Displaying items by tag: sofosbuvir
New age Hepatitis C medicines are more than just a medical wonder. They gave humanity an ability to save lives.
How good are we at saving those lives?
More people die of Hepatitis C than HIV/AIDS
Hepatitis C is a serious disease that ultimately results in death of patients. Approximately 500,000 people die from Hepatitis C and related illnesses in 2013 alone, more than 20,000 of them were US citizens. To put it in perspective: HIV/AIDS has longed been talked about as a very serious disease with a disastrous death toll. However, according to Dr. Laura J. Martin of WebMD nowadays more people die from Hepatitis C than from HIV/AIDS.
Today, there are more than 3.2 million of Hepatitis C patients in the US alone.
In late 2013, however, humanity had a break-through that should by all accounts drastically change lives of people living with Hepatitis C. A new drug, Sovaldi (400mg sofosobuvir), was approved in December 2013 on the US market.
With it, more than 90% of people with Hepatitis C can be cured. But are they really being cured?
Standard Interferon-based treatment
For any disease to be deemed a very problematic one, there are two conditions:
- Disease is serious (causes severe injuries or death)
- There is a lack of efficient cure
Polio, for example, was a very serious disease with a disastrous outcome. However, after discovering an efficient polio vaccine, the number of patient and number of death relating to polio was reduced dramatically.
Hepatitis C prior to 2013 was a very problematic disease because it caused death via liver cirrhosis and liver cancer, and the only treatment we had was 50% efficient.
Hepatitis C patients were put on 6-months long interferon-based treatment which consisted of injecting oneself with interferon and taking additional oral medicines such as ribavirin (antiviral molecule). Nonetheless, for 1 out of every 2 patients treated the treatment has been proven to be unsuccessful.
There was a need for an efficient cure. Newly-discovered sofosbuvir molecule was the answer.
New age Hepatitis C treatment - Sofosbuvir-based medications
With the launch of Sovaldi and Harvoni medicines by a company Gilead Sciences, humanity finally attained a very effective cure for Hepatitis C. Being an all-oral regimen, sofosbuvir pills are taken on a daily basis for 12-weeks (standard treatment), have mild side effects and, above all, more than 95% cure rate. This is what in pharmaceutical industry refer to as a game-changer. Now almost everyone can be cured and Hepatitis C suddenly became an easily curable disease.
Does anybody die of Hepatitis C now?
Simple answer is 'YES'. While the number of deaths has decreased from 500,000 per year, there are still hundreds of thousands of people dying every year. The reason: Hepatitis C.
But if we know Hepatitis C is so easily treatable nowadays, why are people still dying?
Pharmaceutical industry is a profitable business (Money>Patients)
When we spoke about Harvoni and Sovaldi being a game-changer in industrial industry, it was meant more in profits than in saving lives. Here are two simple reasons why people even in the developed world are still dying of Hepatitis C.
- Original Sovaldi (400mg sofosbuvir) costs $80,000 per treatment (US prices)
- Original Harvoni (90mg ledipasvir/400mg sofosbuvir) costs $94,500 per treatment (US prices)
With this in mind, let us calculate the US Hepatitis C market. If we know there are 3,2 million Hepatitis C patients, each in need of an $80,000 cure, the total comes to staggering number: Gilead Sciences is looking to sell more than $250 billion worth of Hepatitis C medicine to patients who can die without it.
Here is a horrifying realization. We have people who will die without the cure. We have the cure. But people who are dying cannot afford the cure because it is priced extremely high. 'What have we come to as a society?' is the right question here.
Way to get Hepatitis C medicines without having to pay massive sums of money
Gilead Sciences, company that markets Sovaldi and Harvoni, offered licences to Indian manufacturers to produce generic version of sofosbuvir-based medicines. In short, India refused to recognise a level of innovation for sofosbuvir molecule that would grant Gilead Sciences a patent and monopoly over Hepatitis C market in India.
This created a loophole. This loophole is now saving lives.
FixHepC Buyers Club to the rescue
All around the world there are Hepatitis C patients that will die without getting the cure - and they are not getting it because the prices of the drugs are so extremely high. This is where FixHepC Buyers Club comes in.
It is our mission to deliver life-saving Hepatitis C medicines to your doorstep for a negligible cost. We have set up a supply chain consisting of sofosbuvir production, packaging and distribution across the world. It is our hope this will bring down the Hepatitis C death toll under 100,000 and that in near future Hepatitis C death cases will be as few in number as possible with sofosbuvir-based medication.
We strive to deliver generic Harvoni anywhere on the planet for less than $2,000 per treatment in about 2-3 weeks. With this prices, we could cure all Hepatitis C patients in the US for less than $7 billion.
Are thing in Hepatitis C market likely to change?
Hardly. Pharmaceutical industry holds on to patents for drugs that last for 20- to 25-years. During this time, the prices of original Sovaldi and Harvoni will be extremely high, and Hepatitis C patients don't have 20 or more year to wait for patents to expire.
Today we compared a new batch of Sofosbuvir and Ledipasvir to our reference sample data and found it consistent.
It's reassuring to see the consistency.
In Australia the PBAC has voted to recommend the inclusion of sofosbuvir in the PBS. This could mean that this vital medication becomes available at affordable prices in Australia, however it's also possible Cabinet will reject this given that inclusion in the PBS could see the current $10 billion spent by the government on all PBS medications blow out to $30 billion. We will keep you posted as to developments.
Here is the PBAC Recommendation
For now the options remain to either pay $100,000 for a private prescription, wait and see, or seek out treatment yourself.
We were quite excited to see the first shipment of Chinese sourced Sofosbuvir and Ledipasvir. A white powder and and off white powder, but what would the NMR show? Here's the NMR for Sofosbuvir which is right on the money.
Ledipasvir: mass [M+H] + 889.4195 ( < 2 ppm error)
- molecular formula - C49H54F2N8O6
Sofosbuvir: mass [M+H] + 530.1699 ( < 0.2 ppm error)
- molecular formula - C22H29FN3O9P
On the 20th May 2015 the Medicines and Healthcare products Regulatory Agency in the UK issued a Drug Safety Update titled:
Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone.
You will find a link to it at: