Merck/Gilead Once-A-Day AIDS Pill Not Available in Most Places - AHF Urges Speed-Up of Registrations


LOS ANGELES, September 10 /PRNewswire/ --

- The once-daily HIV treatment would greatly increase effectiveness for 
patients, but Gilead Sciences and Merck and Co. have failed to register it in 
countries where it is needed most

AIDS Healthcare Foundation (AHF) today called on Gilead Sciences and
Merck to immediately register and distribute the three-in-one, once daily
lifesaving HIV treatment, Atripla, in developing countries. When Atripla
first received approval from the Food and Drug Administration (FDA) in July
of 2006, advocates like AHF applauded the production of a single, once-a-day
drug as a landmark step in treating HIV. However, since its approval, little
progress has been made in expanding the availability of the treatment in the
developing world, where only 28% of those in need of treatment were able to
access it as of December 2006. Efforts made by AHF to clarify what countries
currently can purchase Atripla at the announced US$613 per patient per year
access price have gone unanswered.

"This treatment is a standard therapy in the United States. It is on the
World Health Organization's Essential Medicines List, and is an
antiretroviral drug regimen that could greatly benefit patients everywhere
while reducing costs in the long term," said Michael Weinstein, AIDS
Healthcare Foundation President. "The fact that Gilead and Merck appear to be
unable or unwilling to make it available in resource-poor countries is deeply
troubling, and causing unnecessary suffering. Gilead and Merck should
immediately begin making this treatment available to the rest of the world,
or license it out to a generic drug manufacturer, such as Cipla, which
already produces a generic version in India, that will. In the instances
where the registration process has been initiated such as in the European
Union, governments must also recognize their roles and streamline the
necessary approval processes to facilitate quick distribution of these
lifesaving drugs."

The key value of an all-in-one, one pill per day HIV treatment regimen is
the reduced pill burden required for patients. Currently, the most widely
used regimen for treatment naive patients consists of a combination of at
least two pills taken twice per day, often required to be taken with food and
during mid-day hours. Atripla, however, only requires a single pill to be
taken once daily without food before bed.

"As we have seen in many of our clinics, pill burden and side effects can
be challenging for patients to become accustomed to, and they are among the
primary reasons patients do not follow their treatment regimens," said Dr.
Homayoon Khanlou, AIDS Healthcare Foundation's Chief of Medicine. "With a
complete daily treatment regimen in one pill, the advantage goes much further
than simply fewer pills and fewer side effects. The ease of treatment results
in improved adherence with more patients taking their medication as
prescribed, which greatly increases the effectiveness of treatment. This also
results in fewer patients developing resistance to the drugs, and from having
to move on to more expensive second-line drugs."

AIDS Healthcare Foundation (AHF) is the nation's largest non-profit
HIV/AIDS healthcare, research, prevention and education provider. AHF
currently provides medical care and/or services to more than 61,000
individuals in 15 countries worldwide in the US, Africa, Latin
America/Caribbean and Asia. Additional information is available at
http://www.aidshealth.org.

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Web site: http://www.aidshealth.org

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