Janssen announces U.S. prescribing information update for EDURANT tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT^® (rilpivirine) tablets to include 96-week pooled data from the Phase 3 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 3 trials in treatment-naive subjects.

The following points should be considered when initiating therapy with EDURANT^®:

• More EDURANT^® treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA greater than or equal to 50 copies/mL) compared to EDURANT^® treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.
• Regardless of HIV-1 RNA at the start of therapy, more EDURANT^® treated subjects with CD4+ cell count less than 200 cells/mm³ experienced virologic failure compared to EDURANT^® treated subjects with CD4+ cell count greater than or equal to 200 cells/mm³.
• The observed virologic failure rate in EDURANT^® treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.
• More subjects treated with EDURANT^® developed tenofovir- and lamivudine/emtricitabine-associated resistance compared to efavirenz.