FDA Approves INTELENCE For HIV Combination Therapy
FDA has granted accelerated approval to the anti-HIV medication INTELENCE (etravirine) tablets -- the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment- experienced adult patients with HIV resistant to a NNRTI and other antiretroviral (ARV) agents. INTELENCE, also known as TMC125, was developed by Tibotec Pharmaceuticals, Ltd. and will be marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
"NNRTIs have been used in HIV combination therapy for more than a decade, but their use has been limited by cross-resistance within the class. Resistance to one NNRTI generally meant resistance to all NNRTIs," said Richard Haubrich, M.D., Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, and investigator in the INTELENCE Phase 3 DUET studies. "Etravirine breaks new ground in the NNRTI class, and provides a new option to thousands of treatment-experienced patients with NNRTI-resistant HIV."
INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other ARV agents.
This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.
The following points should be considered when initiating therapy with INTELENCE:
-- Treatment history and, when available, resistance testing, should guide the use of INTELENCE.
-- The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.
-- In patients who have experienced virologic failure on a NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.
-- The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-na