Voxilaprevir (akaGS-9857) - A new Protease Inhibitor

This topic has 49 replies, 11 voices, and was last updated 7 years, 5 months ago by Dr James.

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31 October 2016 at 3:37 pm #24081
vitrus
- Topics: 1
- Replies: 35
- Total: 36
- Treatment Warrior
@vitrus
8 weeks of vox is quite enough, but 12 weeks is significantly better for everyone.

We are going to get lots of data on retreatment this November.
http://www.digitaljournal.com/pr/3091534

New treatments of 2016-2017 (More hope for GT3 patients!)
http://congress-ph.ru/common/htdocs/upload/fm/gepatology/2016/prez/1-3-2.pdf
(Note that the bullets denoting the drugs’ mechanisms of action are misplaced in this presentation)

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.
31 October 2016 at 3:41 pm #24082
Gaj
- Topics: 29
- Replies: 1,402
- Total: 1,431
- Guardian Angel
@gaj
Hi all, I’ve moved these Voxilaprevir posts from the Beacon Sofosvel release thread to this one.

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
14 November 2016 at 12:31 pm #24277
vitrus
- Topics: 1
- Replies: 35
- Total: 36
- Treatment Warrior
@vitrus
Chinese factories started selling vox API, but it’s not clear if it would be easy for a company to make working pills or capsules from it. No data on voxilaprevir solubility and permeability yet.

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.
15 November 2016 at 12:19 am #24286
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
Awesome! I looked at mesochem and couldn’t find it though. Come on Beacon!

splitdog@roadrunner.com

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
15 November 2016 at 12:33 am #24287
Dr James
- Topics: 264
- Replies: 1,968
- Total: 2,232
- Guardian Angel
@fixhepc
Basic data is starting to emerge

http://www.chemspider.com/Chemical-Structure.44209500.html

YMMV
15 November 2016 at 12:57 am #24289
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
Masfik, I am ready. Get Beacon onboard.

splitdog@roadrunner.com

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
15 November 2016 at 1:57 pm #24299
vitrus
- Topics: 1
- Replies: 35
- Total: 36
- Treatment Warrior
@vitrus
Voxilaprevir works for retreatment of non-ns5a daa treatment relapsers either.
http://www.oncologynurseadvisor.com/aasld-2016/sofvelvox-effective-as-retreatment-for-non-ns5a-daa-failures/article/571437/
One way is retreating with sof/vel/riba@24, another one – sof/vel@12, yet another one – sof/vel/vox@12. Each has different effectiveness in different cohorts.

NS3 RAVs resulting from treatment generally mostly disappear by themselves in about more than 1 year. Ns5b sof-related RAVs – in about less than 1 year.
However, acquired NS5A RAVs persist, requiring retreatment with drugs having considerably different resistance profile/mechanism of action/high bareer to resistance.
Results from 3-year follow-up study.

http://www.natap.org/2016/AASLD/AASLD_61.htm

All presentations from AASLD 2016 – the long-awaited data on retreatment.
http://www.natap.org/2016/AASLD/AASLD.htm

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.
28 November 2016 at 12:09 am #24508
thirdtimelucky
- Topics: 0
- Replies: 6
- Total: 6
- Novice
@thirdtimelucky
GENO 2B
TREATED WITH iNTERFERON/RIBA IN 1995 Failed
Treated With Soif/Riba 2015/16 Failed
I have followed all trials on Sof/Vel/Vox and it seems to be my best option out there.
Not sure where to source the meds especially the Vox.
Am going to speak to GP2U tomorrow.
28 November 2016 at 2:25 am #24514
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
I inquired with masfik about Vox and he sent me a response that said, “We are working on it.”

splitdog@roadrunner.com

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
28 November 2016 at 2:37 am #24515
fitz
- Topics: 9
- Replies: 490
- Total: 499
- Guardian Angel
@fitz
Awesome news Splitdog! Beacon it seems doesn’t let any grass grow beneath their feet. Good for them!
8 December 2016 at 3:53 am #24628
vitrus
- Topics: 1
- Replies: 35
- Total: 36
- Treatment Warrior
@vitrus
Found data on voxilaprevir pharmacokinetics!
http://regist2.virology-education.com/2016/17HIVHEPPK/40_Kirby.pdf
Reference AUC and Cmax profiles!
TODO: share with all researchers, the data was hard-to-find. (To be done by someone).

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.
8 December 2016 at 9:48 pm #24635
vitrus
- Topics: 1
- Replies: 35
- Total: 36
- Treatment Warrior
@vitrus
Gilead filed for FDA approval. The approval is expected in several months.
The market is about 18 million people.
http://www.gilead.com/news/press-releases/2016/12/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-the-investigational-single-tablet-regimen-sofosbuvirvelpatasvirvoxilaprevir
P.S. Likely to be approved either in July or October, 2017 depending on designation.

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.
13 January 2017 at 9:49 am #24993
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
Come on, Voxy!!!

splitdog@roadrunner.com

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
25 February 2017 at 3:31 am #25398
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
A Voxilaprevir intermediate is now available in China.

splitdog@roadrunner.com

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
25 February 2017 at 3:44 am #25399
Greedfighter
- Topics: 28
- Replies: 582
- Total: 610
- Guardian Angel
@greedfighter
Haha, so actually available in China even before Gilead goes to market…Awesome

I bet that’s because Gilead is sourcing the API’s from China.
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