Lenacapavir: FDA Approves Twice-Yearly HIV Prevention Injection

The US Food and Drug Administration has approved Lenacapavir, a long-acting drug for HIV prevention. This medication requires only two injections per year and offers nearly complete protection against HIV. The World Health Organization has welcomed this decision, highlighting it as a significant step in global efforts to prevent new HIV infections and provide treatment to all affected individuals.

Despite decades of progress in HIV treatment, over a million new cases are reported annually. A highly effective vaccine remains unavailable. Pre-exposure prophylaxis (PrEP) drugs have existed for years but require daily intake, which many find challenging to maintain consistently.

Clinical Trials and Effectiveness

Lenacapavir has shown remarkable results in clinical trials, reducing the risk of HIV infection by over 99.9% in adults and adolescents. Gilead Sciences conducted two major trials: one with over 2,000 women in Sub-Saharan Africa, resulting in a 100% reduction in infections, and another involving more than 2,000 men and gender-diverse individuals, where only two infections were recorded.

"This is a historic day in the fight against HIV," stated Daniel O'Day, Chairman and CEO of Gilead Sciences. "The drug needs to be administered only twice a year and has demonstrated excellent outcomes in clinical studies," he added.

Cost Concerns

Although Gilead has not disclosed the price of Lenacapavir, analysts estimate that the annual cost for US patients could reach $25,000. There are calls for Gilead to significantly reduce the price to help end the HIV epidemic. Andrew Hill from Liverpool University noted that even high-income countries might struggle to afford Lenacapavir if it costs more than $20,000 annually.

UN Under-Secretary-General Winnie Byanyima expressed concerns about the pricing: "Charging a thousand times more for a drug capable of ending an epidemic is unacceptable." She emphasized that such expensive medications cannot eradicate AIDS.

The approval of Lenacapavir marks an important milestone in combating one of the world's most severe public health challenges caused by the HIV virus. While efforts continue globally to make treatments accessible to everyone living with HIV, this development brings hope for better prevention strategies.