The National Institute for Health and Care Excellence (NICE) has recommended cabotegravir (Apretude, ViiV Healthcare), an injectable form of preexposure prophylaxis (PrEP), marking a major milestone in HIV prevention across England and Wales.

The decision, outlined in NICE’s final draft guidance, follows the drug’s approval for NHS use in Scotland in February 2025. It represents the first UK-wide endorsement of a long-acting injectable PrEP for adults and young people at high risk of acquiring HIV but unable to take daily oral tablets.

The move is regarded as a significant step toward ending new HIV transmissions by 2030.

How It Works and Who Will Benefit

Unlike daily oral PrEP, cabotegravir is administered every 2 months by healthcare professionals in specialist sexual health clinics. It offers a practical prevention option for approximately 1000 people annually who face adherence challenges, medical contraindications, or barriers such as partner violence or homelessness. 

The recommendation applies to adults and adolescents weighing at least 35 kg who are at high risk for sexually acquired HIV-1 infection. This includes: 

• Men who engage in unprotected sex with other men
• Individuals with HIV-positive sexual partners
• Those unable to take oral PrEP because of medical or social factors

However, the guidance does not recommend switching people who can successfully take daily oral tablets to the injectable version.

Professor Yvonne Gilleece, chair of the British HIV Association, said the announcement “will profoundly improve the lives of thousands of individuals by helping them to stay free of HIV,” particularly those “with high additional vulnerabilities, such as women.”

Clinical Evidence 

Cabotegravir blocks the HIV enzyme integrase from enabling viral integration into host DNA. When exposure to HIV-1 virus occurs, it prevents viral replication, reducing the risk for viral multiplication and spread. 

NICE’s recommendation was based on evidence from two major clinical trials: HPTN 083 and HPTN 084. 

HPTN 083, a phase 2b/3 trial in cisgender men and transgender women who have sex with men, showed that cabotegravir reduced the risk of acquiring HIV by approximately 66% compared with tenofovir disoproxil plus emtricitabine, corresponding to a hazard ratio of 0.34. 

HPTN 084, a phase 3 trial in cisgender women aged 18-45 at risk for HIV acquisition, demonstrated an even greater effect, with about an 88% lower risk for HIV acquisition compared with oral PrEP (hazard ratio, 0.12).

Cabotegravir will be administered as part of comprehensive sexual health services, including regular HIV testing, sexual health screening, and ongoing monitoring.

Cost, Access, and Rollout

The list price for Apretude is £1,197.02 per vial (prolonged-release suspension for bimonthly injection) and £638.57 for a 30-day pack of oral tablets. ViiV Healthcare has agreed to supply the drug at a discounted price through the NHS Medicines Procurement and Supply Chain framework.

Implementation will occur through Level 3 sexual health services, where PrEP is currently provided. The rollout is expected to begin approximately 3 months after NICE publishes its final guidance later this year.

PrEP uptake in England continues to expand, with more than 111,000 individuals accessing prevention treatment in 2024 — a 7.7% increase from 2023. Uptake remains high among gay and bisexual men but significantly lower among heterosexual persons, particularly Black African men and women, highlighting persistent disparities in awareness and access.

NICE concluded that cabotegravir is cost-effective only when compared with no prevention treatment, supporting its use exclusively in those unable to take oral PrEP.