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Data From Landmark Study Evaluating Gender Differences in Response to an HIV Therapy Published in Annals of Internal Medicine
Date:9/20/2010

TITUSVILLE, N.J., Sept. 20 /PRNewswire/ -- Data from the GRACE (Gender, Race And Clinical Experience) study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment-experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies. The company has launched www.TheGraceStudy.com to share learnings from the GRACE study and other information for women living with HIV.

Among patients who completed the study, there were no significant differences in treatment responses between men and women who were given PREZISTA® (darunavir) 600 mg coadministered with 100 mg ritonavir twice daily, as part of combination therapy. The GRACE study was designed in partnership with the HIV community and used unique strategies to encourage women living with HIV to participate in the trial. However, even with its novel enrollment strategies, the study showed a higher discontinuation rate among female study participants — making the overall response rate lower among women than among men, and shedding light on the need for additional efforts to retain diverse populations in clinical studies.

"Better representation of women in clinical trials is essential for generating accurate information on the efficacy and safety of medicines and, ultimately, guiding treatment decisions," said Judith Currier, MD, Professor of Medicine, Associate Division Chief, Division of Infectious Diseases, University of California, Los Angeles, Director of the Clinical Trials Unit, UCLA Center for Clinical AIDS Research and Education (CARE), and primary inv
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SOURCE Tibotec Therapeutics
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