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Women Report Better Quality-of-Life Gains
Than Men in GRACE Trial of Darunavir
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1st International Workshop on HIV and Women, January 10-11, 2011, Washington, DC
Mark Mascolini
Women reported greater health-related quality-of-life (QOL) improvements in the GRACE trial than men did [1]. And blacks experienced better QOL gains than whites or Hispanics in this 48-week trial of darunavir/ritonavir in a diverse, mostly US population including high proportions of women and blacks.
GRACE was an open-label, single-arm trial of twice-daily darunavir/ritonavir plus an investigator-selected background regimen for adults with a viral load of at least 1000 copies while taking a regimen including a protease inhibitor or a nonnucleoside [2]. No study participants had taken darunavir, etravirine, enfuvirtide, or tipranavir.
Two thirds of enrollees (67%) were women, 62% were black, 22% Hispanic, and 15% white. A lower proportion of women than men (67% versus 77%) completed the trial, and a lower proportion of blacks (67.4%) than Hispanics (76%) or whites (73.8%) finished the study [2]. An intention-to-treat analysis indicated that 50.9% of women and 58.5% of men had a viral load below 50 copies at week 48. The proportion of black responders (48.5%) was lower than proportions of Hispanic (61.5%) or white (60%) responders. A time to loss of virologic response analysis that excluded nonvirologic failures found a similar 48-week response rate between women (73%) and men (73.5%). But blacks still had a lower response rate in this analysis (68.8%) than did Hispanics (79.7%) or whites (78%).
The QOL study used the Functional Assessment of HIV Infection (FAHI) score, which is based on 47 questions concerning cognitive function and physical, emotional, functional, and social well-being [1]. FAHI scores range from a low of 0 to a high of 176. All study participants completed the questionnaire before starting the trial and at weeks 4, 12, 24, and 48, or at withdrawal if they left the study early.
FAHI scores in the overall population improved almost 30% by week 4, then jumped to about a 70% improvement at week 12 and stayed that high through week 48. These changes from the prestudy score were statistically significant (P < 0.05). Average study entry scores were similar for women (116.8) and men (120.8). But compared with men, women had greater FAHI gains at weeks 4, 12, 24, and 48 (about 80% improvement at week 48 versus about 60% in men). After week 4, gains were significant for both women and men when compared with starting values.
Before the study began, blacks, Hispanics, and whites averaged similar FAHI scores (119.5, 114.1, and 119.5). Throughout the study, FAHI scores improved in all three groups. At week 48 the score had risen almost 90% in blacks versus about 50% in Hispanics and whites.
People with low pretreatment FAHI scores were significantly more likely to drop out of GRACE than people with higher scores (P = 0.044). To determine whether these dropouts had a significant impact on FAHI changes during the trial, the investigators performed a sensitivity analysis in which they excluded patients who left the study. After this adjustment, overall FAHI scores improved about as much through 48 weeks as they did in the unadjusted analysis.
A multivariate analysis to isolate factors associated with improved FAHI scores included five variables that met a threshold of P < 0.10 in univariate analysis: baseline FAHI score, confirmed virologic response, baseline viral load, baseline CD4 count, and history of psychiatric disorders. Neither gender nor race met the univariate cutoff. The multivariate analysis identified four variables independently associated with an improved FAHI score at week 48: lower baseline FAHI score (P < 0.0001), confirmed virologic response (P = 0.0045), lower baseline CD4 count (P = 0.0077), and analysis time point (P = 0.0002), which reflected the FAHI score improvement from baseline to week 4, the improvement from week 4 to week 12, and the relatively stable score after that.
Neither gender nor race emerged as an independent predictor of improved FAHI score in the multivariate analysis. Still, GRACE showed that both women and blacks experienced significant early and sustained improvements in quality of life after starting darunavir, even though those groups had higher dropout rates and lower virologic response rates in the primary virologic analysis.
References
1. Feinberg J, Saag M, Currier J, Squires K, Ryan R, Mrus J. Association of sex and race with health-related quality of life in patients treated with darunavir/ritonavir-based therapy in the GRACE trial. 1st International Workshop on HIV and Women. January 10-11, 2011. Washington, DC. Abstract O_14.
2. Currier J, Averitt Bridge D, Hagins D, et al. Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial. Ann Intern Med. 2010;153:349-357.
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