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Liver Iternational - Generic Hepatitis C Medication

This article about the rationale for using generic hepatitis C medication has just been published in Liver International in their section "Debates in Hepatology".

James A. D. Freeman1 and Andrew Hill2

1 GP2U Telehealth, Hobart, Tas., Australia
2 St Stephens AIDS Centre, Chelsea and Westminster Hospital, London, UK

Liver Int. 2016; 36: 929–932. DOI: 10.1111/liv.13157

Abstract

Hepatitis C, hepatitis B, HIV, TB and malaria are the five major causes of infectious disease death worldwide. In a breakthrough that rivals the invention of penicillin, drugs that cure hepatitis C, with minimal side effects and high success rates, have reached the market, but, in what must be one of the greatest tragedies of modern times, these life-saving medications are not being deployed on a mass scale. Pharmaceutical patents are gifted to private corporations by governments for the dual purposes of protecting R&D expenditure and encouraging innovation. Unfortunately the monopoly pricing power these patents provision currently lacks adequate checks and balances, is open to abuse, and is quite clearly being abused. The sort of legislative changes required to deliver on the original goals of pharmaceutical patents will take years or even decades to eventuate. Parallel importation of generic medication offers hope to the millions of patients with HCV unable to afford access to vastly overpriced originator medications. Doctors prescribing and monitoring patients taking generics can take comfort from the fact that the REDEMPTION trial results show, like the HIV generics that came before them, that HCV generics deliver robust clinical results.

Read the full article at: http://onlinelibrary.wiley.com/doi/10.1111/liv.13157/full 

To find out more about generic hepatitis C medication please visit our forum where you can read the stories of patient successfully accessing and treating their hepatitis C with affordable generic medication.

Приветствуем, всех, кто затронут вопросами хронических гепатитов,

Мы рады представить некоммерческий проект «ГЕПАТИТКА», созданный группой активистов для поддержки, помощи и общения людей, затронутых вирусными гепатитами B, C и D.

Начало этого проекта было положено в марте 2012 года пациентом из Москвы во время того, как он проходил курс лечения гепатита С пегилированнымиинтерферонами и рибавирином. Чтобы облегчить проживание сложных побочных эффектов, связанных с лечением, молодой человек начал взаимодействовать с людьми, затронутыми гепатитом С. Он делился своим опытом, рассказывал, как передается гепатит С, мотивировал лечиться, а не ждать развития фиброза, пояснял, как можно поддержать человека на лечении, организовывал совместное времяпровождение и он-лайн взаимодействие людей, связанных с гепатитом С.  Вокруг него образовывалось сообщество людей, связанных с гепатитом С. Сообщество разрасталось, вышло за пределы Москвы и в октябре 2013 года его товарищ из Минска, замотивированный на лечение гепатита С, создал группу в социальной сети фейсбук. Этой группе далось запоминающееся название – ГЕПАТИТКА.

В 2015 году проект переформатируется, благодаря присоединению к работе и разносторонней поддержке коллег из ITPCru. Весной 2015 года в группе ГЕПАТИТКА в фейсбуке начала появляться информация о прорыве в лечении хронического гепатита С в виде появления на рынке препаратов для лечения гепатита С с принципиально новым принципом действия, с почти 100% эффективностью, легких по переносимости и с сокращенным сроком лечения.  ГЕПАТИТКА была одним из первых ресурсов, где появились новости по доступу к лечению ВГС в мире новыми безинтерфероновыми схемами, где были опубликованы перечни доступных безинтерфероновых генерических препаратов для лечения ВГС с указанием цен  и производителей. Ресурс подкреплял новостную информацию о препаратах переводенными на русский язык международными клиническими рекомендациями по лечению новыми схемами, а также результаты КИ по ним. При этом составом координатором ГЕПАТИТКИ было принято решение поддерживать исключительно традиционные мировые методы диагностики и лечения. Благодаря выкладываемой информации, постоянной работе с пациенстким сообществом и опыту первопроходцев, кто уже не мог откладывать лечение и воспользовался новыми препаратами, появилось много информации о ходе лечения новыми препаратами в режиме он-лайн, и как следствие, много возможностей расширения доступа к лечению гепатита С для всех нуждающихся и очевидная необходимость развития проекта ГЕПАТИТКА в разных направлениях.

На июнь 2016 года проект представлен в следующих ресурсах:

- закрытая группа фейсбук (3477 участников): https://www.facebook.com/groups/NAHCV/

 - закрытая группа в ВКОНТАКТЕ (475 участников):  https://vk.com/gepatitkaru 

- сайт http://gepatitka.ru/, где доступен пациентский форум, а также последние мировые рекомендации по лечению ВГС и бесплатное медицинское консультирование по вопросам хронических гепатитов в режиме он-лайн.

На сегодня проект ГЕПАТИТКА координируется небольшой группой активистов из Москвы, Санкт-Петербурга и Минска. В планах стоит расширение развития в регионах ВЕЦА, в проекте на ежедневной основе задействованы активисты из РФ, Украины и Латвии.  В проект вовлечены два медицинских специалиста, практикующих гепатолога, из Германии и России.

