The US Food and Drug Administration (FDA) has approved a groundbreaking HIV prevention treatment, lenacapavir, marketed as Yeztugo, which requires only two injections per year to protect against the virus. This highly effective, long-acting shot has been shown to reduce the risk of HIV transmission by more than 99.9% in adults and adolescents.
Developed by Gilead Sciences, lenacapavir is a first-in-class capsid inhibitor that has already been approved in the United States as a treatment for people with drug-resistant HIV. The FDA’s approval marks a significant milestone in the fight against HIV, offering a new prevention option for individuals at risk of acquiring the virus.
Yeztugo is administered via two subcutaneous injections given around every six months. This convenient dosing schedule could greatly improve adherence to HIV prevention treatment, particularly for individuals who struggle with daily pill regimens. In clinical trials, Yeztugo demonstrated superiority over daily oral Truvada, with a 100% reduction in HIV infections among cisgender women in sub-Saharan Africa and a 99.9% prevention rate among cisgender men and gender-diverse individuals.
The FDA approval was supported by data from two large-scale clinical trials:
– *PURPOSE 1 trial*: Involving over 2,000 women in sub-Saharan Africa, the trial showed zero HIV infections among participants receiving Yeztugo, demonstrating a 100% reduction in HIV infections.
– *PURPOSE 2 trial*: Enrolling over 2,000 men and gender-diverse individuals, the trial showed only two HIV infections among participants receiving Yeztugo, resulting in a 99.9% prevention rate.
Yeztugo will be available in the United States with a list price of $28,218 per year, slightly higher than Gilead’s other HIV prevention medication, Descovy. Gilead has committed to helping ensure broad insurance coverage for Yeztugo and has established an access strategy to provide the medication to those in need.
The approval of Yeztugo has the potential to transform HIV prevention, particularly for individuals who face challenges with adherence to daily pill regimens. With its convenient dosing schedule and high efficacy rate, Yeztugo could greatly improve HIV prevention outcomes and help reduce the number of new HIV infections.
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