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FDA Approves Twice-Yearly Injectable HIV Prevention Treatment
The FDA approved Yeztugo, Gilead's new twice-yearly injectable HIV prevention treatment, on June 18, 2025, showing over 99.9% efficacy in clinical trials involving over 4,000 participants across diverse populations, but concerns remain about its high potential cost.
- What is the immediate impact of the FDA's approval of Yeztugo on global HIV prevention efforts?
- The FDA approved Yeztugo, a new, twice-yearly injectable HIV prevention treatment from Gilead Sciences. This follows the 2021 approval of a once-monthly injectable, and offers a significant advancement in HIV prevention for adults and adolescents weighing at least 35 kg. Clinical trials showed near-total prevention rates, exceeding 99.9% efficacy.
- How do the clinical trial results for Yeztugo compare to existing HIV prevention methods, and what factors could limit its widespread use?
- Yeztugo, based on the molecule lenacapavir, builds upon Gilead's 2022 antiretroviral Sunlenca. Two large clinical trials—one with over 2,000 sub-Saharan African women, the other with over 2,000 diverse individuals—demonstrated exceptionally high efficacy, with near-elimination of infections. These results were published in the New England Journal of Medicine and Science magazine named lenacapavir "Breakthrough of the Year" in 2024.
- What are the potential long-term implications of Yeztugo's cost and accessibility for global public health, particularly in resource-constrained settings?
- While Yeztugo's efficacy is groundbreaking, its potential impact hinges on affordability. Analysts predict a high price tag, potentially limiting access in high-income countries and excluding low-income nations. Gilead has made agreements for generic production in 120 low- and middle-income countries, but the success of this initiative remains uncertain due to funding issues. The long-term effectiveness relies heavily on broader accessibility and equitable distribution.
Cognitive Concepts
Framing Bias
The article's framing is overwhelmingly positive, emphasizing the groundbreaking nature of the drug and the potential for a near-total elimination of HIV infections. The headline itself suggests a revolutionary breakthrough. The inclusion of quotes from Gilead's CEO and UN officials further reinforces this positive framing. While concerns about cost and access are mentioned, they are presented as secondary to the overall message of triumph.
Language Bias
The language used is largely positive and celebratory, using terms like "revolutionary," "historic," and "groundbreaking." These terms convey a sense of excitement and optimism but lack the neutrality expected in objective reporting. The description of the drug as "functionally similar to a vaccine" is a strong claim that might be considered hyperbole. While the concerns regarding cost are mentioned, the language used to describe them is less emotionally charged than the language used to describe the drug's positive attributes. More neutral language would be beneficial, such as using words such as 'highly effective', 'significant advance' instead of 'revolutionary' or 'groundbreaking'.
Bias by Omission
The article focuses heavily on the positive aspects of the new HIV prevention treatment, Yeztugo, and its potential to revolutionize the fight against AIDS. However, it gives limited detail on potential long-term side effects beyond those immediately following injection. While acknowledging the high cost, the article doesn't delve into the potential impact of this cost on healthcare systems or equitable access beyond mentioning concerns raised by experts and Gilead's agreements for generic production in low- and middle-income countries. The article also omits discussion of alternative prevention methods and their efficacy compared to Yeztugo.
False Dichotomy
The article presents a somewhat simplistic view of the situation, framing the high cost of the drug as the primary obstacle to global access. While cost is undoubtedly a significant factor, the article doesn't explore other potential barriers to widespread adoption, such as infrastructure limitations, healthcare worker training, or cultural factors that might influence uptake in different regions.
Gender Bias
The article mentions that one trial involved "more than 2,000 women of sub-Saharan Africa" and another involved "more than 2,000 people of diverse gender." While this acknowledges the inclusion of women and diverse genders in the trials, it could be improved by providing more specific details on the demographic breakdown of participants in both trials and by avoiding potentially ambiguous phrases like "people of diverse gender." The focus on the positive outcomes of these trials does not appear to be gendered, rather it is focused on the effectiveness of the drug itself.
Sustainable Development Goals
The approval of a new, highly effective, long-acting injectable HIV prevention treatment represents a major advancement in global health. The 99.9% efficacy rate and potential for near-elimination of new infections significantly contributes to SDG 3, ensuring healthy lives and promoting well-being for all at all ages. The accessibility challenges, however, pose a significant obstacle.