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NICE ISSUES POSITIVE RECOMMENDATION FOR ViiV HEALTHCARE’S CABOTEGRAVIR FOR PREP, THE FIRST AND ONLY LONG-ACTING HIV PREVENTION OPTION TO BE REIMBURSED IN ENGLAND AND WALES

  • Eligible people in England and Wales will soon have access to the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option available on the NHS for HIV prevention.1,2
  • Administered six times a year after initiation,2 Apretude (cabotegravir) has been shown in two large head-to-head clinical trials to be more effective at preventing new cases of HIV than daily oral tenofovir disoproxil fumarate/emtricitabine.3,4,5,6
  • Positive recommendations from NICE and the SMC enable access to this additional prevention option to help reduce HIV transmissions and offer choice to meet different needs.7

London, 17 OCTOBER 2025 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced that eligible people living in England and Wales will soon have access to Apretude (cabotegravir), the first and only long-acting injectable suspension available on the NHS for HIV prevention.1,2 This comes as the National Institute for Health and Care Excellence (NICE) published positive guidance recommending long-acting cabotegravir, 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 young people weighing at least 35 kg who cannot have oral PrEP. It follows positive recommendation from the Scottish Medicines Consortium (SMC) earlier this year.7

PrEP medications are used to reduce the risk of acquiring HIV. Long-acting cabotegravir for PrEP, which is made at GSK’s manufacturing facility in Barnard Castle, County Durham, offers people an alternative option for HIV prevention, for those who cannot have oral PrEP.1,2 In blinded post-hoc analyses of two large head-to-head trials, it showed superior efficacy (69% and 90% lower rate of HIV acquisition respectively) compared with daily oral tenofovir disoproxil fumarate/emtricitabine.3,4,5,6,8,9,10 It was generally well tolerated in the trial populations of cisgender women, men that have sex with men, and transgender women.3,4 These data are reinforced by more than three years of real-world evidence across 6 studies, demonstrating more than 99% effectiveness of cabotegravir long-acting at preventing HIV.11,12,13,14,15,16,17

While HIV surveillance data from 2024 show an encouraging reduction in HIV transmissions,18 more needs to be done to meet the UK government’s ambitious goal of eliminating new HIV transmissions by 2030.19  Recent trends highlight particular concerns and unequal progress among heterosexual men and women, ethnically minoritised populations, and people aged 15 to 24 years, where PrEP uptake is lower and HIV diagnoses have increased in recent years.18,20

Expanding available PrEP options to meet different needs is essential to stopping new HIV transmissions. UKHSA data from 2024 highlight that around 24% of people who are likely to acquire HIV need better access to PrEP.18 This includes heterosexual women, who are less likely to be recognised as people who require HIV prevention compared with gay and bisexual men.21

Richard Angell, OBE, Chief Executive of Terrence Higgins Trust, UK, said: “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.”

Juddy Otti, Head of HIV Services at Africa Advocacy Foundation, UK, and Project Lead at Sophia Forum, UK, said: “More needs to be done to prevent the transmission of HIV, especially in women, Black African communities, and other ethnic minority groups, where new HIV transmissions continue to occur and there are inequities in PrEP uptake. It is vital that we provide choice to suit different needs.”

Julie Guest, General Manager at ViiV Healthcare UK, said: “Expanding the range of HIV prevention options could help improve accessibility for individuals who cannot have daily oral PrEP, supporting national efforts to reduce HIV incidence. As the first and only long-acting PrEP option available in the UK, cabotegravir expands our portfolio and offers an alternative option to help people stay protected.”

This positive recommendation from the NICE Committee underpins the final guidance for the NHS in England and Wales. 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.

About cabotegravir long-acting for PrEP2

Apretude long-acting injection is indicated in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg.

Cabotegravir long-acting for PrEP is an integrase strand transfer inhibitor (INSTI). INSTIs inhibit HIV replication by preventing the viral deoxyribonucleic acid (DNA) from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease.

It is provided as an injection administered six times per year by a healthcare professional and is initiated with a single 600 mg (3 mL) injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3 mL) injection given every two months. Cabotegravir oral tablets may be optionally administered for approximately one month before initiating the first injection to assess the tolerability of the medicine and as oral PrEP for individuals who will miss planned dosing with injections.

