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Biotech / Medical : Agouron Pharmaceuticals (AGPH)
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To: Timothy Kross who wrote (3703)2/1/1998 8:12:00 PM
From: JOHN W.   of 6136
 
Abstract 373 / Session 50
Comparison of BID and TID Dosing of VIRACEPTr (Nelfinavir, NFV) in Combination with Stavudine (d4T) and Lamivudine (3TC)

MARGARET JOHNSON* for the European Viracept Clinical Trial Group, ANNKATRIN PETERSEN, JEFF WINSLADE and NEIL CLENDENINN from Agouron Pharmaceuticals, Inc.ÿÿÿ

ÿÿÿ This is a randomized, open- label, two group comparative trial of two nelfinavir dosing regimens, 1250 mg BID vs. 750 mg
TID in combination with standard doses of d4T and 3TC, for a total duration of 48 weeks. Twenty-four sites in Europe are
participating and have enrolled 279 patients from 3/97 8/97. Patients are 3TC naive with less than 6-months of nucleoside antiretroviral
therapy. Mean baseline viral load is approximately 4.80 log copies/ml and the mean baseline CD4+ cell count is 260 cells/mm3.ÿÿÿ
ÿÿÿ A subset of patients (N= 21) participated in pharmacokinetic assessments after approximately 4 weeks of treatment.
Median steady-state values for postdose plasma trough concentration were 0.7 mg/L (C12 for BID) and 1.0 mg/L (C8 for TID);
time-averaged concentration over a dose interval. (Cavg=AUC/tau) was 2.1 vs 1.9 mg/L for BID vs TID respectively. Preliminary viral load
data is available for 81 patients and CD4+ cell counts are available for 107 patients followed for 16 weeks. Eighty-three percent
of 58 subjects on BID dosing and 78% of 23 on TID dosing are below the level of quantification on the Amplicor Monitor assay
(<400 copies/mL). Mean CD4+ cell counts increased 126 vs 123 cells/mm3 in the BID (n=78) vs TID (n=29) groups, respectively. These
data suggests that both treatment regimens are effective in inhibiting the replication of the virus after 16 weeks of treatment.
Additional data will be presented.

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