Hi,
Is there any proof of SVR on any of the generics yet?
Also are the generics bio similar to the licenced orals?
Thanks,
Cindi x
J the young dragon slayer is:
HepC 1a since birth
Male aged 15
VL 2000000
Started Twinvir/ 10-11-15-then Sof/led.
NO sides so far !
after one week VL : 37
after 4 wks VL : UND !
EOT 2/2/16 UND.!
4 wks. post tx results….pending….
7/3/16 VL result : 4 week post tx: SVR !
12 weeks SVR !
24 wks SVR yeeaa!!
Yes, there are patients at SVR4, SVR12 and one I know of at SVR24 (who sourced research APIs very early on)
I have over 100 patients on generics and all but 3 were VL = 0 at 4 weeks. One was VL = 0 at EOT and the other 2 are pending 6 week load testing (one with VL 47 @ 3.5/52, the other < 15)
Bioequivalence as in pharmacokinetic AUC testing is a cheap hack to avoid doing actual trials when introducing generics.
The actual clinical results on these generics are in line with expectations.
.
