Date Published: August 28, 2011
Publisher: Hindawi Publishing Corporation
Author(s): Judith Feinberg, Michael Saag, Kathleen Squires, Judith Currier, Robert Ryan, Bruce Coate, Joseph Mrus.
Background. We report health-related QoL (HRQoL) from GRACE (Gender, Race, And Clinical Experience) study by sex and race over 48 weeks. Methods. 429 treatment-experienced adults (HIV-1 RNA ≥ 1000 copies/mL) received darunavir/ritonavir 600/100 mg twice daily plus an appropriate background regimen. QoL was measured by the Functional Assessment of HIV Infection (FAHI) questionnaire. Results. 67% women and 77% men, including 67.4% black, 76.0% Hispanic, and 73.8% white patients, completed the trial. Baseline total FAHI scores were similar between sexes and races. Total FAHI of the entire population improved by Week 4 (P < .05); near-maximum changes obtained by Week 12 were maintained through Week 48. Women and black patients demonstrated larger improvements in total FAHI versus men, and Hispanic and white patients, respectively. Conclusion. HRQoL improved in all sex and racial/ethnic groups. Sex-based and race-based differences in improvements in FAHI subscales may provide insight into subtle differences of HIV-1 and treatment on HRQoL in different populations.
Improvements in antiretroviral (ARV) therapy have increased the life expectancy of patients with HIV-1 infection, and HIV is now considered a manageable chronic disease . The maintenance of a high quality of life (QoL), as well as optimization of physical, emotional, and social health, is an important aspect of disease management for HIV-1–infected patients. Health-related quality of life (HRQoL) measures are used to quantify the physical and mental aspects of HIV-1 infection that can impact a patient’s overall well-being. Additionally, several studies have demonstrated a correlation between HRQoL and survival of HIV-1–infected patients [2–4], highlighting the need for monitoring and optimizing HRQoL. The GRACE (Gender, Race, And Clinical Experience) study was designed to investigate sex-based and race-based differences in outcomes with darunavir/ritonavir-(DRV/r-) based therapy in treatment-experienced patients. The primary outcomes of the GRACE study have been reported . Here, we report the HRQoL results from GRACE by sex and race over 48 weeks.
Many factors can impact the HRQoL of patients with HIV-1, including the tolerability of different ARV agents. Differences in safety/tolerability, pharmacokinetic parameters, and/or efficacy of ARVs could potentially contribute to sex-based or race-based differences in HRQoL scores. To date, studies investigating sex-based and race-based differences in HRQoL for HIV-1–infected patients have reported conflicting results [9–12]. In the GRACE study, HRQoL significantly improved for all participants. Near-maximal improvements were reached by Week 12 and were maintained through Week 48. When only patients who completed the trial were analyzed, similar improvements in total FAHI score over time were still seen, suggesting that the improvements in the overall population were not an artifact of patients with low HRQoL scores discontinuing the trial.
The sex-based and race-based differences in the improvements in total FAHI score and FAHI subscales may provide insight into the subtly different effects of HIV-1 infection and treatment on HRQoL in different populations. The data from GRACE on HRQoL by sex and race may provide valuable information into methods resulting in future optimization of treatments and retention in care for specific populations of HIV-infected patients.