SOLAR: It starts with proven efficacy

CABENUVA phase 3b, head-to-head, clinical trial efficacy:

Every-2-month CABENUVA was noninferior to daily oral BIKTARVY1,2

SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with daily oral BIKTARVY1,2

  • SOLAR Study Design

    SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY1,2

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

    SOLAR study design screening graphic
    SOLAR study design efficacy endpoints graphic
    • 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.
    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.
    3. Month 12 (OLI and BIKTARVY) and Month 11 (SWI).
    SOLAR study design efficacy endpoints graphic

  • SOLAR Baseline Characteristics

    SOLAR included a broad range of patients (mITT-E)1,2

    • 61% (n=274) of patients in the CABENUVA arm started with injections without oral lead-in (OLI) and 39% (n=173) started with OLI
    SOLAR baseline characteristics chart

SOLAR primary endpoint

The SOLAR primary endpoint was met (mITT-E; HIV-1 RNA ≥50 copies/mL):
Every-2-month CABENUVA was noninferior* to BIKTARVY at Month 12 analysis (1% [5/447] vs <1% [1/223], respectively, adjusted difference = 0.7% [95% CI -0.7 to 2.0]).

  1. Noninferiority shown if the upper bound of the 95% CI for the treatment difference was <4%.
  2. Noninferiority shown if the lower bound of the 95% CI for the treatment difference was > -12%.

  • BMI Subset Efficacy

    CABENUVA was as effective in patients with higher BMI at 12 months (subset analysis)2,3

    BMI ≥30 kg/m2: HIV-1 RNA ≥50 copies/mL: 1% (1/93) of participants treated with CABENUVA vs 0/52 treated with BIKTARVY (difference=1.1, 95% CI -6.5, 6.1)

    Longer needle lengths may be required for patients with higher BMI.

SOLAR safety results

SOLAR confirmed virologic failure

Confirmed virologic failure (CVF) breakdown

SOLAR CVF 12M graphic
  • Key differences in ATLAS-2M: all patients had previously received an NNRTI-, PI-, or INSTI-based regimen. Through Week 152, there were 12 (2%) CVFs in the every-2-month arm and 2 (<1%) in the once-monthly arm4
  • Of the two confirmed virologic failures on CABENUVA, both patients had rilpivirine and INSTI RAMs observed

Patients who met CVF re-suppressed on alternative, highly suppressive antiretroviral therapies

  1. An additional patient on CABENUVA in the ITT-E population met CVF at Month 3 with RPV RAMs.

Other every-2-month dosing studies

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BMI=body mass index; CI=confidence interval; HBV=hepatitis B virus; IM=intramuscular; INSTI=integrase strand transfer inhibitor; IQR=interquartile range; ITT-E=intent-to-treat exposed; M=Month; mITT-E=modified intent-to-treat exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; RAM=resistance-associated mutations; RPV=rilpivirine.

References:

  1. 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
  2. Data on file. ViiV Healthcare group of companies. Durham, NC.
  3. Eu B, Oka S, Sims J, et al. Cabotegravir + rilpivirine long-acting outcomes by sex at birth, age, race, and body mass index: a subgroup analysis of the phase 3b SOLAR study. Presented at: 
IAS Conference on HIV Science; July 23-26, 2023; Virtual and Brisbane, Australia.
  4. Overton E, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b, noninferiority study. Clin Infect Dis. 2023;76:1646-1654. doi: 10.1093/cid/ciad020

PMUS-CBRWCNT240080