October 16, 2008 -- A South African treatment study conducted by researchers in the Department of Epidemiology at the Mailman School of Public Health shows that mortality among TB-HIV co-infected patients can be reduced by a remarkable 55%, if antiretroviral therapy (ART) is provided with TB treatment at the same time. The randomized, known as the SAPIT (Starting Antiretrovirals at three Points in Tuberculosis) trial, randomly assigned TB-HIV co-infected patients to receive ART. Patients who received ART together with their TB treatment (integrated treatment arm) were compared with patients assigned to receive ART upon completion of TB treatment (sequential treatment arm).
"The study shows that integrating TB and HIV treatment and care saves lives," says Salim S. Abdool Karim, MD, PhD, professor of clinical Epidemiology at the Mailman School of Public Health and director of the Centre for the AIDS Program of Research in South Africa (CAPRISA), who led the SAPIT trial. The trial was conducted at the CAPRISA eThekwini TB-HIV Clinic which is attached to the largest TB clinic in Durban, South Africa. The study was initiated in June 2005 and completed enrollment of 645 patients with TB and HIV co-infection in July 2008. It is estimated that about 70% of all TB patients in South Africa are infected with HIV, or about 250,000 of the 353,879 TB patients diagnosed in 2007.
As a result of the higher mortality rate in patients in the sequential treatment arm versus the mortality rate for those patients in the integrated treatment arm, the study's independent Safety Monitoring Committee recommended in their review of the trial in September 2008 that the sequential arm of the trial be stopped and that ART be initiated in this group as soon as possible. The Committee further recommended that the two sub-groups within the integrated treatment arm (early TB-HIV treatment and post-intensive phase TB-HIV treatment) should continue as per protocol.
Dr. Peter Piot, executive director of UNAIDS, commented: "These important results show that a ''two diseases, one patient, one response" integrated approach to TB/HIV treatment avoids unnecessary deaths from TB, the leading cause of death in people living with HIV in Africa". TB is the most common disease occurring in the late stages of HIV infection in southern Africa. As a result, many people throughout southern Africa are first identified as HIV infected when they develop TB. The findings of the SAPIT study call for the accelerated implementation of routine HIV testing in TB treatment services.
The SAPIT trial results provide compelling evidence to support the World Health Organization's call for the greater collaboration between TB and HIV treatment services and provide empiric evidence of the benefits from the initiation of antiretroviral therapy in TB-HIV co-infected patients. Dr Paul Nunn, of the Stop TB Department at the World Health Organization commented, "The results to date clearly show the urgent necessity to make ART available to HIV infected patients with TB worldwide." In South Africa alone, it would result in an additional 100,000 to 150,000 TB patients being initiated on ART resulting in about 10,000 deaths being averted each year.
Ambassador Mark Dybul, Coordinator of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) said: "Scaling up collaborative TB/HIV activities is a priority for PEPFAR. We remain committed to increasing screening for both HIV and TB, which will allow greater numbers of patients to benefit from these study results."
The study was made possible through funding from the PEPFAR, the Global Fund to fight AIDS, TB and Malaria (GFATM), the US National Institutes of Health (NIH), the University of KwaZulu-Natal and CAPRISA.
About the Collaborative AIDS Program of Research in South Africa (CAPRISA)
CAPRISA's goal is to develop and undertake globally relevant and locally responsive research that contributes to understanding HIV pathogenesis and epidemiology as well as HIV/AIDS treatment and prevention. Under the leadership of Salim Abdool Karim, MD, PhD, CAPRISA has become an internationally renowned center of cutting edge HIV/AIDS and TB basic, clinical and epidemiological research. Headquartered in Durban, South Africa, CAPRISA is a unique model of collaboration between research centers from developed and developing countries, blending the strengths of its five collaborating partners: the Universities of KwaZulu-Natal, Cape Town and Western Cape and the National Institute of Communicable Diseases in South Africa, and the Department of Epidemiology at the Mailman School of Public Health.
About the Mailman School of Public Health
The only accredited school of public health in New York City, and among the first in the nation, Columbia University's Mailman School of Public Health provides instruction and research opportunities to more than 1000 graduate students in pursuit of masters and doctoral degrees. Its students and more than 300 multi-disciplinary faculty engage in research and service in the city, nation, and around the world, concentrating on biostatistics, environmental health sciences, epidemiology, health policy and management, population and family health, and sociomedical sciences. www.mailman.columbia.edu