Innovative HIV Prevention Strategy Revolutionizing Long-Acting Treatments

Syringe needle inserted into a vial stopper.

Lenacapavir is redefining HIV prevention with its promise of twice-yearly dosage.

At a Glance

Lenacapavir has shown a 96% reduction in HIV risk in recent trials.
The drug is administered every six months.
Worldwide, efforts are being made to make it more accessible by 2025.
Current trials focus on underrepresented populations.

Clinical Trials and Effectiveness

Two clinical trials are currently evaluating lenacapavir’s efficacy as a long-acting HIV pre-exposure prophylaxis (PrEP) injection. The trials target cisgender women and people who inject drugs, groups that are often underrepresented in HIV research, aiming to examine the safety and pharmacokinetics of the drug. Lenacapavir was shown to provide a 96% reduction in HIV risk and was 89% more effective than daily oral TDF/FTC in prevention.

The PURPOSE-2 trial’s promising results have positioned lenacapavir as a potential game changer in the global fight against HIV/AIDS. Participants have been randomly assigned to receive lenacapavir or an oral PrEP, yielding significant insights into its effectiveness and tolerability.

Speed, scale and equity are needed to translate injectable lenacapavir for #HIV #PrEP into impact — and today's licensing announcement from @GileadSciences is a step in the right direction — but lots more to be done: https://t.co/1vVTAdiv62

— AVAC (@HIVpxresearch) October 2, 2024

Challenges and Accessibility

Despite its promising potential, the cost and accessibility of lenacapavir remain challenges. Its current treatment cost is significantly higher than oral PrEP options. Advocacy groups and health organizations are working together to address these barriers and ensure equitable access globally, with a prospective market launch aimed for 2025. The drug has been highlighted as providing an alternative to daily oral PrEP, which has often faced adherence issues due to stigma and other barriers.

Efforts are being made to overcome the challenges associated with cost by involving international partners who can assist in making this medical breakthrough affordable and widely available. WHO is in the process of developing guidelines for lenacapavir’s use in HIV prevention, ensuring it becomes accessible to those who need it most.

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

Future Outlook

Lenacapavir, named the 2024 Breakthrough of the Year by Science magazine, is considered “a pivotal step toward diminishing HIV/AIDS as a global health crisis.” The drug’s twice-yearly dosing is particularly advantageous for those who struggle with daily oral PrEP, overcoming significant adherence hurdles and contributing significantly to HIV prevention strategies. Researchers believe it represents a major leap forward in medical science that could have a profound impact on global health efforts.

“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,” said Cécile Tremblay, HIV researcher at the University of Montréal.

As lenacapavir continues its journey through clinical trials and regulatory reviews, its success could mark a transformative moment in HIV prevention, offering new hope to millions worldwide and heralding a new era in managing and potentially ending HIV/AIDS.