TOPLINE:

Among adults with HIV who had high CD4+ counts and low baseline cardiovascular risk, early initiation of antiretroviral therapy (ART) did not significantly reduce the risk for cardiovascular disease (CVD) compared with delayed initiation; however, women may have experienced some cardiovascular benefits.

METHODOLOGY:

• Researchers conducted an extended follow-up study of a trial to evaluate whether the initiation of ART worsens CVD outcomes in people living with HIV.
• They included 4684 ART-naive people living with HIV (median age, 36 years; 27% women) with CD4+ counts exceeding 500 cells per μL; participants were randomly assigned to receive either deferred ART (when CD4+ counts were < 350 cells per μL or upon disease progression) or immediate ART.
• The median time to ART initiation was 2.5 years in the deferred arm and 7 days in the immediate ART arm.
• Event rates for the composite CVD outcome, including myocardial infarction, stroke, coronary revascularization, or death from CVD-related causes, were compared between the two arms.

TAKEAWAY:

• Over the entire study period, event rates for the main composite CVD outcome were similar between the immediate and deferred ART arms (0.16-0.18 and 0.17 per 100 person-years, respectively; hazard ratio [HR], 0.98; 95% CI, 0.61-1.56).
• A benefit of immediate over deferred ART was observed in women (HR, 0.19; 95% CI, 0.04-0.86) but not in men (HR, 1.33; 95% CI, 0.79-2.24; interaction P = .014). However, the number of events among women was small.
• Coronary revascularization occurred more frequently in men, whereas strokes were more frequent among women.

IN PRACTICE:

“Acknowledging the very low numbers of events that occurred among female participants, our finding that immediate initiation of ART was associated with a reduction in CVD events among females warrants further evaluation,” the authors wrote.

SOURCE:

The study was led by Nila J. Dharan, PhD, Kirby Institute, UNSW Sydney, Sydney, Australia. It was published online on September 15, 2025, in Open Forum Infectious Diseases. 

LIMITATIONS:

The study was limited by a low number of CVD events, insufficient power to detect significant differences in CVD outcomes, potential underreporting of CVD-attributable deaths (as a notable proportion were classified as occurring due to an unknown cause), and limited generalizability to individuals with advanced immunosuppression or higher baseline cardiovascular risk.

DISCLOSURES:

The study was supported by multiple organizations, including the National Institute of Allergy and Infectious Diseases, the National Health and Medical Research Council, the National Research Foundation, and other organizations. Some authors declared receiving research support, funding, or grants from or served on advisory boards for various pharmaceutical companies. One author declared holding a US patent on Kaposi sarcoma treatment and has research agreements with NeoImmunoTech and Karius.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.