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EFFICACY

IT STARTS WITH

DEMONSTRATED EFFICACY

Every-2-month VOCABRIA + REKAMBYS demonstrated non-inferior efficacy to daily oral therapy with BIC/FTC/TAF in SOLAR1, and sustained efficacy over 3 years in ATLAS-2M.2-6

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

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:1

viiv v+r vx3 phase 2 section efficacy solar solar study design inforgraphic

The figure has been adapted by GSK based on ref. 1

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

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SOLAR investigated virologic suppression, safety and tolerability with every-2-month VOCABRIA + REKAMBYS vs daily oral therapy with BIC/FTC/TAF1

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Outcomes were measured at Month 12 for participants in the ‘oral lead-in’ and BIC/FTC/TAF groups, and Month 11 for participants in the ‘start with injections’ group1

Efficacy and safety endpoints at Month 12 included:1

  • Proportion of participants with plasma HIV-1 RNA ≥50 copies/mL (primary endpoint)
  • Proportion of participants with plasma HIV-1 RNA <50 copies/mL
  • Incidence of CVF‡
  • Adverse events

*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

†Cabotegravir initiation and continuation injections, 600mg (3 mL); rilpivirine initiation and continuation injections, 900 mg (3 mL).1

‡CVF defined as two consecutive measurements of HIV-1 RNA ≥200 copies/mL.1

Key inclusion and exclusion criteria1

Inclusion1

  • No history of NNRTIs, 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 participant’s first or second regimen. If it is their second regimen, their previous regimen must have been INI-based

Exclusion1

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

SOLAR included a range of participants1

BASELINE PARTICIPANT CHARACTERISTICS (mITT-E)1

efficacy solar eligibility criteria

Among participants, 12 transgender females, 1 transgender male and 1 gender non-conforming individual were included.1

EVERY-2-MONTH VOCABRIA + REKAMBYS WAS NON-INFERIOR TO DAILY ORAL THERAPY WITH BIC/FTC/TAF1

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%], 4% non-inferiority margin).1

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

(secondary endpoint; 12% non-inferiority margin)

ML AT MONTH 12

The figure has been adapted by GSK based on ref. 1

LOW INCIDENCE OF CVF AT MONTH 121

SOLAR CVF AND OVERALL RESISTANCE-ASSOCIATED MUTATIONS AT MONTH 12 (ITT-E)1

Low incidence of CVF

The table has been adapted by GSK based on ref. 1

  • 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
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Want to discuss further? Reach out to us

Anita Henriksen
Key Account Manager
anita.x.henriksen@gsk.com
Mobil: 995 25 487

Linda Marie Sørpebøl
Key Account Manager
lindamarie.x.sorpebol@gsk.com
Mobil: 952 32 576

ARV=antiretroviral; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; BMI=body mass index; CAB=cabotegravir; CI=confidence interval; CVF=confirmed virologic failure; HBV=hepatitis B virus; HIV-1=human immunodeficiency virus type 1; INI=integrase inhibitor; IQR=interquartile range; ITT-E=intention-to-treat exposed; mITT-E=modified intention-to-treat exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; PLHIV=people living with HIV; RNA=ribonucleic acid; RPV=rilpivirine.

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. Lancet HIV. 2023 Sep;10(9):e566-e577. Published Online 8th August 2023. https://doi.org/10.1016/S2352-3018(23)00136-4
  2. VOCABRIA Summary of Product Characteristics. ViiV Healthcare;
  3. REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV;
  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. The Lancet. 2021;396(10267):1994−2005. doi:10.1016/S0140-6736(20)32666-0.
  5. Jaeger H, Overton ET, Richmond G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. The Lancet HIV. 2021;8(11):e679– e689. doi:10.1016/S2352-3018(21)00185-5.
  6. Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 (HIV-1) infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b noninferiority study. Clin Infect Dis. 2023;76(9):1646–1654. doi: 10.1093/cid/ciad020.

REKAMBYS (rilpivirine long-acting injection), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under license by the ViiV Healthcare group of companies. All other trademarks are owned by the ViiV Healthcare group.

5/2025, PM-NO-CBR-WCNT-250005