Epclusa and Sofosbuvir + Velpatasvir and Velasof and Sofosvel

As most people now know Gilead has launched its pan-genotype combination Epclusa, which is the combination of Sofosbuvir + Velpatasvir. With its usual eye on the market place Gilead launched Epclusa with plenty of promotions and advertising however the reality of Epclusa is that it is just another expensive and overpriced medicine that Gilead will use to squeeze more money out of the global health care system.

Of course there are fantastic advantages in have a Hep C drug that will cure across all genotypes. Gilead recognised this and the money to be made.

Firstly research has shown that about 10% of people who have Hep C are infected with more than one genotype. That means that if you treat with Harvoni for G1 and you are infected also with G2 or G3 then it is likely that you will get rid of the G1 virus but not the other viruses, against which Harvoni is not very effective.
So for the 10% of people with two virus types a pan-genotype treatment is great news.
However the reality is that Sofosbuvir + Daclatasvir is just as effective as a pan-Genotype Hep C treatment as Epclusa... and a LOT cheaper!

Sofosbuvir+Daclatasvir has one other advantage over Epclusa, that is that the active ingredients are very soluble and easy for the body to absorb. Whereas the Velpatasvir in Epclusa is highly insoluble.

The next good thing about having a pan-genotype Hep C treatment is that it removes the need for a genotype test.
Now for people in wealthy countries with national health services or insurance this is not an issue but for people in poorer countries the cost of a genotype test may be more than one months wages. So if this can be avoided it is a big saving.

So both Epclusa and the Sof+ Daclatasvir treatments offer similar great advantages for people with Hep C however the big difference between Epclusa and Sofosbuvir + Daclatasvir as a treatment option for Hep C is that Epclusa costs about US$80,000 for a 12 week treatment whilst Sofosbuvir + Daclatasvir cost about US$1,100 for a 12 week treatment.
Both a great pan-genotype treatments for Hep C offering almost identical cure rates for all genotypes but one is offered by a company that is famous for ripping off sick people and the other is affordable and is offering hope to sick people.


28th September 2016

The Italian Story
Over the next few days I'm going to spend a little time talking about Italy because that is where I think the next big breakthrough on Hep C generics is going to happen.

Over the last 12 months I have helped a lot of Italians to access generic Hep C medicnes. Some have flown to India, some flew to Barcelona when I was there. Some have rented a room in the UK for a few nights and I organised for the meds to be sent there. Others drove up to Geneva when I was able to organise medicines to be left there. Lots of different ways, all ways for people to get cured of their Hepatitis C.

The story below is one where a shipment of generic Sofosbuvir and Daclatasvir was organised to be sent to London to an Italian lady. The plan was that the meds would be sent to her in a hotel where she would stay. But just at this point in time the Indian Customs started a crack down on the export of generics and every time her meds were sent the Indian Customs would seize them at the airport. However my friend in India who was organising this was determined to get these medicines to the patient and every time Customs siezed the meds... well he just sent another lot until eventually one parcel made it through.
It was a tense time for everyone... here is her story, which she emailed me yesterday.

Hi Greg this is my story,
As you know because of your recommendations I bought the Hep C medicines from Parag on June, and decided to go through the London channels which you kindly explained to me.
It 'was a great adventure!
I had booked the flight, the hotel, but then received word from Parag that the drug would not arrive at the destination. Every time he sent it the Customs seized it in India and it continued to be sent back to him, this for 3 times, while the days were running away with this crazy problem the departure was forthcoming.
The day before the departure I received confirmation from Parag that the parcel had finally got through Customs and was on its way to its destination!

What a relief! I was so worried.

So I arrived at my hotel and the next day there was my purchase. I was so, so pleased then I arranged for the return to Italy.
I decided not to carry the medcines on board in my little suitcase because of exaggerated checks at the airport. So it went in my big suitcase with the luggage. In fact, it took 2 hours to check in!
I was with my partner sitting comfortably in my seat ready for take-off, when the hostess announced that the plane will depart late because disembarking of suspicious luggage.
The plane eventually left after I spent two hours of endless worry that it might be my luggage.
For me it was the first time that the luggage of the passengers were off-loaded in a departing flight.
As soon as we arrived in Italy I went to toilet. I was so very nervous. In the mean time my partner got the luggage and went through Customs.
He told me hurry up and get out of the toilet.
He had suitcase, we had the medicines, the cure and I felt reborn.

