The COMEBACK Study: Social Determinants of Health Impact on Virologic Suppression in a 48-Week Low-Barrier-Care Study of Rapid Antiretroviral Therapy Reinitiation Among Persons with HIV Lost-to-Care

Background Effectively preventing transmission is critical to ending the HIV epidemic (EHE). The primary objective of the COMEBACK study, a 48-week single-center study, was to reengage lost-to-care persons with HIV and rapidly reinitiate antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alefenamide (B/F/TAF) in a low-barrier-care model to promote virologic suppression (VS). Methods Adults off ART ≥2 weeks, without significant B/F/TAF resistance or renal impairment, were started on B/F/TAF upon reengagement after same-day baseline labs (N=100). Participants self-screened into case-management (CM) tiers: minimal, moderate, or advanced. Participants requiring additional support (tier escalation) were identified during the study. The associations of baseline characteristics and five social determinants of health (SDoH) assessments with VS status at study end were analyzed. Results At baseline, median age was 37 years, with 90% Black and 68% cisgender male. Median CD4+ was 310 cells/mm3, with median viral load 11,084 copies/mL (16% VS). Median time off ART was 5 months. Fifty-nine of 100 participants required tier escalation. Sixty-six of 100 participants were retained-in-care at 48 weeks, with VS (HIV-1 RNA <200 copies/mL) in 54% of the intent-to-treat population and 82% (n=54/66) of the observed population. One SDoH (adherence concerns) was significantly associated with non-VS. No resistance to B/F/TAF was detected through 48 weeks. Conclusion VS was high for participants with rapid ART reinitiation retained-in-care. CM escalation and baseline adherence concerns were associated with non-VS at study end. Achieving VS among high-risk populations disenfranchised from care will likely require further innovation in intense individualized CM and retention approaches to capitalize on low-barrier-care models toward EHE.