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

OPERA: Efficacy

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
    Endpoints and censoring criteria for patients in the OPERA study
    Real-World studies disclaimer
    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 CVF rate for CABENUVA patients and oral therapy arm 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.

OPERA: Safety

  • No safety or discontinuation data reported

Real-world evidence from OPERA reinforces results from SOLAR

Review SOLAR efficacy and safety

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.

PMUS-CBRWCNT240094