FDA Approves Groundbreaking HIV Prevention Injection

A Game-Changer in HIV Prevention Emerges

The U.S. Food and Drug Administration (FDA) has approved a twice-yearly injection by **Gilead Sciences** to prevent HIV. The company heralds this as a substantial breakthrough in combating the sexually transmitted virus. This new preventative measure may reshape the fight against HIV globally.

Preventative drugs, known as pre-exposure prophylaxis or PrEP, have been available for more than ten years. However, the requirement of a daily pill has limited their impact on worldwide infections. This new injection presents a less frequent option.

“This is a historic day in the decades-long fight against HIV,”

—Daniel O’Day, Gilead chairman and chief executive

The injection, named Yeztugo (lenacapavir), has demonstrated remarkable efficacy. It diminishes the risk of HIV transmission by over 99.9% in both adults and adolescents. This positions it as almost as effective as a potent vaccine. The company’s trials showed impressive results.

Trial Successes and Results

The first trial involved over 2,000 women in sub-Saharan Africa, leading to a complete elimination of infections, outperforming the daily oral pill Truvada. The second trial included over 2,000 men and gender-diverse individuals, with a 99.9% prevention rate, again exceeding Truvada’s performance. Side effects, such as injection site reactions, headaches, and nausea, were documented.

The findings, published in The New England Journal of Medicine, led to lenacapavir being named the “Breakthrough of the Year” by the journal Science.

Price Concerns Emerge

Despite its promise, concerns about the drug’s high cost may temper enthusiasm. An earlier long-acting HIV prevention shot, cabotegravir, injected every two months and approved by the FDA in 2021, costs tens of thousands of dollars annually and hasn’t significantly impacted global figures.

Analysts predict the US launch cost of Yeztugo could reach $25,000 yearly, though **Gilead** has not disclosed the final price. The current list price for lenacapavir’s previously approved use as an HIV treatment is $39,000 per year, which is expected to drop for preventative use. Activists are urging **Gilead** to lower prices to help end the HIV pandemic.

Recent data indicates that approximately 1.3 million people globally are living with HIV, highlighting the urgent need for accessible and affordable preventative measures. (WHO Fact Sheet).

“Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year,”

—Andrew Hill, Liverpool University

Future Availability

In October, **Gilead** struck agreements with six pharmaceutical firms to produce and distribute generic versions of the drug in 120 low- and middle-income countries, pending regulatory approval. To bridge the gap until these countries start production, the company announced a deal in December with the Global Fund to purchase doses for two million people.

However, cuts to the PEPFAR program under the prior administration have introduced uncertainty regarding the agreement’s future.