The European Medicines Agency (EMA) has formally approved the use of lenacapavir as pre-exposure prophylaxis (PrEP) against HIV. The decision marks a major milestone, as it is the first and only twice-yearly injectable PrEP option to be approved for use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.
How does this innovation help?
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Reduced treatment burden: Instead of taking pills every day, just two injections a year are enough to maintain protection against HIV.
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High efficacy: Clinical trials have demonstrated an efficacy rate very close to 100%.
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International recognition: The World Health Organization recommends its use as an additional preventive option against HIV.
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Regulatory progress: In Europe, the evaluation process was fast-tracked, and an additional year of market protection was granted after it was shown to provide a “significant clinical benefit” compared to existing therapies.
Who is it for?
The European authorisation covers its use in adults and adolescents who are HIV-negative, at high risk of sexual exposure, and weighing at least 35 kg.
Lenacapavir is not a vaccine but a long-acting antiretroviral, and it should be used as part of a comprehensive prevention strategy that also includes other methods, such as condom use and regular testing.
In Spain and other European countries, availability will still depend on price and reimbursement agreements with national healthcare systems.
Challenges and future directions
Although this approval marks a significant step forward, several challenges remain:
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Accessibility and cost: Its price will be a key factor in whether it’s actually adopted by health systems.
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National negotiations: Each country will need to set its own conditions for reimbursement and distribution.
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Adapting to local contexts: This long-acting form of PrEP may be especially beneficial for individuals who face difficulties adhering to daily medication schedules or who live in areas with limited healthcare access.
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Monitoring and real-world data: Monitoring its real-world effectiveness, adherence, side effects, and social acceptance will be essential.
In conclusion, the approval of lenacapavir as a twice-yearly PrEP option in Europe marks a significant advancement in HIV prevention. It reduces the treatment burden for users while offering a more convenient, effective, and promising option for those at risk.
However, the extent of its impact will rely on the rapid and cost-effective integration within healthcare systems. It is still uncertain when and how patients in Spain and other countries will have access to it, as well as how it will be combined with existing prevention approaches.
INFORMATION DOCUMENTED BY:
Dr Josep Mallolas, internist, Head of the HIV/AIDS Unit at Hospital Clínic Barcelona.
