UK approves Gilead’s twice-yearly HIV prevention shot, Yeytuo

UK—Gilead Sciences’ long-acting HIV prevention treatment, lenacapavir, has received approval in the United Kingdom as a pre-exposure prophylaxis (PrEP) option, offering adults and adolescents a twice-yearly injection to reduce their risk of contracting HIV-1.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) authorised the drug as a preventive measure against sexually transmitted HIV-1, marking a new milestone in long-acting HIV protection.

Sold under the brand name Yeytuo in the UK and across Europe, the injectable formulation of lenacapavir is administered once every six months.

The same compound was previously approved in 2022 under the brand name Sunlenca for treating HIV infection in combination with other antiretroviral therapies.

With this latest authorisation, individuals now have access to a long-acting option for prevention rather than daily pill-based regimens.

According to government data, there were 6,402 new HIV diagnoses in the UK in 2023, with 107,949 people receiving HIV care during the year.

The UK government aims to halt new HIV transmissions and eliminate AIDS-related deaths by 2030.

The approval of Yeytuo as a preventive option aligns with this goal and follows similar decisions in the United States and Europe earlier in 2025.

In June, the US Food and Drug Administration (FDA) approved the same treatment under the name Yeztugo, while the European Commission (EC) granted marketing authorisation for Yeytuo in August.

Lenacapavir works by binding to the outer envelope of HIV-1, disrupting multiple stages of the viral lifecycle and reducing its ability to multiply and spread after exposure.

The MHRA recommends using Yeytuo alongside safe sex practices, such as condoms, to enhance protection.

Julian Beach, interim executive director of healthcare quality and access at the MHRA, noted that Yeytuo introduces a long-acting option that “blocks the virus from multiplying if exposure occurs,” providing a valuable choice alongside existing preventive measures.

Despite its regulatory approval, it remains uncertain whether the National Health Service (NHS) will make Yeytuo available to patients.

The National Institute for Health and Care Excellence (NICE) has scheduled a provisional meeting for March 2026 to discuss reimbursement.

NICE has yet to comment on the ongoing evaluation process.

Dr. Paul Martin, chief executive of the LGBT Foundation, described the approval as “a game-changer for HIV prevention,” emphasising that Yeytuo offers people “more choice, more control, and more hope.”

However, he stressed the importance of national collaboration and sustained investment to achieve the 2030 goal.

While the drug’s innovation has been widely praised, concerns remain about its affordability. The US list price for Yeztugo is USD 28,218 per patient annually.

To address accessibility in high-risk regions, Gilead has authorised generic manufacturing in 120 low- and middle-income countries.

Earlier in 2025, the World Health Organization (WHO) endorsed lenacapavir as an effective and convenient preventive treatment, calling it the “next best thing” after a vaccine.

The UK approval coincides with Gilead’s participation in a drug pricing agreement with the Trump administration, under which the company will reduce the price of its Hepatitis C treatment Epclusa (sofosbuvir/velpatasvir) from USD24,920 to USD2,425 for direct purchases through TrumpRx.

In addition, Gilead agreed to provide Yeztugo for up to two million people in the US under a partnership with the State Department and the President’s Emergency Plan for AIDS Relief (PEPFAR).

GlobalData projects that lenacapavir, marketed under various brand names, will generate USD5.3 billion in global revenue by 2031.