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Biotech / Medical : Agouron Pharmaceuticals (AGPH)

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To: per strandberg who wrote (3709)	2/1/1998 9:39:00 PM
From: JOHN W.	of 6136

Abstract 351 / Session 49 The Pharmacokinetics of Nelfinavir Alone and in Combination with Nevirapine. MERRY C.1, BARRY M.G.2, MULCAHY F.M.1*, RYAN M.1, BACK D.J2. 1. St. James's Hospital, Dublin 8, Ireland.ÿ 2. Dept. of Pharmacology & Therapeutics, Liverpool University, UK. Combination therapy with Nevirapine plus Nelfinavir raises clinically important pharmacokinetic issues. Nelfinavir inhibits Cytochrome P450 (CYP3A4) while Nevirapine acts as an inducer. In this study we evaluated the effect of Nevirapine on plasma Nelfinavir levels in 8 HIV positive patients. Pharmacokinetic (PK) studies were performed on patients who had reached steady state Nelfinavir levels on 750mgs 8 hourly. Samples were analysed using HPLC. Repeat PK studies were performed 24 days after the introduction of Nevirapine. Data on the first three patients studied suggests a variable interaction between Nelfinavir and Nevirapine with an average decrease in the AUC of Nelfinavir of 46%. The geometric mean Cmax and AUC0-8h on the first study day were 2.8ng/ml (range 2.22-3.83) and 16.7ng/ml.h (range 13.45-22.88) and on the second day 1.93ng/ml (range 1.10-2.88) and 8.9ng/ml (range 6.63-12.2). Complete data on the cohort will be presented.

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