Do Health Supplements Reduce the Effect of Daclatasvir?

Dr James Freeman and the FixHepC Website.

As you probably know Dr Freeman keeps an eye on everyone’s progress in his Hep C Buyers Club and he reports that in the vast majority of cases (96.2% to be exact) we see viral loads below 30 to undetectable within 4 weeks of treatment starting..

Last week Dr Freeman reported an important new finding related to the use of Daclatasvir in the treatment of Hep C.

It is well known that Daclatasvir levels go up if you take inhibitors of the human enzyme CYP3A4 and go down if you take inducers. These CYP3A4 inhibitors are found in a number of different fruits. To date we have only seen issues with inhibitors like grapefruit, grapes, paw paw, star fruit and pomegranate. Consuming these fruits during treatment can cause toxic Daclatasvir levels. This means the inhibitors in these fruit cause the Daclatsvir level to go UP. This can be bad for the patient in terms of side effects from Daclatasvir because it will make any side effects from Daclatasvir much stronger.

People eating the above fruits will get elevated levels of Dacltasvir because the chemical reactions caused by the fruit slows down the rate at which the body eliminates Daclatasvir.

However when examining patient reports and blood test results Dr Freeman recently got a shock. A patient with Hep C Genotype 3a and an initial viral load of 3,100,000 came back with a 4 week viral load of 935. A viral load level this high after 4 weeks treatment was previously unheard of so Dr Freeman started looking to find out why the virus levels had stayed so high?

Dr Freeman first checked the source of the medications (FixHepC) and knew that they were fine because they passed testing, and also because he could see the results for the patients immediately before and after this patient, who were using the same drugs from the same batch. These were all as expected – <15 or Undetected were the 4 week. So results from all the other patients from this batch of meds were within the correct range. So he ruled out a dodgy batch of drugs as the cause.

Next he checked the patients other medications. The results were all green light on the interactions checker: www.hep-druginteractions.org/Interactions

The next thing Dr Freeman checked was a supplement the patient was using – a body building energy potion taken daily that contained:

Taurine

Caffeine

Green tea extract

Green coffee extract

And the list went on…

So Dr Freeman Googled for taurine and found an article called Taurine modulates induction of cytochrome P450 3A4 mRNA by rifampicin in the HepG2 cell line.

In plain English this article says Taurine increases the levels of the enzyme CYP3A4. This is the enzyme that removes Daclatasvir from your system – in other words if you are consuming Taurine the effect is like you’re taking a 1/2 dose, or maybe even a 1/4 dose of Daclatasvir becauseTaurine will reduce the affect of Daclatasvir SIGNIFICANTLY!!!!

This in turn will mean that your chances of clearing the virus are reduced significantly.

Now taurine may not be the only thing that causes the body to remove Daclatasvir at increased rates, each and every “… extract” will contain dozens of chemicals, all of which might induce or inhibit CYP3A4.

So here is Dr Freeman’s advice:

Do not take random supplements in the hope they may help. They may, they may not – nobody knows for sure.

These new DAA drugs, like Daclatasvir, are still very new. If you want to take extras like Vit D and Vit B12 be sure you have evidence that these will not effect your treatment. You will find there is a lot discussion on many Hep C forums about these supplements and many others.

And remember that Red Bull, V, Monster and other “Energy” drinks all contain taurine and caffeine.

There is also some evidence that suggests that high levels of caffeine may affect how your body uses Daclatasvir so my suggestion is to keep coffee to a couple of cups per day.

Harvoni and Food Supplements

Gilead warns against using antacids when taking Harvoni. Particuarly antacids that contain magnesium.

Using anything that reduces the acidity in the stomach may reduce the amount of Ledipasvir that is absorbed. Ledipasvir is relatively insoluable and stomach acid is needed to disolve Ledipasvir. There is some suggestion that taking Harvoni, or generic Harvoni, with a small amount of food that produces an acid reaction in the stomach might be helpful. For example a bit of toast or egg.

25th February 2016

Gilead Appealing Sofosbuvir Patent In India

As you would know Gilead is trying to do everything it can to block people’s access to affordable Hepatitis C treatment through generic Harvoni and Sofosbuvir.

Fortunately Big Pharma is not currently assassinating Hep C activists (that is a half joke).

