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Voxilaprevir - A new Protease Inhibitor

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Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 7 months ago #23795

Maybe. At any rate, good news as it means Vox is coming soon........
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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 6 years 7 months ago #23796

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splitdog wrote: A Voxilaprevir intermediate is now available in China. :cheer:


:+1: Thanks for finding this SD, although an intermediate won't be suitable for direct purchase and compounding due to solubility issues/bioavailability it means that generics manufacturers are able to develop a usable final product. :)
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
:cheer: :cheer: :cheer:
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Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 7 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
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Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 7 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 4 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 4 months ago #24571

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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
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The following user(s) said Thank You: Gaj, J. Eugene, Iain

Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 3 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?
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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 3 months ago #24716

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Hello Splitdog,

It's not scheduled for approval until August 8 2017

YMMV
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Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 3 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.
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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 3 months ago #24733

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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 3 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
The following user(s) said Thank You: DrJames, coral, Gaj, splitdog, Iain, Mnem

Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 2 months ago #24984

Any day now............. :cheer:
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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 2 months ago #24991

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8th August for the Gilead product Splitdog
YMMV
The following user(s) said Thank You: Gaj, splitdog, Iain

Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 2 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
The following user(s) said Thank You: DrJames, coral, splitdog

Voxilaprevir (akaGS-9857) - A new Protease Inhibitor 6 years 2 months ago #24997

Thank you! I can hardly wait now........ :P
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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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