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EFFICACY
SOLAR Study Design

IT STARTS WITH PROVEN EFFICACY

SOLAR IS THE FIRST HEAD-TO-HEAD SWITCH STUDY COMPARING EVERY-2-MONTH VOCABRIA + REKAMBYS WITH DAILY ORAL THERAPY1-4

Every-2-month VOCABRIA + REKAMBYS demonstrated non-inferior efficacy to daily oral therapy with BIC/FTC/TAF in SOLAR, and sustained efficacy over 3 years in ATLAS-2M.1-3

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In this phase IIIb, open label, non-inferiority study, virologically suppressed* adults with HIV-1 receiving daily oral therapy with BIC/FTC/TAF were randomised to one of three arms for the duration of the 12-month maintenance period:*

efficacy solar study design infographic

Due to protocol non-compliance, 11 subjects from one site were excluded from the intention-to-treat exposed (ITT-E) population, creating a modified intention-to-treat exposed (mITT-E) population. Efficacy is reported on a mITT-E analysis.1

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SOLAR explored virological suppression, safety and tolerability, as well as patient treatment experiences with every-2-month VOCABRIA + REKAMBYS vs daily oral therapy with BIC/⁠FTC/⁠TAF1,4

vocabria + rekambys calendar

Outcomes were measured at Month 12 for participants in the oral lead-in (OLI) and BIC/FTC/TAF groups and Month 11 for participants in the start with injection (SWI) group1,4

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Efficacy and safety endpoints at Month 12 included:1,4

· Proportion of patients with plasma HIV-1 RNA ≥50 copies/mL (primary endpoint)

· Proportion with plasma HIV-1 RNA <50 copies/mL

· Incidence of confirmed virologic failure (CVF)‡

· Adverse events (AEs)

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Patient treatment experience outcomes included:1,4

· Patient preference

· Reasons for preference

· Treatment satisfaction

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The SOLAR primary endpoint was met:

Every-2-month VOCABRIA + REKAMBYS was virologically non-inferior to daily oral therapy with BIC/FTC/TAF at Month 12 (mITT-E: 1.1% [n=5/447] with plasma HIV-1 RNA ≥50 copies/mL vs 0.4% [n=1/223], respectively, adjusted difference = 0.7% [95% CI -0.7%, 2.0%]).*1

*Participants were suppressed for ≥6 months, suppression defined as HIV-1 RNA <50 copies/mL and received BIC/FTC/TAF for ≥6 months prior to screening.1,4
†Cabotegravir initiation and continuation injections, 600 mg; rilpivirine initiation and continuation injections, 900 mg.1
‡CVF defined as two consecutive measurements of HIV-1 RNA ≥200 copies/mL.1

Key inclusion and exclusion criteria:4

Inclusion4

  • No history of non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), C-C Chemokine receptor 5 or other entry inhibitors
  • Must be on the uninterrupted current regimen of BIC/FTC/TAF for ≥6 months prior to screening with an undetectable HIV-1 viral load for ≥6 months prior to screening. BIC/FTC/TAF must be the patient's first or second regimen. If it is their second regimen, their previous regimen must have been integrase inhibitor (INI)-based

Exclusion4

  • History of virologic failure
  • Known or suspected presence of resistance mutations to the individual components of BIC/⁠FTC/⁠TAF, cabotegravir and rilpivirine
  • Hepatitis B virus (HBV) infection at screening
  • Moderate to severe hepatic impairment
  • Women who were pregnant or breastfeeding or planned to become pregnant or breastfeed

SOLAR included a range of participants5

Among the 447 participants switching to every-2-month VOCABRIA + REKAMBYS (mITT‑E):1

 

SOLAR Baseline Characteristics

Among study participants, 12 transgender females, 1 transgender male, and 1 gender non-conforming individual were included1

Every-2-month VOCABRIA + REKAMBYS was non-inferior to daily oral therapy with BIC/FTC/TAF1

SOLAR PLASMA HIV-1 RNA <50 COPIES/ML AT MONTH 12 (mITT-E)1

(secondary endpoint; 12% non-inferiority margin)

SOLAR PLASMA infographic

*4% non-inferiority margin.1

Low incidence of CVF at Month 125

SOLAR CVF AND OVERALL REISISTANCE-ASSOCIATED MUTATIONS AT MONTH 12 (ITT-E)1,5

CVF Rates table SOLAR
  • Two (0.4%) participants receiving every-2-month VOCABRIA + REKAMBYS in the mITT-E population, and one additional participant receiving every-2-month VOCABRIA + REKAMBYS in the ITT-E population, met the CVF criterion through Month 121
  • Two of the participants had on-treatment rilpivirine and/or INI resistance-associated mutations (genotype for third participant failed at baseline)1
  • All three participants with CVF and resistance re-suppressed on alternative ARV therapies1

Explore the ATLAS-2M Study

Every 2-month dosing vs monthly dosing

Learn More About Patient Preferences

Finding a regimen that your patients prefers

AE­=adverse event; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; BMI­=body mass index; CAB­=cabotegravir; CVF­=confirmed virologic failure; HBV­=hepatitis B virus; HIV=human immunodeficiency virus; HIV-1­=human immunodeficiency virus type 1; INI=­integrase inhibitor; LA­=long-acting; mITT-E­=modified intention-to-treat exposed; NNRTI­=non-nucleoside reverse transcriptase inhibitor; OLI­=oral lead-in; PI­=protease inhibitor; PLHIV­=people living with HIV-1; RNA=­ribonucleic acid; RPV=­rilpivirine; SWI­=start with injection.

References
  1. Ramgopal MN, Castagna A, Ca­zanave C, et al. Efficacy, safety and tolerability of switching to long-acting cabotegravir + rilpivirine versus continuing bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed adults with HIV, 12 month results (SOLAR): A randomised open-label, phase 3b non-inferiority trial. The Lancet HIV. 2023. Published Online 8th August 2023. https://doi.org/10.1016/S2352-3018(23)00136-4
  2. VOCABRIA Summary of Product Characteristics. ViiV Healthcare; 2024. Available at https://www.medicines.ie/medicines/vocabria-600-mg-prolonged-release-suspension-for-injection-35220/spc
  3. REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV; 2024. Available at: https://www.medicines.ie/medicines/rekambys-35258/spc
  4. A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long-Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (SOLAR). 2022. Available at: https://clinicaltrials.gov/ct2/show/sCT04542070. Accessed February 2024.
  5. Ramgopal MN, Castagna A, Ca­zanave C, et al. Efficacy, safety and tolerability of switching to long-acting cabotegravir + rilpivirine versus continuing bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed adults with HIV, 12 month results (SOLAR): A randomised open-label, phase 3b non-inferiority trial. Supplementary data. The Lancet HIV. 2023. Published Online 8th August 2023. https://doi.org/10.1016/S2352-3018(23)00136-4

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

REKAMBYS (rilpivirine long acting), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under licence by the ViiV Healthcare group of companies.

All other trademarks are owned by the ViiV Healthcare group, or its licensor.

©2024 GSK group of companies. All rights reserved.

PM-IE-CBR-WCNT-240001
Date of preparation: February 2024