( gnificant difference (p=0.028) -- ...)New Phase 3 Study Published in The Lancet Evaluates Efficacy and,Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination,Therapy in Treatment-Experienced Adults With HIV,Health

gnificant difference (p=0.028) -- The median change in CD4 cell count from baseline was similar between the PREZISTA/r and lopinavir/r arms (88 cells per cubic millimeter vs. 81 cells per cubic millimeter) Development of resistance also was studied. Findings include: -- 10 percent of patients in the PREZISTA/r arm (n=31) experienced virological failure vs. 22 percent of patients in the lopinavir/r arm (n=65) -- Among patients experiencing virologic failure, 21 percent of patients in the PREZISTA/r arm (n=6 of 28 with resistance data available) developed additional primary PI resistance mutations vs. 36 percent of patients in the lopinavir/r arm (n=20 of 56 with resistance data available), and 14 percent of patients in the PREZISTA/r arm (n=4 of 28) developed primary NRTI resistance mutations vs. 27 percent of patients in the lopinavir/r arm (n=15 of 56)

The majority of adverse events in both arms were mild to moderate in severity, with a low incidence of discontinuation. In the PREZISTA/r arm, the most frequently reported adverse events (greater or equal to 10 percent) regardless of severity were diarrhea (32 percent), nausea (18 percent), nasopharyngitis (12 percent), headache (11 percent), and upper respiratory tract infection (10 percent). In the lopinavir/r arm, the most frequently reported adverse events were diarrhea (42 percent), nausea (21 percent) and nasopharyngitis (11 percent). Grade 2-4 diarrhea occurred in 8 percent of patients taking PREZISTA/r compared with 15 percent of patients taking lopinavir/r. Skin rash (all grades regardless of causality) occurred in 16 percent of patients receiving PREZISTA/r compared with 7 percent of patients receiving lopinavir/r. Most rashes were mild and did not lead to discontinuation. Two patients in the PREZISTA/r arm experienced grade 3-4 rash and 2 patients permanently discontinued PREZISTA/r therapy
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