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Increased Quality of Life With Immediate ART Initiation: Results From the START Trial
Alan Lifson; Birgit Grund; for the INSIGHT START Quality of Life Study Group
Univ of Minnesota, Minneapolis, MN, USA
With HIV managed as a chronic illness, quality of life (QOL) is one important outcome in assessing HIV treatment strategies. Development of HIV-related illnesses or medication side effects can both affect QOL. The Strategic Timing of Antiretroviral Therapy (START) study randomized antiretroviral therapy (ART) naive participants with CD4 counts >500 cells/mm3 to starting ART immediately vs. deferring ART until CD4 counts declined to 350 cells or clinical disease required ART. We compared immediate vs. deferred ART groups for changes in QOL.
At baseline, Month 4, 12 and then annually, participants completed a visual analogue scale (VAS) for self-assessment of overall current health and the Short-Form 12-Item Health Survey version 2 (SF-12v2) with 4 week recall. We computed three QOL outcomes from SF-12v2: (1) General health perception (GHP); (2) Physical component summary (PCS), and (3) Mental component summary (MCS). All QOL outcomes are scaled 0-100 (higher score=better QOL). PCS and MCS scores are standardized to a mean=50 in a U.S. reference population. We compared immediate and deferred ART groups for QOL changes from baseline using longitudinal mixed models adjusted for visit and baseline QOL.
Of 4684 START participants, 4561 had both baseline and follow-up QOL data: median baseline CD4=651 cells, median age=36 years, 27% were female, and 46% from high-income countries. Mean QOL baseline scores (with standard deviation) were VAS=80.9 (15.7), GHP=72.5 (21.5), PCS=53.7 (7.2), MCS=48.2 (10.5). Mean follow-up time was 2.6 years. The immediate group spent 95% of follow-up time on ART vs. 28% for the deferred group. Throughout follow-up, all changes in QOL favored the immediate group; modest but significant differences were seen as early as 4 months with increases through 12 months (Fig. 1). Estimated treatment differences during follow-up were: VAS=1.9 (95% CI 1.2-2.5); GHP=3.6 (2.8-4.5); PCS=0.8 (0.5-1.1); MCS=0.9 (0.4-1.3) (p<0.001 for each QOL measure).
In this HIV-positive population with CD4 >500 cells/mm3 that was generally in good health, all QOL measures improved in the immediate compared to the deferred ART group. These findings provide further support to the superiority of early ART as reported for major clinical outcomes in the START study.