Background:  Both AIDS and non-AIDS events have significant clinical and quality of life consequences for HIV⁺ patients. In this study we evaluate the type, frequency and quality of life implications of such events in patients with advanced AIDS having few treatment options.

Methods:  OPTIMA is an ongoing trial of alternative treatment strategies in patients with advanced HIV disease (CD4 <300 cells/mL) and evidence of resistance to 3 classes of antiretroviral (ARV) medications. Three groups were identified:  AIDS-related events, non-AIDS-related serious adverse events, and a random control group having no serious clinical event. Using the Medical Outcomes Study HIV (MOS-HIV) quality of life instrument, both the physical health status and mental health status scores were calculated at baseline, pre-event, and post-event. Non-AIDS serious adverse effects coinciding with AIDS-related events and events with missing MOS-HIV data were excluded from the analysis. Student’s t-test was used to evaluate statistical differences between quality of life scores.

Results:  OPTIMA has enrolled 235 patients‑median CD4 = 115 cells/mm³, median follow-up = 11 months as of September 2003. Of 8 deaths, 6 were due to AIDS and 2 to non-AIDS causes. Of the reported 104 non-AIDS-related serious adverse events in 56 patients and 45 AIDS-related events in 35 patients, 66 events were evaluable. Mean pre-event scores and those from patients without events were similar to baseline scores for physical health status and mental health status (39.7 and 46.2, respectively). Compared with patients without events, physical health status scores declined with non-AIDS-related serious adverse events and mental health status scores declined for both non-AIDS-related serious adverse events and AIDS-related events (see the table). Physical health status and mental health status declines from pre-event to post-event status did not differ between AIDS events and non-AIDS-related serious adverse events. However, significant decrease occurred in physical health status among non-AIDS-related serious adverse events (-3.106, p = 0.009) and in mental health status among AIDS-related events (-5.524, p = 0.006) .

Mean Change in Pre-event vs Post-event PHS and MHS Scores

Conclusions:  In patients with advanced multi-drug resistant HIV, non-AIDS-related serious adverse events occurred more often than AIDS related events. The impact of non-AIDS events on quality of life is equal to or greater than AIDS events in this population.

Keywords: morbidity; drug resistance; disease progression