Timothy Brennan, MD, PhD

A. Start LAI ART in people with HIV (PWH) with detectable viremia if clinic attendance is expected to be high

B. Initiate LAI ART in PWH who are virologically suppressed on oral ART, who do not have known resistance to regimen components, and who have a plan for missed doses

C. Avoid LAI ART in PWH with prior ART failure, even if currently virologically suppressed

D. Require an oral lead-in for PWH to reduce injection reactions and prevent treatment failure

Timothy Brennan, MD, PhD

Timothy Brennan, MD, PhD

United States Food and Drug Administration

Silver Spring, MD, USA

March 10, 2026: Optimization of Long-Acting Injectable Antiretroviral Therapy