Добро пожаловать всем, кто затронут вопросами гепатитов на площадки проекта ГЕПАТИТКА. Вы сможете найти много полезной информации и общения там.

------

Dear all, especially Russian speaking audience,

We are pleased to present a non-profit project "GEPATITKA" for the Russian audience. Project was created by a group of activists to support and to coordinate communication between people, affected by viral hepatitis B, C and D.

Project started in March 2012 while a patient from Moscow (Russian Federation) was undergoing pegylated interferon and ribavirin treatment for hepatitis C. In order to handle tough side effects and not to stay alone with his condition, he started to share his experience with others, started to learn more about HCV and to share his knowledge. Very soon a community of patients grew around him. He treated his HCV and continued his activities to help others. He motivated his friend from Belarus to start treatment as well and in October 2013 the project appeared on-line, on FACEBOOK, and got it name – GEPATITKA (Gepatit means Hepatitis in Russian). 

In 2015 the project GEPATITKA was reformatted (got a new structure), due to the joining of ITPCru. GEPATITKA started to spread out information about new landscapes in HCV treatment, about the DAA appearance in the world with almost 100% efficiency, easy portability and a reduced period of treatment. GEPATITKA was one of the first resources in the EECA region, where information about PEG-IFN-free regimens was published and lists with DAA generics with prices and producers appeared. Project supports its publications with the international clinical guidelines, and only traditional methods of HCV diagnosis and treatment. Due to the strong informational work and very attentive and intense approach to the patient’s community project GEPATITKA became very popular in the Russian speaking countries, especially in Russia, Belarus and Ukraine.

In June 2016 GEPATITKA project is presented in the following resources (only in Russian language):

- Private group on Facebook (more than 3500 participants): https://www.facebook.com/groups/NAHCV/

- Private group in a Russian social network VKontakte (around 500 participants): https://vk.com/gepatitkaru

- at the web site GEPATITKA: http://gepatitka.ru/
This web site provides not only the latest world updates for HCV treatment and free medical consultations for chronic hepatitis in the online mode, but also a platform for the patient’s forum.

Today GEPATITKA project is being coordinated by a small group of activists from Moscow, Saint Petersburg and Minsk (Belarus). They plan to expand in the EECA regions. A number of volunteers, who are affected by hepatitis, from Russia, Ukraine and Latvia are involved in this project on a daily basis. Two medical specialists, hepatologists from Germany and Russia answer questions on the web site free of charge on the daily basis.

Resources of GEPATITKA are very friendly and patient - oriented and warmly welcomes everyone who is affected by hepatits.
Wednesday, 11 May 2016 11:41

Hardev Karar we salute you. R.E.S.P.E.C.T

So now it's common knowledge that the Indian patent office has approved Gilead's sofosbuvir patent but....

What Happened to the Indian Official that Rejected the US Drug Company Gilead’s Patent Application in 2015?

It appears that being a man of honour is less valued than it should be.

http://www.caravanmagazine.in/vantage/indian-official-rejected-gilead-patent-forced-out

Hardev Karar, I salute you as a man of honour and integrity.

Dr James Freeman

 
Thursday, 14 April 2016 18:26

One poignant post that says it all...

Thank you all, I wish I could say Harvoni cured me, but it did not. Generic sofosbuvir and ledipasvir from China did. I would still be very sick without it.

Gilead is a hedge fund under the guise of a pharmaceutical company. They want drugs that will treat diseases that are problems in wealthy, industrialized nations. Don't look for them to come up with a cure for malaria, ebola or Zika-there is just not enough money in it for them to be interested.

They will continue to tend the geese that lay the golden eggs until, like Australia, they are forced to "make the deal". Then they will cook and eat them.

In the US, insurers are relaxing restrictions because of legal pressure brought about by patients over denial of treatment. This will force substantial rises in the cost of health insurance for everyone, with Gilead getting the money. Health insurance companies don‘t go broke. They have reserve funds, and when they have to tap into them one year, they raise the premiums the next to cover the shortfall.

Widespread acceptance of affordable generics is the only way Greediad will have its hand forced. Dr. Freeman's EASL presentation on the stellar findings of the REDEMPTION clinical trials tomorrow could be a major first step.

We are in a high stakes poker game here. The insurance companies are the "house”- Gilead, the well-funded, card-counting professional gambler.

We are the chips.
Saturday, 27 February 2016 03:42

PBS Pricing - Take a deep breath....

So I guess like a lot of people I've been wondering how good a deal the PBS negotiated.

Last week I heard that a major public hospital had ordered 10 lots for $66,000 but thought that must be wrong.

Given the pharmacists have to order these medications I came up with the cunning plan of asking one. The prices were not available earlier in the week, but they are now.

Make of it what you will but the $22 k per month price for Harvoni looks like exactly the same as the price France and Germany negotiated and would allow 15,000 people to be treated for $1 billion.

