Quote from Alex bobby on July 26, 2025, 3:54 AM

EU Regulators Green-light Twice-Yearly HIV Injection, Hailed as Medical Breakthrough

In a significant leap forward in the fight against HIV, European regulators have given the green light to a twice-yearly injection that could transform the way the virus is prevented. The drug, lenacapavir, developed by US pharmaceutical company Gilead Sciences, is being hailed as one of the most important medical breakthroughs of 2024.

The European Medicines Agency’s (EMA) advisory committee issued a positive opinion on lenacapavir for pre-exposure prophylaxis (PrEP) on Friday, marking the final regulatory hurdle before formal approval by the European Commission later this year.

A Game-Changer in HIV Prevention

Lenacapavir is a long-acting PrEP injection that is administered just twice a year, offering an alternative to the daily pills currently required for HIV prevention. In clinical trials, the drug demonstrated 100% efficacy in preventing HIV transmission, a stunning milestone that has ignited hope among healthcare professionals, advocacy groups, and at-risk populations.

“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.”

How Lenacapavir Works

Lenacapavir is a capsid inhibitor, 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 offers protection for individuals who are HIV-negative but at high risk of infection.

The twice-yearly dosage reduces the burden of daily medication adherence, which has long been a challenge in HIV prevention efforts. The EMA emphasised this point in a statement, 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.”

Rising HIV Cases in Europe

The breakthrough comes at a critical moment. 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—an 11.8% increase from the previous year.

Public health experts hope that the availability of a more convenient and longer-lasting prevention option will help reverse that trend. The World Health Organisation (WHO) reports that HIV still affects an estimated 40.8 million people globally, and 630,000 people died from AIDS-related illnesses in 2023 alone.

Global Access and Equity Concerns

While the approval in Europe and the recent green-light by the US Food and Drug Administration (FDA) signal momentum, questions remain about 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 persist about whether this rollout will be fast or far-reaching enough, especially after the United States cut back its funding for international HIV programs earlier this year.

Dr. Michel Sidibé, former executive director of UNAIDS, warned 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.”

A Turning Point in the HIV Epidemic?

The approval of lenacapavir has reignited optimism that an end to the HIV epidemic is within reach—but only if prevention and treatment can be equitably accessed and sustained. Experts note that a 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.

"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."

Looking Forward

As lenacapavir moves toward formal approval by the European Commission, the focus now shifts to implementation, accessibility, and equity. Health systems across Europe must prepare to integrate this innovation into existing HIV prevention strategies, while global health advocates push for broader distribution, especially in low-income regions.

If delivered effectively, lenacapavir could usher in a new era of HIV prevention—one where convenience and efficacy remove some of the greatest barriers to protection. But ensuring that this breakthrough reaches everyone who needs it will be the true measure of its success.

Conclusion

With lenacapavir’s European approval on the horizon, the future of HIV prevention could soon look dramatically different. The convenience of twice-yearly injections, combined with near-total efficacy, makes this drug a potential cornerstone of the next phase in global HIV control.

But science alone won’t end the epidemic. It will require political will, equitable access, and sustained investment to turn this medical marvel into a tool for widespread impact. As Europe prepares for rollout and other regions watch closely, the hope is that lenacapavir will mark not just a new chapter in medicine—but a decisive turn in humanity’s decades-long battle against HIV.

Meta Description:
EU regulators approve lenacapavir, a twice-yearly HIV prevention shot hailed as a medical breakthrough. Here’s how it works, and why it could change the future of HIV prevention.