FDA approves new HIV protease inhibitor, L...( Among patients with high baseline vi...)

FDA approves new HIV protease inhibitor, Lexiva (TM)

Among patients with high baseline viral load (>100,000 copies/mL), 67 percent of 73 patients in the arm containing Lexiva achieved undetectable viral load (<400 copies/mL), compared to 36 percent of 37 patients in the NFV arm.

There was significantly less grade 2-4 drug-related diarrhea in patients receiving Lexiva (5 percent) than in patients receiving NFV (18 percent).

Protease mutations selected at the first failure timepoint with Lexiva (V32I+147V or 154L/M) had limited cross-resistance to other PIs.

The most common adverse events were diarrhea, nausea, vomiting, headache and rash.

The SOLO Study

The SOLO Study reported results of 649 ethnically and gender diverse ART-nave patients, with advanced HIV disease (43 percent of patients had viral load >100,000 copies/mL, 55 percent had CD4+ cell count <200 cells/mm3, and 22 percent were CDC Class C) at entry. Patients in the study took either 1,400mg Lexiva with 200mg ritonavir (Lexiva/r) QD, or 1,250mg NFV BID. Both PIs were administered in combination with abacavir sulfate and lamivudine BID.

69 percent of patients taking Lexiva/r achieved undetectable viral load (<400 copies/mL), compared to 68 percent of patients taking NFV.
Among patients with a high viral load (>100,000 copies/mL) at baseline, 66 percent of 125 patients taking Lexiva/r QD achieved undetectable viral load (<400 copies/mL), compared to 64 percent of 133 patients taking NFV BID.
There was significantly less grade 2-4 drug-related diarrhea in patients receiving Lexiva (10 percent) than in patients receiving NFV (18 percent).
No protease mutations were observed through 48 weeks in the 32 patients who experienced virologic failure with Lexiva/r QD.
There were significantly fewer nucleoside reverse transcriptase inhibitor (NRTI) mutations observed after virologic failure with Lexiva/r QD (4 of 32 patients, or 13 percent) compared with NFV (30 of 54, or
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Contact: Elaine Salewske
esalewske@pcipr.com
312-558-1770
Public Communications Inc.
21-Oct-2003

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FDA approves new HIV protease inhibitor, L...( Among patients with high baseline vi...),Health