FDA Approves INTELENCE(TM) (etravirine) for HIV Combinati... ([p -- Significantly greater mean incr...)

FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy

Date:1/18/2008

[p<0.0001].

-- Significantly greater mean increase in CD4+ cell count from baseline;

mean increase of 81 vs. 64 cells/mm(3)[p=0.0022]

The results of DUET-1 and DUET-2 were published separately in two articles in the July 7, 2007 issue of The Lancet, and the pooled analysis from the DUET studies was presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September 2007.

DUET-1 and -2 Resistance

-- The presence of K103N, which was the most prevalent NNRTI substitution

in DUET-1 and -2 studies at baseline, did not affect the response in

the INTELENCE arm.

-- The presence at baseline of the substitutions V179D, V179F, V179T,

Y181V, or G190S was associated with a decreased virologic response to

INTELENCE.

-- In the DUET-1 and -2 studies, the presence at baseline of three or more

2007 IAS-USA-defined NNRTI substitutions (V90I, A98G, L100I, K101E/P,

K103N, V106A/I/M, V108I, V179D/F, Y181C/I/V, Y188C/H/L, G190A/S, P225H)

resulted in a decreased virologic response to INTELENCE.

-- For patients in the DUET-1 and -2 studies experiencing virologic

failure on an INTELENCE-containing regimen, the substitutions that

occurred most commonly were V179F, V179I, Y181C, and Y181I which

usually emerged in a background of multiple other NNRTI

resistance-associated substitutions. Other NNRTI resistance-associated

substitutions which emerged in patients on INTELENCE treatment in

< 10 percent of the virologic failure isolates included K101E, K103N,

V106I/M, V108I, Y188L, V189I, G190S/C and R356K.

-- Cross-resistance to delavirdine, efavirenz, and/or nevirapine is

expected after virologic failure with an INTELENCE-containing regimen.

DUET-1 and -2 Tolerability

In the DUET-1 and -2 studies, the most common adverse events (> 10 percent) o
'/>"/>

0

GOOD

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:

FDA Approves INTELENCE(TM) (etravirine) for HIV Combinati...([p -- Significantly greater mean incr...)