Making a medication is not a lot different to a chemistry experiment or for that matter a back yard meth lab. Typically you add two chemicals together in a solvent, heat it to such an such a temperature for a while, do something to make what you want separate from what you don’t, then rinse and repeat.

What this means in practical terms is that at the end of manufacture you have a lot of the thing you want (which is the > 99%) and a whole lot of traces of things you don’t want, but can not easily separate. Traces of solvents (from the process), traces of metals (from the containers used in manufacture), and traces of molecules similar, but not identical, to what you have been trying to produce.

Here is the official Chinese analysis of Mesochem’s Sofosbuvir API http://fixhepc.com/images/coa/COA-Sofosbuvir.pdf

Doesn’t chemistry logic dictate that you have to first identify the chemical that you are testing before you can test it’s purity? If you didn’t start with that premise, every chemical you tested would logically be made up 100% of impurities.

99% purity means 99% pure medication + 1% other stuff, mostly solvents used in manufacturing.

Testing is complex, but here it is in a nutshell:

Mass Spectrometry establishes the exact ratio of atoms present, so water would be H₂0 and Sofosbuvir is C₂₂H₂₉FN₃O₉P

Mass spec can also see impurities like stuff that you do not want including heavy metals like Lead, Arsenic, Tin….

Now Mass Spec tells you what atoms are present in what ratios but does not tell you how they are arranged. A technology called NMR tells your the exact arrangement. You can see a simple overview of our results here:

http://fixhepc.com/blog/item/2-sofosbuvir-ledipasvir-nmr-and-mass-spec.html

That’s abbreviated. The full set of tests done have included:

• Mass Balance
• NMR
• qNMR
• 2D NMR
• HPLC
• ELSD
• Karl Fischer
• Thermogravimetric Analysis

We have proven reference samples of these materials and can test any imported material against these.

We have tested all of Sofosbuvir, Ledipasvir, and Daclatasvir at a local facility and they all look good.

We have tested every individual dose to date, with the exception of one patient who could not afford the cost (but we had tested ever other sample from that batch). He’s at SVR so it worked, but it made me worry about “What if?”

Going forward we have negotiated a slightly reduced price from Mesochem if we batch up orders, so we will be able to include the testing with patients not paying any more.

For me testing is my protection – Yes, your honour, I prescribed a Hep C medication to a Hep C patient and I had confidence in that because….

And for patients….. I use the mum test. Would I be happy with my mum getting this treatment in this way?

In Australia we are 54% G1a/G1b and 37% G3a. So that accounts for 91%. We’ve seen quite a lot of G2, probably because Sof/Riba is not a bad choice for it and that’s what came online first out of India and we don’t really have G4 G5 G6 here.

I’m pretty sure I can find a colleague in the UK who will help in which case we could arrange something.

Price is probably the major decision maker in Led vs Dac for someone with G1. For G3 it’s definitely Dac. For G2 you’d be tossing up Sof+Riba vs Sof+Dac.

It will almost certainly change as more data becomes available.