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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

60;Trial sites were selected to correspond with the geographic distribution of women with HIV, with the majority of sites located in the Northeastern (16 sites) and Southeastern (29 sites) United States.  Study sites were initially required to enroll three women before enrolling a man, and thereafter, each site was required to maintain at least 70 percent female enrollment. Men could only be enrolled if their addition did not compromise the 70 percent female quota.

GRACE participants also received 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.

At the end of the study period, there were no statistically significant differences in virologic response (defined as a viral load of <50 copies/mL) rates between women and men. Results from an intent-to-treat time-to-loss of virological response analysis (ITT-TLOVR) showed that 50.9 percent of women reached an undetectable viral load (<50 copies/mL) at week 48 compared with 58.5 percent of men (p=not significant). These figures included men and women who had discontinued the study. When treatment discontinuations for reasons other than virologic failure were discounted, 73 percent of women and 73.5 percent of men reached an undetectable viral load (p=not significant).

Discontinuation rates driven by reasons other than virologic failure were 32.8 percent for women versus 23.2 percent for men.  Loss to follow-up was the most common reason for discontinuation. There were no clinically relevant differences in safety or tolerability between women and men. In adult patients receiving a PREZISTA/r-containing regimen, the most common treatment-related adverse events (≥ 2 percent) reported of at least moderate to severe intensity (≥ Grade 2) w
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SOURCE Tibotec Therapeutics
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