Gilead's (GILD.US) long-acting HIV therapy is set to file for approval

Gilead Sciences (GILD.US) today announced the full results of its second pivotal Phase 3 trial, PURPOSE2, evaluating lenacapavir, a long-acting HIV capsid inhibitor, for the prevention of HIV infection. Analysis showed that up to 99.9% of participants who received lenacapavir were protected from HIV infection, and the prevention of HIV infection was superior to existing daily oral regimens. The data were presented at the International AIDS Society Conference on HIV Science and will be published in the New England Journal of Medicine. Last month, the U.S. FDA granted lenacapavir a breakthrough therapy designation for pre-exposure prophylaxis (PrEP) of HIV infection. The company expects to file a series of global regulatory applications for lenacapavir for PrEP by the end of this year.

Each year, approximately 1.3 million new HIV infections occur globally. In recent years, research has found that taking antiviral medication before becoming infected can reduce the risk of HIV infection. This prevention of HIV infection is called PrEP. The first approved HIV PrEP drug was Truvada, developed by Gilead, which is taken orally once daily and is highly effective at preventing HIV infection if taken as prescribed. Although the daily oral PrEP regimen nearly eliminates HIV infection, the high cost of the medication and the stigma associated with taking HIV-related medications limit adherence, and the actual effectiveness of the oral PrEP regimen is far below the theoretical value. Therefore, there is a significant need to develop a long-acting PrEP regimen that can increase medication adherence.

Lenacapavir (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, acting at multiple stages of the virus life cycle.