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UNDERSTANDING SAFETY AND TOLERABILITY

SOLAR results were consistent with the overall profile of every-2-month VOCABRIA + REKAMBYS[1]

AE rates over 12 months excluding ISRs (intention-to-treat exposed [ITT-E]):[1]

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%).[1]

In the BIC/ FTC/TAF arm, the two drug-related AEs reported were weight gain (<1%) and abnormal hepatic function (<1%).[1]

ISR breakdown:[1]

Patient-reported ISRs decreased over time[2]

SOLAR: Incidence of reported ISRs (all grades) by visit[2]

Most ISRs were Grade 1 or 2 (98%), short lived (median 3 days), with a few participants discontinuity due to injection-related reasons[1,2]

If treatment is discontinued, it is essential to start alternative antiretroviral (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.[3,4]

See the Summary of Product Characteristics (SmPC) for important interactions and contraindications, warnings and precautions, and adverse and serious adverse events.[3,4]

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*Represents the number of participants who received an injection.[1]
†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 injection (SWI) group.[1]
‡There were no Grade 4 or Grade 5 ISRs.[1]
§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.

AE=adverse event; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; IQR=interquartile range; ISR=injection site reaction; SmPC=summary of product characteristics; SWI=start with injection.

References:

  1. Ramgopal MN, Castagna A, Cazanave C, et al. SOLAR 12-Month Results – Randomized Switch Trial of CAB + RPV LA vs. Oral BIC/FTC/TAF. Presented at Conference on Retroviruses and Opportunistic Infections (CROI): February 19–22, 2023. REF-182990.
  2. 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.
  3. VOCABRIA Summary of Product Characteristics. ViiV Healthcare.
  4. REKAMBYS Summary of Product Characteristics. Janssen.

REKAMBYS (rilpivirine long-acting injection), 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.

PM-GB-CBR-WCNT-230001 - August 2023

Prescribing Information

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.