- This topic has 49 replies, 11 voices, and was last updated 7 years, 4 months ago by
.
-
splitdog wrote:
A Voxilaprevir intermediate is now available in China.
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
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 (~196
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 UndetectedHello 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:
Hello Splitdog,
It’s not scheduled for approval until August 8 2017
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.
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
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 (~196
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
- You must be logged in to reply to this topic.