FDA approves new HIV protease inhibitor, L...( uded two nucleoside reverse transcripta...),Health

• Durable anti-viral response through 48 weeks of therapy in ART-naive patients (<400 copies/mL 66 percent to 69 percent)
• All grade 2-4 drug-related adverse events < 10 percent in ART-nave patients
  Significantly less grade 2-4 drug-related diarrhea than nelfinavir
• All grade 2-4 drug-related adverse events < 13 percent in PI-experienced patients
• Flexible once or twice daily options in ART-nave patients with no food or fluid restrictions
• No ART-naive patients receiving Lexiva/r developed any PI mutations. In PI-experienced patients, the following amprenavir resistance associated mutations were selected either alone or in combination: V32I, M46I/L, I47V, I50V, I54L/M and I84V. The clinical significance of resistance data is currently under evaluation.

"It's important for patients to comply with therapy because current treatment is lifelong," said Jeffrey P. Nadler, M.D., professor of medicine and director of clinical research in infectious diseases, University of South Florida College of Medicine, Tampa. "Patients need something they can tolerate, so that they are able to take the medicines as prescribed. Lexiva fits that picture," he said.

The following results were reported for each of the Phase III trials at 48-weeks:

The NEAT Study

NEAT compared Lexiva with nelfinavir (NFV) in 249 ethnically and gender diverse, ART-nave patients, with advanced HIV disease (45 percent of patients had viral load >100,000 copies/mL, 48 percent had CD4+ cell count <200 cells/mm3, and 20 percent were CDC Class C) at entry. Patients took 1,400mg of Lexiva BID or 1,250mg of NFV BID in combination with abacavir sulfate and lamivudine BID.

• 66 percent of patients taking Lexiva achieved undetectable viral load (<400 copies/mL), compared to 52 percent of patients taking NFV.
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