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ATLAS-2M SAFETY & TOLERABILITY

IT STARTS WITH

UNDERSTANDING SAFETY AND TOLERABILITY

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

Every-2-month VOCABRIA + REKAMBYS was generally well-tolerated over 3 years3

AE RATES OVER 3 YEARS EXCLUDING ISRs3

Adverse Events table

No new safety signals were identified between Weeks 48 and 152.3

*Drug-related serious AEs (per investigator assessment) were injection-site abscess (n=1), osteonecrosis (n=1), presyncope (n=1), and acute pancreatitis and sepsis (n=1) in the every-2-month arm, and hypersensitivity and suspected (partial) intravenous administration of rilpivirine (n=1), drug hypersensitivity and suspected post-injection reaction (n=1), and myocardial infarction (n=1) in the monthly arm.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 BREAKDOWN3

ISR Breakdown table
  • 99% (n=9,558/9,662) of ISRs were mild or moderate, with a median duration of 3 days3
  • Over 3 years, <2% of participants (n=8/522) in the every-2-month arm withdrew due to injection-related reasons3

*Each ISR event was counted separately. A participant may have had multiple ISR events following a single injection.3
†There were no Grade 4 or Grade 5 ISRs.3

Patient-reported ISRs decreased over time1,2

ATLAS-2M: INCIDENCE OF REPORTED ISRs (ALL GRADES) WITH NO PRIOR EXPOSURE TO MONTHLY DOSING4

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 therapy1,5

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SOLAR Safety & Tolerability

SOLAR results were consistent with the overall profile of every-2-month VOCABRIA + REKAMBYS6

 

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Patient Preference

Preferred by 9 out of 10 trial patients over daily oral therapy with BIC/FTC/TAF6

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AE=adverse event; ARV=antiretroviral; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; IQR=interquartile range; ISR=injection site reaction; SmPC=Summary of Product Characteristics.

References:
  1. VOCABRIA Summary of Product Characteristics. ViiV Healthcare; 2024.
  2. REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV; 2024.
  3. 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.
  4. Data on file. Overall lSRs from ATLAS-2M to 152 wks, strata with no prior exposure to CAB+RPV. ViiV Healthcare group of companies.
  5. 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 August 2023.
  6. 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

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.

▼ This medicinal product is 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: February 2024 | PM-IE-CBR-WCNT-240005