FDA Approves Gilead's Twice-Yearly HIV PrEP Drug Yeztugo

Gilead Sciences has achieved a landmark approval from the US Food and Drug Administration (FDA) for Yeztugo (lenacapavir), a novel injectable drug designed for pre-exposure prophylaxis (PrEP) to prevent human immunodeficiency virus (HIV) infection. This groundbreaking medication, approved for adults and adolescents weighing at least 35 kg, marks the first PrEP option in the United States that provides protection against HIV for a duration of six months.

HIV remains a significant public health challenge, with over 100 diagnoses occurring daily in the United States during 2023. The effectiveness of PrEP medications in preventing HIV is well-established when taken according to prescription guidelines. However, the existing daily oral therapies face barriers such as adherence issues due to stigma and limited awareness about current prevention options.

The FDA's decision to approve Yeztugo was backed by robust clinical evidence, particularly from the late-stage PURPOSE 1 trial. This trial involved over 5,300 women and adolescent girls aged between 16 and 26 years across various sites in South Africa and Uganda. Participants were randomized to receive either Yeztugo or one of Gilead's daily oral PrEP drugs, Descovy (emtricitabine/tenofovir alafenamide) or Truvada (emtricitabine/tenofovir disoproxil fumarate). Remarkably, the Yeztugo group, consisting of 2,134 individuals, experienced zero HIV infections, while 16 infections occurred among 1,068 participants using Truvada, and 39 infections were reported among 2,136 individuals in the Descovy cohort.

Further reinforcing the approval were positive findings from the phase 3 PURPOSE 2 study, which demonstrated Yeztugo's near-complete 99.9% protection against HIV infection among cisgender men and gender-diverse individuals in a broad and geographically diverse cohort. In this trial, only two HIV infections were reported among 2,179 participants who received Yeztugo twice yearly through subcutaneous injection.

Yeztugo showed superior efficacy in preventing HIV infections compared to background HIV incidence rates in both trials, while maintaining a favorable safety profile with no significant or new safety concerns observed. The FDA's approval of Yeztugo marks a historic advancement in the ongoing battle against HIV.

Daniel O’Day, Gilead’s chief executive officer, expressed optimism about the potential impact of Yeztugo, stating, "This is a historic day in the decades-long fight against HIV. Yeztugo represents one of the most significant scientific breakthroughs of our time and offers a substantial opportunity to help end the HIV epidemic. This medicine, requiring administration only twice a year, has demonstrated remarkable outcomes in clinical studies, and it holds the potential to revolutionize HIV prevention."

Yeztugo's approval offers hope for a transformative shift in the landscape of HIV prevention, enhancing access to effective and user-friendly options. By addressing adherence challenges associated with daily oral PrEP therapies, Yeztugo could significantly contribute to reducing new HIV infections and advancing efforts to ultimately end the HIV epidemic. As Gilead Sciences continues to push the boundaries of medical innovation, Yeztugo represents a promising step forward in safeguarding public health and empowering individuals in the fight against HIV.