Once a Year, Peace of Mind: How Lenacapavir Could Change HIV Prevention Forever

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It’s not every year that a single study ignites excitement across the global HIV prevention movement. But this March, at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025, held in San Francisco from 9 to 12 March, we witnessed something truly promising. A new approach to HIV prevention moved closer to reality: a once-yearly injectable medicine called Lenacapavir could soon transform how we protect people from HIV.

For those of us who have spent years advocating for better, simpler and more respectful prevention options, this is more than just a scientific milestone. It represents hope, delivered in a single injection.

A Single Shot, a Year of Protection

The data came from a Phase 1 study involving 40 HIV-negative adults, aged 18 to 55, all considered at low risk for HIV. Each participant received one injection of Lenacapavir into the buttock muscle, using either a 5% or 10% ethanol-based formulation. They were then followed for 56 weeks.

The results were impressive. Blood levels of Lenacapavir remained well above the threshold needed for HIV protection for more than a year. By week 52, the drug remained at higher concentrations than those seen with the currently available twice-yearly subcutaneous version.

This suggests we are now within reach of a once-a-year PrEP option that offers long-lasting protection while reducing the burden of clinic visits and daily pill-taking.

Safe, Tolerable and Empowering

The treatment was also shown to be safe. No serious side effects were reported during the trial. The most common issue was mild to moderate pain at the injection site, usually resolving within a few days. Some participants used ice packs before the injection, which helped reduce discomfort.

This kind of simplicity could make an enormous difference to people who face stigma, forgetfulness or inconsistent access to healthcare. For many, one injection per year offers a realistic and dignified way to stay protected.

Why Timing Matters in 2025

This development has arrived at a crucial moment. We are now 44 years into the global HIV epidemic, and although there has been significant progress, prevention efforts still leave many people behind.

In the UK, we have seen a decline in new HIV diagnoses among some groups, particularly gay and bisexual men. However, uptake of oral PrEP remains lower among Black communities, women, trans people and migrants. Globally, 1.3 million people acquired HIV in 2023, according to UNAIDS. That number remains far too high.

Gilead now plans to begin Phase 3 trials in the second half of 2025, with the hope of seeking regulatory approval by 2027. The company has also committed to offering generic versions of Lenacapavir in over 100 low- and middle-income countries, including those with the highest rates of new infections.

If delivered fairly and effectively, this could help close the gap in HIV prevention across the world.

What Advocates Must Do Now

This is a turning point, and as advocates, we must take action:

  • Ensure communities are fully informed about Lenacapavir and how it works.
  • Push for fair access and affordable pricing in every region, not just high-income countries.
  • Demand that marginalised voices are included in trials, policy discussions and rollout plans.

This is not just a new medicine. It is an opportunity to rethink how we do prevention, and who we centre in our efforts.

A Vision for 2027 and Beyond

Picture this: it is early 2027. You attend one appointment, receive your yearly Lenacapavir injection and walk out knowing you are protected. No daily pills, no stigma, no complicated routines. Just freedom and peace of mind.

That future is no longer imaginary. It is within reach, and we can help make it happen.

Final Thoughts

The excitement surrounding Lenacapavir is not just about pharmacology. It is about removing barriers and restoring agency to those who have been excluded from health systems for too long.

We now have the chance to make HIV prevention more accessible, more equitable and more humane. Scientific innovation has brought us to this point. It is our responsibility to ensure that these tools reach the people who need them most.

  

Welcome to my blog dedicated to community engagement in HIV research. Here, we delve deep into the latest advancements and discussions surrounding HIV cure, treatment, prevention, and management of advanced HIV infection. My goal is to bridge the gap between complex scientific research and community understanding, ensuring that knowledge is accessible and actionable. Join me as I explore these critical topics, engage with community insights, and contribute to the ongoing fight against HIV.

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