艾滋病流行即将终结？这一药物在美国获批上市

Core Viewpoint - Gilead's HIV-1 capsid inhibitor, Yeztugo (lenacapavir), has been approved by the FDA as a pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in adults and adolescents weighing at least 35 kg, marking a significant advancement in HIV prevention strategies [1][2]. Group 1: Drug Approval and Efficacy - Yeztugo is the first HIV prevention drug that requires administration only twice a year [2]. - In clinical trials (PURPOSE 1 and PURPOSE 2), over 99.9% of participants maintained an HIV-negative status, with PURPOSE 1 showing a 100% reduction in infection rates among cisgender women and PURPOSE 2 showing a 99.9% reduction among men who have sex with men, transgender men, transgender women, and non-binary individuals [2]. Group 2: Mechanism of Action - Lenacapavir works by binding directly to the HIV capsid protein subunits, regulating the stability and transport of the capsid, thereby preventing HIV from entering human cells and inhibiting multiple critical steps in the viral lifecycle [2][3]. - This multi-stage mechanism distinguishes lenacapavir from other approved antiretroviral drugs and shows no known cross-resistance with existing medications [2]. Group 3: Market Context and Future Implications - Prior to this approval, lenacapavir had not been authorized for pre-exposure prophylaxis in other countries, although it had been approved for treating multi-drug resistant HIV in the EU and the US [3]. - The introduction of a biannual dosing regimen could significantly improve adherence among high-risk populations who struggle with daily medication, potentially leading to a further decline in HIV prevalence if widely adopted [3].