Janssen announces U.S. prescribing information update for EDURANT tablets
Published on December 11, 2012 at 6:06 AM
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.