Please refer to the Summary of Product Characteristics for more information. Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

About HPTN 083 (NCT02720094)3,5,8,9
The HPTN 083 trial is a phase IIb/III double-blind non-inferiority trial designed to evaluate the safety and efficacy of cabotegravir long-acting for PrEP administered every two months compared to daily oral tenofovir disoproxil fumarate/emtricitabine (200 mg/300 mg) in 4,566 HIV-negative men and transgender women who have sex with men, who are at increased risk of HIV acquisition. The trial included the prespecified ability to test for superiority of cabotegravir long-acting over tenofovir disoproxil fumarate/emtricitabine.

The trial design included an oral lead-in phase to assess tolerability before administering the intramuscular (IM) injection. Each participant was to receive a maximum of three years of blinded trial medication. The trial is being conducted at research centres in Argentina, Brazil, Peru, the United States, South Africa, Thailand, and Vietnam.

In the blinded post-hoc analysis, participants experienced a 69% lower rate of HIV acquisition (12/2278 cases) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (39/2281 cases).3,8,9

The most common adverse reactions (all grades) observed in at least 1% of subjects were injection site reactions, diarrhoea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, and abdominal pain. Study discontinuation due to treatment-related side effects was uncommon, and the overall frequency of such events was similar in the two groups.

For further information on HPTN 083, please see: https://clinicaltrials.gov/ct2/show/NCT02720094.

About HPTN 084 (NCT03164564)4,6,10
The HPTN 084 trial is a phase III double-blind superiority trial designed to evaluate the safety and efficacy of cabotegravir long-acting for PrEP administered every two months compared to daily oral tenofovir disoproxil fumarate/emtricitabine (200 mg/300 mg) in 3,224 cisgender women who are at increased risk of HIV acquisition. The trial design included an oral lead-in phase to assess tolerability before administering the IM injection. HPTN 084 opened to enrolment in November 2017 and is being conducted at research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda, and Zimbabwe.

In the blinded post-hoc analysis, participants experienced a 90% lower rate of HIV acquisition (3/1613 cases) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (36/1610 cases).4,10

The most common adverse reactions (all grades) observed in at least 1% of subjects receiving cabotegravir long-acting were injection site reactions, diarrhoea, headache, fatigue, sleep disorders, nausea, dizziness, abdominal pain, vomiting, myalgia, and rash. Study discontinuation due to treatment-related side effects was uncommon, and the overall frequency of such events was similar in the two groups.

For further information, please see: https://clinicaltrials.gov/ct2/show/NCT03164564.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

ViiV Healthcare enquiries:
Media: Rachel Jaikaran +44 (0) 78 2352 3755 (London)
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Media: Simon Steel +44 (0) 20 8047 5502 (London)
  Sarah Clements +44 (0) 20 8047 5502
 (London)
Investor Relations: Constantin Fest +44 (0) 7831 826525 (London)
  James Dodwell +44 (0) 20 8047 2406 (London)
  Mick Readey +44 (0) 7990 339653 (London)
  Steph Mountifield +44 (0) 7796 707505 (London)

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q2 Results for 2025.

Registered in England & Wales:

GSK plc                                ViiV Healthcare Limited
No. 3888792                        No. 06876960

Registered Office:

79 New Oxford Street        ViiV Healthcare Limited
London                                 GSK Medicines Research Centre
WC1A 1DG                            Gunnels Wood Road, Stevenage
                                               United Kingdom
                                               SG1 2NY

References:

  1. GSK. European Commission authorises ViiV Healthcare’s Apretude (cabotegravir long-acting and tablets) for HIV prevention. Available at: https://www.gsk.com/en-gb/media/press-releases/european-commission-authorises-viiv-healthcare-s-apretude/. Last accessed: October 2025.
  2. EMC. Apretude 600 mg prolonged-release suspension for injection. Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15696/smpc#gref. Last accessed: October 2025.
  3. Landovitz R, et al. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. The New England Journal of Medicine. 2021;385:595-608. DOI: 10.1056/NEJMoa2101016.
  4. Delaney-Moretlwe S, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. The Lancet. 2022;399(10337):1779-1789. DOI: 10.1016/S0140-6736(22)00538-4.
  5. Clinical Trials.gov - Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men. Available at: https://clinicaltrials.gov/ct2/show/NCT02720094. Last accessed: October 2025.
  6. Clinical Trials.gov - Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. Available at: https://clinicaltrials.gov/ct2/show/ NCT03164564. Last accessed: October 2025.
  7. Scottish Medicines Consortium (SMC). Medicines Advice. Cabotegravir (Apretude). Available at: https://scottishmedicines.org.uk/medicines-advice/cabotegravir-apretude-full-smc2718/. Last accessed: October 2025.
  8. Marzinke M, et al. Characterization of human immunodeficiency virus (HIV) infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. The Journal of Infectious Diseases. 224.9. 2021:1581-1592.
  9. Landovitz R, et al. Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial. The Lancet HIV. 10.12 2023:e767-e778.
  10. Eshleman S, et al. Characterization of human immunodeficiency virus (HIV) infections in women who received injectable cabotegravir or tenofovir disoproxil fumarate/emtricitabine for HIV prevention: HPTN 084. The Journal of Infectious Diseases. 225.10. 2022:1741-1749.
  11. ViiV 2024. ViV Healthcare shows more than 99% effectiveness in real-world studies for Apretude (cabotegravir long-acting), the only approved long-acting HIV PrEP, in data presented at IDWeek 2024. Available at: https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/. Last accessed: October 2025.
  12. Mills A, et al. Cabotegravir Long-Acting for Pre-Exposure Prophylaxis (PrEP): Real World Data on On-Time Dosing, HIV Testing and HIV Acquisition from the OPERA Cohort. Open Forum Infect Dis. 2025;12(Suppl1).
  13. Ramgopal M, et al. Real-world use of cabotegravir long-acting for pre-exposure prophylaxis: Data from Trio Health cohort. Presented at the Infectious Disease society of America (IDSA) IDWeek™ 2024.
  14. Traeger M, et al. Long-acting Cabotegravir PrEP Uptake and Persistence in a Large U.S. Healthcare System. Presented at CROI 2025. Available at: https://www.natap.org/2025/CROI/croi_38.htm. Last accessed October 2025.
  15. Heise M, et al. Low-barrier, rapid cabotegravir PrEP initiation and retention within a US municipal health system. Journal of the International Aids Society. Vol. 27: Special Issue: Presented at HIVR4P 2024 Oral OA0503. MHS San Franciso. Pages 13-14. Available from: https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26351. Last accessed: October 2025.
  16. Turner C, et al. Implementing long-acting cabotegravir for HIV Pre-Exposure Prophylaxis in a large academic hospital-based urban HIV clinic. Presented at HIVR4P 2024. Poster 01725. UC San Diego. Page 344. Available at: https://www.iasociety.org/sites/default/files/HIVR4P2024/abstract-book/HIVR4P-2024_Abstracts.pdf. Last accessed: October 2025.
  17. Hazra A, et al. Long-Acting Antiretroviral Therapy and PrEP. Presented at CROI 2024. Poster 1241. Available from: https://www.croiconference.org/abstract/insurance-type-drives-cabotegravir-delays-real-world-long-acting-prep-outcomes-in-the-midwest-us/. Last accessed: October 2025.
  18. UK Health Security Agency (UKHSA). HIV testing, PrEP, new HIV diagnoses and care outcomes for people accessing HIV services: 2025 report (2024 data). Available at: https://www.gov.uk/government/statistics/hiv-annual-data-tables/hiv-testing-prep-new-hiv-diagnoses-and-care-outcomes-for-people-accessing-hiv-services-2025-report. Last accessed: October 2025.
  19. Public Health England. HIV in the United Kingdom: Towards Zero HIV transmissions by 2030. 2019 report. Available at: https://assets.publishing.service.gov.uk/media/603d1dcae90e07055c1404c8/HIV_in_the_UK_2019_towards_zero_HIV_transmissions_by_2030.pdf. Last accessed: October 2025.
  20. UK Health Security Agency (UKHSA). HIV testing, PrEP, new HIV diagnoses and care outcomes for people accessing HIV services: 2024 report (2023 data). Available at: https://www.gov.uk/government/statistics/hiv-annual-data-tables/hiv-testing-prep-new-hiv-diagnoses-and-care-outcomes-for-people-accessing-hiv-services-2024-report. Last accessed: October 2025.
  21. Department of Health & Social Care. Roadmap for meeting the PrEP needs of those at significant risk of HIV. Available at: https://www.gov.uk/government/publications/roadmap-for-meeting-the-prep-needs-of-those-at-significant-risk-of-hiv/roadmap-for-meeting-the-prep-needs-of-those-at-significant-risk-of-hiv#:~:text=There%20are%20significant%20differences%20in,sex%20with%20men%20(%20GBMSM%20). Last accessed: October 2025.

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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 GSK Reporting Tool link https://gsk.public.reportum.com/. 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.