However whilst Gilead is not actually hiring people to kill activists Gilead is still directly responsible for the death and suffering of hundreds of thousands of people every year. So the line is very blurred about the difference between paying for someone to be killed or killing them by denying them access to the medicine that would save them.

Currently in India Gilead is appealing to the Indian High Court to reverse the decision not to grant Gilead a patent for Sofosbuvir in India.

If this appeal succeeds and Gilead does get a patent in India you can be certain that prices will go up and accessibility will go down.

You can also be certain that the US government is putting pressure on the Indian government to grant the patent.

We all know that the US government is a pawn of Big Pharma.

The current High Court proceedings will have major implications for generic producers in developing countries (Pakistan, Egypt, Bangladesh, Iran) and millions of people waiting for affordable access to a life-saving hepatitis C drug. If Gilead wins the appeal it will also mean that Indian generic Harvoni will return to Gilead’s control.

The Delhi Patent office this week has started the hearings to determine whether Gilead Sciences deserves a patent for sofosbuvir.

Pray that Gilead’s influence and money can not reach that far because this is a key one among many patent applications that Gilead has filed in India.

This is landmark patent opposition as this is the second time that a new compound patent claim is under such bitter dispute.

In early 2015 the Indian controller general’s decision on Gilead’s application for Sofosbuvir held that “there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for.” But Gilead appealed the decision and the Delhi High Court asked the Delhi Patent office to hear all the parties before issuing the final decision.

Even as Natco withdrew its patent opposition after signing the licensing agreement with Gilead, Optimus (API producer), BDR (generic producer), Sankalp Rehabilitation Trust (Lawyers Collective) all filed patent oppositions in 2015. DNP+ and IMAK has already filed their opposition in 2014 which led to the rejection that was appealed by Gilead.

There is immense pressure on the Indian govt from the US to start granting patents to its companies. Please do follow the proceedings, circulate the updates from Lawyers collective, press release tomorrow from IMAK, DNP+ and MSF and join us in solidarity in the Rally that is being planned in front of the Delhi Patent Office.

February 27th 2016

Genotype 3 and the Sofosbuvir + Daclatasvir Treatment and relapses

Over the past 9 months I have assisted several thousand people with Hepatitis C access treatment through generic medicines.

Of those more than 50% have accessed generic Harvoni from India or Australia. This is because Hepatitis C genotype 1 is best treated with the combination of Sofosbuvir + Ledipasvir and in most European and other Western countries genotype 1 is by far the most common form of Hep C.

After genotype 1 the next most common genotype of Hep C is genotype 3.

Genotype 3 is about 25% in the above countries but higher in Asian countries. Genotype 3 is usually treated with Sofosbuvir + Daclatasvir.

I am talking about this because of the very many people I know and keep in contact with who have undertaken generic Hep C treatment there are only four that I know of who have relapsed and all of these people have had genotype 3 and only did 12 weeks treatment.

Towards the end of last year I noticed that people with G3 were contacting me and asking for an extra 12 weeks treatment and telling me that their specialist was wanting them to do 24 weeks instead of 12 weeks.

So now I understand why.

It seems that Hep C G3 is a hard beast to clear and so if your doctor suggest that you might need more than 12 weeks treatment please listen to that advice. I have had to talk to four people who finished 12 weeks’ treatment and thought that they were clear only to relapse. Everyone who has done 24 weeks (that I know of) has remained clear.

Please note that this only applies to Hep C Genotype 3… it is the only genotype I have seen people relapse from.

Of course there will be relapses in all genotypes but I have not personally heard of them.

Please remember that I am not a doctor and this blog is not intended to offer medical advice. I am simply reporting and sharing my experiences with Hepatitis C.

February 29th 2016

A lot of folk are flying to India to pick up the generic Hep C medicines themselves. Some just fly in and fly out. One guy I know jumped on a plane from Alaska, flew to India, met a supplier I put him in contact with there, stayed one night and flew back to Alaska with 6 months supplier of generic Indian Harvoni. He was away from home for four days and changed his life entirely.

