Researchers have reported in The Lancet medical journal that an annual injection designed to protect against Human Immunodeficiency Virus (HIV) has successfully completed a significant early safety trial.
Lenacapavir works by preventing the virus from replicating within cells.
If future trials continue to yield positive results, now that it has cleared the initial Phase I testing stage, it could become the longest-acting form of HIV prevention available.
Currently, individuals can take daily pills or receive injections every eight weeks for pre-exposure prophylaxis (PrEP) to reduce their risk of HIV infection.
PrEP tablets are highly effective, but daily adherence can be challenging for some.
According to the most recent figures from 2023, approximately 39.9 million people are living with HIV, with 65% of them residing in the World Health Organization African Region.
The WHO, Global Fund, and Joint United Nations Programme on HIV and Aids (UNAids) are all working toward strategies to end the HIV epidemic by 2030, which include improving access to medications like PrEP.
Yearly Dosing
In the trial, 40 HIV-negative individuals were administered lenacapavir via intramuscular injection, with no major side effects or safety concerns observed.
After 56 weeks, the medication was still detectable in their bodies.
Researchers emphasized the need for future trials to include a more diverse participant pool at the 2025 Conference on Retroviruses and Opportunistic Infections.
They added, “Yearly dosing of lenacapavir has the potential to further reduce existing barriers to PrEP by improving uptake, adherence, and scalability.”
‘Creating Inequalities’
Richard Angell, from the Terrence Higgins Trust HIV charity, stated, “PrEP as a daily pill has been a game-changer in our HIV response.”
“The prospect of a safe, annual injectable PrEP is both exciting and transformative.”
“It’s encouraging to see these early results indicating that injectable PrEP might be effective for up to 12 months.”
“We must prepare for its rollout now and adequately fund sexual health clinics.”
Mr. Angell highlighted that access to PrEP has been inconsistent, leading to inequalities.
“The oral pill is still not accessible in prisons, online, or in community pharmacies,” he said.
“The Scottish Medicines Consortium has finally approved two-monthly PrEP injections for use in Scotland, but we are awaiting NICE [National Institute for Health and Care Excellence] approval for use in England.”
