Despite lagging global progress in HIV prevention, with 1.3 million new infections reported in 2023, a notable advancement has emerged. The U.S.Food and drug Administration recently approved lenacapavir, a novel preventative HIV treatment administered just twice yearly, offering a perhaps transformative approach to curbing the spread of the virus. Recognized as the 2024 scientific breakthrough by Science magazine,this new therapy demonstrates nearly 100% efficacy in clinical trials and could dramatically ease the burden of preventative care for those at risk.
More than 39 million people worldwide are currently living with HIV. Despite significant efforts, progress toward global targets is lagging, with 1.3 million new infections reported in 2023 – more than three times the goal of reducing that number to under 370,000 by 2025. This week, a new advancement offers renewed hope in the fight against the virus: the U.S. Food and Drug Administration (FDA) approved a novel preventative HIV treatment. This development has the potential to dramatically improve the lives of millions, provided it is accessible to those who need it most.
Effective HIV prevention methods already exist, but adherence and access remain challenges. Condoms remain the simplest and most widely available option, also providing protection against other sexually transmitted infections (STIs). They are a cornerstone of prevention, particularly among young people and in low-income countries.
Another option is pre-exposure prophylaxis, or PrEP, which involves taking a daily pill. While highly effective when taken consistently, PrEP can be limited by factors like missed doses, daily routines, and the stigma associated with taking medication for prevention.
Despite decades of research, the virus continues to spread widely. The approval of lenacapavir as a preventative treatment offers a new avenue for hope. © RAJCREATIONZS, Adobe Stock
Lenacapavir, marketed as Yeztugo, promises a potential revolution in HIV prevention: a treatment administered just twice a year with nearly 100% efficacy. The findings, published in The New England Journal of Medicine, could significantly reduce the burden of preventative medication for individuals at risk.
Two clinical trials involving over 8,000 participants demonstrated the drug’s effectiveness. In sub-Saharan Africa, none of the 2,134 women participating in the study who received lenacapavir contracted HIV. Among the 2,179 men and gender-diverse individuals included in the second trial, only two infections were detected. This surpasses the efficacy of Truvada, a commonly used oral medication to reduce the risk of HIV acquisition. Reported side effects were mild, including redness at the injection site and nausea.
The scientific journal Science recognized this advancement as the scientific breakthrough of 2024, highlighting its potential impact on global health.
“This is a historic day in the decades-long fight against HIV. Yeztugo represents one of the most significant scientific breakthroughs of our time and offers a real opportunity to help bring an end to the HIV epidemic,” said Daniel O’Day, president and CEO of Gilead Sciences.
A Promising Medication, But at What Cost?
According to a study published on June 18, 2025, in The Lancet HIV, experts estimate that generic lenacapavir could be produced for $35 to $46 per person annually. If demand reaches five to ten million people in the first year, the cost could even fall to $25 per year – comparable to, or even lower than, the cost of current oral PrEP treatments.
Gilead Sciences has already signed agreements to produce generic versions in 120 low- and middle-income countries. However, these versions will take time to reach the market. The key challenge remains ensuring this scientific advancement translates into access for all, not just those who can afford it. This is a critical step toward achieving global HIV prevention goals and reducing health disparities.