A man in his 60’s was too ill to fly to India himself and lives in a country that prohibits all imports of generic meds. So his daughter, young woman in her mid 20’s, jumped on a plane and flew to India to save her father’s life. We arranged for her to meet a reliable supplier at the airport. He was waiting for her outside the airport with the meds. She paid him, walked back into the airport and flew home. She was in India for less than 10 hours and returned home with the medicines that would save her father’s life. He is now 6 weeks into treatment with generic Harvoni.

So people are doing this everyday. Some are in India for a couple of days and some stay for a few months and do their whole treatment in India.

Below is a the account of a guy from England who stopped over for a few days on his way to Thailand.

From England to India: a Hep C Journey

I have genotype 1 and previously failed a long and hard, interferon based triple treatment. So the prospect of the new Harvoni treatment…just 1 pill per day, minimal side effects and a 95% success rate…was something I really wanted to do. However there are currently long waiting lists in the UK for an NHS treatment and to do this privately costs more than £50K. I decided to research the costs of just buying generic harvoni in India and stumbled across Greg Jefferys’ blog.

Having emailed Greg a few times for information, I decided to go to Chennai and pick up the meds directly…mainly because I was due to travel to Bangkok and it was easy to build in a stop over as Chennai’s en route from the UK.

Greg recommended I contact a particular Pharma rep he knew in Chennai prior to making any bookings, which I did by email. The rep was very organised and told me all I needed was a valid prescription for harvoni generics and suggested a hospital and consultant if I needed this done in India. He told me to email again a few days before arrival in Chennai and then confirmed he would meet with me after I got the prescription.

As I couldn’t’t find a UK Doctor who would write a prescription for Indian generic harvoni, I needed to book to see a consultant in India. I used the Apollo hospital in Chennai and they have an International patient liaison online so I was able to complete all necessary paperwork to book an appointment with a consultant gastroenteritis (recommended by the pharma rep) from the UK.

If you do this you then just need to print off the documentation and this saves completing a lengthy form when registering at the hospital on appointment day.

The consultant only needed to see something official stating I did have hep c but I had my GP print out my most recent blood tests, including viral load, my last fibroscan and the letter showing I failed interferon triple at SVR 12 as well. I chose an early morning appointment to allow for unexpected delays.

The hospital itself was quite a chaotic experience and I was glad to have allowed 45 minutes to register and find the correct atrium for the consultant. You need to follow signs for International patients on the ground floor just to the right of the main entrance. They check over your passport and the online form and booking and then send you to the cashier next to the pharmacy at the entrance and it costs 250 IN rupees to register (under £3).

There is no real queue system so you need to hold your place firmly and make sure the cashier knows you want to register. The cashier issues your hospital folder and directs you to the correct floor and atrium. This was well signed but you need to negotiate the crowds of patients lining every corridor. The appointment with the consultant was quick and efficient. He discussed my condition and issued the prescription. This cost 1000 INR (£11) payable before leaving the atrium.

With the prescription in my possession, I called the rep Greg Jefferys recommended and he came to my hotel within a couple of hours. The agreed price of 59 400 INR (£660 at that exchange rate) was paid in cash and he issued 3x unopened bottles of Myhep Lvir, correctly packaged and stamped with recent manufacture dates, each with 28 pills inside. He also issued a receipt for purchase and photographed my prescription in case I need to order more and want to have these delivered to the UK by DHL for a courier fee.

I had allowed 3 days in Chennai to do this, expecting delays, however completed the entire process in half a day, allowing plenty of time for some sight seeing, shopping and eating before heading on to Thailand. I decided not to start the meds until returning to the UK as I was a little worried about side effects while abroad.

I have now started – 3 days in and just headache and upset stomach so far – but I also still need to establish exactly how I will monitor progress in the UK as I am not strictly attached to any NHS program for this treatment. I am hoping that the hep c unit that administered the interferon triple will do my blood work and have offered to sign a waiver of liability as they are concerned that the meds were not NHS issued. They are yet to get back to me and did not come through for me when I asked for baseline tests before going to India.

Instead I managed to get my GP to ask for the baseline blood work including viral load and I am hoping that the GP will again be able to ask for these monthly. The results are fairly easy to read as there is a range for each function tested and these are highlighted when they are outside of the expected range. A GP has a good idea of if a particular reading is to be watched or is worrying and needs acting on. Should this occur, I will be able to ask a specific question to the consultant Hepatologist. My feeling is that I survived 7 months on the interferon triple and am hoping for fewer side effects from the Indian Harvoni generics.

