It starts with consistent efficacy and safety observed in real-world patients

BEYOND: Efficacy

BEYOND is an ongoing, 2-year, real-world study of adult participants switching to CABENUVA1,2

  • BEYOND Study Design

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

    BEYOND study design graphic
    Primary outcomes and key secondary outcome for patients in the BEYOND study
    • Analyses based on 233 participants initiating CABENUVA and determined to be consistent with the indication
    • Of these, 156 had a baseline and post-baseline HIV-1 RNA between Months 6 and 12 available by the data cutoff (September 2023)
    1. Suppression defined as plasma HIV-1 RNA <50 copies/mL.
    Primary outcomes and key secondary outcome for patients in the BEYOND study

  • BEYOND Baseline Characteristics

    Demographics and baseline characteristics of patients
initiating CABENUVA

    BEYOND study demographics and baseline characteristics chart
    1. Not mutually exclusive.
    2. Includes Native American, American Indian, or Alaska Native (n=13); Asian (n=5); Native Hawaiian or other Pacific Islander (n=2); a race not listed (n=24); prefer not to answer (n=8).
    3. Patients could switch dosing regimen after baseline.

BEYOND Efficacy

BEYOND reinforces the efficacy of CABENUVA through Month 12 analysis in real-world settings

All 233 participants initiated CABENUVA and were consistent with the indication.

  • Of these, 156 had a baseline and post-baseline HIV-1 RNA between Months 6 and 12 available
BEYOND study rate of maintaining virologic suppression chart
  • 2% (3/156) had an HIV-1 RNA ≥50 copies/mL

Cumulative CVFs Through Month 12 Analysis

BEYOND study confirmed virologic failure at Month 12 graphic

CVF was defined as 2 HIV-1 RNA measurements >200 copies/mL or 1 HIV-1 RNA >200 copies/mL plus discontinuation.

  • There were no new CVFs identified between Months 6 and 12
  • The 2 CVFs transitioned to oral, INSTI-based, single-tablet regimens
  1. Virologic suppression was defined as HIV-1 RNA <50 copies/mL.

BEYOND: Safety

  • BEYOND was not designed to solicit AEs; however, safety events become known through direct disclosure of AEs to site staff, periodic review of participants’ medical records to complete the eCRFs, or follow-up to certain responses to the participant survey. The most common AE reported was ISR
  • Rate of discontinuations due to ISRs at interim Month 12 analysis: 2% of patients (n=5/233)

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References:

  1. Schneider S, Sension M, Dretler A, et al. Clinical outcomes at Month 12 after initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Poster presented at: AIDS 2024; July 22-26; Munich, Germany. THPEB099.
  2. Data on file. ViiV Healthcare group of companies. Durham, NC.

PMUS-CBRWCNT240094