OPERA

EFFICACY

A real-world study of adult participants who switched to CABENUVA or a new oral ART regimen1

  • OPERA Study Design

    Includes routine clinical data from EHRs* from 101 clinics across 23 US states and territories

    • Overall, the OPERA database represents ~14% of people with HIV in the US
    Endpoints
    • Virologic outcomes among those with at least 1 follow-up HIV-1 RNA available
      • HIV-1 RNA <50 copies/mL
      • Confirmed virologic failure
    Censoring criteria
    • Discontinuation of ART regimen of interest
    • Death
    • 12 months after last clinical contact
    • End of analysis period June 30, 2023

    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.

    *Includes patients switched to CABENUVA or a new oral ART regimen between January 21, 2021, and December 31, 2022.

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

  • OPERA Baseline Characteristics

      CABENUVA
    (n=1362)
    ORAL ART
    (n=2783)
    Age, median (IQR), years 39 (32, 52) 45 (34, 56)
    Sex assigned at birth, %
    Female

    17

    18
    Race, %*
    Black

    41

    43
    Hispanic ethnicity, %* 29 24
    Prior core agent class, %
    INSTI-based
    NNRTI-based
    PI-based
    More than one core agent

    74
    8
    3
    16

    68
    17
    7
    8
    Months on prior ARV regimen, median (IQR) 20 (7, 38) 37 (20, 55)
    Duration of follow-up, median (IQR), months 11 (7.6–14.3) 17.1 (11.6–23.5)
      CABENUVA
    (n=1362)
    ORAL ART
    (n=2783)
    Age, median (IQR), years 39 (32, 52) 45 (34, 56)
    Sex assigned at birth, %
    Female

    17

    18
    Race, %*
    Black

    41

    43
    Hispanic ethnicity, %* 29 24
    Prior core
    agent class, %
    INSTI-based
    NNRTI-based
    PI-based
    More than one core agent

    74
    8
    3
    16

    68
    17
    7
    8
    Months on prior ARV regimen, median (IQR) 20 (7, 38) 37 (20, 55)
    Duration of follow-up, median (IQR), months 11 (7.6–14.3) 17.1 (11.6–23.5)

    *Due to data missing in the EHRs, n=133 (race), 132 (ethnicity) were excluded from the calculation.

  • OPERA Efficacy

    High rates of suppression in a broad range of patients observed in the real world

    Rate of Maintaining Virologic Suppression*
    Similar rate of CVF observed between participants switching to CABENUVA or a new oral therapy

    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 are descriptive.

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

    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 with previously treated 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 ART.

    Resistance rates seen in clinical trials

    Explore CVF

OPERA

SAFETY

  • No safety or discontinuation data reported

Expert Perspectives: Conversations on CABENUVA

Real-world evidence from OPERA reinforces results from SOLAR

ART=antiretroviral therapy; ARV=antiretroviral; CI=confidence interval; CVF=confirmed virologic failure; EHR=electronic health record; INSTI=integrase strand-transfer inhibitor; IQR=interquartile range; NNRTI=non-nucleoside reverse transcriptase inhibitor;  OR=odds ratio; PI=protease inhibitor.

Reference:

  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. 

PMUS-CBRWCNT250025