BRIDGEWATER, N.J., July 20 /PRNewswire/ -- Ninety-six week pooled results from two Phase 3 studies (DUET-1 and DUET-2) showed that significantly more treatment-experienced HIV-1-infected adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) resistance had an undetectable viral load (<50 HIV-1 RNA copies/mL) while taking INTELENCE(TM) (etravirine) tablets plus background regimen (BR) compared with placebo plus BR. These findings were presented today at the 5(th) International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009) in Cape Town, South Africa.
In the pooled analysis of the DUET studies at 96 weeks, 57 percent of patients in the INTELENCE arm had an undetectable viral load (<50 copies/mL) compared to 36 percent of patients in the placebo arm (p<0.0001).
"These data are important because they add to the body of knowledge on INTELENCE, an important option for treatment-experienced patients with NNRTI and PI resistance," said DUET clinical investigator Tony Mills, MD, HIV specialist in private practice, Los Angeles, and Assistant Professor of Clinical Medicine, UCLA.
When it received accelerated approval by the U.S. Food and Drug Administration (FDA) in January 2008, INTELENCE was the first NNRTI to be introduced in nearly ten years. Since then, INTELENCE has been approved in nearly 50 countries. In January 2009, an application was submitted to the FDA for traditional approval, which included 48-week data from DUET-1 and DUET-2. The FDA will need to determine if these data are sufficient to support traditional approval.
When it received accelerated approval by the U.S. Food and Drug Administration (FDA) in January 2008, INTELENCE was the first NNRTI to be introduced in nearly ten years. Since then, INTELENCE has been approved in nearly 50 countries. In January 2009, an application was submitted to the FDA for traditional approval, which included 48-week data from DUET-1 and DUET-2.
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:
DUET-1 and -2 Study Design
The DUET-1 and -2 studies, identical in design and conducted across the Americas, Australia, Canada, Europe, Thailand and Europe, assessed the 24-week efficacy and safety of INTELENCE in combination with a BR in treatment-experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. They were large randomized, controlled studies and the primary endpoint was the proportion of patients who achieved a confirmed undetectable viral load (less than 50 copies/mL).
Patients with HIV-1 who were eligible for the DUET trials had a viral load of greater than 5,000 copies/mL, were on a stable antiretroviral therapy regimen, and had evidence of at least one NNRTI-resistance-associated mutation, either at screening or from historical resistance tests as well as evidence of three or more primary PI mutations (D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S, or L90M) at screening.
Participants in the DUET studies were randomized to receive INTELENCE 200 mg twice daily (599 patients) or placebo (604 patients), each given in addition to a BR. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide).
The study was designed to evaluate INTELENCE efficacy and safety over 48 weeks with an optional extension to 96 weeks. The study remained double-blinded until the last study participant reached week 48.
DUET-1 and -2: 96-Week Efficacy Data
The 96-week pooled analysis of the DUET studies showed the following efficacy results:
DUET-1 and -2: 96-Week Safety Data
Important Safety Information
INTELENCE does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
Warnings & Precautions
Use in Specific Populations
Please see full Product Information about INTELENCE for more details. A copy of full Product Information can be obtained by visiting www.INTELENCE-info.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company, with offices in Yardley, PA, USA and its main research and development operations in Mechelen, Belgium. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Media Contact: Pamela Van Houten 908-541-4137 (office) 908-295-7367 (mobile) Investor Relations: Louise Mehrotra 732-524-6491 Lesley Fishman 732-524-3922
|SOURCE Tibotec Therapeutics|
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