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 for ≥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 5 social determinants of health (SDoH) assessments with VS status at study end were analyzed. Results: , with a median viral load of 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. Conclusions: 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.