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Biotech / Medical : Agouron Pharmaceuticals (AGPH)
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To: Timothy Kross who wrote (3703)2/1/1998 9:33:00 PM
From: JOHN W.   of 6136
 
Abstract 352 / Session 49
Saquinavir Pharmacokinetics Alone and in Combination with Nelfinavir in HIV infected Patients.

MERRY C.*1, BARRY M.G.2, MULCAHY F.M.1, BACK D. J2 , 1. St. James Hospital, Dublin 8, Ireland. 2. Dept. of Pharmacology & Therapeutics, Liverpool University, UK.

Combination therapy with Saquinavir plus Nelfinavir is an attractive therapeutic option due to its pharmacokinetic
interaction. In this study we examined the effect of Nelfinavir on plasma Saquinavir levels and steady state plasma Nelfinavir in 6 HIV
positive patients. All 6 patients were at steady state for Saquinavir and had undetectable plasma HIV RNA (Roche Amplicor).
Pharmacokinetic studies using HPLC were performed on Day 1 and Day 3 before and after the addition of Nelfinavir 750mgs 8 hourly to
Saquinavir 600mgs 8 hourly. The geometric mean Cmax and AUC0-8h for Saquinavir on the first day were 253 ng/ml (range <25 to 1200
ng/ml) and 1106 ng/ml.h (range <100 to 3479 ng/ml.h) respectively and on the second study day 1204 ng/ml (range 379 to 2755
ng/ml) and 5472 ng/ml.h (1434 to 12538 ng/ml.h). The mean ratio for Cmax was 4.75 and for AUC0-8h was 4.94. The geometric mean Cmax
and AUC0-8h for Nelfinavir were 5.55ng/ml (range 1.32 to 8.54ng/ml) and 29.3ng/ml (range 6.52 to 48.8 ng/ml.h) respectively.

Nelfinavir increases the oral bioavailability of Saquinavir (hard gel) approximately
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