First HIV prevention injection for people unable to have daily PrEP recommended
A ground-breaking HIV-1 prevention injection has been recommended by NICE, marking a significant advance for a small group of adults and young people unable to have daily pre-exposure prophylaxis (PrEP) tablets.
In final draft guidance published today (Friday 17 October 2025), cabotegravir (Apretude, made by ViiV Healthcare) is recommended as an option for pre-exposure prophylaxis (PrEP) alongside safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults and young people at high risk of getting HIV if they cannot have oral PrEP.
It is the first injectable PrEP option, and the first PrEP medicine, to be appraised by NICE.
Unlike current oral PrEP which requires taking a daily tablet, cabotegravir is administered as an injection every two months by healthcare professionals in specialist sexual health clinics. This approach addresses a critical gap for people who cannot have the daily medication due to medical contraindications, difficulty swallowing tablets, or other challenges adherence such as partner violence or homelessness. Up to 1,000 people are expected to benefit in England per year.
Cabotegravir works by blocking HIV's ability to integrate into cells, providing sustained protection between doses.
Evidence suggests that cabotegravir is effective in reducing the risk of getting HIV.
Today's recommendation for cabotegravir marks a significant milestone - this is the first injectable HIV prevention treatment that is available to patients.
HIV remains a serious public health challenge, but we now have powerful tools to prevent new infections. Around 1,000 people in England cannot have daily oral PrEP due to medical contraindications or other barriers which is why this injection offers an effective option for this community.
Mrs Knight added: "At NICE, we're committed to bringing innovative medicines to NHS patients across England quickly while ensuring value for money. This demonstrates how we work with the life sciences sector to evaluate breakthrough treatments. By broadening access to effective prevention options that meet a range of needs and circumstances, we're supporting the government's goal of ending HIV transmissions in England by 2030.”
The approval of this game-changing injection perfectly embodies what this government is determined to deliver - cutting-edge treatments that save lives and leave no one behind. For vulnerable people who are unable to take other methods of HIV prevention, this represents hope.
We're making real progress on HIV, with PrEP use up by 8% this year, and our ambition goes even further. England will be the first country to end HIV transmissions by 2030, and this breakthrough treatment is another powerful tool in our arsenal to reach that crucial goal.
More than 111,000 people accessed PrEP in sexual health clinics in England during 2024, according to the latest HIV surveillance data published by the UK Health Security Agency (UKHSA). This is a 7.7% increase from 2023 and the largest number since records began in 2021. Most people taking PrEP in 2024 were gay men and other men who have sex with men (96,008). New HIV diagnoses fell by 2% in England over the same period, from 2,838 in 2023 to 2,773 in 2024.
The British HIV Association is delighted to see the announcement from NICE that injectable HIV prevention treatment will now be available to NHS patients. This treatment will profoundly improve the lives of thousands of individuals by helping them to stay free of HIV, particularly individuals with high additional vulnerabilities, such as women. We have worked hard to ensure the needs of these individuals are considered and the NICE announcement confirms this.
HIV (human immunodeficiency virus) is a virus that damages the cells in the immune system and weakens its ability to fight everyday infections and diseases. There are two primary strains, HIV-1 and HIV-2, with HIV-1 being more common.
Cabotegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs). In case of exposure to the HIV-1 virus, it works by blocking an enzyme called integrase that the virus needs to replicate itself in the body, reducing the risk of the virus multiplying and spreading.
Cabotegravir will be provided through existing specialist sexual health services where oral PrEP is currently delivered, ensuring seamless integration into established care pathways.
Healthcare professionals will administer cabotegravir alongside comprehensive sexual health services, including regular HIV testing, sexual health screening, and ongoing monitoring - ensuring people receive holistic care tailored to their prevention needs.
The rollout of cabotegravir is expected to begin three months after NICE publishes final guidance later this year, if not sooner.