Effects of etravirine versus placebo on health-related quality of life in treatment-experienced HIV patients as measured by the functional assessment of human immunodeficiency virus infection (FAHI) questionnaire in the DUET trials

Purpose: To study the effects of etravirine versus placebo on the health-related quality of life (HRQL) of HIV-infected patients.Method: HRQL of HIV-infected patients was measured using the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) questionnaire in two identically designed phase III clinical trials investigating efficacy and safety of etravirine as part of highly active antiretroviral therapy. Pooled analyses of covariance, adjusted for treatment group, baseline FAHI score, CD4 cell count, viral load, and enfuvirtide use helped investigate changes in FAHI scores between baseline and Week 24 in etravirine-treated (n = 599) and placebo-treated (n = 604) subjects. Responder analyses were also conducted.Results: Significant improvements with etravirine treatment were observed for FAHI physical, functional, emotional, and total scores (P < .001). These improvements were greater and statistically different from those with placebo (.013 <P < .033). Baseline FAHI scores were significantly linked to changes in FAHI scores, and CD4 cell count had a significant but small effect on changes in FAHI total and social scores. Predicted percentages of responders were slightly but not significantly higher for etravirine than for placebo (24%-42% vs 23%-40%, respectively, for FAHI total score).Conclusion: At 24 weeks, etravirine in combination with other antiretroviral agents demonstrated incremental improvements in HRQL compared to placebo.