By Gift Briton
The once-a-year injectable pre-exposure prophylaxis (PrEP), Lenacapavir, has shown promising results in a recent Phase 1 clinical trial.
The trial involved 40 healthy adults aged between 18 and 55 years. Participants received a single intramuscular dose of Lenacapavir.
For 56 weeks, researchers monitored the drug’s safety and movement through the body. According to the trial, Lenacapavir was well tolerated and remained in the body at effective levels for the entire period.
Adherence to daily PrEP regimens has been a significant hurdle in HIV prevention. Unlike current PrEP options, which require daily pills or injections every two months, this new injection aims to protect with just one dose per year. This could make it easier for people at risk to stay protected.
According to the 2024 UNAIDS report, only 3.5 million of the 21.2 million people who could benefit from PrEP were receiving it. The burden of daily medication contributes significantly to this gap.
Experts argue that expanding options for PrEP, such as a potential once-a-year injection, can help overcome current barriers to access and adherence and drive progress toward reducing new HIV infections.
Lenacapavir was first developed as an antiretroviral medication used to treat HIV (in combination with other HIV medications). A twice-yearly lenacapavir for PrEP injection is currently under an accelerated review with the US Food and Drug Administration (FDA) with a decision anticipated in June 2025. While the once-yearly formulation is still under investigation, these regulatory advancements indicate a positive trajectory for lenacapavir’s role in HIV prevention.
