The International Liver Congress is a 5-day event where scientists and medical experts from all over the globe come up to speed with what is new in the latest liver research. Arguably, it is the biggest event connected with liver diseases in general, and has the biggest impact factor. This year, more than 10,000 scientific and medical experts met at The International Liver Congress 2016 in Barcelona, Spain. The spotlight of the congress was on what new research says about the possibility of treating liver diseases, and the center was taken by Hepatitis C – the ongoing high prices of Hepatitis C treatments were challenged and alternatives presented.
Dr. Freeman of FixhepC Buyers Club gave one of the most convincing presentations by tackling the most important issue in Hepatitis C treatment today – the high prices of branded drugs coming from Gilead Sciences, Abbvie, BMS and MSD. From the data gathered during large-scale clinical trials with DAA treatments, it is evident, as Dr. Freeman himself pointed out, that patients who cannot afford more than $80,000 for branded Hepatitis C drugs can be treated with DAA with equal success rate. The upside of DAA treatment is the low cost – Hepatitis C patients from all over the world can be cured for as little as $1000.
By proving the generic DAA treatments to be as successful as branded treatment, Dr. James Freeman defined a clear role of generic medicines in Hepatitis C treatment area.
Dr. Freeman's Idea
The International Liver Congress was always a very notable event; however, in recent years the interest and people coming to the event started picking up tremendously. Obtaining a new Hepatitis C cure is a part of the reason why; the other part is that by inventing a very successful Hepatitis C cure, this treatment area became very profitable for everybody who is selling branded Hepatitis C treatments.
One look at the table of the most expensive prescription drugs in the US will tell you why Hepatitis C treatment sell, and they sell for ridiculously high prices.
However, for everybody who can afford Hepatitis C treatments like Sovaldi and Harvoni, there are at least 10 people in the US and around the world who cannot even phantom how to raise $80,000 for the treatment without which they will in all probability die.
Generic Hepatitis C market
The secrets of the success of modern Hepatitis C treatments are the newly found active molecules in branded medicines. These active molecules, which carry all the therapeutic effect, are known as direct-acting antivirals or DAA for short. Because how the Big Pharma works, the DAA such as sofosbuvir, ledipasvir and daclatasvir are readily available in pharmaceutically-based manufacturing companies in India and China.
Dr. Freeman's idea was simple but has a profound effect: Why not use these low-cost DAA, from which branded Hepatitis C treatments are made off, to treat Hepatitis C?
With the redemption trials, Dr. Freeman went out to establish how well do the DAA cure Hepatitis C in comparison with branded drugs such as Sovaldi and Harvoni. The upside, of course, is a huge reduction in Hepatitis C treatment cost. If the DAA work, a patient with Hepatitis C would no longer be asked to pay more than $80,000 for the treatment; he or she will have an alternative option to be treated with DAA for about $1,000. In such a way, millions of Hepatitis C patients all over the world can get an access to the treatment because of it's financial availability.
DAA Redemption Trials
The purpose of DAA redemption trials was to establish how well do the DAA treat Hepatitis C. We know the cure rate of the majority of branded Hepatitis C treatments is above 90% according to respective Phase III clinical trials done by Gilead Sciences, Abbvie, MSD and BMS.
For the purposes of the trials, the low-cost DAA such as sofosbuvir, ledipasvir, daclatasvir and ribavirin were legally imported and tested with modern analytical techniques such as HPLC, NMR and mass spectrometry. Patients involved in redemption trials came from all over the world – US, UK, Australia, Canada, Europe, SE Asia and Africa.
“Our interim data suggests a potential solution for Hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment,” said Dr. James Freeman, the lead author of the study. “At the price level of generic direct-acting antivirals, treating the entire global Hepatitis C epidemic could be financially feasible. Furthermore, if a patient is cured of Hepatitis C, there is evidence for improved survival, and lower risks of liver cancer and liver cirrhosis and cured patients could return to work, delivering further economic benefits to society.”
Trial's results clearly indicate that generic DAA treatment is successful in overall 95% cases in patients with the most common genotype 1. More importantly, this is in line with how well branded medications performed in their respective Phase III clinical trials. This serves as a proof that being treated with banded medication will yield the same results as with generic DAA treatment – however, by choosing the later, you will save $80,000. Not only that, all the patients who cannot afford to fetch up $80,000 will now have an excellent fighting chance by choosing the $1,000 DAA treatment.
Results:
The cure rate for sofosbuvir + ledipasvir (branded medicine: Harvoni) in genotype 1 Hepatitis C patients is 93%.
The cure rate for sofosbuvir + daclatasvir (branded medicine: Sovaldi + Daklinza) in genotype 1 Hepatitis C patients is 97%.
“Across all genotypes, the SVR rate was 94% after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost,” explained Dr. James Freeman.
The Implications of Successful DAA Redemption Trials
About 15 years ago, instead of Hepatitis C, we were dealing with high prices and resulting lack of availability for HIV drugs. People were dying not because of the lack of treatment but because the treatment was too expensive for most of them to afford.
Today everybody infected with HIV is treated with very effective and affordable treatment.
If there was one defining moment in history that changed our view of HIV from a deadly disease to an easily-treatable one, it was a 2004 Lancet published study that proved the same for HIV as Dr. Freeman demonstrated for HCV – Generic medications work as effectively as the originator's medication for a fraction of the cost.
Because of the impact factor the International Liver Congress has, we don't need only to hope for Hepatitis C to be as easily treatable as HIV in 15 years – we can count on it. From an average patient to the US Senate, everybody is pushing for lower cost of Hepatitis C drugs; but as of yet the Big Pharma could not be reasoned with.
Thankfully to Dr. Freeman we don't need Big Pharma to lower the costs any more; now we have a definitive proof that the low-cost generic DAA treatment is equally successful as the drugs Big Pharma wants to sell for above $80,000. We can do it for $1,000 and in such a way we can help everybody – not only 6-figure income people in the US, but a farmer in Australia or a sheep herder in Egypt as well.
“There is a clear role for generic treatments such as these for people with Hepatitis C across the world. The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a ‘cure’ for what is often a debilitating condition,” said Professor Laurent Castera, EASL Secretary General.
We will give you an inside scoop on the details of the study from Dr. Freeman's presentation in our next blog post. If there is one thing to remember from all of this, it is that when Dr. Freeman was done with the presentation a few light bulbs went off above scientific and medical experts heads – the idea that we can cure the whole planet of Hepatitis C, and we can actually afford to pay for it is a reasonable one.
In the video below you can see the highlights from the International Liver Congress 2015. The video for 2016 highlights is currently in production.
https://www.youtube.com/watch?v=btubKE6OZYg
