ViiV Healthcare, a specialist HIV company, has announced that the National Institute for Health and Care Excellence (NICE) has issued positive final guidance recommending its long-acting HIV prevention treatment, Apretude (cabotegravir), for eligible patients in England and Wales.
Founded in 2009 by GSK and Pfizer, with Shionogi joining as a shareholder in 2024, ViiV Healthcare focuses on developing innovative treatments for HIV and AIDS. The long-acting formulation of Apretude is manufactured at GSK’s facility in County Durham.
Following the NICE recommendation, Apretude will be made available via the NHS in England and Wales as a 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 are unable to take oral PrEP.
The therapy is the first and only injectable PrEP option available on the NHS. It was previously approved for use in NHS Scotland by the Scottish Medicines Consortium (SMC) earlier this year.
Support for the recommendation was underpinned by several years of clinical data. A blinded post-hoc analysis of two head-to-head trials comparing Apretude with the current standard of care – daily oral tenofovir disoproxil fumarate/emtricitabine – found statistically significant reductions in HIV acquisition rates among participants receiving Apretude.
These findings were further supported by six real-world evidence studies, which demonstrated the treatment’s effectiveness in preventing HIV and confirmed a well-tolerated safety profile across trial populations.
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.”