Don't worry Angus the doc has just assured the Hep c buyers club that they get 1st grade - top quality medicine. They are not generics. The PBAC recommended for listing on the PBS. The problem is Cabinet oversees all listings. Cabinet has the final word. To date of all the new expensive medicines that have been listed on PBS, heppers have dipped out. It is really dreadful that there are people in dire need of this medicine and cannot afford it - micro finance charities could fill this gap with no interest loans. I am taking it
upon myself but are yet to hear from a person well versed in the best way to go. The hep organisations are utterly useless in every aspect of the generic and 1st grade medicine for either information or how to access it. You have made the right decision.

I am an ardent supporter of generics & am awaiting delivery of mine. But fail to understand why a story a year old which does not represent the current situation is posted as " recent news & a reason not to wait" I do not say we are in a better situation. But for a minute thought that the PBSAC had changed their mind & unrecommended the DAA to the Goverment. Not everyone is as lucky as us & can afford these generics & are hoping like hell their is good news in December ( I dont think so) but this is misleading untill looked at closely. Regards Angus

I am an ardent supporter of generics & am awaiting delivery of mine. But fail to understand why a story a year old which does not represent the current situation is posted as " recent news & a reason not to wait" I do not say we are in a better situation. But for a minute thought that the PBSAC had changed their mind & unrecommended the DAA to the Goverment. Not everyone is as lucky as us & can afford these generics & are hoping like hell their is good news in December ( I dont think so) but this is misleading untill looked at closely. Regards Angus

it's good enough to be considered the same for generic purposes, but it is less

Thanks for that information, don't like the sounds of" but it is less". Do you think I should increase Sosobuvir a bit, I do have a pill cutter

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....

OK Dr so how effect is the stuff we are taking.? kindly

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:

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.

It's not the US that's denying victims affordable treatment, their citizens and government are being held to ransom along with the rest of the world, US tax dollars went to the scientist which helped him develop sofosbuvir who then sold his discovery to gilead, What the real problem is, is that no regulatory law exists that can crush this immoral price gouging from happening, a fair price is a fair price but I think all can agree that that is far removed from this situation, it's all about money and how much they can pocket, the suffering of people is strictly minutiae to what is just blatant profiteering.

I received this message:

Hello James, I have received my medications but why am i afraid to start them?

I'm posting this because it is actually quite common.

I had one patient's family ring me. He was in hospital having had ascites drained. They had the medications to hand but had been delaying giving them. I insisted they go to the hospital and give them. The patient in question, some 2 weeks ago had a MELD score indicating a 20% 3 month mortality. Things have got better and this risk is now reduced to 6%. Still not great but much better.

For this patient the future looked like a game of Russian roulette with 5 bullets and 1 empty chamber. On treatment it looks like 1 bullet and 5 empty chambers.

I know which game I would prefer.

Fear of the unknown is an instinctive response designed to keep us safe. This website exists in part to help reduce that fear that bad things will happen taking generics. We don't censor anything other than spam, so what you're reading is everything everyone is saying.

These medications do have risks with an approximate 1:5000 death rate on treatment, and a 1:100 rate of significant side effects.

The off treatment death rate is 1:10 and the chronic HCV effects are well known and impact > 1:2 - fatigue, brain fog, depression, loss of hope, fear of infecting others....

I know which set of odds I would prefer.

There is a phenomenon called Stockholm Syndrome where hostages start to feel empathy for their captors. Like it or not HCV has become part of your identity and for some people there will curiously be a sense of loss when they get cured.

The treatment experience is usually nothing short of miraculous with 3 days of feeling slightly under the weather (like a hangover or the beginning of influenza) and then within a week feeling better than in 20 years.

These medicines are possibly the best development since penicillin where people who were going to die miraculously got better.

If you have your medications but are afraid to start consider this. Brave you of several weeks ago decided to take a leap of faith. Scared you today is second guessing brave you.

Listen to brave you. He or she knew best.

Get a glass of water, open the bottles, and take the medicine.

The only thing standing between you and a better life is fear.

Don't let it.

Hi Miko3,

I feel your frustrations and anger, but believe they are misdirected here. This isn't about nationalities or even political systems and calling it for that can only be devisive. From what I'm aware both our American and Chinese hepc+ friends (some of whom are members here) are often actually in a worst situation than we Aussies and Kiwis are with regard to support and treatment.

The real issue is the greed being shown by big pharma which in some instances, yes, may have it's corporate HQ in U.S........... or Europe ............or wherever they can get the best tax deal.

Rather than your suggestion, I would like to see citizens all over the world working together to put pressure on their respective governments to tell big pharma & it's shareholders......ENOUGH!!!!

The immediate problem is there are people who need treatment NOW. The government knows people are dying and will continue to die unless they get treatment. Like Dr Miriam said about 20% need affordable treatment NOW. The rest of the schmozzle about pricing can come latter. kindly

James-Freeman-facebook wrote:

Sadly, approving funding for only one drug doesn't make it any cheaper for Government because the number of people requiring treatment is the same. Government pays a fixed price for a cure no matter what drug is used.

I would have to disagree with this. New Zealand uses precisely this strategy. Their policy is that we need 1 or 2 good treatments for this problem, not every treatment from every manufacturer.

This translates into a reverse auction where manufacturers are invited to submit their best prices to get and keep the Government subsidy.

New Zealand's prices prove beyond any doubt that hard negotiation encourages Big Pharma to sharpen their pencils.

We pay 8 times more than New Zealand for the 73 common drugs - I am not making this up....

www.australianprescriber.com/magazine/37/5/150/1

The population of New Zealand is similar to that of Sydney. By rights we should be able to negotiate better volume discounts.

The cost savings to the PBS on this have been estimated to be more than $1 billion a year.

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.

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.

There are no valid grounds for access restrictions based on scientific evidence, current treatment guidelines or clinical data. Such restrictions contradict the American Association for the Study of Liver Disease and the Infectious Disease Society of America treatment guidelines which support treatment for all HCV-infected persons. We will have to wait and see what happens in Australia, but Government will have a tough job imposing something which goes against treatment guidelines.

There has to be a political component, I am sure...as you say its a disease most commonly affecting one of the most maligned/marguinalised groups in society - not really any vote winners on that score.

Have to think it could also be the numbers involved - not quite a quarter mil people - possibly new pricey cancer drugs aren't necessarily going to be used on those kind of patient numbers (just talking off the top of my head here, no stats)