The US Food and Drug Administration (FDA) has granted approval for Intelence, a treatment specifically indicated for treatment-experienced patients who have experienced virologic failure from antiviral-resistant HIV-1 strains.
The FDA has recommended Intelence, 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 antiretroviral (ARV) agents.
Approval for the treatment, currently marketed in the US by Tibotec Therapeutics, was based on successful 48-week data from two Phase 3 studies known as DUET-1 and DUET-2.
In each study, more patients achieved a significantly undetectable viral load with Intelence tablets plus a background regimen compared with a placebo plus a background regimen.
DUET clinical investigator Charles Hicks said that Intelence (etravirine) has become an important option for many treatment-experienced patients with resistance to NNRTIs or other antiretrovirals.
Intelence received accelerated approval from the FDA in January 2008 and has since been approved in more than 50 countries. This additional indication was submitted to the FDA in January 2009.