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Clinical Results Show Integrating Medical Care With Community Supports Is Key To Successful Outcomes For HIV Patients In Resource-Limited Settings


WEBWIRE

TORONTO, CANADA (August 13, 2006) -- Twelve-month interim clinical data from a study in four sub-Saharan African countries show that HIV-positive patients who receive integrated medical care and broad-based community programs achieve and sustain good clinical outcomes. Researchers from SECURE THE FUTURE®, an initiative of Bristol-Myers Squibb and the Bristol-Myers Squibb Foundation to address HIV in Africa, including scaling up HIV/AIDS care and support in resource limited settings, presented the data today at the XVI International AIDS Conference.

“These data show not only that antiretrovirals (ARVs) can work even in remote, poverty stricken areas where healthcare and other resources are limited, but also that integrated social supports such as nutrition, psychosocial care, income generation and home-based care play a key role in achieving and sustaining good clinical outcomes,” said Sebastian Wanless, M.D., senior medical director of SECURE THE FUTURE. “The care model that we have implemented and are evaluating with our partners moves beyond a disease focused approach to also address social determinants of health that can limit the therapeutic benefit of HIV medicines.”

“This project is also going the extra step in conducting an independent evaluation of the community services in order to truly understand and describe their value to patients and their impact on achieving and sustaining outcomes,” said Walter Obiero, senior technical officer, Evaluation and Research Division of Family Health International.

An intent-to-treat analysis from the first 992 patients on ARV therapy at SECURE THE FUTURE’s Community-Based Treatment Support sites in South Africa, Namibia, Botswana and Lesotho - that is, an analysis of every patient in the study who received any ARV treatment, and the gold standard for clinical trial analysis - showed an overall efficacy of 64%, where efficacy is defined as a sustainable, greater-than-50 increase in CD4 count. The results also showed an increase in CD4 count to a median of 270 from a median of 105 before treatment was initiated. Viral load was undetectable in 92% of the 296 patients for whom viral load was tested, and adherence to medication was greater than 95% in 84% of the 522 patients for whom adherence was measured. Other successes are in the levels of HIV education and testing - including a 10-fold increase in the number of clients receiving voluntary testing and counseling since the program’s inception - and in community mobilization to fight the disease and overcome its associated stigma.

Preliminary data from the independent evaluation of the community services provided to 587 patients on ARVs showed that those who report that they are satisfied with the community services they receive have a better quality of life, lower perceived stigma, faster rate of increase and higher levels of CD4 cells than patients who are not satisfied. The findings were similar with respect to the level of satisfaction with family support offered at the four centers evaluated.

Specifically, a cohort of patients satisfied with community services reached a median CD4 T-cell level of 251 at six months vs. a median level of 216 for a cohort of patients who also received these services but reported that they were not satisfied with them. Those satisfied with family support reached a median of 232 at six months vs. a median of 198 for a like cohort of those not satisfied. It is generally held that a CD4 count of 200 or less is associated with a higher rate of opportunistic infections and other serious complications of HIV.

This research on the efficacy and feasibility of ARV treatment and on the comprehensive model of care in resource-limited settings is part of a SECURE THE FUTURE program with local governmental and NGO partners to scale up comprehensive HIV/AIDS care in Africa. To date more than 13,400 patients have enrolled in the treatment centers and programs in KwaZulu


Natal, South Africa; Maseru, Lesotho; Mbabane, Swaziland; Bobirwa Sub-District, Botswana; Caprivi Region, Namibia, and Koulikoro District, Mali. More than 5,700 patients are on ARV therapy and more than 7,700 are receiving services other than ARVs.

Community support services available at the Community-Based Treatment Support Centers include community mobilization efforts to reduce stigma about HIV/AIDS and to help at-risk people get tested; home-based care and support from volunteers; volunteers support groups that meet regularly to offer mutual support, including groups staffed by people living with HIV/AIDS; a “buddy system” to provide support and education on a one-to-one basis to people living with HIV/AIDS; food security and income generating activities and programs to train traditional birth attendants, traditional leaders, church leaders and to sensitize traditional healers.

SECURE THE FUTURE is a comprehensive public-private initiative to help alleviate the HIV/AIDS crisis among women and children in sub-Saharan Africa. Developed in 1999 by Bristol-Myers Squibb and the Bristol-Myers Squibb Foundation, the initiative combines multiple approaches to making a measurable impact in fighting HIV/AIDS where the needs of people infected with and affected by the disease are great and health care and other resources limited.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.



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