Navigation Links
FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy
Date:1/18/2008

tially or completely stop the NNRTI from binding to the reverse transcriptase enzyme, causing the drug to lose effectiveness. As with other HIV medications, patients can develop resistance to INTELENCE; for more information see the resistance section below.

DUET-1 and -2 Study Design

The DUET-1 and -2 studies, identical in design but conducted in different regions, assessed the 24-week efficacy and safety of INTELENCE in combination with a background regimen (BR) in treatment-experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. They were large randomized, controlled studies with a primary endpoint of less than 50 copies/mL (known as undetectable viral load). IAS-USA treatment guidelines define less than 50 copies/mL as the goal of therapy for treatment-experienced patients when two or more potent drugs are identified.

Patients with HIV-1 who were eligible for the DUET studies had a viral load of greater than 5,000 copies/mL, while on a stable antiretroviral therapy regimen for at least eight weeks and had evidence of at least one NNRTI resistance-associated mutation, either at screening or from prior 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.

DUET-1 and -2 Efficacy

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 24-week pooled analysis of the DUET studies showed the following results for INTELENCE plus BR vs. placebo plus BR:

-- Significantly more patients in the INTELENCE arm achieved undetectable

viral load (less than 50 copies/mL); 59.8 percent vs. 40.2 percent


'/>"/>

SOURCE Tibotec Therapeutics
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
2. FDA Approves New Mechanism of Action Labeling for Ranexa(R)
3. FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children
4. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
5. FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
6. FDA Approves Genzymes Renvela(TM) for Dialysis Patients
7. FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
8. FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
9. FDA Approves Administration of LEXIVA(R) with Lower Dose of Boosting Medication Ritonavir
10. FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)
11. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/22/2014)... and SHENZHEN, China , July ... LTD, (BGI Tech), a subsidiary of BGI, the ... launch of a new human whole exome sequencing ... newly offered service includes in-depth bioinformatics analysis and ... until December 31, 2014. Complete ...
(Date:7/22/2014)... Ore. , July 22, 2014  Semler ... an emerging medical risk assessment company that develops ... patients and evaluating chronic diseases, today announced that ... before the open of U.S. financial markets on July ... Semler will host a conference call at 11 a.m. ...
(Date:7/22/2014)... , July 22, 2014  United Therapeutics Corporation ... it will release its second quarter 2014 financial ... 2014. United Therapeutics will host a ... 9:00 a.m. Eastern Time.  The teleconference is accessible ... A rebroadcast of the teleconference will be available ...
(Date:7/22/2014)... Biofeedback – When a behavioral ... selecting medication to best treat it can become a ... using electroencephalography (EEG) can help predict which medicine will ... of adverse drug events. , The article “Medication ... current issue of the journal Biofeedback offers evidence that ...
Breaking Biology Technology:BGI Tech Launches Human Whole Exome Sequencing Service on Complete Genomics' Advanced Platform 2BGI Tech Launches Human Whole Exome Sequencing Service on Complete Genomics' Advanced Platform 3Semler to Report Second Quarter 2014 Financial Results and Host Conference Call on July 25, 2014 2Analyzing Brain Patterns with EEG Can Help Predict Effective Use of Medication 2Analyzing Brain Patterns with EEG Can Help Predict Effective Use of Medication 3
... Red Herring has announced,that ProGenTech Limited was a winner of the ... technology companies based in Asia. , ... Asia and identified the top 100 out of more than 1,000,closely ... "It is truly an honor ...
... the U.S. Patent and Trademark Office has ... for Traumatic Injury to the Nervous System”, ... University of Florida with the company as ... method of determining the presence of neural ...
... Inc.,(Nasdaq: BNVI ) will present findings on the ... Annual San Antonio Breast Cancer Symposium,being held at the Henry ... Bionovo,s poster presentation will ... BN107. As explained by Dr. Emma Shtivelman,Director of Cancer Research ...
Cached Biology Technology:Red Herring Awards ProGenTech Limited for the 2008 Red Herring Asia 100 2 Banyan Biomarkers Announces Issuance of U.S. Patent for Biomarkers for Traumatic Injury 2Bionovo to Present Recent Findings of BN107, its Anticancer Agent, at the 31st Annual San Antonio Breast Cancer Symposium 2
(Date:7/22/2014)... allergic to dust mites (and chances are you are), ... the University of Iowa have developed a vaccine that ... immune response. In animal tests, the nano-sized vaccine package ... to the allergens, according to the paper, published in ... Journal . One big reason why it works, ...
(Date:7/22/2014)... Health Policy and Economics have linked tighter Medicaid ... for schizophrenic individuals. , The study comes amid ... actually save money, when other costs are taken ... extra approval step before tests or treatments can ... prior authorization is intended to encourage physicians ...
(Date:7/22/2014)... be on the horizon. Bacteria that produce a ... insulin resistance and other adverse effects of a ... discovered., "Of course it,s hard to speculate from ... Ph.D., assistant professor of Pharmacology. "But essentially we,ve ... in mice, even though they,re eating a high-fat ...
Breaking Biology News(10 mins):Researchers create vaccine for dust-mite allergies 2Are state Medicaid policies sentencing people with mental illnesses to prison? 2Vanderbilt study shows therapeutic bacteria prevent obesity in mice 2
... lice treatments such as the pyrethroids cypermethrin and deltamethrin, ... increased from 2008 to 2009, although use of emamectine ... again due to resistance problems, e.g. azametiphos, diflubenzuron and ... 1997, was also used again in 2009, mainly under ...
... The National Foundation for Cancer Research announced today ... the Department of Molecular and Experimental Medicine at The ... of the 5th Annual Szent-Gyrgyi Prize for Progress in ... on a humble chicken virus in the early 1960s, ...
... older than previously thought, says a new analysis of the ... plants, or angiosperms, first arose 140 to 190 million years ... Proceedings of the National Academy of Sciences pushes back ... 25 to 75 million years earlier than either the fossil ...
Cached Biology News:5th Annual Szent-Györgyi Prize for Progress in Cancer Research awarded 25th Annual Szent-Györgyi Prize for Progress in Cancer Research awarded 3Molecular study could push back angiosperm origins 2Molecular study could push back angiosperm origins 3
... cDNA Library Panels were designed for full-length ... of PCRs to identify the desired cDNA ... in a 96-well "Master Plate," where each ... Having identified the positive well(s) by gel ...
... Library Panels were designed for full-length gene ... PCRs to identify the desired cDNA clone. ... a 96-well "Master Plate," where each well ... identified the positive well(s) by gel electrophoresis ...
... Technologys R.A.P.I.D. System (Ruggedized Advanced Pathogen ... PCR thermocycler designed for field hospitals, ... In addition to its ruggedness, it ... and specify as the LightCycler instrument. ...
Application: For use as a carrier in nucleic acid purification and precipitation. Physical form: Solution in 10 mM Tris HCl, pH 7.4, 1 mM EDTA Concentration: 9-11 mg/mL Physical Form: buffered aqu...
Biology Products: