Gilead's Tenofovir 'Access Program' For Developing Countries: A Case Of False Promises?

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/Medecins Sans
Frontieres (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(R) (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
HIV/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.


MSF and HIV/AIDS Treatment:


MSF began providing HIV/AIDS prevention and care services
in the 1990s. In 2000, MSF introduced antiretroviral
therapy in its projects in Thailand, South Africa, and
Cameroon. Currently, MSF provides antiretroviral therapy
to nearly 60,000 patients in 50 projects in 29 countries.


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