Revolutionary HIV Prevention: New Injectable Reduces Dosing Needs

Syringe needle inserted into a vial stopper.

In a significant leap forward, lenacapavir offers a revolutionary semi-annual injectable solution in the fight against HIV.

At a Glance

Two clinical trials for lenacapavir, a twice-yearly injectable preparation, have commenced.
The drug shows a 96% reduction in HIV risk, outperforming daily oral PrEP alternatives.
Challenges persist with cost and regulatory approvals for widespread use.
Welcomed as a potential game-changer, especially in high-prevalence regions.

A Novel HIV Prevention Approach

Clinical trials are currently assessing lenacapavir, a promising new option for HIV prevention that requires only biannual administration. This approach could transform current prevention strategies, shifting from daily oral medication to a long-acting injectable. The trials specifically target high-risk populations such as cisgender women and people who inject drugs.

Lenacapavir, already approved for particular HIV therapies, is being tested for safety, acceptability, and efficiency compared to oral PrEP formulations in these trials. Participants are randomly assigned to receive either the injectable or a daily oral preparation, aiming to enhance adherence and reduce the incidence of HIV.

PURPOSE-2 TRIAL: Lenacapavir is an injectable HIV medication (antiretroviral) that can be given every 26 weeks (twice yearly) to prevent HIV. We have the data in women and now this @NEJM study today summarizes data in menhttps://t.co/gQDzOFUZMM

— Monica Gandhi MD, MPH (@MonicaGandhi9) November 28, 2024

Clinical Trials and Results

The PURPOSE-2 trial highlights lenacapavir’s potential, showing a remarkable 96% decrease in HIV risk compared to daily oral PrEP. Trials reveal it is 89% more effective than the current daily oral options. The drug has received commendations for being well-tolerated, with no significant safety concerns emerging from the research data collected so far.

Cécile Tremblay, an HIV researcher at the University of Montreal, said: “Not only is lenacapavir extremely efficacious but the efficacy has been shown in a population of women in sub-Saharan Africa where the epidemic is the greatest, and oral PrEP has not performed as well due to stigma and discrimination.”

Despite the drug’s potential to simplify treatment regimens, challenges concerning cost and regulatory approvals remain. Currently, lenacapavir’s treatment cost is higher than oral PrEP options. Efforts persist to make it more accessible globally, with projected availability by 2025.

@gnpplus acknowledges the step by @GileadSciences to make generic injectable #lenacapavir for HIV prevention available in 120 countries, with some African nations prioritized for production. But this isn't enough. Treatment and prevention must be accessible to everyone, not just… https://t.co/QAWvX3ZgIL

— GNP+ (@gnpplus) October 4, 2024

Looking Forward

The global HIV prevention community views lenacapavir as a substantial advancement. WHO is working on the guidelines for its worldwide use, emphasizing affordable and equitable access. Researchers and advocacy groups recognize its groundbreaking potential for high-prevalence areas, especially where stigma diminishes the effectiveness of current treatments.

As lenacapavir secures its place in HIV prevention, it provides a beacon of hope for a future with dramatically reduced infection rates. Recognition by Science magazine as the “2024 Breakthrough of the Year” underscores its significance in addressing the global HIV/AIDS challenge.