Once-a-year shot for HIV protection passes early safety trial

According to research published in The Lancet medical journal, an annual injection for HIV prevention has successfully passed an initial safety trial.

According to ‘LGBTQ Nation’, the drug, lenacapavir, has completed a crucial Phase I trial, potentially paving the way for it to become a highly effective and convenient option for preventing HIV. Lenacapavir functions by inhibiting HIV replication within cells. Existing PrEP methods, delivered as a daily pill or bi-monthly injections, already significantly reduce the risk of HIV transmission.

In the lenacapavir trial, 40 HIV-negative individuals received a muscle-targeted injection of the drug. No significant side effects or safety issues were observed, and the medication remained detectable in their bodies 56 weeks later.

Researchers stated, “By decreasing dosing frequency and providing an additional PrEP option for people who want or need PrEP, yearly dosing of lenacapavir has the potential to further decrease current barriers to PrEP by increasing the uptake of, persistence on, and, therefore, scalability of PrEP.”

Richard Angell from the HIV charity Terrence Higgins Trust told the BBC, “PrEP as a daily pill has been a game-changer in our HIV response. The prospect of ‘safe’ annual injectable PrEP is as exciting as it is transformational. It’s great to see these early results that suggest injectable PrEP might be effective for up to 12 months.”

Angell also highlighted access inequalities in treatment availability.

“The oral pill is still not available in prisons, online, or in community pharmacies,” he noted. “We need to get ready for its rollout now and fund sexual-health clinics to do so.”

Approximately 40 million people worldwide are living with HIV, with 65% residing in Africa, according to the World Health Organization.

Researchers emphasised at the 2025 Conference on Retroviruses and Opportunistic Infections that future trials must include a more diverse range of participants.