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Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 8 months ago #21033
And a link to the article Splitdog was quoting. regist2.virology-education.com/2016/12co...ion/21_Sulkowski.pdf 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 | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 8 months ago #21035
Thanks Splitdog, great idea (and article). I think there will be a few GT3s watching this with particular interest. 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: LondonGirl, pat1, sabrecat, Ariel, beaches, Hieupham, splitdog, fitz, Donna, thirdtimelucky? | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 8 months ago #21063
Here is some further info on thirteen clinical trials involving Vox that I have been able to track down. I've included trial numbers for all phases for completeness but only a shortcut to Phase 3 which are the ones of most interest to us as they determine approvals. The four phase 3 trials are called Polaris 1 - 4. Phase 1 completed: NCT02402452, NCT02533427, NCT02397707, NCT02185794 Phase 2 completed: NCT02378935, NCT02378961, NCT02202980, NCT02536313 Phase 2 active(recruiting): NCT02745535 Phase 3 active(not recruiting): NCT02607735, NCT02639338, NCT02607800, NCT02639247 clinicaltrials.gov/ct2/results?term=Gs-9...rcv_e=&lup_s=&lup_e= 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 | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 8 months ago #21073
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 7 years 8 months ago #21076
And a bit of 'light' reading for those who are interested. hepatitiscnewdrugresearch.com/sofosbuvir...vir-and-gs-9857.html 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 | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 6 months ago #22290
"Come on Vox!" 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 7 years 6 months ago #22297
| Yes, come on you Vox 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 |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 6 months ago #22369
SOF+VEL+VOX will be Gilead's answer for relapsed patients. Hope it can be approved soon | |
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 7 years 6 months ago #22370
Me, too! 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 7 years 6 months ago #22461
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 - A new Protease Inhibitor 7 years 6 months ago #22467
| Hi From the waiting room Geno 2b Apparently since a blood transfusion and subsequent yellow Jaundice in 1963 Diagnosed in1991 failed a 24 week ribavirin/Peginterferon course 2015 started on course of Sof/rib after many problems 2016 failed the Sof/Riba course after 12 weeks Complete relapse. Awaiting lab test reports on type of mutation. Hope the new sof/vel/vox will be applicable. It looks promising. I am being told that the new thinking is virus mutates after completion of meds and have to wait before starting next course, Are there any planned fixhepc trials with Vox? TTL dw |
Voxilaprevir - A new Protease Inhibitor 7 years 6 months ago #22470
Hi TTL, Sorry to hear that your previous treatments failed you. Fortunately there are now better options available or in the pipeline. Voxilaprevir in combination with Sof/Vel is one that does look promising for the future per this thread fixhepc.com/forum/relapse-corner/1263-vo...inhibitor.html#22461 I'm not an expert but you don't appear to have treated with a NS5a combination, just with Sof/Riba? If that is the case and assuming you don't have a Sofosbuvir resistance (extremely unusual) there may well be current options that would be effective for a genotype 2b patient without needing to wait for Vox to become available such as Sof/Daclatasvir or Sof/Velpatasvir. If you can provide a bit more information about how soon after finishing treatment you relapsed and what your fibrosis levels are that may assist others to comment. 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 | |
Voxilaprevir - A new Protease Inhibitor 7 years 6 months ago #22477
Vox is not available as a generic yet, but your SVR rate with either Sofosbuvir + Daclatasvir or Sofosbuvir + Velpatasvir will be >95% YMMV | |
Voxilaprevir - A new Protease Inhibitor 7 years 5 months ago #22495
Yes, you may not need voxilaprevir. Sofosbuvir (an ns5b inhibitor) creates temporary resistance s282t that gets cleared by itself in 6-12 months. onlinelibrary.wiley.com/doi/10.1111/jvh.12405/summary There are also L159F and V321A, but those were found to be weak and to not influence treatment outcomes greatly. jid.oxfordjournals.org/content/early/2015/11/24/infdis.jiv564 In contrast, Ns5a inhibitors create permanent resistance. Yes, you should wait for lab tests for resistance to see if you have any baseline RAVs, except possible ribavirin resistance. www.ncbi.nlm.nih.gov/pmc/articles/PMC3961994/ www.ncbi.nlm.nih.gov/pmc/articles/PMC4786064/ www.nejm.org/doi/full/10.1056/NEJMoa1512612#t=article Resistance profile of velpatasvir looks slightly better then the one of daclatasvir for gen 2 viruses. (According to the articles above). The choice between vel and dac, of treatment duration and whether to include ribavirin for the third time is a really important one and depends on your fibrosis state and baseline RAVs. The addition of vox vs using ribavirin for the third time, if needed, also depends. You should research it very carefully. Vox may be not necessary and would possibly bring in NS3 resistance, if failed. The outlook for you is very good though, if treated properly (and timely). 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. | |
Voxilaprevir - A new Protease Inhibitor 7 years 5 months ago #22505
Gilead announces SVR12 Rates From Four Phase 3 Studies of sofosbuvir + velpatasvir + voxilaprevir! (20 October 2016) Filing FDA application very soon. www.gilead.com/news/press-releases/2016/...hcvinfected-patients www.empr.com/idweek-2016--adult-infectio...-hcv/article/566893/ The most common prior NS5A inhibitors were ledipasvir (55 percent) and daclatasvir (23 percent). Complete results from all four studies will be presented at the AASLD Liver Meeting® 2016 in Boston. Nov 11 - 15, 2016. www.pr-medicalevents.com/congress/aasld-2016/ 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. | |
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