BEYOND: Real-world evidence

BEYOND is an ongoing, 2-year, real-world study of adult participants switching to CABENUVA1

BEYOND study design

A 2-year, prospective, observational, real-world study of participants with HIV initiating CABENUVA across 27 US sites

SOLAR study design screening graphic
SOLAR study design efficacy endpoints graphic

  • Analyses based on 233 participants initiating CABENUVA and determined to be consistent with the indication

    • Virologic suppression (HIV-1 RNA <50 copies/mL) at baseline
    • No history of prior virologic failure
    • No documented resistance to cabotegravir or rilpivirine
  • Of these, 187 reached Month 6 by the data cutoff (January 10, 2023)
  1. Suppression defined as plasma HIV-1 RNA <50 copies/mL.
  2. Patients could switch dosing regimen after baseline.
SOLAR study design efficacy endpoints graphic

BEYOND efficacy

BEYOND reinforces the efficacy of CABENUVA through Month 6 analysis in real-world settings1*

Of the 187 patients reaching Month 6, 150 had at least 1 post-baseline HIV-1 RNA available from medical records

SOLAR CVF 12M graphic
  • Virologic suppression defined as plasma HIV-1 RNA <50 copies/mL
  • 3% (4/150) had an HIV-1 RNA ≥50 copies/mL
SOLAR CVF 12M graphic

CVF defined as 2 consecutive plasma HIV-1 RNA measurements ≥200 copies/mL or 1 HIV-1 RNA measurement ≥200 copies/mL and discontinuation within 3 months of viral load ≥200 copies/mL.

  • One of the two participants with CVF had NNRTI and INSTI RAMs‡

BEYOND was not designed to solicit AEs, however, safety events become known through direct disclosures of AEs to site staff, periodic review of participants' medical records to complete the eCRFs or follow up to certain responses to the participant survey. The most common AE report was ISR.

  • Rate of discontinuations due to ISRs at interim Month 6 analysis: 2% of patients (n=4/187)
  1. At the Month 6 cutoff, a median of 4 injection visits per participant was reported.
  2. Includes participants with at least 1 viral load test.
  3. NNRTI RAMs: L1000I, K103NS. INSTI RAMs: E138KA, G140SAC, Q148HRK.

BEYOND reinforces the results of SOLAR

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

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AE=adverse event; ARV=antiretroviral; CVF=confirmed virologic failure; eCRF=electronic case report form; INSTI=integrase strand transfer inhibitor; ISR=injection site reaction; M=month; RAM=resistance-associated mutation; RPV=rilpivirine.

References:

  1. Sinclair G, et al. Clinical outcomes at month 6 after initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Poster presented at: IDWeek on HIV Treatment; October 11-15, 2023; Boston, MA.
  2. 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
  3. Data on file. ViiV Healthcare group of companies. Durham, NC.

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