A	B	C
1	Main
2		Brand Name	Selzentry
3		Generic Name	maraviroc
4		Indication	Treatment-experienced HIV.
5		Mechanism	CCR-5 inhibitor.
6		Administration	Oral
7		Competition	GSK aplaviroc discontinued due to hepatotoxicity. SGP vicriviroc has resistance issues?. INCY program. Isentress, Fuzeon, Panacos
8		Safety	Cancer, CV and infection concerns. Black box warning regarding hepatotoxicity.
9		PK	Poor efficacy at trough serum levels? Requires tropism testing.
10		Price	$29/day, roughly $10,500/year.
11		Timeline	NDA submitted December 2006. Advisory committee 4/24/2007. Approvable 6/20/2007. Approved 7/2007. Launch mid-9/2007.
12		Clinical Trials
13			MOTIVATE -1, -2 - Treatment-Experienced - Presented at CROI 2007
14			n=1050 randomized to receive OBT with placebo or maraviroc 150mg qd or bid.
15			-1.83 and 1.95 log vs 1.03 for placebo.
16			Liver-related AE common. QT prolongation in PC. CXCR4 tropism shift. Increase in candidiasis & herpes.
17
18
19			Phase III Treatment-Naïve
20			Combination with Combivir.
21			n=500 treatment-naïve.
22
23
24			Phase II Rheumatoid Arthritis
25			n=130