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Gilead's Tenofovir 'Access Program' for Developing Countries: A Case of False Promises?
Denver, CO, February 7, 2006 — As AIDS experts gather this week in Denver to discuss advances in treatment at the 13th Conference on Retroviruses and Opportunistic Infections (CROI), Doctors Without Borders/Médecins Sans Frontières (MSF) is concerned that innovations from years ago are still not reaching people in developing countries. More than three years after Gilead Sciences first announced its "Access Program" for tenofovir, this key antiretroviral medicine remains largely unavailable in developing countries.
Marketed as Viread® (tenofovir disoproxil fumarate) in the United States, tenofovir was approved by the US Food and Drug Administration more than four years ago and is now an important option for antiretroviral treatment for both AIDS patients starting therapy for the first time, and those that require access to newer drugs a few years down the line, particularly because it has fewer side effects than older antiretrovirals.
As Gilead is the sole producer of tenofovir (no generic versions have been internationally validated), MSF and others are dependent on the willingness of the company to make this urgently needed drug widely available. In December 2002, Gilead announced that tenofovir would be available at a reduced price initially to 68, and then to 97 developing countries through its Viread Access Program. Over three years later, tenofovir is registered for use in only six of these countries — the Bahamas, Gambia, Kenya, Rwanda, Uganda, and Zambia. The company has failed to request marketing clearance or otherwise make their drugs available in most developing countries.
"Gilead is proud to show physicians and shareholders how effective tenofovir is in treating AIDS, but other than issuing press releases and empty promises, the company has done little to ensure that the medicine is available to those who need it most in developing countries," said Dr. Alexandra Calmy, AIDS specialist with MSF's Campaign for Access to Essential Medicines, attending CROI in Denver this week.
In South Africa, Gilead only completed its registration application in November 2005, three years after it announced the price reduction for selected developing countries. Considering the average time between filing and approval of a drug registration application in South Africa, this means the drug is unlikely to reach patients before 2007. That's a five-year gap between Gilead's announcement and availability in the country.
To obtain the drug for patients in South Africa today, MSF physicians running AIDS treatment programs are forced to go through a series of burdensome procedures, like providing the name of each patient needing the drug, in order to import tenofovir directly from Gilead in California under a special authorization of South African law.
"The complicated application process and in particular the difficulties and added expense of shipping from California means that the vast majority of physicians in South Africa will not have access to tenofovir. And if shipments get delayed, we will also be faced with the painful reality of needing to ration the drug." said Dr. Eric Goemaere, head of mission for MSF's HIV/AIDS treatment project in Khayelitsha, outside of Cape Town.
Gilead does not consider Thailand as an "Access Country" and has, to date, not marketed the drug there. "When MSF met with the Gilead representatives at the International AIDS Conference here in Bangkok back in July of 2004, they assured us they would register the drug right away," said Dr. David Wilson, medical coordinator for MSF's AIDS treatment programs in Thailand. "18 months later, we are still waiting."
"If Gilead waits to register tenofovir in Thailand until after the US-Thailand Free Trade Agreement is signed, the company could have five years of exclusivity on the drug. One can't help but wonder if this is motivating the delay," Wilson concluded.
MSF is urging Gilead to turn its promises on paper into pills for patients and make good on its promises.
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