NICE approves first HIV prevention injection for people unable to have daily tablet

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In final draft guidance published today (Friday 17 October), cabotegravir (Apretude, made by ViiV Healthcare) is recommended as an option for pre-exposure prophylaxis (PrEP) alongside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 to 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. 

Helen Knight, director of Medicines Evaluation at NICE, said: "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.

"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.”

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.

Professor Yvonne Gilleece, Chair of the British HIV Association (BHIVA), said: “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 publishing final guidance later this year, if not sooner.

Record numbers accessing HIV prevention treatment

Pre-exposure prophylaxis (PrEP) became routinely available through sexual health clinics in 2020, with NICE recommending the tablets for people at high risk of HIV in 2021.

We have also approved today a two-monthly PrEP injection, offering an alternative for people unable to take daily tablets. This new treatment option will help tackle inequalities and bring England closer to its goal of ending new HIV cases by 2030.

Over 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 and bisexual 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.

Figure 1: Number of people taking PrEP in sexual health services in England

Source: UK Health Security Agency

What is PrEP?

Pre-exposure prophylaxis (PrEP) is a daily pill taken by HIV-negative people to prevent HIV infection. It can also be taken on demand before and after sex. The medicine stops the virus from getting into the body and replicating. When taken correctly, daily PrEP is 99% effective.

NHS England rolled out routine PrEP services in specialist sexual health clinics in 2020. In 2021, NICE recommended offering the tablets to people at high risk of catching HIV. Men who have unprotected sex with men and people whose partners have HIV are among those at high risk.

The NICE guideline aimed to raise awareness of PrEP among healthcare professionals and facilitate access to treatment. The guidance recommended regular support for people taking the medicine, including HIV testing and STI screening every three months. It also advised incorporating peer support to normalise PrEP use and reduce stigma.

System partners, including local authorities, NHS England, and healthcare providers, have worked together to expand PrEP access across the country.

The proportion of people at high risk of HIV receiving PrEP has also continued to rise. In 2024, 76% of people at high risk who attended specialist sexual health services in England began or continued the treatment. This is a slight increase from 75% in 2023 and 70% in 2021.

Nearly four in five gay and bisexual men who needed PrEP received it, regardless of whether they were White (79%) or from ethnic minority backgrounds (78%).

However, uptake remained much lower among heterosexuals. Just over one-third of Black African heterosexual women (35%) and men (36%) at high risk of HIV received the treatment.

Eric Power, deputy director in NICE's Centre for Guidelines: “These record uptake figures demonstrate the growing confidence people have in PrEP as an effective HIV prevention tool. The increased usage shows real progress towards the goal of ending new HIV transmissions in England.

“The high take-up rate for PrEP among gay and bisexual men is encouraging but we know there is more to be done. Today's approval of the first injectable preventative option for those people who are unable take tablets is an important step forward. It means people at high risk of HIV now has access to another treatment option.”

Figure 2: Proportion of people at high risk of HIV taking PrEP in England, by gender and sexual orientation

Source: UK Health Security Agency

By sexual orientation, uptake has increased across all groups since 2021. The lowest use was among heterosexual men and women, with less than half of eligible people in this group accessing PrEP in 2024.

Young people less likely to take the treatment

PrEP use has increased in all age groups but remains lower among young people.

Figure 3: Proportion of people at high risk of HIV taking PrEP in England, by age group

Source: UK Health Security Agency

Only 65% of those aged 15 to 24 at high risk of HIV accessed the treatment in 2024, compared with 81% of people aged 50 to 64.