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, PCS53.7, 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.
Bibliographical noteFunding Information:
We thank all participants, investigators, and funders who made the START study possible. The START trial was designed and conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), funded by NIH Grants UM1-AI068641 and UM1-AI120197. Antiretroviral drugs were donated to the central drug repository by AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmith-Kline/ViiV Healthcare, Janssen Scientific Affairs, and Merck. The funders did not contribute to the study design, data analysis, or content of the manuscript. Author contributions: A.L. and B.G. were lead on planning and overseeing this analysis and writing of the manuscript, with assistance from N.E., E.G., E.D. and other co-authors. All co-authorswere involved in helping to develop the study design and interpret study results. B.G. and N.E. performed the statistical analysis, and prepared figures and tables. A.L., B.G., N.E., and E.D. represented the START Statistical and Data Management Center. E.G., R.K., C.C., F.C., S.D., E.F., J.S., and S.E. represented the International Coordinating Centers and local sites where data collection and follow-up of study participants occurred. All co-authors reviewed interim drafts of this manuscript, and approved the final version. Research reported in this publication was supported by the National Institute of Allergy and Infectious Disease of the National Institutes of Health under Award Numbers UM1AI068641 and UM1AII20197.
- Antiretroviral therapy
- Clinical trial
- Mental health
- Quality of life