• VOLITION Study Design

    An ongoing phase 3b, multicenter, non-randomized, open-label study

    Co-primary endpoints: (1) Time to virologic suppression (HIV-1 RNA <50 copies/mL) from Baseline (Day 1) with DTG/3TC treatment; (2) Percentage of participants with plasma HIV-1 RNA <50 copies/mL with CABENUVA treatment as per FDA Snapshot Algorithm at Month 11 (ongoing).

    Upon suppression, participants completed a Day-of-Choice survey, and selected their maintenance phase treatment.

    *Participants given the option to switch on the "Day of Choice," which followed the first plasma HIV-1 RNA results <50 copies/mL between Week 4 and Week 16.

  • VOLITION Baseline Characteristics

    At time of switch to CABENUVA

      Every-2-Month CABENUVA
    (n=129)
    Median age, years
    Range    		 31
    (18-67)
    Women (self-identified gender), n (%) 34 (26)
    Race, n (%)
    Black/African American
    White
    Other races*
    Not reported/unknown
    42 (33)
    77 (60)
    5 (4)
    5 (4)
    Hispanic/Latinx ethnicity, n (%) 66 (51)
    Weight (kg) and BMI (kg/m2)
    Median (IQR) weight
    Median (IQR) BMI
    BMI category, n (%)
    Overweight (25 to <30)
    Obese (≥30)
    77.7 (65.3 – 86)
    25.5 (22.4 – 29.4)

    47 (36)
    27 (21)
    Median (IQR) CD4+ T-cell (cells/mm3) 555 (427, 668)
    CD4+ T-cell (cells/mm3) category, n (%)†
    <100
    100 to <200
    200 to <350
    ≥350
    1 (<1)
    7 (6)
    20 (16)
    98 (78)
      Every-2-Month CABENUVA
    (n=129)
    Median age, years
    Range    		 31
    (18-67)
    Women (self-identified gender), n (%) 34 (26)
    Race, n (%)
    Black/African American
    White
    Other races*
    Not reported/unknown
    42 (33)

    77 (60)
    5 (4)

    5 (4)
    Hispanic/Latinx ethnicity, n (%) 66 (51)
    Weight (kg) and BMI (kg/m2)
    Median (IQR) weight
    Median (IQR) BMI
    BMI category, n (%)
    Overweight (25 to <30)
    Obese (≥30)    		 77.7 (65.3 – 86)
    25.5 (22.4 – 29.4)

    47 (36)

    27 (21)
    Median (IQR) CD4+ T-cell (cells/mm3) 555 (427, 668)
    CD4+ T-cell (cells/mm3) category, n (%)†
    <100
    100 to <200
    200 to <350
    ≥350
    1 (<1)
    7 (6)
    20 (16)
    98 (78)

    *Other race participants: Multiple, n=3; Asian, n=2.

    †n=126.

  • VOLITION EFFICACY

    VIROLOGIC SUPPRESSION
    Maintained in Participants Who Had an Early Switch to CABENUVA

    Primary Endpoint: Per modified snapshot* algorithm, at M11, 113/129† (88%) participants maintained virologic suppression with CABENUVA

    These results are descriptive in nature.

    Injection Site Reactions and Discontinuations

    49% (n=63) of patients experienced an injection site reaction.
    There were no adverse events among participants receiving CABENUVA that led to discontinuation.

    *In the modified Snapshot algorithm, results from one assay were prioritized over another when available and also within the Snapshot window.

    †5% (6/129) had an HIV-1 RNA of ≥50 copies/mL. 8% (10/129) had no virologic data in the Snapshot window.

    ‡Includes only participants with available virologic data in the Snapshot window.

    §5% (6/119) were virologic non-responders.

    ||NNRTI: M230L; INSTI: E138K and Q148K.

Patient desire survey results

3TC=lamivudine; ART=antiretroviral therapy; BMI=body mass index; c=cobicistat; CVF=confirmed virologic failure; DoC=Day of Choice; DRV=darunavir; DTG=dolutegravir; FTC=emtricitabine; HBV=hepatitis B virus; HCV=hepatitis C virus; INSTI=integrase strand-transfer inhibitor; IQR=interquartile range; M=Month; NNRTI=non-nucleoside reverse transcriptase inhibitor; RAM=resistance-associated mutation; TAF=tenofovir alafenamide fumarate.

Reference:

  1. Rolle C-P, et al. Early switch to CAB + RPV LA in treatment-naive adults with HIV-1: Month 11 outcomes from VOLITION. Presented at the Conference on Retroviruses and Opportunistic Infections, February 22-25, 2026, Denver, CO. P525

PMUS-CBRWCNT260001