The Medicines and Healthcare products Regulatory Agency (MHRA)
has today (19 December 2025)
approved lenacapavir (Yeytuo) for the prevention of sexually
transmitted HIV-1 infection in adults and adolescents.
Lenacapavir works by reducing the risk of the HIV-1 virus
multiplying and spreading throughout the body if a person is
exposed to the virus.
Lenacapavir binds to the HIV-1 virus's outer layer, interfering
with the virus' ability to multiply and spread. It is
recommended to be used alongside safer sex practices, such
as condoms.
Lenacapavir is administered via a combination of tablets and
injections. It is given as an injection once every six months.
For the first dose only, people also take two days of tablets by
mouth.
Beach, Interim Executive Director
of Healthcare Quality and Access at the MHRA,
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.”
A full list of side effects can be found in the Patient
Information Leaflet (PIL) or the Summary of Product
Characteristics (SmPC), which will be published on the MHRA
website within 7 days of approval.
Anyone who suspects they are having a side effect from this
medicine is encouraged to talk to their doctor, pharmacist or
nurse.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of
the benefit/risk balance of the medicinal product.
Report any suspected adverse reactions to the MHRA Yellow Card
scheme, either through the website (https://yellowcard.mhra.gov.uk)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
