Improved quality of life with immediate versus deferred initiation of antiretroviral therapy in early asymptomatic HIV infection

Abstract

Objective: To determine if immediate compared to deferred initiation of antiretroviral therapy (ART) in healthy persons living with HIV 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 the Strategic Timing of Antiretroviral Therapy study, which randomized healthy ART-naive persons living with HIV with CD4 cell counts above 500 cells/μl from 35 countries to immediate versus deferred ART.

Methods: At baseline, months 4 and 12, then annually, participants completed a visual analog scale (VAS) for 'perceived current health' and the Short-Form 12-Item Health Survey version 2 from which the following were computed: general health perception; physical component summary (PCS); and mental component summary (MCS); the VAS and general health were rated from 0 (lowest) to 100 (highest).

Results: QOL at study entry was high (mean scores: VAS = 80.9, general health = 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 as follows: VAS = 1.9, general health = 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.

Conclusion: In an international randomized trial in ART-naive participants with above 500 CD4 cells/μl, 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.

Figure 1

Number of participants enrolled in the START study who were included in the quality of life primary analysis, by ART treatment arm.

Figure 2

Change from baseline in four quality of life outcomes, for the immediate and deferred ART groups in the Strategic Timing of Antiretroviral Therapy trial. (A) Current health visual analogue scale (VAS), (B) General health perception, (C) Physical component score (PCS), (D) Mental component score (MCS). General Health, PCS and MCS are derived from the SF-12v2 survey. Footnote: The treatment groups were compared by intent-to-treat, using t-tests for changes from baseline to individual visits, and using longitudinal mixed models for changes from baseline through follow-up. The longitudinal models included baseline QOL, visit and treatment group indicators as independent variables.

Figure 3

Subgroup analyses for changes in current health (Visual Analogue Scale), Strategic Timing of Antiretroviral Therapy trial Footnotes: 1) Estimates within each subgroup were calculated using longitudinal mixed models that contained visit, baseline QOL and treatment group indicator. An interaction p-value ≤ 0.05 is evidence for heterogeneity in the treatment effect across the subgroups; the estimates and p-values for the interaction between the treatment group indicator and the participant characteristic defining the subgroups were calculated using longitudinal mixed models that contained baseline QOL, visit, and subgroup and treatment group indicators. For subgroups that were formed by discretizing continuous variables (e.g., age), the interaction effect was estimated using the continuous variable. 2) Additionally, subgroups by ART type were analyzed for participants whose pre-specified ART regimen contained (or did not contain) protease inhibitors (17.6% of participants), or tenofovir (88.4%). Treatment effects were homogeneous across these subgroups.