. In any case, we're cheering for you Splitdog. _______________ * my entry in the naming contest. _______________ I've been curious about the nomenclature, and the obvious just struck me .... NS5B RNA polymerase inhibitors .... the "B" = buvir NS5A inhibitors ... the "A" = asvir NS3/4A protease inhibitors ... the "P" in Protease = previr | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 9 months ago #24997
Thank you! I can hardly wait now........ This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James The following user(s) said Thank You: coral | |
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