We are pleased to share the news that ViiV Healthcare has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for Apretude (cabotegravir extended-release injectable suspension and tablets) for HIV prevention in the UK. Cabotegravir is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in high-risk adults and adolescents weighing at least 35 kg.

Cabotegravir long-acting (LA) for PrEP is the first and only long-acting HIV prevention option approved in the UK that is dosed via intra-muscular injection as few as six times per year, offering people a new option for prevention to suit their individual circumstances and needs.

This marketing authorisation is supported by data from two international phase IIb/III multicentre, randomised, double blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of acquiring HIV.

The UK has set an ambitious goal of achieving zero HIV transmissions by 2030. While great progress has been made, there were 3,805 new HIV diagnoses in the UK in 2022, including a rise in diagnoses among some populations, including Asian men, men of mixed or other ethnicity, and heterosexual women. Expanding HIV prevention options is a crucial component for eliminating HIV transmission and we believe the MHRA approval of Apretude will bring the UK one step closer to their goal.

Apretude is approved for use in the US, EU, Australia and South Africa as well as a number of other countries and submission to other regulatory agencies is ongoing. For more information on submissions around the world, click here.

The summary of product characteristics for Apretude in the UK will shortly be available on the MHRA Products website.

Media contacts

For our corporate press office, email: Rachel Jaikaran

OR call +44 7823 523 755

For US-specific media enquiries, email: Audrey Abernathy

OR call +1 919 605 4521

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

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