Many thanks to Greg Jefferys as I was at a low ebb in January when I contacted him, feeling the treatment I needed was not available to me. It has been an uplifting experience to take control of the situation and have an affordable option presented and get the meds.

As I understand it people from the UK do not need to travel to India to get these as Greg tells me it is both easy and legal to have them shipped from India but either way, I would advise to follow Greg’s advice to ensure a reputable supplier as there will inevitably be fakes coming onto the market and unscrupulous vendors who will take advantage.

J

Friday 4th March 2016

As I have mentioned in other parts of this blog one of the services that I happily provide for free is to give people contact details for honest and reliable suppliers of Hep C generics around the world. There are good contacts for Hep C generics in India, Bangladesh, Thailand, Australia and also now Honduras. So for many people, those who live in countries where mail order importation if difficult or prohibited, flying to another country to buy their generic Hep C treatment is the best of options.

So I recommend people in what country is best, suppliers who are trustworthy.

I only recommend people that I have had multiple good reports on from impartial people. If I get even one bad report then I cease to recommend them.

I do not ask for, or receive, any commissions or any other benefit of any kind from recommending these people. My only, and best, reward is knowing that people are going to buy genuine generic Hepatitis C medicines from honest and reliable people.

Here is another story from someone who just returned from getting generic Harvoni in Mumbai, India. He flew from Mexico to India.

Hi Greg,

My wife Claudia sent you a FB inbox about my experience traveling to India and purchased generic Harvoni there. First of all thank you for all your support on my trip, It took gutts to fly sick, and alone to an unknown country and purchased meds from an unknown person. Here’s my story:

I chose to buy meds from Nirav, who you recommended, based on Mumbai. He also requested me all my lab tests and medical prescription translated to English to be able to get an Indian Hepatologist prescription to buy Hepcvir-L. He has the policy to sell meds the “legal way” in order to avoid drug traffic.

From the 4 brands of generic Harvoni available in India he suggested me to buy Cipla’s Hepcvir-L as Cipla is ranked at top 5 of pharmaceuticals in India. So I asked him that if he would have HCV which brand would he take? and he picked Hepcvir-L as he said it has the best quality.

I spent only 3 days in Mumbai, Nirav delivered me 3 bottles of treatment at my hotel room and also offered me a city tour of Mumbai which I gladly accepted! Nirav is a gentlemen and a very kind person. He also was very supportive and was pending of my trip from and back at all time, even more pending that my family!

I decided to carry on my meds with me on my hand luggage and crossed 4 security check points and 4 customs (India, Turkey, USA and Mexico) and had not a single trouble. No one asked me anything about the 3 bottles of tablets. In case of trouble I had prescriptions in English and Spanish to prove they were for personal use.

Once in Mexico I took the meds before my Hepatologist who is the head of liver transplant unit in Mexico’s National Institute of Medical Sciences and he said I am the first Mexican to take generic Harvoni and after only 2 weeks of taking 1 pill a day my viral load went from 3.2 million units to less than 18 units of HCV. So generic med efficacy is un believable! My doctor and his team are very excited and hopeful that generics are working same as the original so now I’m a success case of study in Mexico. I can share with you my viral load tests if you wish.

Same as you, I will open a profile on Facebook about Generic Hep C meds targeted to Mexico to help all people who is in the same case as me. Nirav has also shared my results with other patients that had purchased meds from him to give them confidence.

It would be great if you can post my experience on your FB page to encourage people to take generic harvoni and get cured as I did, because I feel that all every body is scared with the idea to fly to India and buy meds there!

Once again thank you being an encouraging element on my decision to go to India!

Best regards!

Xavier

12th March 2016

As you have read in the preceding stories traveling either to India or Bangladesh or Australia or Thailand to get generic Hep C medicines is a good option for some people and I happily provide free advice on traveling to these countries, who to buy from and, if you want to have medical treatment or supervision I can provide information of good hospitals and doctors.

However for a lot of people it is too expensive or they are unable to travel due to poor health or some other reason. In these cases having the medicine shipped by courier or by mail is the best option. I get many enquiries from many different countries around the world every day and so for this reason, over the last nine months, I have investigated the importation rules of most countries on the Earth.

