Home Forums Main Forum FixHepC Admin Q & A SVR?

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  • #2528
    Sir-Paul-Paul-MJ-twitter
    • Topics: 1
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    • Acolyte
    • ★★
    @sir-paul-paul-mj-twitter
    CJ wrote:

    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

    Have a good read here Cindi http://blogs.hepmag.com/gregjefferys/

    cheers


    Gen 3a Started Sof Dac 16/10/15
    V/L 20 Mill +
    Hep C pos approx. 27 yrs

    Non responder 2011 BMS (dac) Peg Rib

    #2539
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    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.


    YMMV

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