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With preliminary results from a study in Botswana, Harvard School of Public Health researchers have found that people with HIV-1 subtype C in resource-poor settings, who receive antiretroviral (ARV) therapy, can achieve comparable results to those in the developed world. A fully supported health care delivery system and infrastructure help ensure this success, according to data published in November 2005 issue of the Journal of Acquired Immune Deficiency Syndromes (JAIDS).

More than 95 percent of HIV-infected people live in resource-poor nations -- and only a fraction of the people have access to the potentially lifesaving treatment. This study evaluated the effectiveness of combination ARV treatment in decreasing HIV disease and death. With more than one year of follow-up for clinical and laboratory outcomes and two years of follow-up for survival estimates, the majority of enrolled patients on ARV treatment experienced favorable clinical outcomes, including improved CD4 counts, decreased viral load and weight gain comparable with other successful care and treatment programs in the developed world.

"This data confirms what we are starting to see throughout the developing world. Patients will do fine regardless of social and economic status, provided the necessary infrastructure and funding are in place," said Richard Marlink, M.D., senior author of the article and professor in the Department of Immunology and Infectious Diseases at Harvard School of Public Health (HSPH).

The clinical data was collected from a public-private partnership between the Botswana-Harvard School of Public Health AIDS Initiative Partnership for HIV Research and Education (BHP) and the Infectious Disease Care Clinic (IDCC) at Princess Marina Hospital and funded through Bristol-Myers Squibbs' Secure the Future initiative. Initiated in April 2001, this public sector treatment program led to the development of the Botswana's national program and provided the first clinica l outcomes data among ARV-treated adults in Botswana.

"These results underscore the importance of monitoring not only clinical outcomes, but also ARV drug tolerability and toxicity as well," said William Wester, M.D., lead author of the article and research associate, Department of Immunology and Infectious Disease at HSPH. "Patients will respond to ARV therapy, but especially early on in their ARV treatment course, drug toxicity may significantly affect ones' quality of life and drug adherence rates." Results from the study have led to changes in the drug regimen to improve patients' drug adherence and prognosis.

In addition to creating the first public sector ARV clinic, Harvard has used the grant received in 2000 through the Secure the Future program to:

Ø Help build the initial HIV Reference Laboratory in Botswana; and

Ø Initiate the groundbreaking "Adult Antiretroviral Treatment and Drug Resistance Study to examine the three main reasons patients fail ARV therapy: drug resistance, tolerability and adherence. This study is also called the "Tshepo" Study, "Tshepo" is the word for "hope" in Setswana. This study was recently extended through 2007, making it the largest and longest running adult ARV treatment research study in the region.



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