VOLITION

  • VOLITION Study Design

    An ongoing phase 3b, multicenter, non-randomized, parallel-group, 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. 

    The median age was 31 years, 26% were female, 30% were Black/African American, and the median CD4+ T-cell count was 396 cells/mm3.

    *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 Patient Desire

    At “Day of Choice,” after virologic suppression with DTG/3TC was achieved, eligible patients (n=145)* were given the choice to continue DTG/3TC or switch to CABENUVA

    What they chose

    At baseline, 85% (101/119) of participants expressed an interest in switching to CABENUVA.

    Why they chose it

    Patients in VOLITION were asked their reasons† for switching to CABENUVA (tertiary endpoint). Of the patients who choose to switch (n=129), the top 5 reasons included: 

    These results are descriptive in nature and should not be used to infer clinical significance.

    *Four participants withdrew from the study prior to “Day of Choice;” 22 were ineligible to switch.

    †Responses were pre-populated and respondents were permitted to choose more than one reason. Participant experience was evaluated using questionnaires.

See why some patients preferred CABENUVA

BEYOND Preference Data

SOLAR Preference Data

3TC=lamivudine; ART=antiretroviral therapy; DTG=dolutegravir; HBV=hepatitis B virus; HCV=hepatitis C virus; M=month; RAMs=resistance-associated mutations.

Reference:

  1. Felizarta F, Gutner C, Jonsson-Oldenbuttel C, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in newly diagnosed people living with HIV. Presented at the 13th IAS Conference on HIV Science; July 13-17, 2025, Kigali, Rwanda, and virtually. EP1070.

PMUS-CBRWCNT250026