The U.S. Food and Drug Administration has granted approval for cabotegravir and rilpivirine injectable formulation for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed on a stable antiviral drug regimen, with no history of treatment failure. It is indicated for those who have no known or suspected resistance to either cabotegravir or rilpivirine.

This has become the first FDA-approved injectable formulation complete regimen for adults living with HIV. It is given once a month.

The FDA also granted approval for cabotegravir tablet formulation, to be taken in combination with oral rilpivirine for one month before initiating treatment with injectable cabotegravir-rilpivirine. This is aimed at ensuring that the medication is tolerated well… (FDA, January 21, 2021)