New Injectable Drug Offers Six-Month HIV Prevention

European regulators recommend twice-yearly jab hailed as potential epidemic game-changer.

A groundbreaking injectable medication for HIV prevention, administered just twice a year, has received a recommendation for authorization from the European Medicines Agency. Scientists believe this long-acting drug could significantly curb the virus’s transmission globally.

Major Public Health Advance

The EU’s drug regulator determined that lenacapavir, marketed as Yeytuo by Gilead Sciences, is highly effective and represents a critical public health interest. This recommendation, once formally accepted by the European Commission, will grant access across all 27 EU member states, plus Iceland, Norway, and Liechtenstein.

Clinical studies last year indicated that lenacapavir, already in use for HIV treatment, demonstrated near 100% efficacy in preventing transmission in both men and women. This development offers a potent new tool in the fight against HIV.

“This could change the trajectory of the HIV epidemic if it is made available to everyone who needs it.”

—Winnie Byanyima, Executive Director of the U.N. AIDS agency

Global Adoption and Availability

The U.S. Food and Drug Administration authorized lenacapavir for HIV prevention in June. Earlier this month, the World Health Organization also recommended its adoption by countries as an additional preventative option for individuals at risk.

This new injectable offers a distinct advantage over existing prevention methods, such as daily pills or the every-two-month injectable cabotegravir. Its six-month dosing schedule may appeal to those concerned about daily adherence or the potential stigma associated with taking medication.

However, concerns persist regarding the drug’s widespread availability to halt global outbreaks. Gilead Sciences has committed to licensing generic versions for 120 low-income nations with high HIV rates, primarily in Africa, Southeast Asia, and the Caribbean. This initiative aims to ensure access in regions most affected by the epidemic.

Addressing Disparities in Access

Despite these efforts, the exclusion of most of Latin America, where HIV rates are rising, has raised alarms about a missed opportunity to control the disease. Ensuring equitable access remains a paramount challenge.

Globally, the HIV epidemic continues to have a profound impact. In the past year, approximately 630,000 lives were lost to AIDS, with over 40 million people estimated to be living with HIV, according to UNAIDS data.

The accessibility of such a crucial preventative drug highlights the ongoing need for global cooperation and strategic partnerships. As of 2022, the number of people living with HIV globally stood at approximately 39 million, with new infections continuing to occur, particularly in specific geographic regions and demographic groups (UNAIDS).