Provided by ACT-UP Paris
Hepatitis C: Shame on Gilead! / HCV: Shame on Gilead!
published online: 12 August 2013
People living with hepatitis C and whose state of health emergency should benefit from drugs under development and not yet available on the market. For this, there is a temporary authorizations device use (ATU).
At noon, the activists of Act Up-Paris traveled to Boulogne-Billancourt to the French headquarters of Gilead Sciences Inc. to remind the company that it must follow the advice of the National Security Agency of the drug (MSNA ). Gilead refuses to give early access to sofosbuvir (SOF) to patients because they are therapeutic impasse with molecules currently available on the market, received a nominative ATU ANSM. The activists put up posters on the French headquarters of the firm are poured fake blood, unfurled a banner "Shame on Gilead" and chanted slogans such as "SOF is our right" or "We need this drug." The attitude of Gilead is denounced by several patient groups and national and international coalitions whose TRT-5, CHV, Treatment Action Group (USA) and the European AIDS Treatment Group (EATG). An online petition has collected more than 400 signatures of natural and legal persons.
Laure Pora, president of Act Up-Paris, said: "For Gilead, monopolistic logic premium on therapeutic requirements; compassionate access sofosbuvir is not the only example. We ask members of the Economic Committee of Health Products, which sets the price of drugs to financially penalize the firm when comes the time to fix the price of sofosbuvir and politicians denounce the attitude of Gilead. We call to sign the online petition "
Act Up-Paris requires Gilead Sciences immediately provide the sofosbuvir to all persons who have registered ATU.
To gather information on the ATU anti-hepatitis C molecules in development, the group has set up an observatory that can be supplied by patients, relatives, doctors and associations.
Gilead deliberately expose patients to deadly risks
Press Release interassociative group TRT-5 and Collective viral hepatitis
published online: 12 August 2013
People living with hepatitis C and whose state of health emergency should benefit from drugs in development and close to putting them on the market. For this, there is in France a device called Temporary Authorization for Use (ATU), which could save lives by providing early access to such drugs.
On 23 July, the National Security Agency of Medicines (MSNA) had granted 96 nominative ATU - ie based on the state of health of the person - sofosbuvir of a molecule developed by Gilead, to people with received a liver transplant, people waiting for transplants and people with cirrhosis therapeutic impasse. Gilead but refused to give the molecule in the majority.
Data from early access programs (or compassionate) can be used to determine the safest and most effective ways to treat HCV in people who need it most. For example, the cohort ANRS CUPIC provided essential information to understand what cirrhosis patients were more likely to get better, or worse - with treatments based on boceprevir or telaprevir. If Gilead refuses to study sofosbuvir "in real life", the opportunity is lost to minimize damage and maximize profits.
That's why we ask Gilead to give sofosbuvir NOW to those who have the greatest need, including those with advanced (Child-Pugh B or C), cirrhosis, some of which are living with HIV or another disease. For this purpose, a petition was launched in ten days which has raised more than 400 individual signatures and associations worldwide.
Of projects ATU cohort and clinical trial (sofosbuvir ledipasvir +) are under consideration in MSNA, but these projects appear equally restrictive and Gilead refuses to disclose its information to patients' associations. It is thus highly likely that doctors have not requested nominative ATU hoping that their patients could access treatment in a cohort ATU or a test, then they will be excluded.
Neglecting health emergencies, building useful prescription and pharmacovigilance scientific data, the Gilead, which markets life-saving medicines is not up to its ethical and social responsibilities.
Declaration of interest link: TRT-5 in 2013 received a grant of € 15,000 from Gilead.
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