The National Institute for Health and Care Excellence (NICE) has issued positive draft guidance recommending cabotegravir long-acting injection for HIV prevention in England and Wales, marking a significant advancement in pre-exposure prophylaxis (PrEP) options. The bimonthly injection, marketed as Apretude by ViiV Healthcare, represents the first and only long-acting injectable PrEP option that will be available on the NHS for HIV prevention.
Health Secretary Wes Streeting described the approval as "gamechanging," stating that "for vulnerable people who are unable to take other methods of HIV prevention, this represents hope." The injection is already available on the NHS in Scotland following earlier approval from the Scottish Medicines Consortium.
Clinical Evidence and Efficacy
Cabotegravir long-acting demonstrated superior efficacy in two large head-to-head clinical trials compared to daily oral tenofovir disoproxil fumarate/emtricitabine. In the HPTN 083 trial involving 4,566 HIV-negative men and transgender women who have sex with men, participants experienced a 69% lower rate of HIV acquisition (12/2,278 cases) compared to daily oral PrEP (39/2,281 cases).
The HPTN 084 trial, conducted with 3,224 cisgender women at increased risk of HIV acquisition, showed even more dramatic results. Participants receiving cabotegravir experienced a 90% lower rate of HIV acquisition (3/1,613 cases) compared to daily oral PrEP (36/1,610 cases).
These clinical findings are reinforced by more than three years of real-world evidence across six studies, demonstrating more than 99% effectiveness of cabotegravir long-acting at preventing HIV infection.
Treatment Administration and Patient Population
The injection is administered six times per year by healthcare professionals, with an initial dosing schedule of 600 mg injections given one month apart for two consecutive months, followed by continuation injections every two months. NICE's recommendation specifically targets adults and young people weighing at least 35 kg who are at high risk of HIV but cannot take oral PrEP due to medical contraindications or other barriers.
Helen Knight, director of medicines evaluation at NICE, noted that "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." Up to 1,000 people are expected to benefit from the new treatment in England annually.
Current PrEP Landscape and Unmet Needs
More than 111,000 people accessed PrEP in sexual health clinics in England in 2024, representing a 7% increase over the previous year. However, UKHSA data from 2024 highlight that around 24% of people who are likely to acquire HIV need better access to PrEP, including heterosexual women who are less likely to be recognized as requiring HIV prevention compared with gay and bisexual men.
Recent surveillance data show particular concerns among heterosexual men and women, ethnically minoritized populations, and people aged 15 to 24 years, where PrEP uptake is lower and HIV diagnoses have increased in recent years.
Safety Profile
The injection was generally well tolerated in trial populations of cisgender women, men who have sex with men, and transgender women. The most common adverse reactions observed in at least 1% of subjects included injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, and abdominal pain. Study discontinuation due to treatment-related side effects was uncommon, with similar frequencies observed between treatment groups.
Implementation Timeline
The rollout is expected to begin approximately three months after NICE publishes its final guidance later this year. Pending any appeals from consultees, the NHS should make long-acting cabotegravir for PrEP available within two months in Wales and three months in England.
Richard Angell, Chief Executive of Terrence Higgins Trust, emphasized the urgency: "We are not on track to meet the 2030 goal of no new HIV transmissions and there are stark inequalities in who is accessing HIV prevention. We need to ensure that everyone across the UK understands the HIV prevention options available and can access one that works for them."
The approval supports England's ambitious goal to become the first country to end HIV transmissions by 2030, providing another powerful tool in the arsenal to reach this crucial milestone.
