The New Game-Changer In HIV Prevention: What Makes Lenacapavir Unique?

Lenacapavir might be the innovative solution the global community needs in the fight against HIV, but will it overcome accessibility challenges?

At a Glance

Clinical trials for lenacapavir, a long-acting HIV PrEP injection, have started.
Lenacapavir is effective in reducing HIV risk and outperforms daily oral PrEP.
Regulatory review continues, with full approval for prevention pending.
Challenges remain with cost, but efforts are underway for global accessibility.

The Emergence of Lenacapavir in HIV Research

Lenacapavir represents a transformative advance in preventing HIV. Clinical trials have been launched to evaluate lenacapavir’s effects on cisgender women and individuals who inject drugs, two groups often underrepresented in HIV studies. The drug, approved for treating multi-drug-resistant HIV in specific cases, offers a new means of pre-exposure prophylaxis via a biannual injection. These trials will examine the drug’s safety, acceptability, and metabolic processes.

Participants in the trials will either receive lenacapavir or a daily oral PrEP. The PURPOSE-2 trial showed a remarkable 96% reduction in HIV risk among those using lenacapavir. With an advantage over the conventional oral TDF/FTC approach, lenacapavir stands out, having an 89% greater efficacy than the daily alternative. The medication’s twice-yearly dosing appeals particularly to individuals who struggle with daily adherence, offering a new path in HIV prevention.

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

A Game-Changer in the Global Health Arena

Lenacapavir has demonstrated significant promise in HIV prevention, gaining accolades such as the 2024 Breakthrough of the Year by Science magazine. A WHO representative noted this development as “a pivotal step toward diminishing HIV/AIDS as a global health crisis.” Yet, the challenge lies in obtaining approval for its preventive use in several jurisdictions, despite its prior approval for treatment use in the U.S.

According to Cécile Tremblay, HIV reseacher at the University of Montreal: “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.”

Addressing barriers faced globally, lenacapavir offers a viable option versus oral PrEP, whose adherence is hampered by societal factors, such as stigma. By presenting an alternative, lenacapavir could substantially alter efforts to combat HIV, particularly in regions like sub-Saharan Africa where prevalence remains high.

We are investing $22M to accelerate access to lenacapavir, a groundbreaking long-acting HIV prevention drug. With just 2 injections a year, it offers a gamechanging solution for those most at risk. Together, we can transform HIV prevention.

Learn more: https://t.co/wx37t5ak34 pic.twitter.com/t2N1wZbUXr

— Unitaid (@UNITAID) November 30, 2024

The Challenge of Access and Cost

One of the significant hurdles for lenacapavir is its cost, markedly higher than current oral PrEP options. However, the potential market introduction by 2025 is focusing on broader accessibility, aiming for affordability through collaborations with global health organizations. WHO is in the process of crafting guidelines for lenacapavir’s use, ensuring structured methods for its adoption.

Ethel Weld, assistant professor of medicine at the Johns Hopkins University School of Medicine, called the breakthrough “a thrilling game changer for HIV prevention.”

In essence, lenacapavir brings to light the intersection of scientific progress and public health policy, spotlighting the need for effective resource distribution. As we look towards promising solutions, attention must be paid to overcoming accessibility issues, enabling a wider impact of HIV prevention strategies globally.