I do know which countries allow residents to import medicines for personal use and which prohibit this importation. I also know which countries have slightly vague or contradictory rules about personal importation.

I can say that I have been able to assist many people from many different countries to import life saving generic Hepatitis medicines without actually breaking any laws.

To do this in some countries we have had to find loop holes in their rules and in other countries we have used “back door” routes. I have done my best to get medicines to the people who need them without breaking any laws but the truth is if a person was dying and I had the medicines that would save their life I would happily break some stupid law to get that medicine to them.

Here I will list the countries that it is possible to ship generic Hepatitis C medicines to; I will include some comments on each country. I have not included every country, just ones I have helped people with shipping generic Hepatitis C treatments.

Australia:

It is legal and easy to ship generic Hep C medicines to Australia however the treatment is now available through the health system so for most people it is not necessary.

Canada:

Canada allows mail order / courier importation of generic medicines only if it is done by a doctor or pharmacist. If you have a supportive doctor or pharmacist it is no problem to import generic Hepatitis C medicines into Canada.

UK

Britain has the best rules in the world for importing medicine for personal use. Unfortunately the British Medical Association appears to be totally in the pocket of Big Pharma so it is difficult to get a prescription from a UK doctor because most British doctors are cowards.

However the good news is that, under British law, you do not require a prescription from a cowardly UK doctor to import generic Hep C treatment into the UK. Any recent medical report will suffice and that makes it easy and cheap to import generic Hep C meds into the UK. We regularly send shipments to the UK.

USA

The USA is a strange situation where technically the FDA has discretion about whether or not to allow a person to access generic medicines. In other words the FDA decides who will live and who will die. However the FDA very rarely gets involved in the shipping of generic Hep C meds to the USA and even when they do we still have a 100% success rate of getting the meds to the patients. We have been helping people from the USA get generic Hep C treatment for more than 9 months now and every single shipment has reached the patient.

Like the UK Big Pharma has the US medical profession by the balls and it is difficult, but not impossible, to find a doctor to write a prescription in the USA. That said it is definitely easier to find a caring and courageous doctor in the USA than in the UK. We regularly send shipments to the USA and have had no problems.

Romania

There is no problem at all importing Hep C meds into Romania. A Romanian resident simply needs a Romanian doctor’s prescription and to pay the import tax on receiving their medicines. We regularly send shipments to Romania.

Lithuania

There is no problem at all importing Hep C meds into Lithuania. A Lithuanian resident simply needs a their doctor’s prescription and to pay the import tax on receiving their medicines. We regularly send shipments to Lithuania.

Latvia

There is a stipulation in Latvian law that prohibits importation of generics from places like India and Bangladesh but allows importation from Australia so if you are in Latvia you would need to import Australian generic Hep C meds. In the case of Sofosbuvir + Daclatasvir this combination is actually cheaper in Australia than in India. In the case of generic Harvoni it is about $400 more expensive.

Poland

Like most East European countries (except Serbia) Importing medicines into Poland for personal use is no problem if you have a prescription. For extensive information on importing Hepatitis C generic treatments into Poland please use this link to visit the Polish support website. It has everything you need http://noweleki.hepatitisc.pl/p/leki-z-indii.html

Slovakia

It is possible to import generic Hep C meds in Slovakia and I have assisted a number of people to do this. It requires a local doctor’s prescription.

Slovenia

It is more difficult to import into Slovenia but can be done with a local doctor’s prescription

Greece

There are no problems importing generic Hep C medicines into Greece. A local doctor’s prescription is desirable but not essential. The main problem for Greeks is the issue of sending money over seas as there is a limit of $500 per month.

Bulgaria

Like many countries a local doctor’s prescription is preferred but not essential to import generic medicines into Bulgaria.

Serbia

It is not possible to import generic Hep C medicines into Serbia

New Zealand

New Zealand has about the same rules for importing generic Hep C medicines as Australia and we organise shipments to New Zealand regularly.

China

It is preferable to have a prescription from a Chinese Doctor if you want to get generic Hep C medicines into China or Hong Kong however we can organise shipments to China without a prescription and do so regularly.

Taiwan

As with China it is preferable to have a local doctor’s prescription however Big Pharma, particularly Gilead, has put a lot of pressure on Taiwanese doctors. So we can organise shipment without a local prescription and do so several times every month.

