Gilead's long-acting HIV therapy application will soon be submitted for approval.

Gilead Sciences, Inc. (GILD.US) today announced the results of the second key Phase 3 trial of its HIV capsid inhibitor lenacapavir, which is administered once every six months for the prevention of HIV infection. The analysis showed that up to 99.9% of participants who received lenacapavir were not infected with HIV, and its efficacy in preventing HIV infection was superior to existing once-daily oral therapy. Detailed data was presented at the International AIDS Conference and will be published in the New England Journal of Medicine. Last month, the US FDA granted breakthrough therapy designation for lenacapavir for pre-exposure prophylaxis (PrEP) for HIV infection. The company expects to start a series of global regulatory applications for lenacapavir for PrEP by the end of this year. There are approximately 1.3 million new HIV infections worldwide every year. In recent years, studies have found that taking antiretroviral drugs before exposure can reduce the risk of HIV infection. This preventive therapy is known as PrEP therapy. The first approved HIV PrEP drug is Truvada, a daily oral drug developed by Gilead, which is highly effective in preventing HIV when taken as directed. However, due to the cost of the medication and the stigma associated with taking HIV-related drugs, many people have difficulty adhering to daily dosing, resulting in lower effectiveness of oral PrEP therapy in practice than in theory. Therefore, there is a significant demand for a long-acting PrEP therapy that can improve medication adherence. Lenacapavir (sold under the brand name Sunlenca) is a first-in-class long-acting HIV capsid inhibitor that interferes with the assembly and disassembly of the HIV capsid protein, playing a role in multiple stages of the virus lifecycle.