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SOLAR SAFETY & TOLERABILITY

IT STARTS WITH

UNDERSTANDING SAFETY AND TOLERABILITY

Every-2-month VOCABRIA▼+ REKAMBYS▼ was generally well-tolerated, as demonstrated through a robust clinical trial programme.1-4

SOLAR results were consistent with the overall profile of every-2-month VOCABRIA + REKAMBYS3

AE RATES OVER 12 MONTHS EXCLUDING INJECTION SITE REACTIONS (ISRs) (ITT-E)3

Adverse events table

The most commonly reported drug-related AEs in the every-2-month VOCABRIA + REKAMBYS arm were pyrexia (3%), headache (2%), fatigue (2%) and diarrhoea (2%).3

In the daily oral therapy with BIC/FTC/TAF arm, the two drug-related AEs reported were weight gain (<1%) and abnormal hepatic function (<1%).3

  • exclamation mark icon If Treatment is Discontinued

    If treatment is discontinued, it is essential to start ARV therapy no later than 2 months after the final injections (or 1 month if after first initiation injections) in order to minimise the risk of resistance.1,2

    See the SmPC for important interactions and contraindications, warnings and precautions, and AEs and serious AEs.1,2

ISR BREAKDOWN5

ISR breakdown table

Most ISRs were Grade 1 or 2 (98% [n=1,886/1,915]), short-lived (median 3 days), with few participants discontinuing due to injection-related reasons.3

*Represents the number of participant who received an injection.3

†A single injection could result in more than one ISR. Grading was missed for one ISR event in the every-2-month VOCABRIA + REKAMBYS start with injections group.3

‡There were no Grade 4 or Grade 5 ISRs.3

§Includes participants who discontinued due to ISR AEs, and an additional participant who withdrew from the study citing injection intolerability. This also includes one participant who was excluded from the primary analysis (mITT E) population.3

Patient-reported ISRs decreased over time3

SOLAR: INCIDENCE OF REPORTED ISRs (ALL GRADES) BY VISIT6

Patient reported ISRs graph
injection icon

SOLAR Study Design

SOLAR is the first head-to-head study comparing every-2-month VOCABRIA + REKAMBYS with daily oral therapy.1,7

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ATLAS 2M Safety & Tolerability

Every-2-month VOCABRIA + REKAMBYS was generally well-tolerated out to 3 years, as demonstrated through a robust clinical trial programme.1,2,4

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Patient Preference

Preferred by 9 out of 10 trial patients over daily oral therapy with BIC/FTC/TAF.5

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AE=adverse event; ARV=antiretroviral; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; IQR=interquartile range; ISR=injection site reaction; ITT E=intention-to-treat exposed; mITT E=modified intention-to-treat exposed; SmPC=Summary of Product Characteristics.

References
  1. VOCABRIA Summary of Product Characteristics. ViiV Healthcare; 2023. Available at: https://www.medicines.ie/medicines/vocabria-600-mg-prolonged-release-suspension-for-injection-35220/spc#tabs [Last Accessed: January 2024]
  2. REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV; 2023. Available at: https://www.medicines.ie/medicines/rekambys-35258/spc [Last Accessed: January 2024]
  3. 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
  4. 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.
  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
  6. Data on file. Study 213500 Month 12 analysis for CAB+RPV Q2M incidence of drug-related ISR AEs Overall. January 2023. ViiV Healthcare group of companies.
  7.  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/NCT04542070. Accessed February 2024.

 

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.

Date of Preparation: March 2024 | PM-IE-CBR-WCNT-240004