The US Food and Drug Administration (FDA) made a significant announcement on Wednesday, granting approval to Gilead Sciences for its revolutionary twice-yearly injection aimed at preventing HIV. This development is being hailed as a major breakthrough in the ongoing battle against the sexually transmitted virus, which affects millions globally.
For over a decade, medications designed for HIV prevention, known as pre-exposure prophylaxis (PrEP), have been available. However, the traditional requirement of taking a daily pill has hindered widespread adoption and success in reducing global HIV infections. Gilead's chairman and CEO, Daniel O'Day, expressed the significance of this approval, stating, "This is a historic day in the decades-long fight against HIV."
The newly approved drug, lenacapavir, marketed under the brand name Yeztugo, has demonstrated remarkable efficacy, showing a reduction in the risk of HIV transmission by more than 99.9 percent in both adults and adolescents. This performance positions it as a powerful alternative to current preventive methods, effectively functioning as a vaccine.
Gilead conducted two extensive clinical trials to validate lenacapavir's effectiveness. The first trial was conducted with over 2,000 women in sub-Saharan Africa, yielding a remarkable 100 percent reduction in HIV infections and proving superior to the daily oral medication Truvada. The second trial, which included more than 2,000 men and gender-diverse individuals, reported only two infections, resulting in a 99.9 percent prevention rate—again outshining Truvada.
Results from both clinical trials have been published in The New England Journal of Medicine, and lenacapavir has been recognized as the 2024 Breakthrough of the Year by the journal Science.
Despite these groundbreaking results, there are concerns regarding the anticipated high cost of lenacapavir. An earlier long-acting HIV prevention shot, cabotegravir, which is administered every two months, carries a hefty price tag in the tens of thousands of dollars per year. Gilead has not yet disclosed the price for Yeztugo, but analysts predict the launch cost in the US could reach $25,000 per year.
Currently, lenacapavir’s list price for its previously approved use as an HIV treatment is approximately $39,000 annually. However, this price is expected to decrease when the drug is utilized for preventive measures. Activists and healthcare advocates are urging Gilead to significantly lower the price to ensure that lenacapavir can be broadly accessible, emphasizing that even high-income countries would struggle to afford its use at prices exceeding $20,000 per year.
Winnie Byanyima, the Under-Secretary-General of the United Nations, commended Gilead and US partners for this important advancement, stating, "Lenacapavir could be the tool we need to bring new infections under control – but only if it is priced affordably and made available to everyone who could benefit."
In a proactive move, Gilead has signed agreements with six pharmaceutical companies to produce and distribute generic versions of lenacapavir in 120 low- and middle-income countries, pending regulatory approval. However, as production timelines may vary, Gilead has also entered a separate agreement with the Global Fund to procure doses for two million individuals, supported by international partnerships such as the US President's Emergency Plan for AIDS Relief (PEPFAR).
Nevertheless, uncertainties loom over the future of these initiatives due to cuts to the PEPFAR program during the administration of former President Donald Trump, raising questions about the sustainability of these agreements.
