Can imagine its an anxious wait, Seymour, esp with two previous treatment attempts. Great that you were able to get on a trial – and hopefully the 2wk undetected is a good sign for SVR.Fingers crossed for you

You are right mate – I hope the publicity and media focus is causing the Govt to squirm uncomfortably too, as it bloody well should. As Dr James has pointed out, no one in authority seems to be pulling their finger out in the way NZ does when negotiating meds pricing, to their shame.

Believe they are in the same process as we are, re the new meds berrinice – but the Dr pointed out they are generally able to negoitiate lower pharm prices than Aust does…at least we could try his suggestion of not asking for all the new drugs at once but maybe a couple of start with, to keep the price more affordable.

And they are advising a 2-3 yr wait before expected approval of sovaldi + Intf/Riba, according to the hepatits Foundation of NZ

http://www.hepatitisfoundation.org.nz/index.php/hepc/treatment/

Sure Seymour…why they will be forced to triage the meds, as every other Western country has had to do. Its never going to be universal access for everyone affected.

Very interesting link, thanks Dr James.

This is particularly pertinent – seems the majority oif drugs listed on the PBS are adjuncts to existing publicly-funded medications, not those which are “important therapeutic innovations”. And that NZ funds less of these adjunct-meds than we do, leaving more $ for other drugs with new therapeutic advantages:

Only a minority of new drugs provide a definite therapeutic advantage over standard treatments. Of the 217 approvals by the Australian Therapeutic Goods Administration between 2005 and 2007, only seven were rated as important therapeutic innovations.8 Most of the drugs funded in Australia and not in New Zealand were additions to an existing therapeutic class rather than new drugs providing important therapeutic benefits.4 New Zealand is less likely to fund ‘me too’ products.

With the exception of Havoni, for which there is trial data from ION-1 for n=1952 people (enough to make the margin of error roughly +/- 2%) pretty much all the other HCV trials have been so small that the margin of error is +/- 5% (n=384) or +/- 10% (n=96). See the trials and the discussion of margin of error here:

http://fixhepc.com/getting-treated/major-clinical-trials.html

As a result claims of superior clinical performance lack the raw statistical horsepower delivered by a large n to prove that. It’s simply a marketing smokescreen.

Even Gilead has adjusted the goals. The commercial Sofosbuvir is NOT the medication used in the Phase 3 trials where Form I crystals of Sofosbuvir were used. In the commercial product it is the Form II crystal (also known as Form 6) that is used. Forms 2-5 are all hygroscopic and un-useable. Form II is more stable but less soluble than form I. In other words the Sofosbuvir on sale is actually a GENERIC of the original Phase 3 trial medication that proved it up.

See page 12 of the TGA submission and the AUC data showing that Form II is not as well absorbed as Form I (it’s good enough to be considered the same for generic purposes, but it is less) and that also confirms Form I was used in the Phase 3 trials.

The Buyers club uses Form I because this was what was proven up in Phase 3 and has better solubility.

The Form II is available but we choose to go with what was actually tested, not the internal generic.

Form I and Form II are the same chemical but in a different crystal structure that can only be shown by melting point analysis or Xray Crystallography.

Diamonds and Graphite are different crystal structures of carbon. With Sofosbuvir the difference is not so marked but you get the idea….