New York, NY - Sept. 2, 2010 – Prompted by clinical research into the early initiation of antiretroviral therapies for HIV performed at the GHESKIO clinic in Port-au-Prince, Haiti, the World Health Organization (WHO) has revised its treatment protocols for HIV patients.
Final results from the four-year study, led by Weill Cornell Medical College's infectious and tropical disease experts, were published in the July 15 issue of the New England Journal of Medicine.
The research indicates that rather than waiting until a patient's CD4+ T cells fall below the 200 cells per cubic millimeter threshold, as the previous WHO guidelines suggested, immediately initiating antiretroviral therapy (ART) greatly improved the efficacy of those medications. The study also linked early intervention with a decreased rate of incident tuberculosis, a leading cause of death among HIV patients in resource-poor countries.
"Beginning antiretroviral therapy before T-cell counts drop to 200 will save lives. In developed countries, HIV has, in recent years, become a manageable, chronic disease rather than the death sentence it was just a decade ago. These results further strengthen the assertion that the right therapies, initiated as soon as possible, can hold the virus at bay," says Dr. Warren Johnson, study co-author and director the Center for Global Health and the B.H. Kean Professor of Tropical Medicine at Weill Cornell Medical College.
In December 2009, seven months after the researchers concluded their data gathering, the World Health Organization and the United States Department of Health and Human Services both updated their HIV treatment recommendations to reflect the GHESKIO conclusions: that for HIV-1-infected patients, ART is best initiated at a CD4 count of 350 or lower.
Between 2005 and 2008, the investigators recruited 816 HIV-1-infected patients at the GHESKIO clinic. All had CD4 counts between 200 and 350, had no history of AIDS illness, and had never received ART, a drug cocktail that works by inhibiting the enzyme that enables HIV to hijack healthy cells and replicate. The cocktail in this case comprised zidovudine, lamivudine and efavirenz. Study participants were randomly divided into two groups; those in the first group began ART immediately, and those in the second (control) group received ART only when their CD4 counts measured 200 or lower -- standard treatment protocol. Of the 408 subjects in the control group, 160 reached that point and received ART during the study.
"Clinical evidence has long shown that HIV patients become vulnerable to life-threatening illness long before their CD4 count hits 200, but no one had yet definitively established that ART is effective before that crucial number," says Dr. Patrice Severe, study lead author and graduate student in the Weill Cornell Medical College Program in Clinical Epidemiology and Health Services Research. "Because antiretroviral medications are prone -- much like antibiotics -- to eliciting drug resistance in the target disease, establishing that evidence was essential. The GHESKIO study has filled that gap."
Along with Drs. Johnson and Severe, the paper's authors include Drs. Daniel W. Fitzgerald, Roy M. Gulick, Jean W. Pape, Heejung Bang and Ms. Alison Edwards -- all from Weill Cornell; Drs. Marc Antoine Jean Juste, Alex Ambroise, Ludger Eliacin, Claudel Marchand and Ms. Sandra Apollon -- all from GHESKIO; Ms. Janet Nicotera, Vanderbilt University, Nashville; and Dr. Catherine Godfrey, National Institute of Allergy and Infectious Diseases, Bethesda, Md.
Founded in 1982, GHESKIO (Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, or the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections) is a nongovernmental research and training center internationally recognized for its pioneering work in the treatment of HIV and AIDS-related illnesses. GHESKIO maintains a close relationship with Weill Cornell Medical College. Its founding director, Dr. Jean Pape, is a professor of medicine at Weill Cornell Medical College. Since its inception, GHESKIO has never closed its doors to patients, not even during the recent 7.0 magnitude earthquake that struck Haiti.
Weill Cornell Medical College
Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances -- including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston, making Weill Cornell one of only two medical colleges in the country affiliated with two U.S.News & World Report Honor Roll hospitals. For more information, visit www.med.cornell.edu.