8th June 2015
Well it's 1 a.m. and I'm having a dose of the old insomnia. I find the worst thing is to lay in bed and try and get to sleep when it just is not going to happen; so here I am up typing some of the things that were rolling around in my head as the clock struck midnight.

Buying Harvoni in India.
Because for a lot of folk Harvoni represents the best chance for a complete cure from Hepatitis C, particularly for genotype 1, I have been researching its likely availability in India. ( For the latest and most up to date information on buying generic Harvoni please email me for a free Harvoni Information Sheet in which I continually update availability, prices and reliable suppliers for buying generic Harvoni online or for travelling to India or Bangladesh)

My information, from several reliable sources in India, is that GILEAD has licensed Mylan to manufacture Harvoni in India and Mylan has applied for approval from the relevant Indian Authorities. I have been advised that this approval should be granted within the next six months. So some time before Christmas.

So it is very strange that a number of Indian online pharmacies and other suppliers are claiming that they can already supply Harvoni to customers. Because it has not yet been approved in India so how can they be selling it?
Once more a reminder to be very cautious when buying medicines over the Internet.


10th June 2015
Well here it is nearly one in the morning and after an hour or so of laying in bed waiting for sleep to come I am up typing again.
Yes insomnia is still really the only noticeable, annoying side effect from the Sofosbuvir/Ribavirin medication. I just read the list of 59 possible side effects from Ribavirin. They list insomnia along with irritability, but I'm normally an irritable old coot so that does not seem a problem. They also list Euphoria... hmm I wouldn't mind that one; but no, I have not been euphoric much lately.
I have been getting hundreds of emails from people asking advice about going to India to get Sofosbuvir or how to get Sofosbuvir from India and I try to reply to everyone. I have made a couple of information sheets that summarise the process I went through going to Chennai to get the medication and also the mail order thing, which I send out to help people get a clear idea of the processes.

I am also still trying to find people who are willing to act as a facilitator for people who are not comfortable jumping through the hoops alone in India. So far there is one fellow in Hyderabad who looks like he might be interested in doing that.
Really it's just a waiting thing now. Waiting for the first test results on the viral load and enzymes. Waiting for the last pill to be swallowed at the end of 84 days. Waiting for the post treatment blood tests. I cannot complain, the ball is rolling and there is light at the end of the tunnel.
I might go and try some yoga in front of the fire (its 4 degrees and raining outside).

Friday 12th June
It's 1 a.m. in the morning again
Well the insomnia thing seems to happen every second night. I guess after one night with little sleep you get a good night's sleep the next night because you are so tired? That's how it seems to be with me.
This afternoon I will get my blood results. I know quite a few people are waiting to hear about that to see if the medication I brought home was fake or not.
The Fake Medication Issue.
I have been over this generic versus fake meds issue before but I am seeing a different angle to it now, as a reason that doctors are refusing to write prescriptions for people with Hep C so they can bring the medication into their country.
As mentioned before I get a lot of emails from people around the world seeking information about how to get generic Sofosbuvir from India. Some wish to go there themselves, as I did, buy it and bring it home. That is quite an affordable option if you live in Europe or in some other country close to India. However a lot of people are either too sick to travel or they can not afford the combined cost of travel and the medication. For these people importing the Sofosbuvir and Ribavirin treatment is the only option.

Many countries are like Australia in that they will allow their citizens to import medication for their own use if they have a prescription from a doctor in their own country. What I am hearing from a lot of people who want to go down the personal importation path is that they are having a real problem finding a doctor to write a prescription. The doctors are saying that they cannot be sure about the quality of the drug because it is made in India however they may not realise that 40% of all prescription drugs consumed in the USA originate in India(USA FDA figures in the Wall Street Journal 14th May 2014). 

Indian pharmaceutical manufacturers have over 500 manufacturing factories registered and approved by the FDA and these are regularly inspected by the FDA. Many Indian drug companies are actually manufacturing arms of US or European companies. 

For example Mylan, who manufacture Sovaldi and the generic version Myhep, was founded in the USA in 1961 specifically to manufacture generic drugs. Its Indian branch manufactures for the US and European markets as well as India and Asia. It is FDA approved and Gilead licensed.