Cambodia

There are not problems sending generic meds to Cambodia

Philippines

There is no problem sending generic Hep C medicines to the Philippines, a local doctor’s prescription is required.

Indonesia

There are no problems sending generic Hep C treatments to Indonesia but a local doctor’s prescription is required

Ukraine

There is no problem sending to the Ukraine but it requires a doctor’s prescription and then permission from the Ministry or Health. This process usually takes about 3 weeks.

South Africa

Like Ukraine a prescription and permission is required. There is a form called a “Section 20” this will give you permission to bring in the generic Harvoni or Daclatasvir. It will also take about 3 or 4 weeks to process.

The rest of Africa

There are no problems with sending generics to most African countries and they are generally available there already because the Bangladesh maker of Twinvir, Incepta, is already distributing through most African countries.

Saudi Arabia

A doctor’s prescription is required

Ireland

It is not legal to import generic Hep C meds into Ireland by mail order or courier however it is legal to import them on one’s person. As most Irish people have friends or relatives in the UK then the best option is to go to the UK for a week or so and have the meds sent to the address where you are staying and take them home to Ireland. All totally legal.

Europe

Rules vary from country to country. As with the USA and the UK Big Pharm has a lot of influence and control over the medical professions in the countries of “Old Europe” that is the parts of Europe that were not part of the Soviet Union.

So countries like France, Germany, Italy, Austria, the Netherlands, Denmark and so on have restrictive rules against importing medicines for personal use. Most allow their citizens to bring medicines back home if they have been abroad so the best solution for people in these countries is to simply go to the UK and stay in a hotel or B&B or with a friend for a week and get the medicines sent to them in the UK and then head home.

It is cheaper and easier than flying to India.

South America

There a some major differences between various South American countries.

The countries where there are favorable importation rules are:

Ecuador

Columbia

Brazil (for more information on importing generic Hep C treatment into Brasil click here)

Peru

Honduras

Venezuela

Bolivia

I have helped people from all the above countries import generic Hep C treatment with no problems. However all require a local doctor’s prescription.

For people in Argentina then they must travel to another country

For the people of Chile it is possible to import but requires Health department permission.

14th March 2016

Currently the cure rate is over 96% for people using generic DAAs to treat their Hepatitis C. The generics used in this study include APIs from China, unlicensed generics from Bangladesh and licensed generics from India. So all generic sources of Hep C treatment.

The results are based on more than 400 case studies from people who have completed their treatment and shared their treatment results either with me or Dr Freeman. Dr Freeman has compiled and analyzed the results and we are jointly publishing a paper on this in the very near future.

These results are exactly the same as the results from the branded versions of these drugs and the publication of this study will put to rest any doubts about generics being an effective and affordable way for treating Hepatitis C.

I applaud Dr Freeman for his dedication and tireless efforts to make people aware of the effectiveness of generic Hep C treatment.

Of the five relapses that I have had some personal involvement with 3 of them were genotype 3 and 2 were genotype 2.

Both of the genotype 2 cases were using Sofosbuvir + Ribavirin and did a 12 week treatment.

The three genotype 3 cases were all using Sofosbuvir + Dacalatasvir and also did 12 weeks.

I noticed over the last few months that most Australian Hep C specialist doctors were putting patients with G3 onto 24 weeks treatment with Sofosbuvir + Daclatasvir.

Apart from one guy who washed down his pills with a drink full of Tarine ( which inhibits the body’s absorption of Daclatasvir) there seems to be no obvious reasons why the other people failed to clear the virus when so many other with the same virus and the same medicines have succeeded.

Some authorities argue that patients with a fibrosis reading from F3 to F4 should be doing a minimum of 16 weeks treatment.

Some argue that body weight may have an affect.

Some argue that the length of time a person had carried the virus will influence the outcome.

The reality is that we really do not know for certain, other than a longer treatment seems to have better results than a shorter treatment.

So amongst every 100 people with Hep C who undergo treatment with the new DAAs, whether generic or branded the results will be the same. Out of every 100 there will be two or three who will relapse until such time as someone discovers why.

The work done by Dr James Freeman in compiling and collating the results of hundreds of cases will be very important to discovering why relapses occur.