Lenacapavir: a twice-yearly injection to prevent HIV, approved in the US and the EU

On 18 June 2025 the US Food and Drug Administration (FDA) approved lenacapavir, sold as Yeztugo, to reduce the risk of sexually acquired HIV. The medicine, developed by Gilead Sciences, is indicated for adults and adolescents weighing at least 35 kg who are at risk of infection. It is a form of pre-exposure prophylaxis (PrEP) given as an injection under the skin once every six months; at the start, the first injection is accompanied by tablets for two days.

What the trials showed

The approval rested on two phase 3 trials. In PURPOSE 1, among women in sub-Saharan Africa, there were no HIV infections among the 2,134 participants who received lenacapavir. In PURPOSE 2, among men and gender-diverse people, there were two infections among 2,179 participants, meaning 99.9% did not acquire HIV. In both trials lenacapavir was superior to the daily PrEP pill.

WHO and the European Union

On 14 July 2025 the World Health Organization recommended injectable lenacapavir as an additional PrEP option, especially for people who struggle with daily pills, face stigma or have limited access to health care. WHO also recommended HIV rapid tests to make delivery simpler. In Europe, the scientific committee of the European Medicines Agency (EMA) gave a positive opinion on 24 July 2025 after an accelerated assessment. On 25 August 2025 the medicine received an authorisation valid throughout the European Union, under the name Yeytuo.

What it means for patients now

Lenacapavir is not a vaccine and does not treat an existing infection. A negative HIV test is required before the first dose and before every injection: if someone with undiagnosed HIV receives it, the virus can become resistant. The most common side effects reported were injection-site reactions, headache and nausea. The drug can remain in the body for 12 months or longer after the last injection.

The European authorisation is also valid in Romania, but that does not automatically mean the medicine is already available here: decisions on pricing and reimbursement are taken at national level. If PrEP is relevant to you, discuss the available options with an infectious-disease specialist.

What we don't know yet

WHO said access outside clinical trials is limited for now and called for data on uptake, adherence and real-world impact. It remains to be seen how easily the six-monthly visits and the required HIV tests can be organised in everyday practice.