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
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.
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.
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.
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:
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.
Voxilaprevir (akaGS-9857) - A new Protease Inhibitor
5 years 7 months ago #24887