The European Medicines Agency's (EMA) advisory committee has issued a positive opinion on lenacapavir for pre-exposure prophylaxis (PrEP), marking the final regulatory hurdle before formal approval by the European Commission later this year. The drug, developed by US pharmaceutical company Gilead Sciences, represents a significant advancement in HIV prevention as the first twice-yearly injection for this indication.
Revolutionary Efficacy and Dosing Schedule
Lenacapavir demonstrated 100% efficacy in preventing HIV transmission during clinical trials, a milestone that has generated significant optimism among healthcare professionals and advocacy groups. The long-acting PrEP injection is administered just twice annually, offering a substantial improvement over current daily pill regimens.
"This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world," said Dr. Dietmar Berger, Gilead Sciences' Chief Medical Officer. "Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care."
Novel Mechanism of Action
Lenacapavir functions as a capsid inhibitor, representing a novel class of antiretrovirals that works by blocking the HIV virus from replicating and spreading throughout the body. As a form of PrEP, it provides protection for HIV-negative individuals at high risk of infection.
The twice-yearly dosing schedule addresses a critical challenge in HIV prevention efforts: medication adherence. The EMA emphasized this advantage, noting that "PrEP is very effective at preventing infections if taken as prescribed. However, uptake and adherence are often suboptimal because access to some medicines is limited, and other available medicines require strict daily intake."
Addressing Rising European HIV Cases
The regulatory approval comes at a critical juncture for European public health. Despite major advances in prevention and treatment, HIV cases have been rising across Europe. In 2023, there were more than 24,700 new diagnoses in the European Union, Iceland, Liechtenstein, and Norway—representing an 11.8% increase from the previous year.
Public health experts anticipate that the availability of a more convenient and longer-lasting prevention option will help reverse this concerning trend. The World Health Organisation reports that HIV still affects an estimated 40.8 million people globally, with 630,000 people dying from AIDS-related illnesses in 2023 alone.
Global Access and Implementation Challenges
While the European approval and recent FDA authorization signal regulatory momentum, questions persist regarding global access to lenacapavir, particularly in low-income countries where HIV rates are highest. Gilead has committed to making generic versions of the drug available in 120 low-income countries, a move welcomed by global health advocates.
However, concerns remain about the speed and scope of this rollout, especially following the United States' reduction in funding for international HIV programs earlier this year. Dr. Michel Sidibé, former executive director of UNAIDS, cautioned that "a breakthrough drug is only a breakthrough if the people who need it can get it. We must ensure that innovations like lenacapavir don't become luxuries for the Global North while the Global South continues to struggle."
Target Populations and Public Health Impact
Experts note that the twice-yearly injection could be particularly effective for young people, sex workers, men who have sex with men, and other groups who face stigma or logistical barriers to daily pill regimens. The convenience factor may significantly improve prevention uptake among these high-risk populations.
"This is more than a scientific breakthrough—it's a public health opportunity," said Dr. Andrea Ammon, director of the European Centre for Disease Prevention and Control (ECDC). "We must now focus on ensuring that the people most at risk can benefit from this innovation without delay."
Implementation and Future Outlook
As lenacapavir moves toward formal approval by the European Commission, attention shifts to implementation, accessibility, and equity considerations. Health systems across Europe must prepare to integrate this innovation into existing HIV prevention strategies, while global health advocates continue pushing for broader distribution in low-income regions.
The convenience of twice-yearly injections, combined with demonstrated near-total efficacy, positions lenacapavir as a potential cornerstone of the next phase in global HIV control. However, ensuring equitable access across all populations will determine the true measure of this breakthrough's success in the ongoing battle against HIV.