Cipla who manufacture Hepcvir under licence from Gilead also manufacture in an FDA approved factory.

So we have this situation where Sofosbuvir is being manufactured under licence from Gilead in factories inspected and approved by the US FDA and yet doctors are saying:
 "Oh no we can not prescribe generic Sofosbuvir out of India because we can not trust the quality."

When the reality is that up to half of the drugs that doctors prescribe every day are probably manufactured in India.

So what is really going on here?

We have a situation where hundreds of thousands of people are suffering and dying from a disease for which there is a cheap and effective cure but their doctors are not prepared to write a prescription for the medication that will cure them because the medication comes from a country that manufactures about 40% of the world's prescription medicines. 

No wonder I can not get to sleep!

8 pm 12th June
I went to get my liver enzyme and viral load results today. First the bad news. There was a letter from Pathology saying that they had not done my viral load because the request had not been written by a specialist. Oh well if I had known that I would have gone to the specialist! Anyway I will organise that next week. 
Now the GOOD NEWS!!!
My liver enzyme results were better than I had hoped (warning: only people with an ailing liver will get excited by these figures).

These tests were taken on the 3rd June 2015, 11 days into my treatment using Indian generic Sofosbuvir (Myhep) with generic Ribavirin. The results are compared with a test from 4th of May 2015 a week before I left for India.
ALP...............down from 98 to 68
Gamma GT....down from 222 to 109
ALT...............down from 464 to 32

All other enzymes in normal ranges. So for those of you who are worried about the Indian generic Sofosbuvir give up the fear and grab hold of hope!

14th June
After posting the above test results quite a few folk emailed me about them. These included a doctor from the USA who has been following this blog. He spoke to me about my liver enzyme level test results.

"Hi Greg, I had never read your whole history of Hep C. Now I can see why you wanted to get treated ASAP. With liver functions like that GGT and ALT your liver was actually getting destroyed by the virus. I cannot believe that you were not given first priority. I'm sure your virus load will now be very low. Good News!"

 Actually things were a lot worse when I first got diagnosed so to put the above test results in context below are four test results from 4th September 2014, 23rd March 2015, 4th May 2015 and 3rd June 2015

ALP: 125 then 85 then 98 then 68
Gamma GT:692 then 227 then 222 then 109
ALT: 760 then 240 then 464 then 32

 The big drop between Sept 2014 and March 2015 was brought about by dietary and life style changes but as you see by May 2015 the virus was fighting back and gaining ground again and I would guess that if I had not got the Indian generics and started the Sofosbuvir treatment my liver would now be on the rapid downward spiral to oblivion, cirrhosis and beyond. 

So don't wait around for doctors, bureaucrats and health department functionaries to decided your fate, take personal control of your health and start treatment now, it is not difficult and not expensive. You can either fly to India and get the medication yourself or you can have it couriered to your door. It depends on the Customs laws in your country. Some people might need to go to India and do the treatment there. You can live comfortably in India for less than $200 per week. 

If you have genuine financial difficulties and can not afford the current cost of around US$1,100 for getting the generic Sofosbuvir shipped to you, talk to me and I will do what I can to help you.






19th of June
Well I've been exactly one month on the medication so I went and had half a dozen vials of blood taken out of my arm for the full blood tests, including viral loads. There were so many vials that on the last one the needle slipped out of my vein and my dangerous blood oozed out all over the place. End of next week for the results.

Side effects
Side effects are pretty minor. Still a bit of insomnia but not too bad, it helps if I am really tired when I go to bed. Also if I have done some hard physical work so that I am physically as well as mentally tired.
Yes I make more mistakes when I am typing and, more often than normal, my memory has a spasm.
Oh and I am not getting irritable, its just that other people are getting more annoying.
So all in all the side effects are pretty much nothing compared to the stories I have heard about the Interferon based treatments.

Fear Mongers and Fear Mongering.
Because of this blog and other stuff that has happened I have become quite involved in a few Hep C forums and have noticed that there is a lot of fear floating around about the idea of buying the Sofosbuvir and Ribavirin treatment from India. First there is the fear of being ripped off by an unscrupulous online supplier. Second there is the fear of breaking some law by importing the Sofosbuvir and Ribavirin into one's home country.

