The FDA has approved lenacapavir, marketed as Yeztugo, a groundbreaking drug that provides nearly complete protection against HIV with just two injections per year.

Clinical trials, known as PURPOSE 1 and PURPOSE 2, showed that almost all participants receiving lenacapavir remained HIV-negative, achieving a 100% reduction in infections compared to traditional daily oral PrEP options.

Despite its promise, only about 400,000 Americans currently use some form of PrEP, highlighting significant barriers to uptake, including stigma and low awareness.

Concerns have been raised regarding the potential high cost of Yeztugo, with estimates suggesting a launch price of around $25,000 per year in the U.S., which could limit accessibility, especially in low-income countries.

Gilead is committed to making lenacapavir accessible through patient assistance programs and partnerships with telehealth services, aiming to reduce costs for eligible patients.

However, challenges remain in ensuring equitable distribution, particularly for marginalized populations who may not benefit from the drug without substantial outreach efforts.

Public health experts warn that systemic healthcare issues, including funding cuts to HIV programs, may hinder the effective rollout of lenacapavir.

Winnie Byanyima, head of UNAIDS, has called for a global rollout of lenacapavir, referring to it as a 'miracle tool' that could revolutionize preventive treatment and potentially lead to the end of AIDS.

Healthcare professionals emphasize the need for broader access to effective PrEP options like lenacapavir, particularly for vulnerable populations such as women and marginalized communities.

Real-world monitoring and ongoing data collection will be essential post-approval to ensure lenacapavir meets diverse community needs and improves accessibility.

Experts believe that lenacapavir could significantly enhance PrEP uptake and persistence, addressing barriers faced by those on more frequent dosing regimens.

Overall, while lenacapavir represents a significant advancement in HIV prevention, its success will depend on overcoming financial, infrastructural, and outreach challenges.