BEYOND

  • BEYOND Study Design

    Prospective, observational, real-world study of participants with HIV initiating CABENUVA across 27 US sites

    • Analyses based on 233 participants initiating CABENUVA and determined to be consistent with the indication
    • Of these, 160 had a baseline and post-baseline HIV-1 RNA between Months 12 and 24 available by the data cutoff (July 2024)
    Primary outcomes
    • Reasons for initiating CABENUVA
    • Demographic characteristics
    • Clinical characteristics of participants upon initiation
    Key secondary outcomes
    • Virologic outcomes, including suppression* and CVF
    • Discontinuation of CABENUVA

    Real-world studies are designed to complement clinical trial data, not definitively establish causality. Data may better reflect actual patient populations and clinical care. Data are susceptible to bias. Observational studies have the potential for missing, inaccurate, incomplete, or overlapping data.

    *Suppression defined as plasma HIV-1 RNA <50 copies/mL.

  • Adherence Results

    Through 2 years in the BEYOND real-world study, a post-hoc analysis revealed:

    • Adherence was assessed using the previous injection date as the basis for subsequent injection date and the ±7-day dosing window
    • A prespecified analysis was performed, which used the initial injection date as the basis for all future injection dates. In that analysis, 59% of injections were given within ±7 days of the target date, 30% early, and 11% late†
    • Counsel patients about the importance of continued medication adherence and scheduled visits

    These results are descriptive in nature and should not be used to infer clinical significance.

    *8 or more days before or after the Target Treatment Date.

    †Study sites were not given instruction on how to schedule injection visits.

See rates of real-world retention in care observed

Retention-in-care data

ART=antiretroviral therapy; CVF=confirmed virologic failure; M=month.

Reference:

  1. Blick G, Santiago-Colon L, Richardson D, et al. Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the 13th IAS Conference on HIV Science; July 13-17, 2025; Kigali, Rwanda, and virtually. EP1078.

PMUS-CBRWCNT250026