It starts with an established safety profile in clinical trials

SOLAR: Drug-related adverse events through Month 121,2

SOLAR drug-related AEs 12M graphic SOLAR drug-related AEs 12M graphic

Most common adverse events ≥1%

  • Most drug-related AEs were Grade 1 or 2 in CABENUVA patients; all were Grade 1 or 2 in BIKTARVY patients
  • 2% of CABENUVA patients (event level) discontinued treatment due to injection-related reasons, and 2% discontinued due to non-ISR, drug-related AEs
  1. Defined as “treatment-related” as assessed by the investigator. Only maximum-graded report per adverse reaction contributes to table.
  2. Pyrexia: includes pyrexia, feeling hot, chills, influenza-like illness, body temperature increased.
  3. Fatigue: includes fatigue, malaise, asthenia.
  4. Musculoskeletal pain: includes musculoskeletal pain, musculoskeletal discomfort, back pain, myalgia, pain in extremity.
  5. Sleep disorders: includes insomnia, poor quality sleep, somnolence.
SOLAR ISRs over time graphic SOLAR ISRs over time graphic

Injection site reactions (ISRs)1,2

  • The median duration (IQR) of ISRs was 3 days (2-5)
  • 2% of CABENUVA patients (event level) discontinued treatment due to injection-related reasons

Patient-reported ISRs decreased over time1,2*

Majority of ISR events (event-level: 98% [1885/1915]) were Grades 1-2.

Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study.

SOLAR ISRs graphic

Majority of ISR events (event-level: 98% [1885/1915]) were Grades 1-2.

Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study.

*Participants’ injection schedule during the maintenance phase: oral lead-in—Month 1, 2, 4, 6, 8, 10, 12; direct to injections—Day 1, Month 1, 3, 5, 7, 9, 11. Data for the 2 arms have been combined.

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

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AE=adverse event; 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; NA=not applicable; NNRTI=non-nucleoside reverse transcriptase inhibitor; OLI=oral lead-in; PI=protease inhibitor; 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.

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