HIV treatment-experienced women and African Americans had greater improvements in quality of life than men, whites or Latinos after switching to a regimen that contained Prezista (darunavir). These new data from the GRACE study were presented at the 1st International Workshop on HIV and Women, held January 10 to 11 in Washington, DC, and reported by the National AIDS Treatment Advocacy Project (NATAP).

The purpose of the GRACE study was to determine whether the efficacy and safety of Prezista—in treatment-experienced patients—were equivalent across both gender and race. Unlike most antiretroviral (ARV) drug studies in the United States, more than two thirds of the GRACE participants were women and more than two thirds were black. Ultimately, GRACE found no significant differences based on gender, but black participants were less likely than white or Latino participants to maintain undetectable HIV levels over the course of the study—largely due to the fact, according to later analysis, that far fewer black participants were retained in the study.

Researchers in the GRACE study also conducted extensive questionnaires called the Functional Assessment of HIV Infection (FAHI), which is based on 47 questions concerning cognitive function and physical, emotional, functional and social well-being. FAHI scores range from a low of 0 to a high of 176. The current analysis focused on those measures.

The study's authors reported that quality of life increased dramatically for all participants after switching to a new regimen containing Prezista, with 30 percent gains by week four of the study and 70 percent gains by week 48.

Before people started treatment there were no differences in FAHI scores based on either race or gender. Over time, however, scores increased by a significantly higher degree in women compared with men (80 percent compared with 60 percent), and in black participants compared with either Latino or white participants (90 percent compared with 50 percent for Latinos and whites).

Other factors that predicted greater gains in quality of life included having a lower CD4 count, a lower FAHI score or a higher viral load, all before switching treatment. Two other factors that predicted increased quality of life were a history of psychiatric disorders and a better virologic response to treatment.

The authors conclude that although women and black participants were more likely to drop out of the trial, and black participants were less likely than Latino or white participants to maintain good virologic control, it is heartening to know that switching treatment can bring greater gains in quality of life to these two groups.