The US FDA has approved the two-drug combination of bictegravir and lenacapavir (Bixlenvo) as a complete regimen for the treatment of HIV-1 in adults who are virologically suppressed and have no known or suspected resistance to either component. The combination is indicated as a replacement for the patient’s current antiretroviral regimen. Mode of action Bictegravir is an HIV-1 integrase strand transfer inhibitor (INSTI) that inhibits viral integrase, preventing the integration of linear HIV-1 DNA into host genomic DNA.

This blocks formation of the HIV-1 provirus and subsequent viral propagation. Lenacapavir is an HIV-1 capsid inhibitor that interferes with multiple stages of the viral life cycle, including capsid-mediated nuclear uptake of proviral DNA, viral assembly and release, and capsid core formation. Clinical evidence The safety and efficacy of bictegravir and lenacapavir were…