Health-Related Quality of Life in the Gender, Race, And Clinical Experience Trial
Author Information
Author(s): Judith Feinberg, Michael Saag, Kathleen Squires, Judith Currier, Robert Ryan, Bruce Coate, Joseph Mrus
Primary Institution: University of Cincinnati College of Medicine
Hypothesis
The GRACE study investigates sex-based and race-based differences in health-related quality of life (HRQoL) outcomes with darunavir/ritonavir therapy in treatment-experienced patients.
Conclusion
HRQoL improved in all sex and racial/ethnic groups, with notable differences in improvements among women and black patients.
Supporting Evidence
- 67% of women and 77% of men completed the trial.
- Total FAHI scores improved significantly by Week 4 and were maintained through Week 48.
- Women and black patients showed larger improvements in total FAHI scores compared to men and other racial groups.
Takeaway
This study shows that people with HIV can feel better over time when they get the right treatment, and that women and black patients felt the most improvement.
Methodology
The study was a 48-week, open-label, Phase IIIb trial measuring HRQoL using the FAHI questionnaire in treatment-experienced adults.
Potential Biases
Potential biases may arise from the higher discontinuation rates among women and black patients.
Limitations
The study's single-arm design limits conclusions about the relative effectiveness of darunavir/ritonavir compared to other treatments.
Participant Demographics
The study included 429 treatment-experienced adults, with 67% women, 61.5% black, 22.4% Hispanic, and 15.2% white.
Statistical Information
P-Value
<0.05
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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