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96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy
Date:7/20/2009

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:

  • 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-naive adults.

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:

  • Fifty-seven percent of patients in the INTELENCE arm had an undetectable viral load (<50 copies/mL) compared with 36 percent of patients in the placebo arm (p<0.0001).
  • Sixty percent of patients in the INTELENCE arm achieved an undetectable viral load (<50 copies/mL) at 48 weeks compared to 57 percent at 96 weeks vs. 39 percent of patients in the placebo arm at 48 weeks and 36 percent at 96 weeks.
  • Ninety-one percent of patients in the INTELENCE arm who achieved an undetectable viral load (<50 copies/mL) at week 48 maintained virologic suppression through week 96 vs. 88 percent of patients in the placebo arm.

DUET-1 and -2: 96-Week Safety Data

  • In the DUET studies, the most commonly reported adverse events (greater than or equal to 10 percent) among patients in the INTELENCE arm vs. placebo arm, regardless of causality, were rash (21 percent vs. 12 percent), diarrhea (19 percent vs. 24 percent), nausea (15 percent vs. 14 percent), nasopharyngitis (14 percent vs. 12 percent), headache (12 percent vs. 14 percent), cough (11 percent vs. 9 percent) and herpes simplex (10 percent vs. 10 percent).
  • The incidence of nervous system and psychiatric AEs was comparable between the INTELENCE and placebo arms. Nineteen percent of patients in the INTELENCE arm experienced nervous system disorders and 20 percent reported psychiatric disorders, compared to 21 percent of patients in the placebo arm who experienced either AE.

Important Safety Information

INTELENCE does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Warnings & Precautions

  • Severe Skin Reactions: Severe and potentially life-threatening skin reactions, including Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema multiforme, have occurred (<0.1%) in patients taking INTELENCE. Treatment with INTELENCE should be discontinued and appropriate therapy initiated if severe rash develops. In general, in clinical trials, rash was mild to moderate, occurred primarily in the second week of therapy, and was infrequent after Week 4. Rash generally resolved within 1-2 weeks on continued therapy. Discontinuation rate due to rash was 2%.
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.
  • Immune reconstitution syndrome has been reported in patients treated with ARV therapy, including INTELENCE.

Use in Specific Populations

  • Hepatic Impairment: INTELENCE should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE have not been evaluated in these patients.

Adverse Reactions

  • The most common adverse events (>10%) of any intensity that occurred at a higher rate than placebo at 24-weeks were rash (16.9% vs. 9.3%) and nausea (13.9% vs. 11.1%).
  • The most common treatment-emergent adverse reactions (Grade 2-4) that occurred in patients receiving an INTELENCE-containing regimen vs. placebo at 24-weeks were rash (9.0% vs. 3.1%), diarrhea (5.2% vs. 9.6%), nausea (4.7% vs. 3.5%), fatigue (3.3% vs. 4.0%), abdominal pain (3.0% vs. 2.5%), peripheral neuropathy (2.8% vs. 1.8%), hypertension (2.8% vs. 2.2%), headache (2.7% vs. 4.1%), and vomiting (2.3% vs. 2.0%).

Drug Interactions

  • INTELENCE should not be co-administered with the following ARVs: tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without ritonavir, and other NNRTIs.
  • INTELENCE should not be co-administered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing protease inhibitor/ritonavir) or products containing St. John's wort (Hypericum perforatum).
  • INTELENCE and lopinavir/ritonavir should be co-administered with caution.
  • Co-administration of INTELENCE with other agents such as substrates, inhibitors, or inducers of CYP3A4, CYP2C9, and/or CYP2C19 may alter the therapeutic effect or adverse events profile of INTELENCE or the co-administered drug(s). This is not a complete list of potential drug interactions.

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


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SOURCE Tibotec Therapeutics
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