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  • 28 December 2015 at 8:53 pm #7461
    Avatar photoVororo
    • Guardian Angel
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    @vororo

    Here is a recent presentation by Raymond Schinazi (creator of Sofosbuvir) on “Rational Pricing and the Role of Generics”:

    http://regist2.virology-education.com/2015/2ndhepcure/12_Schinazi.pdf

    A few key points:

    * Highlights the disparity of Hep-C prices around the world – even in “high income” countries (slides 12+13)

    * Mentions the Australian ASHM and NSW Health policy (cites FixHepC) as a “new driver towards generics” (slide 14)

    * According to Canadian Family Physician (CFP) review, “generic medications are bioequivalent and produce similar clinical outcomes to brand-name medications” (slide 15)

    * Numerous reports of equivalent efficacy and safety of generic compared to brand for other life-threatening conditions (slide 15)

    * Shows some examples of (apparently?) counterfeit products – “SoviHep”, “Sofeni”, “Dactinna”. “Ledisofo” (slide 17)

    * Shows some promising RVR (rapid virological response) results for 3-therapy (Sof+Led/Dac+Asv/Smv) treatments (slide 25)

    * Highlights that as of 2015 only about 600 000 people world-wide have been cured of HCV (slide 29)

    * Promises a new 4-therapy treatment of only 3 weeks in the pipeline (slide 30)

    Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
    Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
    Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
    Week4: AST 47, ALT 58. VL < 15 (unquantifiable). Week12 (EOT): AST 30, ALT 26, VL UND Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND Ever grateful to Dr James. Relapsed somewhere after all that... Bummer! Jan 2018: VL 63 000 (still GT3).

    29 December 2015 at 5:38 am #7480
    Avatar photoJoy
    • Guardian Angel
    • ★★★★★
    @joy

    Thanks V, you are such a good researcher!

    I don’t understand a lot of it, but good to see Schinazi is working on even better meds. And fantastic that fixhepc is mentioned.

    So ‘Generics account for 78% of all US prescriptions’ ? (Slide 15) Hallelujah.

    He has a sense of humour doesn’t he – naming the ultimate C-Pak SCHINAZIVIR? (Slide 31).

    29 December 2015 at 5:40 pm #7493
    Avatar photoVororo
    • Guardian Angel
    • ★★★★★
    @vororo

    I was curious about Raymond Schinazi’s slide on “counterfeit” HVC treatments, so I did some more searching on Google.

    * definition of “counterfeit”: made in imitation so as to be passed off fraudulently or deceptively as genuine; not genuine; forged (dictionary.reference.com/browse/counterfeit).

    In all fairness, I have no idea what Schinazi actually said when he showed that slide.

    I just want to remind anyone who looks at his slides that “generic” does not automatically mean “counterfeit”… And in fact, most generics are perfectly legal if they are made and properly tested by an authorised manufacturer.

    * SoviHep is made by Zydus Cadila, which has a “Voluntary Licence” with Gilead. So presumably the picture shown in Shinazi’s slide is a counterfeit copy (not made by Zydus) of a licensed product.

    * Sofeni and Dactinna are manufactured by Tongmeng (Laos) pharmaceutical and food Co. Ltd.

    http://www.tlph-lao.com/product.php

    Laos is a “Least Developed Country” and is not listed as one the 91 countries to which Indian generic manufacturers that have a Gilead Voluntary Licence are allowed to export to. So like Bangladesh, Laos can legally manufacture its own hepatitis C treatments:

    http://fixhepc.com/forum/media-news/94-incepta-s-twinvir.html?start=48#1740

    According to a web page of Dr Dunin, Deputy Chief Physician at PLA Hospital for Integrative Liver Disaease Treatment and Research, the Tongmeng company has been authorised by the Laos Ministry of Health.

    http://www.haodf.com/zhuanjiaguandian/dbb302_3465510740.htm

    So without strong evidence otherwise, it seems that Sofeni and Dactinna are legally authorised generics in Laos.

    So, again, the picture of Sofeni and Dactinna shown in the slide is a counterfeit only if the product was not legally made by Tongmeng.

    * Ledisofo was apparently produced by a company called “LAFEPE”, which was identified by ANVISA (Brazilian Health Surveillance Agency) as being not registered to manufacture the product. ANVISA stated that the product is counterfeit.

    http://crfsc.gov.br/confira-as-suspensoes-da-anvisa-desta-quarta-1811/

    But strictly speaking, this does not necessarily mean that the actual chemical formulation was not genuine, only that its manufacture was not authorised by an appropriate Brazilian government agency. So if the molecule was geuinine, it seems fair enough for Schinazi to call this a “true counterfeit” (if that is what he actually said).

    —–

    Bottom line:

    * The term counterfeit should only be used for provably false or unauthorised products.

    * Only a NMR spectrum can tell whether molecule is genuine or not:

    http://fixhepc.com/blog/item/16-testing-provisions-patient-safety.html

    Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
    Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
    Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
    Week4: AST 47, ALT 58. VL < 15 (unquantifiable). Week12 (EOT): AST 30, ALT 26, VL UND Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND Ever grateful to Dr James. Relapsed somewhere after all that... Bummer! Jan 2018: VL 63 000 (still GT3).

    30 December 2015 at 2:55 am #7512
    avatar876.jpegGaj
    • Guardian Angel
    • ★★★★★
    @gaj

    Hi Vororo,

    As with you, I don’t know what he actually said to accompany that slide. However my take was that he wasn’t stating that any particular one was real or not but instead claiming that if DAAs were more affordable there would be no need for people to go through the process that you just did of trying to determine which are genuine patent product, authorised generics, unauthorised generics or just counterfeits of one of these that didn’t contain correct amounts or possibly any APIs.
    With cheaper prices that problem just goes away, much like with aspirin where you can purchase Disprin as the branded product or you can go anywhere in the world and purchase any aspirin product and be confident that you are getting what you paid for and that it will work as intended because there is no financial incentive (and probably a disincentive) to make a fake product.

    But as you say, until that happens, it is buyer beware.

    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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