Impact of indinavir on the quality of life in patients with advanced HIV infection treated with zidovudine and lamivudine

Objective. In AIDS Clinical Trial Group (ACTG) study 320, triple-combination antiretroviral therapy including indinavir significantly slowed progression to acquired immunodeficiency syndrome or death, compared with treatment with dual nucleoside reverse-transcriptase inhibitors (NRTIs) alone, in zidovudine-experienced patients with advanced human immunodeficiency virus (HIV) infection. We examined the impact of indinavir on quality of life in participants from this study. Methods. A total of 1156 protease inhibitor- and lamivudine-naive patients stratified by CD4 cell count (≤50 and 51-200 cells/mm³) were randomized to receive zidovudine (or stavudine) and lamivudine, with or without indinavir. Health-related quality of life was measured using the ACTG QoL601-602 questionnaire, which assesses general health status measured on a visual analogue scale and 8 specific health-related domains. Quality-adjusted survival time was estimated using the visual analogue scale for general health. Results. Mean changes in general health scores after 24 weeks were +2.9 in the triple-therapy group versus -0.2 in the dual-therapy group (P = .018). By week 24, scores in all specific domains were higher with triple-drug therapy than dual-drug therapy, with statistically significant differences in role function, energy, and pain scores. Benefits of triple-drug therapy were largely confined to patients with CD4 cell counts of ≤550 cells/mm³. Quality-adjusted survival time did not differ significantly between the 2 treatment groups. Conclusions. Triple-drug therapy with indinavir and 2 NRTIs resulted in a significant improvement in general health status after 24 weeks, especially in patients with low CD4 cell counts. Patients receiving triple-drug therapy also had significantly better role function, energy, and pain scores than did patients treated with dual-drug therapy.