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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
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
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
The figure has been adapted by GSK based on ref. 3.
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 VISIT
The figure has been adapted by GSK based on ref.3
Explore the overall safety profile of VOCABRIA + REKAMBYS
Click here
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
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.
- VOCABRIA Summary of Product Characteristics. ViiV Healthcare;
- REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV;
- 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
- 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-250001
