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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
K. Squires1, J. Currier2, D. Bridge3, D. Hagins4, C. Zorrilla5, R. Ryan6, R. Falcon7, A. Tennenberg7, J. Mrus7, on behalf of the GRACE Study Group
1Jefferson Medical College of Thomas Jefferson University, Philadelphia, United States, 2University of California, Los Angeles, School of Medicine, Los Angeles, United States, 3The Well Project, Inc., Atlanta, United States, 4Chatham County Health Department, Savannah, United States, 5University of Puerto Rico School of Medicine, San Juan, United States, 6Tibotec, Inc, Yardley, United States, 7Tibotec Therapeutics, Bridgewater, United States
Background: Women and people of color have been largely underrepresented in clinical trials of antiretrovirals in HIV. GRACE is a first-of-its-kind study focused on these populations.
Methods: This multicenter, open-label, phase IIIb study enrolled treatment-experienced adults with HIV-1 RNA ≥1000 copies/mL. Patients received darunavir/ritonavir 600/100mg bid plus an investigator-selected optimized background regimen consisting of commercially available NRTIs +/- NNRTIs (including etravirine). The primary objective was to evaluate sex differences in efficacy (HIV-1 RNA < 50 copies/mL) over 48 weeks. Virologic response is reported for intent-to-treat (ITT) and non-virologic failure (non-VF) censored populations using time-to-loss of virologic response (TLOVR) algorithm. Safety and tolerability were assessed.
Results: GRACE enrolled 67% women and 84% people of color.
[Table 1]
The difference in virologic response (women - men), adjusted for baseline HIV-1 RNA and CD4 count, was -9.6 (95% CI: -19.85, 0.68) for ITT-TLOVR and -3.9 (95% CI: -13.89, 6.02) for TLOVR-non-VF censored analyses, respectively.
Conclusions:
Experience with GRACE demonstrates that it is possible to enroll large numbers of women and people of color from North America in antiretroviral treatment trials. The higher rate of discontinuation among women, which was driven by reasons other than virologic failure, highlights the need for additional focus on retaining diverse populations in future trials. Through 48 weeks of therapy, there were no statistical differences in virologic response rates between women and men receiving darunavir/ritonavir, and no clinically relevant sex-based differences in AEs. AEs were generally comparable to those seen in previous studies of darunavir/ritonavir in treatment-experienced patients. Additional subgroup analyses, including race/ethnicity, are ongoing.
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