G'day,

Here is a list of the three medications and the quotes from our suppliers. I did some further investigation after our phone call and found that the prices on the websites were completely wrong. I called the suppliers and got the correct quote. As such, I have not attached any screen shots - as these would be very misleading!

  • Daklinza 60mg 28 tablets- $7,736.30
  • Harvoni 90/400mg 28 tablets- $22,135.00
  • Sovaldi 400mg 28 tablets- $19,367.00
Stock for Daklinza is available for order, and so we can have this within 24 hours of ordering.

Stock for Harvoni and Sovaldi are not available with our suppliers yet, but they have ordered it - and so hopefully it isn't too far away (but they could not give me an ETA).

If you have any further questions please do not hesitate to ask either myself or J.

Kind Regards,

D
In the beginning God created heaven and earth. Dr Schinazi created PSI-6130

PSI-6130 www.ncbi.nlm.nih.gov/pmc/articles/PMC1932527/ 

ACKNOWLEDGMENTS

This work was supported in part by NIH grants 5R37-AI-041980, 4R37-AI-025899, 5P30-AI-50409 (CFAR), and RR000165 (to Harold M. McClure) and the Department of Veterans Affairs.

R. F. Schinazi is the principal founder and a former director of Pharmasset, Inc. He is also a major shareholder of Pharmasset, Inc., and Idenix Pharmaceuticals
.

Now PSI-7851 comes directly from the development of PSI-6130

www.wikinvest.com/stock/Pharmasset_(VRUS)/Psi-7851

PSI-7977 (aka Sofosbuvir) is the active metabolite of PSI-7851 so is also directly related to PSI-6130...

files.shareholder.com/downloads/VRUS/0x0...4533817aa73/PSI-7977

So the baby (invention) was born from NIH and VA grant money and was created by someone who was 7/8 time employed by the US Government.

So what you say?

Executive Order 10096, issued by President Harry S. Truman in 1950, I say.

www.tms.org/pubs/journals/JOM/matters/matters-9004.html

The main section of the executive order provides that the government shall obtain all rights to any invention made by an employee if any one of the following conditions applies: the invention is made during working hours; the invention is made using either government facilities, equipment, etc., or is made with the help of another government employee who is on official duty; or the invention relates to the official duties of the inventor.

So what did Dr Schinazi do in 2007-2010 and what were his "official duties"?

This document indicates he was employed by the VA as a research chemist and did indeed make the invention in relation to "the official duties of the inventor" as in on government time, in a government lab.....

tel.archives-ouvertes.fr/pastel-00605911/document

The research presented in this dissertation was performed in the Laboratory of Biochemical Pharmacology (LOBP) at the Veterans Affairs Medical Center/Emory University. LOBP is a drug discovery and preclinical drug development laboratory directed by Dr. Raymond F. Schinazi.

Developed in the 1/8 non government time. This is fantasy, fiction, and BS.

Developed on the government ticket. Owned by the US government.

Brilliant, breakthrough and stellar but not done independently.

And it is all documented.
Monday, 01 February 2016 04:00

ASHM Gearing Up For PBS Listing

Dear Colleague,
 
ASHM is running the Treatment of hepatitis C with Direct Acting Antivirals course at the Rydges Melbourne, Victoria on Saturday, 20 February 2016. This course is being delivered as part of the Control and Elimination within AuStralia of HEpatitis C from people living with HIV (CEASE) project in partnership with the Kirby Institute.
 
This full day, face-to-face course is designed to up-skill the primary care-based workforce in the current assessment and treatment of HCV infection, to enable rapid scale-up of interferon-free therapy with direct acting antivirals (DAA) for HCV. The course is designed for HIV prescribers, but may also appeal to General Practitioners, Sexual Health Physicians, OST prescribers, clinicians working in AOD settings, custodial settings and Aboriginal Medical Services.
 
This is a FREE course, which has been approved for 40 Category 1 RACGP points. A small number of travel scholarships for rural and regional medical practitioners to attend may be available upon request.
 
I have attached a flyer with further details – Feel free to forward to your colleagues and extended networks. To register for this course please go to the courses page on the ASHM website http://www.ashm.org.au/courses.
 
Please do not hesitate to contact me via return e-mail if you have any queries.
 
Kind regards,

Annabelle Kennett
Project Officer
National Policy and Education
ashm | Supporting the HIV, Viral Hepatitis and Sexual Health Workforce
Tel: +61 2 8204 0742 | Fax: +61 2 8204 0782 | E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
LMB 5057 DARLINGHURST NSW 1300 | www.ashm.org.au -

A short excerpt from a recently discovered audio recording of the Rev. Dr. Martin Luther King Jr. speaking at Syracuse University in July of 1965.

There are some things so dear, some things so precious, some things so eternally true that they're worth dying for. And if a man has not discovered something that he will die for, he isn't fit to live.

Tuesday, 12 January 2016 11:35

Hepatitis C Virus Life Cycle Video

Awesome animated video of HCV life cycle.

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