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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

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

To: per strandberg who wrote (3709)	2/1/1998 9:45:00 PM
From: JOHN W.	Read Replies (2) \| Respond to of 6136

Abstract 387 / Session 50 Can Nelfinavir substitute for other protease inhibitor(s) in persons with plasma HIV- 1 RNA below 500 copies/ml before the substitution? CJ COHEN*1, HELLINGER JA1, STEIN AJ2, GATHE J3, KEISER P4.ÿ 1-CRI New England, MA; 2-CRI So. Florida, FL., 3-Houston TX; 4-Dallas TX. Background: While the goal of HIV combination therapy is maximal durable suppression, persons must be able to tolerate all components of that regimen.Nelfinavir (N), the most recently approved protease inhibitor in the US has a unique schedule, side effect profile, and resistance mutation pattern, persons may choose to switch to nelfinavir. The success when making this switch was the focus of this retrospective chart review. Methodology: We reviewed records from three large clinical practices. Charts were from any individuals switched from a protease containing regimen on which the viral load (VL) was below the limit of quantification before switching to nelfinavir. Patients may have also switched other antivirals at the same time though this was not required. All VL measures after the switch were noted. Results: Data from 39 charts were included: 13 on indinavir [I], median CD4+ÿÿÿ 222 (range 22-498); 26 on ritonavir/saquinavir [IVS] combination, median CD4+ 368 (range 14-1059). After the I containing regimens, 8/12 (66%) were measured and still below detection at week 6 (one had no measure in the window). Afterÿ the R/S regimens, 17/22 (77%) had VL measured and it was below detection at week 6, 14/17 (82%) at week 12. Reasons for switching included: PI related side effect (36%), medication preference (64%). Conclusions: In persons with VL < 500 copies/ml on either I or R/S regimens,persons switching to nelfinavir had continued VL suppression 74% of the time atfirst follow up. These data support that persons switching to nelfinavir who haveVL suppression on another PI should have early VL measures in the first 6 weeksto monitor for the outcome of this switch. A prospective study is required to define the potential success for those switching to nelfinavir.