FDA updates prescribing information for Edurant (Tibotec) for AIDS patients

The FDA has approved a prescribing information update for Edurant (rilpivirine) tablets, from Tibotec, to include 96-week pooled data from the Phase III ECHO and THRIVE studies, which evaluated the efficacy and safety of Edurant for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) in antiretroviral treatment-naive adults. In addition to the inclusion of the 96-week data in the prescribing information, the Indications and Usage section was revised to read: Edurant in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. This indication is based on safety and efficacy analyses through 96 weeks from two randomized, double-blind, active-controlled Phase III trials in treatment-naive subjects.