Abstract:
OBJECTIVE: To determine if immediate compared to deferred initiation of antiretroviral therapy (ART) in healthy persons living with HIV (PLWH) had a more favorable impact on health-related quality of life (QOL), or self-assessed physical, mental and overall health status. DESIGN: QOL was measured in START (Strategic Timing of Antiretroviral Therapy), which randomized healthy ART naive PLWH with >500 CD4+ cells/mul from 35 countries to immediate versus deferred ART. METHODS: At baseline, months 4 and 12, then annually, participants completed a visual analogue scale (VAS) for "perceived current health" and the Short-Form 12-Item Health Survey version 2 from which were computed: (1) General health (GH) perception; (2) Physical Component Summary (PCS), and (3) Mental Component Summary (MCS); the VAS and GH were rated from 0 = lowest to 100 = highest. RESULTS: QOL at study entry was high (mean scores: VAS = 80.9, GH = 72.5, PCS = 53.7, MCS = 48.2). Over a mean follow-up of 3 years, changes in all QOL measures favored the immediate group (p < 0.001); estimated differences were: VAS = 1.9, GH = 3.6, PCS = 0.8, MCS = 0.9. When QOL changes were assessed across various demographic and clinical subgroups, treatment differences continued to favor the immediate group. QOL was poorer in those experiencing primary outcomes; however, when excluding those with primary events, results remained favorable for immediate ART recipients. CONCLUSIONS: In an international randomized trial in ART-naive participants with >500 CD4+ cells/mul, there were modest but significant improvements in self-assessed QOL among those initiating ART immediately compared to deferring treatment, supporting patient-perceived health benefits of initiating ART as soon as possible after an HIV diagnosis.
