Medicines regulator approves new HIV medicine

Lenacapavir, a medicine for the prevention of HIV-1 in adults and adolescents, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

Lenacapavir works by reducing the risk of the HIV-1 virus multiplying and spreading in the body if someone who has been exposed to the virus.

It binds to the HIV-1 virus’s outer later, disrupting its ability to multiply and spread. It is recommended to be used alongside safer sex practices, such as using condoms.

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Lenacapavir is administered through a combination of tablets and injections. It is given as an injection once every six months and for the first dose only, people also take two days of tablets by mouth.

Interim executive director of healthcare quality and access at the MHRA, Julian Beach, said: ‘The approval of Lenacapavir marks the introduction of a 6-monthly long-acting preventative option for sexually transmitted HIV-1 infection.

‘Blocking the virus from multiplying if exposure occurs, Lenacapavir offers an additional choice alongside existing safer sex practices. As with all licensed medicines, we will continue to monitor its safety and effectiveness closely as it becomes more widely used.’

The approval was granted on 19 December 2025 to Gilead Sciences LTD, and any suspected adverse reactions should be reported for the MHRA Yellow Card Scheme.

In October, it was announced that a new long-acting injection would be offered to around 1,000 people at risk of HIV on the NHS.

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The cabotegravir injection would be available to people who could not have pre-exposure prophylaxis (PrEP) tablets – such as those who have difficulty adhering to a daily oral PrEP regimen or who have kidney issues – following approval by the National Institute for Health and Care Excellence (NICE).

NHS England said the rollout would bring the NHS ‘one step closer’ to being the first country in the world to end HIV transmissions – a goal hoped to be achieved by 2030.

In the same month, the latest UK Health Security Agency (UKHSA) data showed that HIV diagnoses fell by 4% from 2023 to 2024 – ‘encouraging progress’ in efforts to reduce transmission.

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However, access to Pre-Exposure Prophylaxis (PrEP) – a medicine taken by people at risk of HIV to prevent them from developing the disease – varied across different demographics.

The highest uptake of PrEP was among white (79.4%) and ethnic minority (77.8%) men who have sex with men, while Black African heterosexual women (34.6%) and men (36.4%) had much lower uptake rates.