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People living with HCV who are in a urgent need of new treatments should get an early access to compounds that are in their latest stage of development, and therefore not yet on the market. The French early access system called ATU (Temporary Authorization of Use) allows this early access.

The French national regulation agency (Agence Nationale de Sécurité du Médicament, ANSM) has granted patient name-based temporary authorization of use (ATU) of sofosbuvir, a Gilead new compound, to people on the waiting list for a hepatic graft and to cirrhotic patients with no therapeutic option. Gilead Sciences Inc refuses to provide their new compound sofosbuvir.

The delivery of this Direct Acting Antiviral (DAA) agent against Hep C virus is refused by Gilead on the ground of fairness between European countries and to a so called limited capacity of production.

Yet, a European market application for sofosbuvir has been filed two months ago by Gilead Sciences, which implies that Gilead does actually have a large-scale production capacity.

Regarding fairness between European countries, this is an argument we cannot accept. In the other European countries, there are many patients with no therapeutic option who are also in an urgent need to have access to new compounds. Unlike France, many European countries do not have the legal system that allows early access to therapeutic innovations. But considering the fact that some patients are at great risk to lose their lives, a European initiative should allow to set up early access programs without delaying the provision of the compounds in the countries with adequate regulatory and medical agencies.

This provision of the drug through an early access program will also allow the collection of scientific data concerning the safety and efficacy of sofosbuvir in cirrhotic patients and patients waiting for a liver transplant.

Gilead has to meet the needs of the severely advanced HCV patients by providing their compound to clinicians and regulators who are waiting for it, and therefore provide sofosbuvir immediately for the people in the most severe situations