The European Union has given the green light to Yeytuo, an injectable treatment that promises to mark a before and after in the fight against HIV. Its active ingredient, lenacapavir, is administered only twice a year and is intended for adults and adolescents at high risk of infection.
It is the first pre-exposure prophylaxis (PrEP) to be administered biannually available in all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. A novelty that not only facilitates adherence, but also raises questions: will this format be the key to reaching those who until now did not have access to daily prevention?
Why is it important?
Every year around 25,000 new HIV infections are diagnosed in the EU and the European Economic Area. Despite progress, traditional prevention options have not been able to cover all realities, especially in more vulnerable communities.
Yeytuo seeks to respond to this need with a simpler scheme: a dose every six months instead of the daily pill. According to Professor Jean-Michel Molina (Université Paris Cité), this could be the transformative tool that allows us to reduce new infections and move towards the end of the epidemic in Europe.
What clinical trials say
The approval is supported by the international studies Purpose 1 and Purpose 2, in which thousands of people from different profiles and regions participated. The results have been overwhelming:
- In Purpose 1, none of the 2,134 cisgender women in sub-Saharan Africa who received lenacapavir contracted the virus.
- In Purpose 2, only two infections were recorded among 2,179 people, which is equivalent to 99.9% effectiveness in cisgender men and gender diverse people.
- In both cases, the therapy was well tolerated and without relevant safety problems.
The data was so strong that Science magazine named this strategy the Scientific Breakthrough of the Year in 2024.
A look beyond Europe
The European Commission’s move comes after the US FDA approved the drug and the WHO included it in its guidelines as an additional PrEP option.
Gilead, the company behind Yeytuo, is now working on a global strategy to expand access in low- and middle-income countries, many of them with a very high HIV burden. Through programs such as EU-Medicines for all (EU-M4all) and voluntary licensing agreements, it is intended that this advance is not restricted to regions with greater resources.
An open question
The speed of authorization reflects the potential of Yeytuo, but also reminds us that no tool is sufficient on its own. Prevention continues to depend on social, cultural and economic factors that go beyond medication.
Perhaps the most relevant question is not just whether Yeytuo works, but how we actually get it to those who need it.
