Do I understand correctly that France and Fixhepc just became brothers?

As long as France wants to renegotiate HCV drug prices, what France just did is a great strategic move.

FedEx and DHL have a fast learning curve. They will be become “proactive” in short order, I imagine, making sure that all documentation is in order for a successful delivery to the destination country (France) before sending the package on its way. That has been my experience in dealing with them as far as US shipments go.
m

Thanks Vororo.

For those who can’t read French here is a translation of the full article courtesy of Mr Google who is much better at it than me.

May 2016 – Hepatitis C: Indian generic AAD as effective as the originator 
Vincent Richeux – Medscape – 2016




Generic AAD, imported from India by patients with hepatitis C (HCV) through a dedicated website, have proven as safe and effective as the originator molecule, reported Dr. James Freeman (Hobart, Australia), at the International Congress Liver (ILC), 2016, Barcelona [1].A new step towards widespread access to ADF? 

Excessive Price AAD originator treatments are regularly criticized because they represent the brake to access therapy to cure the infection with HCV. For 12 weeks of treatment with sofosbuvir, leader of the AAD produced by Gilead, the price ranges from 900 euros in Egypt to 84 000 in the United States. In France, it takes 46,000 euros. 

Several countries, such as China and India, were able to obtain the licenses of originator, following agreement with manufacturers to produce their own generic AAD at a price of around 1,000 euros per treatment. 

Import for personal use via a “buyer’s club” 

”When the first patient asked council to import generic drugs from Chinese manufacturers in order to treat his hepatitis C, I decided to buy myself and test them to make sure of their quality” , explained Dr. Freeman. 
It thus began the FIXhepc Australian initiative, which assists patients HCV + who wish to obtain generic AAD, inaccessible in their country. Drugs are now ordered from Indian manufacturers, who obtained the license of the originator. 
”The process is legal,” says Dr Freeman. “It is based on the authorization granted in some countries, such as Australia and the United Kingdom to import drugs for personal use not exceeding three months of treatment. ” 
On the dedicated website, patients are encouraged to incorporate a “buyer’s club”, with $ 1,600 for a 12-week treatment of sofosbuvir + ledipasvir or $ 1,500 for the combination sofosbuvir + Daclatasvir. 

Sustained response rate of 95%

FIXhepc proposes to import generic Australia, test and deliver them to patients in countries allowing personal importation. According to the site, the United Kingdom, but also Italy, Switzerland, Poland or Romania are the countries of Europe, where delivery is possible.
From January 2016, Dr. Freeman included patients wishing to import generic, through the buyer’s club, in an observational study, named REDEMPTION (DAA Reviewing efficacity Managing Patient Treatment in Online Neighbourhoods).The results presented at the ILC concern a total of 448 patients, 54 years on average in Australia, mostly, but also in Asia and South America. At the time of inclusion, they were naive to treatment half and 30% had cirrhosis. Imported generic were analyzed by chromatography and mass spectrometry. The sofosbuvir / ledipasvir combination was a majority (45%), followed by sofosbuvir / Daclatasvir (42%). In other cases, these combinations were associated with ribavirin.

No more side effects

Of all the tested generic, the virologic response rate (SVR) amounted to 95%. It reached 97% for the combination sofosbuvir / Daclatasvir. “The response rates appeared similar to those reported for the originator in Phase 3 clinical trials,” said Dr. Freeman.
Patients were followed remotely via telemedicine. The most frequently reported adverse events were insomnia, fatigue and headaches. According to the doctor, “there were no more adverse effects compared with AAD.”
Three patients had cirrhosis temporarily switch to a decompensated stage, but the treatment was maintained. Four died due to hepatocellular carcinoma.
“These results show that we have there an effective treatment to cure patients with hepatitis C for less than 1000 dollars. Millions of people could benefit. So it is now time to use them, “concluded Dr. Freeman before being greeted by long applause.

French patients go abroad to treat you!

In France, the new ADF are reimbursed in adults chronically infected with HCV from the stage “F2 severe” and, whatever the stage of liver fibrosis in people co-infected with HIV and those with a mixed cryoglobulinemia or a B lymphoma associated with HCV.
Asked by Medscape French edition, the general secretary of the French Association for the Study of Liver (AFEF), Prof. Victor Lédinghen, said he was “delighted” the results presented by Dr. Freeman. “Now we can tell our patients, without access to treatment, they may consider a therapeutic stay abroad.”
If France does not import drugs, she allows the transportation of personal medicines from a foreign country. According to French customs, “the quantity transported corresponds to the duration of treatment prescribed on the order or, failing that, three months of treatment.”
The law is in favor of transport medicine, “this opens the door to therapeutic stay,” says Prof. De Lédinghen. “It will ensure, however, choose the destination country, focusing on manufacturers who have obtained the license of originator.” “Never generic only appeared so soon after the arrival of a new treatment on the market.Results regarding their effectiveness once again raises the issue of widespread access to ADF. The situation became absurd. ”
The secretary hopes an announcement in the sense of the Health Minister, Marisol Touraine, during the National Day against hepatitis B and C, to be held on 25 May.

REFERENCE:
[1] – Freeman J, High sustained virological response rates using Direct acting generic antiviral treatment for hepatitis C, imported into Australia, April 16, 2016, ILC 2016, Barcelona.
http://fixhepc.com/getting-treated/how-to-do-it/worldwide-import-regulations.html