BEYOND

EFFICACY

A 2-year, real-world study of adult participants switching to CABENUVA1,2

  • 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
    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.

  • BEYOND Baseline Characteristics

      CABENUVA
    (n=233)
    Age
    Mean (SD), years
    ≥50, %
    45.8 (12.9)
    38
    Sex assigned at birth, %
    Male
    Female
    88
    12
    Race (self-identified by participant), %*
    White
    Black or African American
    Other race    		 49
    39
    26
    BMI, median (range),
    kg/m2    		 27.8 (16.9, 57.5)
    Years since initiation of first ART
    Median (range)    		 n=229
    10.3 (0.1, 35.7)
    Top 3 ART regimens before CABENUVA initiation, %
    BIKTARVY
    DOVATO
    TRIUMEQ    		 37
    10
    13
    Initiation of CABENUVA, %
    Oral lead-in use
    No oral lead-in    		 76
    24
    Initial CABENUVA injection schedule, %†
    Monthly
    Every 2 months    		 50
    50
    Receiving Q2M injection at 24 months, % 98
      CABENUVA
    (n=233)
    Age
    Mean (SD), years
    ≥50, %
    45.8 (12.9)
    38
    Sex assigned at birth, %
    Male
    Female
    88
    12
    Race (self-identified by participant), %*
    White
    Black or African American
    Other race    		 49
    39
    26
    BMI, median (range),
    kg/m2    		 27.8 (16.9, 57.5)
    Years since initiation of first ART
    Median (range)    		 n=229
    10.3 (0.1, 35.7)
    Top 3 ART regimens before CABENUVA initiation, %
    BIKTARVY
    DOVATO
    TRIUMEQ    		 37
    10
    13
    Initiation of CABENUVA, %
    Oral lead-in use
    No oral lead-in    		 76
    24
    Initial CABENUVA injection schedule, %†
    Monthly
    Every 2 months    		 50
    50
    Receiving Q2M injection at 24 months, % 98

    *Not mutually exclusive.

    †Patients could switch dosing regimen after baseline.

  • BEYOND Efficacy Results

    Durable efficacy observed through Month 24 analysis in real-world settings1,2

    BEYOND, a real-world study of patients receiving CABENUVA (N=233), observed high rates of viral suppression through Month 24:*

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

    Real world studies are designed to evaluate associations among variables and not to definitively establish causality. These results are descriptive.
    • At year 1, 2% (3/156) had an HIV-1 RNA ≥50 copies/mL
    • At year 2, 3% (5/160) had an HIV-1 RNA ≥50 copies/mL

    *Virologic suppression was defined as HIV-1 RNA <50 copies/mL.

    †Two CVFs occurred in the first 6 months and were transitioned to oral INSTI-based single-tablet regimens.

    ‡156 individuals had a baseline and post-baseline HIV-1 RNA between Months 6 and 12 available.

    §160 individuals had a baseline and post-baseline HIV-1 RNA between Months 12 and 24.

    Resistance rates seen in clinical trials

    Explore CVF

BEYOND

SAFETY

BEYOND was not designed to solicit AEs; however, safety events become known through direct disclosure of AEs to the 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 discontinuation due to ISRs at Month 24 analysis: 3% of patients (n=6/233)*

*Reasons for discontinuation were available for 44 participants from the consistent-with-label group.

You may have virologically suppressed patients like Will who are ready to switch to a long-acting regimen

After years on oral ART, Will considered a new treatment that fit with his changing health needs.

See Will’s story

AE=adverse event; ART=antiretroviral therapy; BMI=body mass index; CVF=confirmed virologic failure; eCRF=electronic case report form; INSTI=integrase strand-transfer inhibitor; ISR=injection site reaction; Q2M=every 2 months.

References:

  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.
  2. Dandachi D, Garris C, Richardson D, et al. Clinical outcomes and perspectives of people with human immunodeficiency virus type 1 twelve months after initiation of long-acting cabotegravir and rilpivirine in an observational real-world US study (BEYOND). Open Forum Infect Dis. 2025;12(5):ofaf220. doi:10.1093/ofid/ofaf220

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