ViiV's bimonthly HIV PrEP jab cleared for use by NHS

An injectable form of HIV pre-exposure prophylaxis (PrEP) developed by GSK's ViiV Healthcare unit will be offered by the NHS in England and Wales, ending a disparity in access within the UK.

Reimbursement authority NICE has said that Apretude (cabotegravir) can now be used as an alternative to daily oral PrEP pills to reduce the risk of sexually acquired HIV in adults and young people at high risk of getting infected, for example because they have an HIV-positive partner.

That brings the two UK nations into line with Scotland, where Apretude has been available via the NHS since February. The drug was approved by the UK medicines regulator, the MHRA, in May 2024 as the first injectable product for HIV PrEP.

Another injectable option, Gilead Sciences' twice-yearly lenacapavir, has been approved in the US and EU as Yeztugo and Yeytuo, respectively. It has not yet been submitted for approval in the UK, although a filing is expected this year.

Apretude, given as an injection every two months, can now be used by an estimated 1,000 people at risk of HIV who need PrEP but cannot have pills to protect them from the virus, according to NICE.

It said the new option addresses a "critical gap" for people who cannot take daily medication due to contraindications, difficulty swallowing tablets, or other challenges to adherence like partner violence or homelessness.

Apretude will play a role in helping the NHS in England meet the target of ending new HIV cases by 2030, said Health and Social Care Secretary Wes Streeting, who pointed to the progress being made towards that goal with PrEP use rising 8% this year.

More than 111,000 people accessed PrEP in sexual health clinics in England during 2024, according to the latest HIV surveillance data published by the UK Health Security Agency (UKHSA).

"England will be the first country to end HIV transmissions by 2030," Streeting pledged, adding: "This breakthrough treatment is another powerful tool in our arsenal to reach that crucial goal."

The rollout of Apretude is expected to begin up to three months after NICE publishes final guidance later this year.

The decision was welcomed by Richard Angell, chief executive of the Terrence Higgins Trust, who said the injectable will be "transformative for our HIV response" because it is "a vital tool for tackling inequalities – with the potential to reach those who are not currently accessing other HIV prevention."

He also called for the government to explore the delivery of PrEP in settings outside of sexual health services.