I started my treatment immediately, my good doctor followed me step by step, and he was as pleased as me when the results from the first check up showed that the virus was not detected !!!
Today I took my last pill, next week will make my blood test and I will meet my doctor.
I'm genotype 3 with FibroScan F1 my treatment Sofosbvuir and Daclatasvir for 12 weeks.
Now I just have to wait for the next six months, my mood is positive! smile emoticon:)
I feel I have to thank you Mr. Greg for what you do , thanks to Parag, and thanks to my doctor!
Wishing you all the best for you and your family
#####



1st of October 2016

The Italian Story: Part 2.

The number of people with Hepatitis C in Italy is close enough to the world average of a little below 2% of the population according to figures released in 2015.
This means that about one million Italians have Hepatitis C and the genotype spread is similar to the rest of Western Europe and the USA with about 50% carrying HCV genotype 1, about 30% carrying Hep C genotype 3 and the remainder scattered between genotype 2 and genotype 4 with a small number of G5 and G6.

A very high number of Italians contracted Hepatitis C through tainted blood transfusions.

Like most European countries Italy has a reasonably good public health system and is committed to treating Italian citizens who are infected with Hep C. However like other health services throughout Europe it is not possible for Italy’s Health Service to find the extraordinary amount of money demanded by pharmaceutical companies like Gilead to treat all Italian’s with Hepatitis C.
The maths is simple. For treating genotype 1 Gilead wants more than 50,000 Euros per treatment for Harvoni or Epclusa. So to the treat the more than one million Italians with Hep C it would cost the Italian health system more than 50,000,000,000 Euros; an impossible amount.
So as with other Health services in Europe the Italian government triages their Hepatitis C patients and only the sickest can access treatment through the Italian health system.
One of the interesting things about Italy that I have noticed is that Italian doctors are generally more supportive of their patients doing the generic Hep C treatment however the Italian medical "Establishment" and the Italian National Health Service is not supportive of generic treatment.
Nor is the Italian Customs Department.
This means that those who are not sick enough to access treatment through the public health service must either wait until they get sick enough to get government treatment or seek an alternative to the government treatment, which is obviously to use generic Hepatitis C medication from India or Bangladesh.

The problem for Italians is that the Italian Customs is not permitting Italians with Hepatitis C to import generic medicines for person use. If generic Hep C medication is shipped to Italy then the Italian Customs will seize it and either destroy it or return it to the sender.

I have tried many different ways of sending Hep C medication direct from India to Italy and all attempts have failed.
However there are ways for Italians to get generic Hepatitis C treatment.
The simplest is if they have friends or family in the UK because the UK has very favourable rules for its residents and allows the importation of medicine for personal use without a prescription. This method is safe and also legal whilst the UK is still in the EU however once the UK leaves the EU this door will close.

So many Italians either fly to the UK and have the generics sent to them there or have the generics sent to friends in the UK who then simply mail the medicines to Italy.
Because mail between the UK and Italy is treated as “internal mail” it not subject to the same level of Customs inspection as parcels from places like India and all shipments sent from the UK to Italy this way have been successful.
Of course Italians can also fly to India and buy their Hep C meds there and return home. It is completely legal to do this but it is expensive and time consuming.

So far all this is rather similar to many other European countries where the governments enforce rules that favour the big pharmaceutical companies to the disadvantage of their own citizens and indeed their own national economies.
However what is unique about Italy is that the Italian constitution guarantees the right of Italians to good health. The Italian Constitution specifically states that Italians have “a right to good health.”

Article 32 of the Italian Constitution:

"The Republic safeguards health as a fundamental right of the individual and as a collective interest, and guarantees free medical care to the indigent.
No one may be obliged to undergo any health treatment except under the provisions of the law.
The law may not under any circumstances violate the limits imposed by respect for the human person."

