E-DRUG: PEPFAR grantee supports use of WHO pre-qualified FDCs
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STATEMENT BY ALLAN ROSENFIELD, MD, DEAN
MAILMAN SCHOOL OF PUBLIC HEALTH, COLUMBIA UNIVERSITY
Regarding the use of generic and fixed-dose combinations of
antiretrovirals as a low-cost treatment option for HIV/AIDS in
resource-limited settings globally
For Release April 14, 2004
The availability of generic antiretrovirals (ARVs), including
fixed-dose combinations (FDCs), has been a major step forward in the
effort to provide ARVs to the resource-poor countries hardest hit by
the AIDS pandemic, thus helping to expand the number of people living
with AIDS receiving lifesaving drugs. The World Health
Organization's (WHO) pre-qualification process greatly facilitates
access to these generic ARVs.
The Mailman School's MTCT-Plus (Mother-to-Child Transmission)
Initiative, has established HIV care and treatment programs in
several resource-limited countries, and has utilized UNICEF in ARV
procurement for its sites. This program has been generously funded
from many sources, including several private foundations and USAID.
The goal of MTCT-Plus is to assist in the global efforts to fight the
AIDS pandemic by developing models for providing ARV treatment and
HIV care to as many people as possible as quickly as possible. This
program has utilized various ARVs, including some generic products
that have received WHO pre-qualification, and recently, fixed-dose
combination ARVs.
The recently announced U.S. government sponsored HIV care and
treatment initiative (Emergency Plan for AIDS Relief) provides
funding that can make the treatment of millions of HIV-infected
individuals globally a reality. We are grateful to be a grantee of
such funding and to be offered the opportunity to participate in this
ground-breaking effort.
The use of low-cost generic ARVs allows these life-saving drugs to be
available to a larger number of people than otherwise possible and
enables the rapid scale-up of HIV care and treatment efforts. In
addition, the use of FDCs provides a much more convenient dosing
regimen consisting of few pills each day. This will enhance the
ability of patients to adhere to their treatment regimen and delay
the development of resistant strains of HIV.
Thus, the use of generic ARVs and FDCs will facilitate the
achievement of the goals of the Emergency Plan for AIDS Relief-to
rapidly increase the number of individuals receiving HIV treatment.
We hope that the U.S. government will adopt the WHO pre-qualification
process for the approval of high-quality generic drugs so as to
enable the use of U.S. government funding to procure these drugs. The
urgent needs of the millions suffering from HIV/AIDS today compel us
all to work together to make treatment for them a reality.
For more information contact:
Randee Sacks, Mailman School of Public Health
212-305-8044
Asia Russell
Health GAP
asia@healthgap.org
+1 267 475 2645 mobile
+1 215 474 9329 office
http://www.healthgap.org
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