It starts with the safety profile

SOLAR safety data: Drug-related adverse events through Month 12

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

Most Common Adverse Events ≥1%1,2

  • Most drug-related AEs were Grade 1 or 2 in CABENUVA patients; all were Grade 1 or 2 in BIKTARVY patients2
  • 2% of CABENUVA patients (event level) discontinued treatment due to injection-related reasons, and 2% discontinued due to non-injection site reaction (ISR) drug-related AEs1
  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

ISRs over time1,2

  • The median duration (IQR) of ISRs was 3 days (2-5)1
  • 2% of CABENUVA patients (event level) discontinued treatment due to injection-related reasons1

ISRs with CABENUVA during maintenance phase of SOLAR1,2*

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

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.2

  • 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

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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; 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.

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