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INTRODUCING CARLOS

A real-world evidence study of effectiveness, adherence and patient experience with every-2-month VOCABRIA + REKAMBYS1,2

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This 3-year, non-interventional, multicentre, prospective, real-world study aims to describe effectiveness, adherence and patient experience from the perspective, of people living with HIV who switched from daily oral therapy to every-2-month VOCABRIA + REKAMBYS in routine care in Germany.*1,2

Study Overview for CARLOS
  • Clinical characteristics were collected from medical records of virologically suppressed (HIV-1 RNA <50 copies/mL) adults with HIV-1 receiving treatment with every-2-month VOCABRIA + REKAMBYS in Germany.1-3
  • Virologic suppression in the effectiveness set,† tolerability (injection site reactions [ISRs] and drug related AEs) and adherence to the ±7-day dosing window were assessed in participants who reached the Month 6 window‡ or those who discontinued treatment but would have reached Month 6 at the time of data cutoff (May 2022).1
  • Exploratory outcomes relating to participants’ experience with every-2-month VOCABRIA + REKAMBYS, including treatment preferences, were assessed through optional surveys administered at baseline and/or Month 6.§2,3

*6-month interim data is presented here.1,2
†The inclusion criteria for the effectiveness set was participants from the analysis population who received ≥1 injection; the exclusion criteria was participants with missing viral load data in the Month 6 window or who were lost to follow-up.1
‡Target date for injection 4 ±63 days.1
§Only participants that completed surveys at both time points were included; participants with missing data were excluded from the analysis.2

CARLOS Baseline Characteristics1,2

Consistent with clinical trials, every-2-month VOCABRIA + REKAMBYS showed high effectiveness in the CARLOS real-world study1,4-6

90% high effectiveness graph
0.5% incidence rate for CVF

*Effectiveness set (n=200).1
†CVF was defined as confirmed HIV-1 RNA ≥200 copies/mL or single HIV-1 RNA ≥200 copies/mL followed by treatment discontinuation.1

Nearly half of people living with HIV in CARLOS reported facing hidden challenges with their daily oral therapy2

49% visual with guy smiling

49% (n=158/325) of people living with HIV on daily oral therapy reported always or often experiencing at least one of the following challenges at baseline in the CARLOS study:2

NA

Worried about forgetting to take their HIV medication

NA

Worried about people unintentionally discovering their HIV status

NA

Felt that taking their HIV medication was an uncomfortable reminder of their HIV status

  • Adherence Icon Adherence to the Flexible Dosing Window

    People living with HIV on every-2-month VOCABRIA + REKAMBYS showed high adherence1

    91% visual with guy smiling

    91% (n=574/633) of injection visits for people living with HIV in CARLOS occurred within the Flexible Dosing Window* after 6 months of receiving VOCABRIA + REKAMBYS†1

    *±7 days from the Target Treatment Date.1
    †6.5% (n=41/633) occurred early and 2.8% (n=18/633) occurred late; the most common reasons for late injections were missed appointments (n=11) and pandemic/COVID-19-related delays (n=3).1

As was seen in the SOLAR clinical trial, people living with HIV who switched to VOCABRIA + REKAMBYS in a real-world setting preferred it over daily oral therapy2,4

99% visual with guy smiling

(n=253/255) of people living with HIV in CARLOS preferred every-2-month VOCABRIA + REKAMBYS over daily oral therapy* for the benefits it offers them, including:2

NA

Convenience

NA

Easing struggles with daily oral therapy

NA

Alleviating pill fatigue

  • injection icon Reasons for Preference

    Top five reasons selected by those who preferred VOCABRIA + REKAMBYS over daily oral therapy in CARLOS (n=253):2

    76%

    It is more convenient for me to receive injections every 2 months

    68%

    I do not have to worry as much about remembering to take my HIV medication every day

    67%

    I was tired of taking tablet(s) for my HIV every day

    57%

    I do not have to carry my HIV medication with me

    47%

    I do not have to think about my HIV status every day

People living with HIV receiving every-2-month VOCABRIA + REKAMBYS responded to a questionnaire at Month 6.2
*255 of 351 participants who received every-2-month VOCABRIA + REKAMBYS responded; 99% (n=253/255) preferred VOCABRIA + REKAMBYS; <1% (n=1/255) preferred their prior daily oral therapy and <1% (n=1/255) reported no preference.2

The tolerability profile of every-2-month VOCABRIA + REKAMBYS in the CARLOS real-world study was consistent with clinical trials1,4-6

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Adverse events tabble

The most common (>2 events) drug-related AEs, excluding ISRs, were pyrexia (n=10), pain (n=6), headache (n=6), pain in extremity (n=3), nausea (n=3), fatigue (n=3) and sleep disorder (n=3).1

*Including oral lead-in and oral therapy to cover missed doses.1

†Hospitalisation due to worsening of anxiety disorder.1
‡In two participants during the injection phase: headache (n=1) and worsening of anxiety disorder (n=1). In four participants during the oral lead-in phase: headache and insomnia (n=1), nausea (n=1), fatigue (n=1) and pruritus (n=1).1

ISR breakdown table

*In 65 participants (28%).1

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Resources

Explore our Resource page for Vocabria + Rekambys to help you and your patients in your practice

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SOLAR Safety & Tolerability

SOLAR results were consistent with the overall profile of every-2-month VOCABRIA + REKAMBYS4

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Patient Preference

Preferred by 9 out of 10 trial patients over daily oral therapy with BIC/FTC/TAF4

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AE=adverse events, AIDS=acquired immunodeficiency syndrome; ART=antiretroviral therapy;BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; BMI=body mass index; COVID-19=coronavirus disease 2019; CVF=confirmed virologic failure; DTG/3TC=dolutegravir/lamivudine; DTG/3TC/ABC=dolutegravir/ lamivudine/abacavir; HIV=human immunodeficiency virus; HIV-1=human immunodeficiency virus type 1; IQR=interquartile range; ISR=injection site reaction; RNA=ribonucleic acid.

References
  1. Borch J, Scherzer J, Jonsson-Oldenbüttel C, et al. 6-Month Outcomes of Every 2 Months Long-Acting Cabotegravir and Rilpivirine in a Real-World Setting – Effectiveness, Adherence to Injections, and Patient-Reported Outcomes of People Living With HIV in the German CARLOS Cohort. Presented at: HIV Drug Therapy Glasgow; October 23–26, 2022; Glasgow, UK. Presentation O43.
  2. Scherzer J, Noe S, Jonsson-Oldenbüttel C, et al. Perceptions of Cabotegravir + Rilpivirine Long-Acting (CAB+RPV LA) From People Living With HIV (PLHIV) in the CARLOS Study. Presented at: The 12th IAS Conference on HIV Science; July 23–26 2023; Brisbane, Australia. Poster EPE0863. 
  3. Scherzer J, Noe S, Jonsson-Oldenbüttel C, et al. Perceptions of cabotegravir + rilpivirine long-acting (CAB+RPV LA) from people living with HIV (PLHIV) in the CARLOS Study. Presented at: The 12th IAS Conference on HIV Science; July 23–26 2023; Brisbane, Australia. Abstract EPE0863.
  4. Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety and tolerability of switching to long-acting cabotegravir + rilpivirine versus continuing fixed-dose 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;10(9):e566-e577. doi: 10.1016/S2352-3018(23)00136-4.
  5. 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#tabs
  6. REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV; 2024. Available at: https://www.medicines.ie/medicines/rekambys-35258/spc#tabs

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-240011 | Date of Preparation: September 2024