Injection site reactions
2-monthly VOCABRIA + REKAMBYS was generally well-tolerated with data from SOLAR (12 months)[1]
SOLAR injection site reactions (ISRs) breakdown
Most ISRs were Grade 1 or 2 (98% [n=1,885/1,915]), of short duration (median 3 days), with few participants discontinuing due to injection-related reasons.[1]
*Represents the number of participants who received an injection.[2]
†A single injection could result in more than one ISR. Grading was missed for one ISR event in the 2-monthly VOCABRIA +
REKAMBYS ‘start with injections’ group.[1,2]
‡There were no Grade 4 or Grade 5 ISRs.[1,2]
§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.[1,2]
AE=adverse event; IQR=interquartile range; ISR=injection site reaction; ITT=intention-to-treat; mITT-E=modified intention-to-treat exposed.
References:
- Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and 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.
- Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and 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. Supplementary data.
- Data on file. Study 213500 Month 12 analysis for CAB+RPV Q2M incidence of drug-related ISR AEs Overall. January 2023. REF-183162. ViiV Healthcare group of companies.
REKAMBYS (rilpivirine long-acting), 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 or licensed by the ViiV Healthcare group. ©2025 ViiV Healthcare group of companies or its licensor. All rights reserved.
PM-GB-CBR-WCNT-250008 | March 2026
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.
