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FDA approves a new preventive treatment against HIV

It is Yeztugo (lenacapavir), an injectable HIV-1 capsid inhibitor. The announcement was made by Gilead Sciences, the laboratory that developed the drug.

FDA building

FDA buildingGetty Images via AFP.

Williams Perdomo
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On Wednesday, the Food and Drug Administration approved a new treatment to prevent HIV that could revolutionize the fight against AIDS. The announcement was made by Gilead Sciences, the lab that developed the drug.

"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 eradicate the HIV epidemic," said Daniel O'Day, president and chief executive officer of Gilead Sciences.

It is Yeztugo (lenacapavir), an injectable HIV-1 capsid inhibitor. It was approved as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg.

"This makes it the first and only option available in the United States, to be administered twice a year, for those who need or want to receive PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV-negative," the lab explained.

The first PrEP

The first PrEP drug, created by Gilead, received approval in the United States in 2012. However, according to the most recent data available from the Centers for Disease Control and Prevention (CDC), in 2022 only about 1 in 3 people (36%) who met the eligibility criteria set by the CDC received a prescription for some form of PrEP.

"CDC data show that all U.S. populations are still not using PrEP at rates that could end population-level transmission of the virus," Gilead detailed.
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