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Tibotec Therapeutics Launches GRACE Campaign for Women and People of Color Living With HIV/AIDS

Wednesday, December 2, 2009 General News J E 4
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BRIDGEWATER, N.J., Dec. 1 Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that it is launching a new initiative to raise awareness of issues affecting women and people of color living with HIV/AIDS. Through a comprehensive campaign including local educational events, media outreach and a new Web site, www.TheGraceStudy.com, the company is sharing learnings from the GRACE study, the largest clinical trial in North America among women with HIV who had previously taken HIV medications. GRACE, which stands for Gender, Race And Clinical Experience, examined differences in response to an HIV medication in combination with other HIV medications.

(Logo: http://www.newscom.com/cgi-bin/prnh/20091201/CG18505LOGO)

The GRACE campaign will include perspectives from study participants, physicians, and advocates. Campaign materials, which will be available in English and Spanish, and supporting activities will address the unique design of the GRACE study and the novel recruitment and retention strategies that were used to encourage women and people of color to enroll and stay in the trial. These novel strategies and the study findings have important implications for the long-term care of women and people of color living with HIV.

"The GRACE study not only provides a new model for HIV research, it also has implications for the care of women and people of color living with HIV," said Dawn Averitt Bridge, Founder and Chair of The Well Project, and a paid consultant on the GRACE study. "GRACE proves that women and people of color can and will participate in clinical trials if they are designed and supported in the right way, and these strategies and support techniques can be applied to the everyday care of people living with HIV."

In the United States, HIV/AIDS is on the rise among women and people of color. Today, women account for more than one-quarter of all new HIV/AIDS diagnoses, and African-American and Latina women represent 79 percent of women living with the disease. Overall, 65 percent of people living with HIV in the United States are people of color. Despite these staggering statistics, women and people of color are under-represented in clinical treatment studies, often due to barriers such as availability of child care, lack of transportation, financial burden, and stigma.

The GRACE study enrolled 67 percent women and 84 percent people of color, despite the fact that these groups are typically less likely to participate in clinical trials. The study was designed in partnership with the HIV community and used unique strategies to encourage women and people of color living with HIV to participate in the trial. For example, GRACE participants could receive support to cover costs associated with study participation, including assistance for travel, childcare and food vouchers, and study sites could access grants for patient support activities such as lunch-and-learn sessions and patient support groups for ongoing education and camaraderie.

"The GRACE trial was made possible through widespread collaboration between Tibotec Therapeutics and the HIV community, providing an example of what needs to be done to truly address disparities in HIV care," said Glenn Mattes, President of Tibotec Therapeutics. "Individuals who participated in GRACE have played a historic role in advancing the understanding of HIV treatment in women and people of color."

GRACE Study Design

GRACE (Gender, Race And Clinical Experience) compared gender differences in the efficacy, safety, and tolerability of PREZISTA (600 mg with 100 mg ritonavir twice daily) in combination with other HIV medications over 48 weeks in HIV-1-infected women and men who have previous treatment experience.

What the HIV Community Can Learn from GRACE

The GRACE study showed that successful management of HIV comes from a combination of support and appropriate treatment. People who are living with HIV can develop a strong network of support by:

For more information about the GRACE study, local GRACE events, and information for people living with HIV, visit www.TheGraceStudy.com.

Selected Important Safety Information

Please see additional Safety Information below

About PREZISTA

PREZISTAŽ (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

PREZISTA is always taken with and at the same time as ritonavir (NorvirŽ), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA should also be taken with food.

PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Please read Important Safety Information below, and talk to your healthcare professional to learn more about PREZISTA.

Important Safety Information

This is not a complete list of all adverse drug reactions reported with the use of PREZISTAŽ. Please see full Prescribing Information for more details. Full prescribing information is also available at www.PREZISTA.com.

About Tibotec Therapeutics

Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.

-- Identifying friends and family members who will offer encouragement and care-- Drawing on the support of others living with HIV, either on a one-on- one basis or by joining a support group for people living with HIV-- Tapping into local HIV/AIDS service organizations and community groups for information and a broad range of assistance and services-- Partnering with their health care providers to understand their treatment options and take an active role in managing their disease

SOURCE Tibotec Therapeutics
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