It starts with consistent efficacy observed in real-world patients

OPERA is a real-world study of adult participants who switched to CABENUVA or a new oral ART regimen1,2

  • OPERA Study Design

    OPERA includes routine clinical data from electronic health records* from 101 clinics across 23 US states and territories

    OPERA study design graphic
    Endpoints and censoring criteria for patients in the OPERA study
    • Overall, the OPERA database represents ~14% of people with HIV in the US
    1. Includes patients switched to CABENUVA or a new oral ART regimen between January 21, 2021 and December 31, 2022.
    2. Suppression defined as plasma HIV-1 RNA <50 copies/mL.

  • OPERA Baseline Characteristics

    Demographics and baseline characteristics

    OPERA study demographics and baseline characteristics for CABENUVA vs Oral ART
    1. Due to data missing in the electronic health records, n=133 (race), 132 (ethnicity) were excluded from the calculation.

OPERA Efficacy

OPERA: Switching to CABENUVA showed similarly high rates of maintaining virologic suppression vs a new daily oral therapy

OPERA study virologic suppression efficacy chart for CABENUVA vs daily oral therapy

Similar rate of CVF observed between participants switching to CABENUVA or a new oral therapy

(adjusted OR [95% CI] = 0.64 [0.40 to 1.02])

OPERA confirmed virologic failure rate for CABENUVA patients

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

  • Following CVF, patients in each group had similar rates of virologic re-suppression†
  • The most common regimens switched to were oral, INSTI-based regimens

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These results of OPERA and BEYOND are descriptive.

  1. Virologic suppression was defined as HIV-1 RNA <50 copies/mL.
  2. Among those with a viral load available post-CVF, HIV-1 RNA <200 copies/mL: 95% (18/19) of patients previously treated with CABENUVA and 84% (36/43) of those previously treated with oral ART. HIV-1 RNA <50 copies/mL: 79% (15/19) of patients 
previously treated with CABENUVA and 72% (31/43) of those previously treated with oral ART.

BEYOND is an ongoing, 2-year, real-world study of adult participants switching to CABENUVA2,3

  • 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 patient 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 virologic suppression efficacy chart
  • 2% (3/156) had an HIV-1 RNA ≥50 copies/mL

Cumulative CVFs Through
Month 12 Analysis

BEYOND confirmed virologic failure 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.

Real-world studies: Safety

Real-world evidence reinforces the results of SOLAR

SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY.2

Review SOLAR efficacy

Review SOLAR safety

CABENUVA access and acquisition

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AE=adverse event; ART=antiretroviral therapy; ARV=antiretroviral; CAB=CABENUVA; CI=confidence interval; CVF=confirmed virologic failure; eCRF=electronic case report form; INSTI=integrase strand-transfer inhibitor; IQR=interquartile range; ISR=injection site reaction; M=month; n=number; NNRTI=non-nucleoside reverse transcriptase inhibitor; OR=odds ratio; PI=protease inhibitor; SD=standard deviation.

References:

  1. Hsu RK, Sension M, Fusco JS, et al. Real-world effectiveness of cabotegravir + rilpivirine vs standard of care oral regimens in the US. Poster presented at: Retroviruses and Opportunistic Infections (CROI); March 3-6, 2024; Denver CO.
  2. Data on file. ViiV Healthcare group of companies. Durham, NC.
  3. 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.

PMUS-CBRWCNT240080