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| |  Treatment of HIV With Darunavir Appears as Successful in Treatment-Experienced Men as in Women: Presented at IAS By Ed Susman CAPE TOWN, South Africa -- July 21, 2009 -- The potent protease inhibitor darunavir, boosted with ritonavir, works as well in treatment-experienced women as in men to suppress HIV to undetectable levels, researchers reported here at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. In a presentation here on July 20, researchers noted that about two-thirds of the patients recruited into the Gender, Race and Clinical Experience (GRACE) study were women. The results of the trial demonstrated that through 48 weeks of therapy, there were no statistically significant differences in virologic response rates between treatment-experienced women and men receiving darunavir 600 mg boosted with ritonavir 100 mg and other antiretrovirals. In addition, there were no clinically relevant sex-based differences in adverse events. "GRACE not only showed us that darunavir/ritonavir had similar efficacy and tolerability in treatment-experienced men and women, but it also taught us that through unique recruitment and retention strategies, a large number of women and people of colour can enrol and stay in HIV clinical trials," said Kathleen Squires, MD, Division of Infectious Diseases, Thomas Jefferson University, Philadelphia, Pennsylvania. "GRACE has the potential to shape how future HIV studies should be conducted because it addressed head-on the social and economic barriers, such as lack of support, stigma, availability of child care and lack of transportation, which often have prevented women and people of colour from participating in HIV clinical studies and remaining in care," said Dr. Squires. The open-label, postmarketing study compared gender differences in the efficacy, safety, and tolerability of darunavir/ritonavir among treatment-experienced women and men. The trial enrolled 287 women and 142 men. Results from an intent-to-treat time-to-loss of virological response analysis showed that 51% of treatment-experienced HIV-1 infected women reached an undetectable viral load using the <50-copies/mL assay at week 48, compared with 59% of men. The difference did not reach statistical significance. The average age of the women in the trial was 41.7 years compared with 45.2 years for the men. About two-thirds of the women were black compared with 51.35 of the men. More women than men were noncompliant with treatment or withdrew from the trial. However, virologic failure was less then 3% for both sexes. Funding for this study was provided by Ortho Biotech Services. [Presentation title: GRACE (Gender, Race, and Clinical Experience): 48-Week Results of Darunavir/r-Based Therapy in the Largest Trial in North America Focused on Treatment-Experienced Women. Abstract MOPEB042]
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