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The U.S. Food and Drug Administration (FDA) has approved lenacapavir, a groundbreaking long-acting injectable medication for HIV prevention, requiring only two doses annually. Clinical trials demonstrated that the drug reduces the risk of HIV transmission by over 99.9% in both adults and adolescents, achieving a 100% prevention rate in a study involving over 2,000 women in sub-Saharan Africa. "This is a historic day in the decades-long fight against HIV," stated Daniel O'Day, Chairman of Gilead Sciences, emphasizing the potential for lenacapavir to transform the landscape of HIV prevention.
Despite its promising efficacy, concerns loom over the drug's expected high cost, estimated to reach up to $25,000 annually in the U.S. Critics, including UN officials, argue that such pricing could hinder widespread access, calling for Gilead to lower costs significantly. Previous long-acting options have faced similar accessibility challenges, limiting their global impact. Reports from The New England Journal of Medicine highlighted the robust results, alongside side effects such as injection site reactions and nausea, raising important discussions about equitable access to this breakthrough therapy.