For something to qualify as a generic it must show similar pharmacokinetic properties (in English similar blood levels at different points of time after taking it). You will find all the nitty gritty here:
The Form I vs Form II argument is probably irrelevant to clinical results but it remains a fact that Form I was what was used in the Phase 3 trials everyone reads and Form II is what is used in the commercial product.
It is unlikely to make a significant difference. A 50 kg person is getting 150% of the dose an average 75 kg person gets in mg/kg terms. A 150 kg person is getting only 50% in mg/kg terms. Provided the therapeutic window is wide enough dose adjustment is not required and a one size fits all dose is fine.
That said my eyes nearly fell out of my head when I saw that Gilead had changed from using what was tested to something that was not tested in the same way (Phase 3) but rather in the same way a generic is declared bio-identical.
YMMV
The following user(s) said Thank You: Alsdad, isaing4
Treatment over waiting for SVR
8 years 9 months ago #2794
I am about 68kg so the answer is yes, if I want 150% dosage. Which I do. I am hard to treat 3 non responder. I never want to go down this path ever again; its been a total nightmare. kindly
Treatment over waiting for SVR
8 years 9 months ago #2798
One more point Doc, those Hep organisations should have picked this deception up.(there is enough of them spread across the country) Its wrong that we are only learning about it now. We have a right to know. The public has a right to know. This must be a new news worthy story. kindly
Treatment over waiting for SVR
8 years 9 months ago #2805
berrinice wrote: I am about 68kg so the answer is yes, if I want 150% dosage. Which I do. I am hard to treat 3 non responder. I never want to go down this path ever again; its been a total nightmare. kindly
I'm a 96 kg 3a non responder with a knocked around liver but have had a great response with Sof and Dac regular dose so far. Week 2 bloods Alt Ast within range V/L 19 mill down to 16.
Two time relapser.
SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated
GT 3 - about 28 yrs with HCV
Treatment over waiting for SVR
8 years 9 months ago #2817
That's interesting James, and I don''t doubt you are right, but some drugs are more effective with different genotypes eg Viekira Pak with 1b. Wouldn't it be better if Government negotiated the best price for a cure for each genotype.
1b is the easiest genotype to treat with DAAs and can be done in 3 weeks with 3 DAAs