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:

http://www.australianprescriber.com/magazine/26/4/85/7

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.

That info about Gilead quietly changing the product is simply breathtaking Doc. For once, I’m almost lost for words! hmy:

You would be better off doing Sof+Dac+Riba

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

http://news.sciencemag.org/health/2015/10/study-suggests-unprecedented-3-week-hepatitis-c-cure

See LB-23 here….

http://www.aasld.org/sites/default/files/TLM-2015-LakeBreakingAbstracts.pdf

Simeprevir is already listed so 1/4 of a course of Harvoni and 1/4 a course of Olysio looks like it will do the trick for RVR patients.

AbbVie and Viekira Pak are more civilized in their PBS negotiations. Better ? It just got a black box FDA warning….

http://www.fool.com/investing/general/2015/11/05/does-abbvies-viekira-pak-warning-land-express-scri.aspx

We, as in Australia do not need all the manufacturers products.

We, as in Australia should invite those Pharma companies who want our TAX DOLLARS to sharpen their pencils.

We, as in Australia should cure as many patients now as we can afford.

Hypothetically why not cut a deal with one?

That would be infinity percent more patients getting treatment. Currently it is a division by zero error.

We need Sarah Henderson on the case.