INTELENCE Effective As Part Of HIV Combination Therapy
At 48 weeks, significantly more treatment-experienced adults with HIV-1 with documented resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) had an undetectable viral load (defined as less than 50 HIV-1 RNA copies/mL) with INTELENCE (etravirine) tablets plus a background regimen (BR) compared with placebo plus a BR. These findings from two ongoing double-blind, placebo-controlled, randomized Phase 3 studies (DUET-1 and DUET-2) were presented at the 15th Conference on Retroviruses and Opportunistic Infections in Boston.
In the DUET-1 and -2 studies, 60 percent and 61 percent of patients in the INTELENCE arms had a confirmed undetectable viral load at 48 weeks compared with 39 percent and 41 percent of those in the placebo arms, respectively. In each study, this difference was significant [p<0.0001].
INTELENCE, a new NNRTI from Tibotec, received accelerated approval from the U.S. Food and Drug Administration (FDA) on January 18, 2008. It is the first NNRTI to receive approval in almost ten years. INTELENCE received approval based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled DUET-1 and -2 studies. The 48-week results will be filed with the FDA for consideration of traditional approval of INTELENCE.
"Etravirine is an important new option for treatment-experienced patients with NNRTI resistance and these data build upon the 24-week data that had previously been available," 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.
INTELENCE, in combination with other antiretroviral (ARV) 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 an 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