Gilead Sciences’ twice-yearly injectable pre-exposure prophylaxis (PrEP) drug has been approved by the US Food and Drug Administration (FDA) to prevent human immunodeficiency virus (HIV).
Yeztugo (lenacapavir), which has been authorised to reduce the risk of sexually-acquired HIV in adults and adolescents weighing at least 35kg, is now the first PrEP option in the US that offers six months of protection against the virus.
More than 100 people in the US were diagnosed with HIV every day in 2023. PrEP is highly effective for preventing HIV when taken as prescribed. However, there are barriers surrounding adherence to daily oral therapies, including stigma and low awareness of current options.
Among the clinical evidence supporting the FDA’s decision on Yeztugo were results from the late-stage PURPOSE 1 trial, which randomised over 5,300 women and adolescent girls aged 16 to 26 years across sites in South Africa and Uganda to receive Yeztugo or one of Gilead’s once-daily oral PrEP drugs, Descovy (emtricitabine/tenofovir alafenamide) and Truvada (emtricitabine/tenofovir disoproxil fumarate).
There were zero HIV infections among the 2,134 participants in the Yeztugo group, 16 among 1,068 in the Truvada group and 39 among 2,136 in the Descovy cohort.
Positive results from the phase 3 PURPOSE 2 study, in which Gilead’s drug delivered near-complete (99.9%) protection against HIV infection in a “broad and geographically diverse” range of cisgender men and gender-diverse people, also informed the approval. There were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group.
In both trials, Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence and was generally well-tolerated, with no significant or new safety concerns observed.
Gilead’s chief executive officer, Daniel O’Day, said: “This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.
“This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention.”