Etravirine or TMC125 was developed by Tibotec Pharmaceuticals as the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment-experienced adult patients with HIV resistance to an NNRTI. TMC125 was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in January 2008. In August 2008, the European Medicines Agency (EMEA) granted conditional approval to TMC125, which authorizes its use throughout the 27 member states of the European Union, as well as Norway and Iceland. Since then, TMC125 has been approved in Canada, Japan, and many other countries across the world. Approvals are based on Week 24 and Week 48 analyses from two randomized, double-blind, placebo-controlled trials,DUET 1 and DUET 2. Both studies were conducted in clinically advanced, three-class antiretroviral treatment-experienced adults. For further information on these studies, please visit www.clinicaltrials.gov.



A regulatory dossier for TMC125 has also been submitted to several resource-poor countries in Africa, Asia and Latin America, where the pandemic has a devastating impact. Tibotec and its partners will do the utmost to ensure that the compound is made available to patients in need.



In the US, TMC125, 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 an NNRTI and other ARV agents.



In the European Union, TMC125, in combination with a boosted protease inhibitor and other ARV medicinal products, is indicated for the treatment of HIV-1 infection in ARV treatment-experienced adult patients.



TMC125 Clinical Trials



The pooled 48-week efficacy and safety of etravirine in treatment-experienced HIV-1 patients data from the DUET studies were published in AIDS, 2009.



TMC125 PEDIATRIC PROGRAM



A clinical study (PIANO) to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents, aged 6-17y is currently ongoing. For further information on this study, please visit www.clinicaltrials.gov.



TMC125 EAP



Results of the US expanded access program (EAP) were published in the Journal of Acquired Immune Deficiency Syndromes 53(5): 614-618.