This means that when the Italian Customs officials seize medicines that are the only way that the person can regain good health then the official and the Customs Department are actually breaking the Italian Constitution by denying the Italian citizen access to their right to good health.
So we have a government department in breach of the Italian Constitution and no-one in Italy is doing anything about it… well that is not entirely true because there are some people in Italy who are going to do something about it, and very soon!
But that is another story, a story at is unfolding as I write


3rd October 2016
The Italian Story: Part 3 EPAC

In Italy, as in most other developed nations, there is a Hepatitis C advocacy group that gets a major part of its funding from Big Pharma.
In Italy the major Hep C advocacy group is EPAC. Epatite is Italian for Hepatitis so EPAC is simply Epatite C.
It was founded in 1999 with the aim of lobbying the Italian government to put more funding into Hep C treatment and research.
As awareness of Hep C grew so did EPAC and as the opportunities to make money out of Hep C grew so did the donations from Big Pharma to EPAC also grow.
Since its beginnings EPAC has relied on donations to function and since the beginning Big Pharma has been donating about half of EPAC’s total annual income.
In 2006 EPAC’s income was about 340,000 Euros of which approximately half was donated by Big Pharma. In 2016 I understand that EPAC’s annual income is closer to one million Euros and again about half of that income is from Big Pharma. (Because I can on read Italian the actual amounts might be a little out but I believe they are correct as I have been told by Italian associates)

Like the World Hepatitis Alliance, which receives more than 95% of its income from Big Pharma, like Hepatitis Australia which receives about $250,000 per annum from Big Pharma, EPAC took a strong position against Hep C generic treatment the moment that generic treatment became available. Despite the fact that these treatments are licensed by the patent holders and chemically identical to the expensive branded version and despite overwhelming scientific proof that generic Hep C DAAs are just as effective as the expensive branded versions sold by EPACs major sponsors.
So why would an organisation that was set up to improve treatment options for Italians with Hep C actively campaign AGAINST an effective and cheap cure for Hepatitis C?
The obvious answer would seem to be that EPAC is reluctant to support something that runs against the interests of their major sponsors, Big Pharma.
Money talks, money buys loyalty, money buys submission.

As the saying goes: “Love of money is the root of all evil.” And people who start out with the best intentions have found themselves warped and twisted by the power of money.

Has EPAC sold out to Big Pharma, has it betrayed its own avowed goals and, indeed, it’s very purpose for existing in the first place? I will let you make up your own mind on that, but consider this:

If EPAC was set up to serve the best interests of people with Hep C in Italy.
If EPAC was set up to improve treatment options for people with Hep C in Italy.
If EPAC was set up to improve access to treatment for people with Hep C in Italy.

Then why is EPAC actively campaigning against the use of licensed generic Hep C treatment in Italy when they know for certain that it is as effective as any other treatment option available?
It would seem to me that there is only one answer to this question, APEC has been bought off by Big Pharma. Maybe I am wrong? Time will tell because the truth always comes out in the end.
I will close this story with a reply I got from an Italian Hep C activist who I asked for information about EPAC.

Hi Greg,
EPAC does good disease prevention information, conferences, leaflets, but they are subsidized for approximately half a million euro per year by Gilead et comp. Their people are invited to some AIFA(NHS) workshops and meetings as representatives of the patients. They do have a policy against generics and against people who support the use of generics ...............
Of course you know that I support the use of generics and I deal differently with the Hep C problem, different assistance, care, information and support to the patient ........ EPAC and I, well we don't have a pink coloured relationship.

To give a fair and honest and EXACT idea of what EPAC has to say about generics here is a quote from the EPAC official site regarding posts on its forum:
................
" Any post will be deleted if :

• It contains specific instructions on how and where to acquire generic drugs (internet sites, etc.).

• It contains guidance on how to purchase and import

• people who offer themselves "to accompany other patients" in foreign travel "

• people who offer to act as "intermediaries"
• people who will insist on accusing the association of "censoring" or other
damaging assertions, "