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1. (WO2010121352) USE OF (HEXENOYL TRANS-3)HGRF(L-44)NH2 AND SIMVASTATIN IN COMBINATION THERAPY

Pub. No.:    WO/2010/121352    International Application No.:    PCT/CA2010/000548
Publication Date: Fri Oct 29 01:59:59 CEST 2010 International Filing Date: Wed Apr 21 01:59:59 CEST 2010
IPC: A61K 38/16
A61K 31/366
C07K 14/60
C07K 17/02
A61K 38/27
Applicants: THERATECHNOLOGIES INC.
MARSOLAIS, Christian
Inventors: MARSOLAIS, Christian
Title: USE OF (HEXENOYL TRANS-3)HGRF(L-44)NH2 AND SIMVASTATIN IN COMBINATION THERAPY
Abstract:
A combination therapy is described comprising the CYP-metabolized compound Simvastatin and the growth hormone releasing factor (GRF) analogue (hexenoyl trans-3)hGRF(l-44)NH2 (tesamorelin), for the treatment of HIV- associated lipodystrophy. Human growth hormone may modulate cytochrome P450 (CYP) enzyme activity. Therefore, the potential impact of tesamorelin on CYP3A activity was investigated by examining its effect on the pharmacokinetics (PK) of simvastatin ( a CYP3A-substrate), a drug that is potentially administered concomitantly with tesamorelin. This study showed that the impact of tesamorelin on CYP3 A activity appears to be minimal. Simvastatin may be co-administered with tesamorelin, without changing the dosing regimen.