SOLAR: It starts with proven efficacy

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

Every-2-month CABENUVA was proven as effective as continuing daily oral therapy with BIKTARVY1,2

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

  • SOLAR Study Design

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

    A large, phase 3b, open-label, noninferiority study of virologically suppressed* adults (≥18 years) with HIV-11

    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 requirements2
    • Safety analyses were based on ITT-E (N=681) population1,2
    SOLAR study design efficacy endpoints graphic
    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 (HIV-1 RNA ≥400 copies/mL).1
    2. Patients randomized to CABENUVA were given the option of 1-month oral lead-in (OLI) or to start long-acting IM CABENUVA directly (SWI). 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

  • SOLAR Baseline Characteristics

    SOLAR included a broad range of patients1,2

    • 61% (n=279) of patients in the CABENUVA arm started with injections without OLI and 39% (n=175) started with OLI1
    SOLAR baseline characteristics chart

SOLAR primary endpoint

The SOLAR clinical trial primary endpoint was met (mITT-E, HIV-1 RNA ≥50 copies/mL)1: 
Every-2-month CABENUVA was noninferior to BIKTARVY at the Month 12 analysis (mITT-E: 1% [5/447] vs <1% [1/223], respectively, adjusted difference = 0.7% [95% CI -0.7% to 2.0%]). Noninferiority shown if upper bound of the 95% CI for the treatment difference was <4%.

SOLAR Plasma HIV-1 RNA less than 50 graphic

SOLAR safety results

SOLAR confirmed virologic failure

CVF Breakdown1

SOLAR CVF 12M graphic

SOLAR: Confirmed virologic failures were seen in 2 patients receiving CABENUVA (in mITT-E)1

  • Patients who met the CVF criteria were tested for emergent INSTI (cabotegravir) or NNRTI (rilpivirine) substitutions conferring resistance
  • Patient 1: Emergent RPV RAM (M230L) and an INSTI RAM (Q148R) at Month 6
  • Patient 2: Emergent RPV RAM (K101E) and an INSTI RAM (G118R) at Month 11
  • An additional patient on CABENUVA in the ITT-E population met CVF at Month 3 with treatment-emergent RPV RAMs E138E/K and Y181Y/C

Patients who met CVF re-suppressed on highly suppressive antiretroviral therapies2

Key differences in ATLAS-2M: all patients had previously received an NNRTI-, PI-, or INSTI-based regimen.4
Through Week 152, there were 12 (2%) CVFs* in the every-2-month arm and 2 (<1%) in the once-monthly arm.5

  1. CVF was defined as 2 consecutive RNA levels ≥200 copies/mL.2

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BMI=body mass index; CVF=confirmed virologic failure; HBV=hepatitis B virus; INSTI=integrase strand transfer inhibitor; INSTI RAM=integrase strand transfer inhibitor resistance-associated mutations; IM=intramuscular; 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; RVP RAM=rilpivirine resistance-associated mutations; SWI=starting with injections.

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. ClinicalTrials.gov. SOLAR Study. Available at: https://clinicaltrials.gov/ct2/show/NCT04542070. Accessed February 16, 2023.
  4. Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2020;396(10267):1994-2005. doi:10.1016/S0140-6736(20)32666-0
  5. 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

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