I have already dealt with the issue of buying Sofosbuvir from India and, apart from the people I have recommended there are no doubt other honest online pharmaceutical suppliers in India.

Bringing Sofosbuvir into your country for personal use.

Bringing Sofosbuvir into Australia for personal use.
The Australian government's position on this is very clear and very accessible. You can acquire Sofosbuvir (and we hope soon generic Harvoni) from either a friend or supplier in India. There is no problem with this. Please read the section of the relevant Act. It's easy reading and very clear.
https://www.tga.gov.au/personal-importation-scheme

Importing Sofosbuvir for personal use into the UK or the USA.

Like much of the discussion around Sofosbuvir, Sovaldi and the new generation Hep C drugs the discussion about the legality of importing these life saving drugs into one's own country for personal use, is full of fear mongering and false or erroneous information. Particularly in the case of the UK and the USA where the relevant legislation is much harder to locate. However thanks to friends and much Google searching I have pulled a couple of bits of information that will be very useful to people living in the UK and USA.

Firstly bringing Sofosbuvir into the USA for personal use.

For the information of people living in the USA, this is to counter the fear mongering going around about bringing Sofosbuvir into the USA for personal use. Check out the link yourself but these are my thoughts.

http://www.fda.gov/Abou.../Transparency/Basics/ucm194904.htm

The correct interpretation of this bulletin by the FDA is important. This first paragraph (below), by the FDA, summarises the FDA's position:

"FDA has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:"

The following sentences are written by the FDA to further clarify their position. The critical sentence, that is often misinterpreted is sentence 2. This sentence means that the importer has no intention of commercialising or promoting the drug to U.S. residents. It does not refer to existing corporate commercialisation or promotion of the drug. In my humble opinion (and the opinion of other more knowledgeable people) this means that a U.S. resident CAN import a three month supply of Sofosbuvir etc.for personal use, from India or wherever else. The USA's position is in total harmony with the position of Australia and the UK.
 
From the FDA Bulletin: 
1.The drug is for use for a serious condition for which effective treatment is not available in the United States (If you can not afford to buy it then it is not available to you. Greg)
2.There is no commercialization or promotion of the drug to U.S. residents; 
3.The drug is considered not to represent an unreasonable risk; 
4.The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and 
5.Generally, not more than a 3-month supply of the drug is imported

Bringing medicine into the UK 

Much of the official concern about prescription drugs is directed at internet pharmacies and people selling drugs illegally, and you're unlikely to find yourself in trouble for bringing prescription drugs into Britain. It's not illegal to bring them home, as long as they are for personal use. Even anabolic steroids can be imported for personal use, according to customs officials. 
The Medicines and Healthcare products Regulatory Agency (MHRA) however, will take action if they suspect that people plan to supply medications to others. 'If you are coming back from a country and bringing in huge quantities of medications, then common sense will dictate that you aren't going to get through those medications yourself, therefore you must be planning to sell them on,' says a MHRA spokesperson

If you want to bring medicine into the UK, first check that it is licensed for use. Always carry medicines in a correctly labeled container as issued by the pharmacist. Otherwise, bring a letter from your doctor or a personal health record card giving details of the drug prescribed, in case it is queried by customs or you require additional supplies. Remember that some medicines available over-the-counter in other countries may be controlled in Britain, and vice versa. 
For further information please contact HM Customs and Excise Advice Centre, Tel: +44 (0)20 8929 0152

So the upshot of all this seems fairly simple: If the medication is for personal use then it is okay to bring in a three month supply. Generally it seems wise to have a doctor's prescription as well.

I do not know about other countries but I believe most countries follow a similar philosophy to the UK, USA and Australia (apart from Austria and a few other anal European countries). Check with your local authorities to be sure of your country's regulations.







Greg Jefferys Blog is not intended as medical advice but is a record of Greg Jefferys' experiences in treating his Hepatitis C with Generic Sofosbuvir acquired in India. Greg Jefferys blog is also intended to record general discussions around  Hep C issues and by people treating or seeking to treat their Hepatitis C infection using affordable generic medicines
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