OPERA

EFFICACY

A real-world study of the effectiveness of long-acting CABENUVA or daily BIKTARVY1

  • OPERA Study Design

    OPERA includes prospectively captured, routine clinical data from electronic health records from 101 clinics across 23 US states/territories

    Selected Endpoints
    • Maintenance of virologic suppression over follow-up
    • Confirmed virologic failure (CVF)†
    • Ever re-suppressed to
viral load (VL) <50 copies/mL
    Inclusion Criteria
    • Adults with HIV
    • Treatment-experienced
    • Virologically suppressed (VL <50 copies/mL)
    • Switched to CABENUVA or BIKTARVY for the first time between February 1, 2022 and March 31, 2025
    Censoring Criteria
    • Discontinuation of regimen of interest
    • End of study analysis (September 30, 2025)
    • Loss to follow-up (no clinic contact for 12 months)
    • Death

    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.

    *Viral suppression was defined as VL <50 copies/mL.

    †2 consecutive VL ≥200 copies/mL or 1 VL ≥200 copies/mL followed by discontinuation within 4 months.

  • OPERA Baseline Characteristics

      CABENUVA
    N=4090    		 BIKTARVY
    N=2699
    Age, median years (IQR) 38 (32, 49) 47 (36, 58)
    Female sex, n (%) 569 (14) 448 (17)
    Black/African American, n (%) 1739 (42) 1112 (41)
    Hispanic ethnicity, n (%) 1372 (34) 725 (27)
    Injection drug use, n (%) 231 (6) 289 (8)
    Care in Southern US, n (%) 2166 (53) 1723 (64)
    CD4 cell count, median cells/μL (IQR) 714 (532, 918) 694 (506, 914)
      CABENUVA
    N=4090    		 BIKTARVY
    N=2699
    Age, median years (IQR) 38
    (32, 49)    		 47
    (36, 58)
    Female sex, n (%) 569 (14) 448 (17)
    Black/African American, n (%) 1739 (42) 1112 (41)
    Hispanic ethnicity, n (%) 1372 (34) 725 (27)
    Injection drug use, n (%) 231 (6) 289 (8)
    Care in Southern US, n (%) 2166 (53) 1723 (64)
    CD4 cell count, median cells/μL (IQR) 714
    (532, 918)    		 694
    (506, 914)

  • OPERA Efficacy Results

    OPERA: Efficacy of CABENUVA and BIKTARVY observed across a broad range of patients in the real world1

    OPERA captured real-world treatment patterns over 3+ years in virologically suppressed patients switching to CABENUVA or BIKTARVY

    Median (range) duration of follow-up:
    CABENUVA, 15 months (8, 25); BIKTARVY, 22 months (14, 31).

    Rate of virologic suppression (HIV-1 RNA <50 copies/mL)
    CVF when switching to CABENUVA or BIKTARVY*

    aOR (95% CI): 0.72 (0.46 to 1.11)†

    CVF was defined as 2 HIV-1 RNA measurements ≥ 200 copies/mL or 1 HIV-1 RNA ≥ 200 copies/mL plus discontinuation within 4 months.

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

    *46 BIKTARVY patients and 46 CABENUVA patients experienced virologic failure; and most patients (68% in CABENUVA group and 69% in BIKTARVY group) re-suppressed before study end.

    †Not statistically significant. Adjusted for age, sex, ethnicity, US geographic region, injection drug use, AIDS-defining events, hepatitis C ever, CD4 cell count, comorbid conditions ever, and core agent of prior regimen.

    Resistance data for CABENUVA

    Explore CVF

OPERA

SAFETY

  • No safety data reported

Expert Perspectives: Conversations on CABENUVA

Real-world evidence from OPERA reinforces results from SOLAR

SOLAR Efficacy and Safety

aOR=adjusted odds ratio; 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; VL=viral load.

Reference:

  1. Hsu RK, Sension M, Levis B, et al. Comparable virologic effectiveness with long-acting cabotegravir + rilpivirine vs daily bictegravir/emtricitabine/tenofovir alafenamide in the US-based OPERA cohort. Poster presented at: AIDS 2026; July 26-31, 2026; Rio de Janeiro, Brazil. WEPEB099.

PMUS-CBRWCNT260018