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吉利德(GILD.US)长效HIV疗法上市申请即将递交

The application for the long-acting HIV therapy by Gilead (GILD.US) is about to be submitted.

Zhitong Finance ·  Nov 14, 2024 09:47

Gilead Sciences (GILD.US) today announced all results from its second key Phase 3 trial, PURPOSE 2, of the HIV capsid inhibitor lenacapavir administered once every six months for the prevention of HIV infection.

According to Zhitong Finance APP, Gilead Sciences (GILD.US) today announced all results from its second key Phase 3 trial, PURPOSE 2, of the HIV capsid inhibitor lenacapavir administered once every six months for the prevention of HIV infection. Analysis showed that up to 99.9% of participants receiving lenacapavir were not infected with HIV, and its effectiveness in preventing HIV infection is superior to existing daily oral therapies. Detailed data will be presented at the International Conference on Antiviral Research for HIV Infection and will be published in the New England Journal of Medicine. Last month, the usa FDA granted breakthrough therapy designation for lenacapavir for pre-exposure prophylaxis (PrEP) against HIV infection. The company expects to initiate a series of global regulatory submissions for lenacapavir for PrEP by the end of this year.

Globally, approximately 1.3 million new cases of HIV infection occur each year. Recent studies have found that taking antiviral medications when not infected can reduce the risk of HIV infection. This preventative approach to HIV infection is called PrEP therapy. The first approved HIV PrEP drug is Truvada, developed by Gilead, which is significantly effective in preventing HIV if taken as directed. Although daily oral PrEP therapy can nearly eliminate the risk of HIV infection, many people struggle to adhere to daily medication due to factors such as the cost of the drugs and the stigma associated with taking medications related to HIV/AIDS. Consequently, the actual effectiveness of oral PrEP therapy is much lower than the theoretical value. Therefore, there is a significant demand for developing a long-acting PrEP therapy that can enhance medication adherence.

Lenacapavir (brand name Sunlenca) is a "first-in-class" long-acting HIV capsid inhibitor that disrupts the assembly and disassembly of HIV capsid proteins, acting at multiple stages of the viral life cycle.

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