[Ip-health] Columbia Statement on Generic Fixed-Dose Combination ARVs

[Mike Palmedo]

For Release April 14, 2004

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

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