EU approves breakthrough HIV treatment amid accessibility concerns

Wednesday 27 August 2025 - 15:50

By: Dakir Madiha

EU approves breakthrough HIV treatment amid accessibility concerns

The European Union has officially approved the new HIV prevention treatment developed by the American pharmaceutical company Gilead. Known as "Yeytuo" in Europe, the drug requires just two injections per year, offering a simpler alternative to the daily pills currently used by most patients. This development raises hopes for improved prevention, particularly among at-risk populations in developing countries, yet concerns remain regarding its affordability and accessibility.

A simplified approach to HIV prevention

The European Commission’s decision, announced on August 26, follows a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This approval comes as Europe continues to struggle with approximately 25,000 new HIV infections annually, signaling unmet needs in current prevention strategies.

Professor Jean-Michel Molina, an infectious diseases specialist at Parisian hospitals Lariboisière and Saint-Louis, described the drug’s potential impact: "The current prevention methods are failing many vulnerable populations." He emphasized that the ease of administering just two injections annually could enhance adherence and expand prevention efforts globally.

Clinical trials show remarkable efficacy

Gilead’s clinical trials revealed a striking reduction in HIV transmission risk—over 99.9% among adults and adolescents. These results have sparked optimism about the long-term eradication of HIV. However, challenges persist regarding equitable access, particularly given the drug’s high cost in the United States, where it is marketed as "Yeztugo."

Pricing and accessibility concerns

In the U.S., the annual cost of Yeztugo is $28,000 per patient, raising fears about its financial accessibility in Europe. Gilead has yet to disclose pricing details for the European market, leaving healthcare providers and advocacy groups in uncertainty.

To mitigate these concerns, Gilead has previously partnered with manufacturers to produce generic, low-cost versions of its anti-HIV drugs for over 100 developing countries. The Global Fund also announced a contract in July to supply affordable doses to low- and middle-income nations. Despite these efforts, the pricing strategy for Europe—a key market—remains unclear.

As the EU welcomes this innovative treatment, the debate over its affordability and distribution underscores the ongoing challenge of balancing medical advances with equitable healthcare access.