It starts with patient preference observed in the real world
CABENUVA was preferred by nearly all survey respondents

Patients in BEYOND who reached Month 12 or discontinued were asked to respond to a survey question about which regimen they preferred. 
Of the 176 respondents:

Patient Ambassador Jorge facing forward

98%

reported a preference for CABENUVA1

  • 0.6% (n=1/176) preferred their previous daily oral HIV therapy and 1.1% (n=2/176) had no preference

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

Real-world study limitations: single-arm, prospective, observational, multi-cohort study. Interpret results using limitations in study design.

  • BEYOND Study Design

    A prospective, observational, real-world study of participants with HIV initiating CABENUVA across 27 US sites2

    BEYOND study design graphic
    BEYOND study design graphic
    Primary outcomes and key secondary outcomes for patients in the BEYOND study
    • Analyses based on 233 participants initiating CABENUVA and determined to be consistent with the indication
    • Of these, 156 had a baseline and post-baseline HIV-1 RNA between Months 6 and 12 available by the data cutoff (September 2023)
    1. Suppression defined as plasma HIV-1 RNA <50 copies/mL.
    Primary endpoint, exclusion criteria, and key baseline characteristics for patients in the SOLAR study

It starts with a regimen that some patients prefer

In SOLAR, every-2-month CABENUVA was preferred by 9 out of 10 survey respondents vs daily oral therapy with BIKTARVY3

At Month 12 analysis or study withdrawal (secondary endpoint), all CABENUVA-treated patients in SOLAR (mITT-E; n=447) were asked to respond to a question about which regimen they preferred. 22 patients did not respond. Of the 425 survey respondents:

Patient Ambassador Miranda on long-acting CABENUVA

90%

reported a preference for CABENUVA

  • Patients were asked to compare their experience using CABENUVA versus BIKTARVY, to select the treatment they preferred, and then select from a list of provided statements to support their preference
  • 5% (n=21/425) preferred BIKTARVY and 5% (n=22/425) had no preference

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

  • SOLAR Study Design

    SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY3

    A large phase 3b, open-label, noninferiority study of virologically suppressed* adults (≥18 years) with HIV-1

    CABENUVA vs BIKTARVY SOLAR study with virologically-suppressed patients
    Primary endpoint, exclusion criteria, and key baseline characteristics for patients in the SOLAR study
    • Efficacy analyses, baseline questionnaire, and preference calculation were based on the mITT-E (N=670) population. After consultation with a blinded external expert, 11 participants at a single study site were excluded from the ITT-E population due to critical findings related to significant and persistent noncompliance to protocol requirements
    • Safety analyses were based on ITT-E (N=681) population
    1. Suppression defined as plasma HIV-1 RNA <50 copies/mL. A single prior INSTI-based regimen was allowed for reasons other than treatment failure.1
    2. 39% (n=173) started with oral lead-in (OLI) and 61% (n=274) of patients in the CABENUVA arm started with injections (SWI) without OLI. OLI regimen consisted of 30-mg cabotegravir and 25-mg rilpivirine once daily given for 1 month; on last day of the OLI period, patients received 2 sets of initiation CABENUVA injections 1 month apart followed by every-2-month injections thereafter.1
    3. Month 12 (OLI and BIKTARVY) and Month 11 (SWI).1
    Primary endpoint, exclusion criteria, and key baseline characteristics for patients in the SOLAR study

  • Why did patients prefer CABENUVA?

    The most commonly chosen responses were3*:

    85%“I do not have to worry as much about remembering to take HIV medication every day.”

    83%“It is more convenient for me to receive injections every 2 months.”

    74%“I do not have to carry my HIV medication with me.”

    61%“I do not have to think about my HIV status every day.”

    59%“I do not have to worry about others seeing or finding my HIV pills.”

    Respondents could choose one or more reasons for their preference.

    1. Patients who preferred CABENUVA were given a list of 11 reasons to choose from; more than one reason could be chosen.

Identifying patients for a long-acting regimen

Patient Ambassador Miranda Patient Ambassador Miranda

Miranda—Patient Ambassador

Unfortunately, sometimes having a bottle in your medicine cabinet, you know, it just gives you away.

See Miranda's story

ART=antiretroviral therapy; ARV=antiretroviral; BMI=body mass index; CVF=confirmed virologic failure; HBV=hepatitis B virus; INSTI=integrase strand-transfer inhibitor; ITT-E=intent-to-treat exposed; M=month; mITT-E=modified intent-to-treat exposed; SD=standard deviation.

References:

  1. Valenti W, et al. Perspectives of people with HIV (PWH) 12 months following a switch to cabotegravir and rilpivirine long-acting (CAB+ RPV LA) in an observational real-world US study (BEYOND). Presented at: AIDS 2024, July 22-26, 2024, Munich, Germany. TUPEB116.
  2. Schneider S, Sension M, Dretler A, et al. Clinical outcomes at Month 12 after initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Poster presented at: AIDS 2024, July 22-26, 2024, Munich, Germany. THPEB099.
  3. Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023;10(9):E566-E577. doi.org/10.1016/S2352-3018(23)00136-4

PMUS-CBRWCNT240081