HIV Prevention Drug Could Be a Game-Changer, But Price Concerns Remain

A potentially revolutionary drug could soon become available in the United States, promising to halt the HIV pandemic. However, the anticipated cost of this groundbreaking medication has sparked significant worry, as it might limit access to those most in need, risking its potential impact on global health.

The Promise of Lenacapavir

The medication, lenacapavir, is administered as a bi-annual injection. Clinical trials suggest it effectively prevents HIV infection. While official U.S. regulatory approval is pending, the manufacturer, **Gilead**, is urged to price it affordably. The drug is already approved in some countries.

Despite the current price estimations that place it around $25,000 annually, research indicates the drug could be manufactured for just $25 per year, including a profit margin. The dramatic difference in cost raises urgent concerns.

“Even high-income countries will not be able to afford wide scale use of lenacapavir at prices above $20,000 a year.”

—Dr. Andrew Hill, Researcher

In 2023, there were approximately 1.3 million new HIV infections worldwide. Considering that, according to UNAIDS, about 10 million individuals require HIV prevention drugs, the price will play a critical role in global health. The possibility that new infections could be averted is a motivating factor.

Pricing Discrepancies and Access Concerns

Independent analysis suggests lenacapavir could be mass-produced for significantly less than its expected retail price. The discrepancy between the potential manufacturing cost and the anticipated market price has led to widespread criticism. The executive director of UNAIDS, **Dr. Winnie Byanyima**, has expressed her concerns.

“To charge 1,000 times more for a medicine with pandemic-ending potential would be abhorrent. We cannot end Aids with medicines that are so costly.”

—Dr. Winnie Byanyima, UNAIDS Executive Director

The situation could be particularly dire in low- and middle-income countries, where access to essential medicines is already a significant challenge. The World Health Organization reports that approximately 29.8 million people living with HIV are accessing antiretroviral therapy as of the end of 2022. The pricing of this medication will determine how quickly this number is impacted.

Gilead’s Stance and Future Prospects

**Gilead** has established agreements with generic manufacturers to facilitate the production of affordable versions in over 120 low-income countries. However, campaigners have pointed out that certain regions, like Brazil and parts of Eastern Europe, are excluded. **Gilead** aims to make lenacapavir for prevention available to a large global population, with a focus on the areas where the need is greatest.

While **Gilead** states they understand the importance of affordable access, they acknowledge the high research and manufacturing investments. Pricing decisions will also take into account the extensive research and development efforts, to offer lenacapavir at scale.