NEW YORK – A thousand patients with AIDS in Haiti who received antiretroviral therapy had a one-year survival of 87 percent for adults and 98 percent for children, triple the 30 percent one-year survival of Haitian patients without the therapy – according to a study authored by Haitian and U.S. physician-scientists of Weill Medical College of Cornell University and the GHESKIO Center in Port-au-Prince, Haiti.

The research is being published in the New England Journal of Medicine on December 1, World AIDS Day. The largest of its kind, the study provides evidence in support of international efforts to make antiretroviral therapy available to patients with AIDS in developing countries.

"Our study demonstrates the feasibility of rapidly and effectively initiating antiretroviral therapy in a large number of patients in an impoverished country," says Dr. Jean William Pape, the study's co-author, an internationally recognized infectious-disease expert, professor of medicine at Weill Medical College of Cornell University, and director of GHESKIO. GHESKIO (Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes) is a Haitian non-governmental organization (NGO), which works in partnership with the Haitian government and is dedicated to training, research, and the provision of HIV/AIDS care. GHESKIO has collaborated with Cornell University for 25 years.

"Antiretroviral therapy is the international standard of care for patients with AIDS, and has recently become available in Haiti and in other developing countries. With limited data on its efficacy in developing countries, there has been concern that poverty, malnutrition, tuberculosis, and lack of infrastructure would prove limiting. Our study showed that these barriers can be overcome," says Dr. Daniel W. Fitzgerald, the study's senior author and assistant professor of medicine at Weill Cornell Medical College.

The study examined treatment outcomes of 1,004 AIDS patients consecutively started on antiretroviral therapy at the GHESKIO clinic in Port-au-Prince, Haiti, beginning in March 2003, immediately after international funding for antiretroviral therapy first became available.

Patients with AIDS at GHESKIO were treated according to World Health Organization (WHO) guidelines for the use of antiretroviral therapy. Of the 910 adults and 94 children infected with HIV who received the three-drug antiretroviral therapy, after one year, 87 percent of adults survived and 98 percent of children survived. Other measures of antiretroviral treatment response were also remarkable, including virologic response rate of 76 percent (the percentage of those with no presence of HIV in their blood) and a median increase in CD4 T-cell count of 163 per cubic millimeter (an indication of a healthy immune system) at one year in adults and adolescents.

Importantly, the treatment outcomes in Haiti were comparable to treatment outcomes achieved in HIV clinics at the best academic medical centers in the United States.

The care of the 1,004 patients receiving antiretroviral therapy was supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria; and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). The study's authors estimate that the overall cost of treating a patient with antiretroviral therapy was about $1,600 per year, with antiretroviral medications accounting for 35 to 45 percent of the total. The majority of the patients earned less than $1 a day, the World Bank's international poverty line.

While there have been smaller studies with comparable results in Africa and Haiti, the current study represents the largest group studied to date to receive antiretroviral therapy in a developing nation. Additionally, the study examined patients of all ages consecutively started on therapy without regard to perceived likelihood of adherence. The patient population studied is therefore representative of a clinic population that would be found in other urban areas severely affected by HIV in the Caribbean or sub-Saharan Africa.

Haiti is the poorest country in the Western Hemisphere and has suffered from nearly constant political unrest for the past 20 years. HIV infection occurs primarily through heterosexual sex, and the prevalence is currently estimated at 3 percent in the adult population.

"Poverty, malnutrition, and tuberculosis present serious challenges to providing antiretroviral therapy in developing countries," says Dr. Pape. "In response to poverty, we have worked to integrate our antiretroviral-therapy program with existing social programs that help give patients access to free care, food, and clean water, and assist with transportation to and from the clinic. In response to malnutrition, we provided daily multivitamin supplements to all our patients who were receiving antiretroviral therapy and a monthly stock of rice, beans, and vegetable oil to the most undernourished patients. In response to tuberculosis, we provided tuberculosis treatment on-site at our clinic."

Continues Dr. Pape: "The single greatest logistical challenge was maintaining the supply of antiretroviral drugs. Delays in delivery resulted in a change in the antiretroviral-therapy regimen for 7 percent of our patients. Developing reliable manufacturing and distribution systems for antiretroviral drugs is an urgent international priority."

The study is one of the first to examine treatment outcomes of children with AIDS in a developing country. Dr. Peter Wright of Vanderbilt University was a co-author and lent the study his expertise in pediatric HIV care.

"There are a number of other intangible factors that significantly contributed to the successful implementation of this program, including continuity of leadership, international collaborations, and dedicated GHESKIO personnel," says Dr. Warren D. Johnson, co-author, chief of the Division of International Medicine and Infectious Diseases and B.H. Kean Professor of Tropical Medicine at Weill Cornell, and attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

Notably, the first--eight authors of the study, including the study's lead author, Dr. Patrice Severe, are Haitian physicians at GHESKIO and recipients of training from Weill Medical College of Cornell University. They also include Drs. Paul Leger, MacArthur Charles, Francine Noel, Gerry Bonhomme, Gyrlande Bois, Erik George, and Stefan Kenel-Pierre. Dr. Charles is an infectious-disease fellow and Dr. George is a pediatric infectious-disease fellow – both at Weill Medical College. Dr. Roy Gulick of Weill Cornell also co-authored the paper.

"The Haitian clinical team are heroes," says Dr. Fitzgerald. "They were on the front lines every day providing treatment to poor AIDS patients in the slums of Port-au-Prince, even during times of violent political unrest. This study documents the results of their hard work and dedication."

Additional funding for the study included the National Institute of Allergy and Infectious Diseases (NIAID) and Fogarty International Center – both part of the National Institutes of Health (NIH).